Pfizer

Nervous system symptom reports

Female, 26 - 39 years

Age Reported Symptoms Notes
26 2021-01-01 numbness, tingling Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I ... Read more
Vaccine was administered at 12:15 pm on 12/29/2020. I continued to work the remainder of the day. I began to feel fatigue around 7 pm that afternoon and fell asleep. When I woke up at midnight on 12/30/20 I noticed numbness beginning in my left foot and spreading into my face over a course of 30 minutes. I never noted any muscle weakness, but felt a tingling sensation on the left side of my body. Then I began to experience chills and sweating. I was able to return to sleep around 2 AM. When I woke up at 5:30 the numbness had resolved.
26 2021-01-03 migraine Migraine; Feeling foggy; Malaise; Swollen lymph nodes; Could not lift arm more than a few inches
26 2021-01-03 pain in extremity, numbness On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outsi... Read more
On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.
26 2021-01-03 pain in extremity Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, exp... Read more
Upon immediate injection, reports joint pain on inner left wrist and left thumb. Day 2- present, experiencing increased joint pain on left wrist and thumb as well as swelling at base of thumb and inability to move, pinch, grab, stretch left hand. Occasionally pain spread up left forearm to elbow.
26 2021-01-03 flushing increased (rapid) heartrate at rest, an hour following administration of vaccine. Symptom persisted ... Read more
increased (rapid) heartrate at rest, an hour following administration of vaccine. Symptom persisted for half an hour, followed by flushing of the face and slight nausea.
26 2021-01-04 pain in extremity Arm tenderness; This is a spontaneous report from a non-contactable healthcare professional. A 26-ye... Read more
Arm tenderness; This is a spontaneous report from a non-contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231, expiry date not reported), via an unspecified route of administration on the right arm on 28Dec2020 16:00 at a single dose for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. The patient experienced arm tenderness on 28Dec2020. No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.
26 2021-01-04 numbness, facial paralysis, tingling The night after the covid vaccine, the patient started experiencing left-side facial numbness and ti... Read more
The night after the covid vaccine, the patient started experiencing left-side facial numbness and tingling of the V2 and V3. Patient also started experiencing ear pain. Patient also had uncontrollable drooling and dry eye. The next day, the patient went to work and there the adverse events started worsening. Patient went to the ER and did a full workup. CT scan to rule out stroke and full blood work. As per the neurologist (MD), patient is developing mild Bell's Palsy. No course of treatment was given.
26 2021-01-04 flushing headache, low grade fever,runny nose, loss taste and smell, feels flushed
26 2021-01-04 pain in extremity mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; m... Read more
mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with Ibuprofen; This is a spontaneous report from a contactable healthcare professional. A 26-year-old female patient started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), intramuscular on the left arm on 23Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 11:00, the patient experienced mild left arm soreness for 1 day, mild headache at 24 hrs post vaccine, alleviated with ibuprofen. Clinical outcome of the events was recovered on an unspecified date in Dec2020. No follow-up attempts are possible. No further information is expected.
26 2021-01-05 hot flush, flushing, tenderness -Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flu... Read more
-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs
26 2021-01-05 numbness Numbness in hand Narrative: Numbness in left fingers lasted 10-15 minutes
26 2021-01-05 flushing, difficulty speaking Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began... Read more
Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration
26 2021-01-05 hot flush, tingling Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitat... Read more
Pt states feeling flushed, lightheaded, tingling in hands, chest and feet, and heart racing/palpitations.
26 2021-01-06 pain in extremity 12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- ext... Read more
12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.
26 2021-01-06 tremor I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body a... Read more
I experienced side effects from the COVID vaccine, including notable fatigue, chills/shaking, body aches for approximately 2 days. The third day I woke up without any symptoms.
26 2021-01-06 feeling cold, sensory loss patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms ... Read more
patient received vaccine 0818, in observation area 08:30 reported that she felt cold, sweaty palms and decreased sensation in hands, ate yogurt 2 hours prior to vaccine 08:32 bp: 124/85, o2sat 99%, hr 94, drinking pepsi, ate peanut butter crackers and granola bar 08:40 patient reports palms less sweaty, bp 141/63, hr 90, 1 glucose tablets administered 08:50 glucometer 130, bp 130/65, hr 83 9:10 T 98.0 oral, bp 125/78, hr 83, patient reports hands no longer cold, palms not sweaty, sensation normal in hands 9:22 patient left to go home, states she felt normal
26 2021-01-07 weakness 24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in ... Read more
24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in my injection arm and my armpit lymph nodes were swollen. I treated the pain with Advil and a heating pad. 72 hours after the vaccine I felt faint, dizzy, and nauseous. I began to vomit and have diarrhea that entire night and next morning. I felt very weak and was unable to keep any foods or liquids down. I was unable to walk around. I took Zofran 8mg which helped with the severe nausea and weakness. These symptoms are ongoing.
26 2021-01-07 weakness About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, ... Read more
About ten hours after the injection, started having severe chills, N/V, severe headache, dizziness, fever, severe muscle soreness, active loss of smell and taste. General malaise and weakness.
26 2021-01-07 feeling hot, feeling of body temperature change Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, ... Read more
Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, chills when cold, extreme fatigue and weariness. As of the writing of this form, I am still experiencing some lightheadedness, and this morning, I felt very warm, but I overall feel much better.
26 2021-01-07 pain in extremity Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet an... Read more
Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet and knee area. Patient got CBC and went to PCP. CBC was normal except platelets low-normal 150,000. No itching, swelling, etc. This occurred about 9 days after vaccination. Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine. No other symptoms reported besides sore arm for 2 days.
26 2021-01-07 pain in extremity Rigors, fever, headache and arm soreness
26 2021-01-07 pain in extremity, numbness, migraine Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursd... Read more
Vaccinated in left arm 12/29 ? initial soreness Wed 12/30 -Headache onset; pain 5 (out of 10) Thursday 12/31- some pain/soreness in arms and legs; no HA Friday 1/1- pain worse (7 out of 10); temp 99.8; Sat 1/2 cough in the morning, soreness; in the evening pain worse; cough resolved; Sunday 1/3 extreme pain 10 out of 10; presented to the ED; prescribed Toradol and excedrin Numbness and pain in upper and lower extremities, particularly in R arm; 10 out of 10 pain; 101.0 temperature Monday 1/4 temperature down to 99.5 this am (has been taking Tylenol); still experience significant pain Headache that she describes as migraine worsens with standing up, walking, talking Pain in legs, if stands for more than 10 seconds she experiences extreme pain Denies SOB, wheezing, coughing The ED advised her to take Toradol for 48 hours and contact a PCP for follow up.
26 2021-01-07 numbness mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower ... Read more
mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.
26 2021-01-08 pain in extremity Pain and swelling in left arm and axilla that radiates to her back for 9 hours.
26 2021-01-09 pain in extremity Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sle... Read more
Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache
26 2021-01-09 pain in extremity Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm... Read more
Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.
26 2021-01-10 weakness, tingling Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was n... Read more
Approximately 15 min after vaccination began to experience tingling sensation under tongue. It was not bothersome so I proceeded to go home. At 2:04 pm, approximately 40 minutes after vaccination was driving home and began to experience an elevated HR, shortness of breath/difficulty breathing and throat tightness. Proceeded to pull over to a gas station and felt extremely weak when trying to walk and a tingling sensation all over. Took 25 mg of Benadryl tablets and symptoms began to subside within about 10 minutes or so. Proceeded to continue driving home and had another episode at 2:49 pm, experienced significant shortness of breath and tingling sensation in mouth spread to back of tongue and it felt swollen. I bought liquid Benadryl instead and took ~20 mL. This episode resolved within 10-20 minutes as well and was okay for the rest of the evening.
26 2021-01-10 pain in extremity Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day an... Read more
Extreme soreness in arm that night but especially next day Headache/ borderline migraine next day and continuing for about a week and a half (so far) Mild body aches/ malaise the day after Fatigue next day and for next week and a half (so far) afterwards
26 2021-01-10 weakness, tingling, feeling cold Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; ... Read more
Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.
26 2021-01-10 seizure, tingling, numbness Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after v... Read more
Numbness and tingling bil upper extremities, seizure, temporary paralysis R arm. Started day after vaccine given, was observed overnight in hospital.
26 2021-01-11 night sweats Fevers of 102, chills, night sweats, body aches, headaches, nausea.
26 2021-01-11 tingling Pt reported shortly after receiving her vaccine that she had tingling feeling on the top of her head... Read more
Pt reported shortly after receiving her vaccine that she had tingling feeling on the top of her head, bilateral wrists, mid back, and right lower extremity. This was coming and going and had not happened the last about 10 minutes she was in the clinic.
26 2021-01-11 numbness, tingling Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face n... Read more
Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right side of face numb/tingling NO drooping or asymmetry 2 weeks post vaccine; Right ear feeling blocked 2 weeks post vaccine; This is a spontaneous report from a contactable nurse. A 26-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 at a single dose for covid-19 vaccination. Medical history included migraine. The patient has no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received her most recent COVID-19 vaccine in a hospital. The patient had right sided face numb/tingling with no drooping or asymmetry and right ear feeling blocked 2 weeks post vaccine (30Dec2020). The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment for the adverse event. The adverse event result in emergency room/department or urgent care. The event was considered as non-serious. The outcome of the events was recovering.
26 2021-01-11 pain in extremity Sore arm low grad fever week later, lymph node on arm pit was swollen and tender
26 2021-01-11 pain in extremity Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side ... Read more
Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side arm pit
26 2021-01-11 pain in extremity Sore arm low grade fever week later, lymph node on arm pit was swollen and tender
26 2021-01-11 tingling Tingling to right fingers and palm. No other symptoms, no treatment, resolved.
26 2021-01-11 hot flush chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fat... Read more
chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue
26 2021-01-11 tremor palpitation, redness and tremulous
26 2021-01-12 hot flush Post nasal drip, headaches, chills, hot flashes, and red raised bumps that are raised
26 2021-01-12 migraine Rash, body aches, migraine
26 2021-01-12 flushing, tremor, pain in extremity, one side paralysis Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, swea... Read more
Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.
26 2021-01-12 tremor Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. Thi... Read more
Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching
26 2021-01-12 nerve pain, pain in extremity first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like ner... Read more
first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.
26 2021-01-12 pain in extremity headache, fever, chills and pain in arm
26 2021-01-13 tremor About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - ... Read more
About 16 hours after second dose of the Pfizer COVID-19 vaccination: - Fever of 101-102F - Chills - Body aches - Joint aches - Headache About 40 hours after time of vaccine: - Fainting spells x2 (shakiness, blurry vision, ringing in ears, loss of balance)
26 2021-01-13 feeling hot Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolve... Read more
Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolved by am
26 2021-01-13 flushing, feeling hot Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observa... Read more
Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.
26 2021-01-13 weakness Systemic: shaky, weak, tachycardic, gave O2, pt has heart issues already
26 2021-01-14 pain in extremity, tingling, tremor 12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described a... Read more
12 hours after administration, woken up from sleep by tingling, throbbing in lower legs. Described as a nerve and muscle ache/throb, or "growing pains"/RLS symptoms. Put on compression socks which helped, but still too uncomfortable to sleep. Was able to sleep after taking ibuprofen 800mg and drinking water. 6 hours after the ibuprofen was administered, pain returned in lower legs as well as neck/ears with body temperature swings (cold, teeth chattering to sweating uncontrollably in a few minutes). After 1 hour of trying to sleep but failing, put compression socks back on. Temperature rose to 100-100.2 F, chills causing whole body to shake under multiple blankets. Tingling/muscle pains extremely uncomfortable and unable to rest, took another ibuprofen 800mg and water and was able to sleep. Tingling and muscle pains have continued as soon as ibuprofen wears off and come back more intense each time, most notably in the lower legs and near ears/neck and elbow of arm administered in (similar to "tennis elbow," assumed to be provoked by inflammation, happened with first dose).
26 2021-01-14 tingling Complained of tingling entire left arm. No other symptoms.
26 2021-01-14 flushing, tingling I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart ra... Read more
I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.
26 2021-01-14 tingling Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vacc... Read more
Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.
26 2021-01-14 pain in extremity severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and musc... Read more
severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and muscle; pain in shoulder and muscle; This is a spontaneous report from a contactable other healthcare professional (hcp). A 26-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date not reported), intramuscular on 07Jan2021 08:45 at a single dose in the left arm for COVID-19 immunization. Medical history included allergic to tree nuts and patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medication included tetanus vaccine on 02Jan2021 at a single dose. The patient had no other medications in two weeks. On 10Jan2021, the patient experienced severely sore arm as well as feeling as though patient injured a ligament in the shoulder. The patient was unable to lift arm without pain in shoulder and muscle. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Treatments was not received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events severely sore arm, injured a ligament in the shoulder, unable to lift arm, and pain in shoulder and muscle. Information on the lot/batch number has been requested.
26 2021-01-15 tremor Fatigue, dizziness, confusion, tremors, brain fog, irregular menstrual period
26 2021-01-16 pain in extremity Low grade fever, chills, body aches, headache, arm soreness
26 2021-01-17 tingling Burning when it went in, tingling left arm down to hand, left left foot. Feels like it's gett... Read more
Burning when it went in, tingling left arm down to hand, left left foot. Feels like it's getting worse. Advised to see PCP.
26 2021-01-17 migraine Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; F... Read more
Tachycardia up to 150 resting; Nausea; Vomiting; Diarrhea; Headache; Migraine; Body aches; Chills; Fever up to 102; This is a spontaneous report from a contactable nurse (patient). This 26-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248), intramuscular on 08Jan2021 at 07:45 AM at single dose on right arm for COVID-19 immunisation. Medical history included anxiety and depression. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), diphenhydramine hydrochloride (ZZZQUIL). No other-vaccine-in-four weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EK5730), intramuscular on 22Dec2020 at 08:00 PM on right arm for COVID-19 immunisation. The patient experienced tachycardia up to 150 resting, nausea, vomiting, diarrhea, headache, migraine, body aches, chills and fever up to 102. Symptom onset around 7PM on 08Jan2021 and stopped around 12PM 09Jan2021 except for headache which was still persisting as of 9PM 09Jan2021. No treatment was received for the events. The outcome of headache was not recovered. The outcome of other events was recovered on 09Jan2021 at 12PM. The patient did not have COVID-prior-vaccination. The patient did not have COVID tested post vaccination.; Sender's Comments: The reported tachycardia was probably related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
26 2021-01-18 bell's palsy, facial paralysis, face paralysis Approximately 4 days after my second dose of Pfizer vaccine, I started noticing my left eye being sw... Read more
Approximately 4 days after my second dose of Pfizer vaccine, I started noticing my left eye being swollen and constantly watering. 7 days post vaccine, I started having left sided facial weakness and droop. I was diagnosed with Bell's palsy by my Primary Care Physician today (8 days post vaccine).
26 2021-01-18 feeling cold, hot flush Chills, aches, diarrhea, headache, hot and cold flashes
26 2021-01-18 weakness I woke up at 3:10am and had severe chills and a fever of 102°F. My fever didn?t go down to 99° unt... Read more
I woke up at 3:10am and had severe chills and a fever of 102°F. My fever didn?t go down to 99° until 11 hours later. The following day I was really shaky and dizzy. I had to take off two days from work then went to work on Friday and was weak and exhausted all day.
26 2021-01-18 numbness and pain in extremities, burning sensation New onset peripheral neuropathy evening after shot, felt like a deep burn that started mid shin to t... Read more
New onset peripheral neuropathy evening after shot, felt like a deep burn that started mid shin to toes, not radiculopathy. Constant for 3 days, worse in the evenings. Associated with mild frontal bilateral HA and a few occurrences of fleeting fasciculation of R lip and R paraspinal muscles. Symptoms complete resolved after 1 week.
26 2021-01-18 flushing Put had facial and chest flushing. give po 25mg Benadryl
26 2021-01-18 pain in extremity Shooting pain up L arm, nausea, dizziness, rash, increased BP
26 2021-01-18 flushing The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with dip... Read more
The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with diphenhydramine prior to the 2nd dose of the OVID-19 vaccine. 9 minutes after the vaccination, the patient felt itchy, flushed and received oral dexamethasone. [atient was sent out with oral dexamethasone home.
26 2021-01-18 migraine, weakness, feeling hot generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccin... Read more
generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID. The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.
26 2021-01-19 tenderness, pain in extremity Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm ... Read more
Headache; Fever up to 100.5; Extreme fatigue; Muscle aches; Nausea; Lack of appetite; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; Immediate arm pain - swelling, tender to touch; This is a spontaneous report from a contactable Nurse. A 26-year-old female patient patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246) intramuscular, on 08Jan2021 at 16:00 on left arm at single dose for COVID-19 immunization. Relevant medical history included that patient had a Covid diagnosis on early October. Vaccination history included first dose of BNT162B2 (lot number: EK5730) on 18Dec2020 at 10:00 AM, Intramuscular on Left arm .Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). The patient was not pregnant. On 08Jan2021 at 16:00 the patient experienced Immediate arm pain - swelling, tender to touch. On the same day at 22:00 the patient experienced Fever up to 100.5, extreme fatigue, muscle aches, nausea and lack of appetite. Treatment received included Tylenol. The patient recovered from Immediate arm pain - swelling, tender to touch on an unspecified date, from other reported events, recovered on 10Jan2021.
26 2021-01-19 numbness Hives noted the following morning that were described as red, hot and itchy. Located on chest, head... Read more
Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.
26 2021-01-19 feeling cold I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this ... Read more
I experienced chest pain or discomfort intermittently mid-day and afternoon. It subsided after this point. The night of 1/13/21, I fell asleep but awoke multiple times cold. I experienced the chills through about midnight. The next morning, 1/14/21, I woke up with a headache at about 5:30am. I took a dose of Aleve and the symptoms had subsided by about 6:30am
26 2021-01-19 muscle spasms My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second ... Read more
My hip feels sore and achy, but I only feel slight spasms when I put weight on it.; With the second dose I woke up the next morning feeling very fatigued; dry cough; dizziness/slight dizziness; an aching headache that felt heavy (4/10 pain)/slight headache (2/10 pain); muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; muscle spasms in my hips, knees, shoulders, and jaw (7/10 pain).; This is a spontaneous report from a contactable healthcare professional (patient). This 26-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) on 08Jan2021 at 16:45, in left arm, for COVID-19 immunization. Medical history included GERD, IBS, gastritis, asthma, anxiety/depression. The patient had known allergies to penicillin, cefalexin monohydrate (KEFLEX), lactose. The first dose of BNT162B2 vaccine (lot EH 9899) was given on 18Dec2020 at 16:00, in left arm and the patient experienced a sore throat for 3 hours, mild difficulty breathing, mild fever (99.1), fatigue and throbbing headache (6/10 pain). No other vaccine was given in 4 weeks. Concomitant medications included albuterol, pantoprazole, fluoxetine, cholestyramine. After the second dose of vaccine, the patient woke up on 09Jan2021 at 06:30 feeling very fatigued with a dry cough, dizziness, an aching headache that felt heavy (4/10 pain). Later in the day she started having muscle spasms in her hips, knees, shoulders and jaw (7/10 pain). These spasms felt like someone was stabbing her with an electric knife. Over the day the spasms settled into her right hip and knee. Paracetamol (TYLENOL) helped managing the pain and sleep helped the pain getting better. On 10Jan2021 the patient woke up with a slight headache (2/10 pain) and slight dizziness. Her hip felt sore and achy, but she only felt slight spasms when she put weight on it. The events were resolving at the time of report.
26 2021-01-19 pain in extremity sore arm for a day
26 2021-01-20 tingling, numbness Numbness and tingling of bilateral feet and lower legs started about 30 minutes after receiving vacc... Read more
Numbness and tingling of bilateral feet and lower legs started about 30 minutes after receiving vaccine. Numbness and tingling has been continuous for 30 hours and counting. Was told by nurse practitioner that this could be the start of Guillain-Barré syndrome.
26 2021-01-20 weakness Pfizer Covid Vaccine; 26 y.o. female who presents after feeling weak and dizzy after COVID vaccinat... Read more
Pfizer Covid Vaccine; 26 y.o. female who presents after feeling weak and dizzy after COVID vaccination. Patient received the vaccination at 1230 and is still symptomatic. There is no sign of anaphylaxis. Obtained orthostatics at bedside and she is not orthostatic. Patient appears very anxious. Will give patient juice and crackers as well as obtain a glucose. Gave the option to obtain labs however she declines at this time. Patient was given 216 oz bottles of water and a 12 oz bottle of grape juice and a muffin and also saltines. Patient is now stable for discharge
26 2021-01-20 tingling Systemic: hyperventillating, tachycardia, tingling in fingers
26 2021-01-20 feeling cold, migraine The first side effect appeared around 8:30 pm. I felt extremely cold and got chills. I put an additi... Read more
The first side effect appeared around 8:30 pm. I felt extremely cold and got chills. I put an additional sweater on but the chills increases. I developed a fever by 10 pm. My entire body started shivering by 11:30 pm and I was feeling extremely cold. Additionally, I had extreme body and joint pain. The joint pain were especially in me knees, elbows, and my back. I felt sick to my stomach but did not vomit. The next day (Jan 20) I still had extreme body and joint pain, a strong migraine, fever, and felt very fatigue.
26 2021-01-21 tingling, numbness, bell's palsy 26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states sh... Read more
26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay.
26 2021-01-21 cold sweat, feeling hot 3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous s... Read more
3 hours following vaccine: nausea, dizziness, and irritability 6 hours following vaccine: previous symptoms + headache (5 out of 10) and cold sweats 8 hours following vaccine: previous symptoms + widespread body aches (6 out of 10) Restless sleep punctuated by waking up with cold sweats or overheating. 24 hours following vaccine: previous symptoms persist. Headache and body aches have worsened in severity. Unable to work for the morning but was able to go in the afternoon for a short time period. Lower body aches are particularly severe. Fatigue is noticeable. Mental health conditions have worsened but that may be due to lack of sleep. 30 hours following the vaccine: chills, nausea, and dizziness have dissipated completely. They were slowly improving throughout the day. Body aches and headache still severe but lessened with marijuana use. 48 hours following the vaccine: all symptom seemed to have subsided during the night. Sleep was much better quality. Only remaining symptom is an ache on the right side of my chest towards my ribs.
26 2021-01-21 numbness, tingling, face paralysis First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated ... Read more
First, flu-like symptoms (body aches, chills, fever, fatigue), then progressive tingling associated with numbness and weakness of the Left Arm, Left Leg, Left side of the face.
26 2021-01-21 flushing Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 h... Read more
Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.
26 2021-01-21 tingling Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath... Read more
Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath and the feeling of pins and needles which also brought itching and some minor hives with it. The dizziness, nausea, and feeling of fainting went away after about 10 minutes and I had to go to the Emergency Department to take care of the shortness of breath and hive like reaction. I was given some medications and they diagnosed it as a moderate allergic reaction to the vaccine. I was completely fine with the first one.
26 2021-01-22 weakness, flushing, feeling cold, slurring Within minutes of injection dizziness, increased heartrate, increased blood pressure, flushed color,... Read more
Within minutes of injection dizziness, increased heartrate, increased blood pressure, flushed color, feeling of weakness in limbs, and shakey hands and feet. This was treated by reclining with feet up, sitting in a dark room, and drinking cold water while monitoring symptoms. Symptoms resolved within minutes. About an hour after injection lethargy, feeling chilled, in particular hands were very cold, mental fog, and slurred speech. This resolved without intervention within a couple of hours.
26 2021-01-22 pain in extremity side effects after 2nd shot only: - fever x4 days (and counting) - body aches x2 days - chills x2 d... Read more
side effects after 2nd shot only: - fever x4 days (and counting) - body aches x2 days - chills x2 days - sore arm Fever brought down with Tylenol.
26 2021-01-23 pain in extremity Muscle aches, headache, chills, nausea, diarrhea, chills, right arm pain, severe right armpit swelli... Read more
Muscle aches, headache, chills, nausea, diarrhea, chills, right arm pain, severe right armpit swelling (lymph node swelling).
26 2021-01-23 numbness, tingling Probably 5 minutes after receiving the vaccine I started noticing that my right side of my face was ... Read more
Probably 5 minutes after receiving the vaccine I started noticing that my right side of my face was numb. Over time the numbness faded into tingly ness (like after getting a numbing shot at the dentist). It was only the right side of my face and focused around my corner of my mouth and along my jawbone. Over time the feeling subsided probably an hour. While being observed at the clinic they did not notice signs of Bells palsy( facial muscles were still responding symmetrically). Had not sign of allergic reaction at the injection site.
26 2021-01-24 feeling hot As patient was waiting in waiting area approximately 5 minutes after receiving her 1st COVID vaccine... Read more
As patient was waiting in waiting area approximately 5 minutes after receiving her 1st COVID vaccine, pt's friend called pharmacist over as patient felt she was about to faint. She had her eyes closed and said she felt faint. Notified incident command to call for provider. We moved her to an exam room so she could lie down. She said she felt warm and dizzy. Pt breathing heavily. Denied chest pain. Had stomach pain and some nausea. Pt was given water. ER provider arrived about 4:30 and listened to lungs, carotids, talked to patient regarding vasovagal reaction. Pt slowly began to feel better and was talking and laughing. Waited with patient until 4:50, able to stand on own, not dizzy anymore, felt okay to leave.
26 2021-01-24 pain in extremity Diarrhea, fatigue. arm pain. Swollenl lymph nodes in arm pit area.
26 2021-01-24 pain in extremity, tremor Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Se... Read more
Dose Number:1/ Date of start of drug:22Dec2020 / Dose Number:2/ Date of start of drug: 08Jan2021; Serious chills to the point of physical shaking; serious chills to the point of physical shaking; Nausea; Vomiting; Dry heaving; Significant body aches, especially pronounced in lower back region occurred; Significant body aches, especially pronounced in lower back region occurred; Headache; Having sweats; Possible fever (didn't have thermometer to accurately verify this though); My average HR is usually 70's. For about 36 hours, it ran 100-130's; Dehydration; Feeling fatigued/Excessive fatigue; Had some general arm soreness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EJ 1686, unknown expiration), intramuscular in right arm on 08Jan2021 at 13:30 at a single dose for COVID-19 immunization in a hospital. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ 1685, unknown expiration) via intramuscular in right arm on 22Dec2020 at 12:30 PM for COVID-19 immunization in a hospital. Concomitant medications included ibuprofen (MOTRIN) as needed and unspecified birth control. The patient has no known allergies. The patient started feeling fatigued about 1900 hours (07:00 PM) on 08Jan2021 and only had some general arm soreness. She woke up on 09Jan2021, with serious chills to the point of physical shaking; nausea started soon after and around 0300, began vomiting and dry heaving. The patient also experienced significant body aches, especially pronounced in lower back region occurred. Headache also present at this time (09Jan2021). She began having sweats and possible fever (didn't have thermometer to accurately verify this though). The patient's average HR is usually 70s. For about 36 hours (09Jan2021), it ran 100-130s. Vomiting episodes continued and for all of 09Jan2021, the patient did absolutely nothing. The patient described her body ached like it had been beaten by a baseball bat. On 10Jan2021, her HR at rest back in 70s, but with minimal exertion, will go to 110-120s. She had to call out of work from 11Jan2021 and 12Jan2021 due to continued nausea, dehydration and excessive fatigue. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior to vaccination and was not tested for COVID post vaccination. The patient's symptoms still persisting at the time she is reporting this event. The patient did not receive treatment for the events. The outcome of the event "having sweats" was unknown, while the patient is recovering for the remaining events.; Sender's Comments: The reported serious chill was likely related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and known safety profile of this product.
26 2021-01-24 night sweats Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Feve... Read more
Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; Fever, chills, night sweats, fatigue, headache; This is a spontaneous report from a contactable physician (patient). A 26-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), intramuscular (vaccine location: Left arm) on 11Jan2021 09:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had no medical history. The patient was not pregnant. The patient had no known allergies. The patient's had no concomitant medications. There had been no other vaccine in four weeks. There were no other medications in two weeks. The patient had no prior covid vaccination. The patient experienced fever, chills, night sweats, fatigue, and headache on 11Jan2021 22:00. The patient has not been tested for covid post vaccination. No treatment was provided. The outcome of the events was not recovered. Information on the Batch/Lot number has been requested.
26 2021-01-24 nerve pain Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (p... Read more
Nerve pain from right upper arm to fingers; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the second single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) at 11:00AM 12Jan2021 at right arm for COVID-19 immunisation. The first dose was received on 23Dec2020 10:30 AM at right arm. The patient had no medical history, no known allergies and had no Covid-19 before vaccination. The patient had not received other medications in two weeks and no vaccine received in four weeks. At 11:15 AM after the second dose, the patient experienced nerve pain from right upper arm to fingers. Pain was with usage of hand and fingers. Patient had not received treatment for the event. The patient had not tested after vaccination. The event was resolving at the time of reporting. The reporter considered that the event was non-serious. No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
26 2021-01-24 migraine, feeling cold, weakness Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got... Read more
Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.
26 2021-01-25 pain in extremity Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced ... Read more
Approximately 12 hours after the administration of the second COVID19 Pfizer vaccine, I experienced chills and myalgia through the night. I did not improve when I woke up on 01/25. The chills and myalgia worsened and were complicated by vomiting without blood. I called off sick from work and took 3 Aleve tablets. I went back to sleep with improvement in symptoms approximately 6 hours later, with only mild myalgias and a very sore L. arm. Symptoms completely resolved by the morning of 01/26.
26 2021-01-25 hot flush Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report ... Read more
Fever; cold chills; Hot flashes; Nausea; Headache; increase body pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), intramuscularly on the left arm on 04Jan2021 11:00 at a single dose for COVID-19 immunization. Medical history included liver failure, mononucleosis, gallbladder disease, mitral regurgitation of the heart and fibromyalgia; patient had no known allergies. Concomitant medications were not reported. Patient did not have COVID prior vaccination, no other vaccine was given in four weeks prior and patient did not receive other medications within two weeks of the vaccine. The vaccine was given at a nursing home/senior living facility. On 04Jan2021, the patient experienced fever, cold chills, hot flashes, nausea, headache and increased body pain. Moderate side effects were also reported from 05Jan2021 to 09Jan2021. No treatment was given for the events. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on 04Jan2021 and saliva swab test for COVID: pending result on 11Jan2021. Outcome of the events was recovering. Information on the lot/ batch number has been requested.
26 2021-01-25 migraine G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness ... Read more
G2P0, 5w5d; The patient is calling with vaginal bleeding in pregnancy. Calling with c/o dizziness with headache; Has a history of migraines; States she has subclinical hypothyroidism. Has tried Tylenol 500 mg for headache that worked for a little while; She denies vomiting, but does have nausea; Will try to increase water and protein intake; Will let us know if she gets worse/vision changes and will check in with PCP as they wanted to do a VV if dizziness got worse. Bleeding continued into following day. Documented as likely / threatened miscarriage.
26 2021-01-25 cold extremities Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted. Mild anx... Read more
Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted. Mild anxiety. 25 mg Benadryl po administered. Returned to work at 10:25 am. No reaction to first dose reported.
26 2021-01-26 flushing After receiving the second dose of the covid 19 vaccine, as I was walking to the elevator, my vision... Read more
After receiving the second dose of the covid 19 vaccine, as I was walking to the elevator, my vision started to become blurred and I began to see stars. I walked over to a nearby chair and as I sat down it felt as if my throat was closing. I began sweating profusely and my whole body was flushed. My heart rate was tachycardic and my blood pressure was hypertensive when checked in the ED. When I got to the ED, my vitals were obtained like I described but my heart rate had slowed down by time I got there. A nurse passing by explained that my heart was tachycardia when he assessed me in the chair. The ED did an EKG of my heart that determined my heart rate was normal sinus rhythm in the 70s. They observed me for roughly an hour and let me go home. My discharge papers explain I had a vagal response.
26 2021-01-26 migraine, pain in extremity I had a very sore arm which is normal, however the day after I received the vaccine I was extremely ... Read more
I had a very sore arm which is normal, however the day after I received the vaccine I was extremely nauseous and I threw up 5x at 7:30 AM. I had a migraine the rest of the day and was extremely tired, sleeping a total of 19 hours.
26 2021-01-26 pain in extremity Sore arm day off and for 48 hours following, severe abdominal pain approx 36 hours after injection
26 2021-01-26 numbness Symptoms from the Pfizer vaccine has been numb like feeling in the face, arms, legs, and hands. Thes... Read more
Symptoms from the Pfizer vaccine has been numb like feeling in the face, arms, legs, and hands. These symtoms arised Saturday Jan. 23, 2021 (a day after vaccine). Within the next couple of days, symtoms were still present, and presented more frequently throughout the days. Occuring more than 4 times a day.
26 2021-01-26 weakness syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report ... Read more
syncope; Fever; Joint pain; Weakness; Dizziness; Tachycardia; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EL3302 via an unspecified route of administration in left arm, on 12Jan2021 17:00 at single dose for covid-19 immunisation. Previously the patient received the first dose of BNT162B2 on 22Dec2020 at 17:00, lot number EJ1685, in left arm, for covid-19 immunisation. The vaccine was administered at Hospital Facility. No other vaccine was administered in four weeks. No COVID prior vaccination. COVID was not tested post vaccination. No known allergies. Medical history included asthma and postural orthostatic tachycardia syndrome, from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 12Jan2021 the patient experienced syncope, fever, joint pain, weakness, dizziness, tachycardia, fatigue. The events required Physician Office visit. The patient was not treated for the events. The outcome of the events was resolving.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported syncope cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-01-27 pain in extremity Arm soreness that evening and the next morning. Later in the afternoon the next day, my other arm fe... Read more
Arm soreness that evening and the next morning. Later in the afternoon the next day, my other arm felt sore and was aching. 2 days later, I developed a sore throat and general malaise.
26 2021-01-27 weakness Body aches, chills, weakness
26 2021-01-27 inability to speak, feeling hot Immediately after vaccine administration, Patient reported feeling warm and requested for a chair to... Read more
Immediately after vaccine administration, Patient reported feeling warm and requested for a chair to elevate her legs. Patient was provided with a chair and elevated her legs with assistance. While elevating legs, patient began leaning to the side and sliding down in the chair. RN held patient to prevent a fall and called for help. We tried communicating with patient but she only produced humming sounds. Approximately 10 seconds later patient verbalized her name upon questioning. Patient reported later that she "blacked out" while her eyes were open. Patient verbalized that she has a history of sweating and vaso-vagal response to blood draws and vaccine administrations.
26 2021-01-27 weakness Pfizer-BioNTech COVID-19 Vaccine 17 hours post-vaccine: a brief moment of dizziness before waking a... Read more
Pfizer-BioNTech COVID-19 Vaccine 17 hours post-vaccine: a brief moment of dizziness before waking and weakness upon waking but subsiding immediately. Upon waking: left sided neck pain, and left sided chest pain aggravated only by extending left arm forward. 24 hours post-vaccine: fatigue and brain foggyness 30 hours post-vaccine: aforementioned joint pain relieves 48 hours post-vaccine: relief of most symptoms
26 2021-01-27 tingling, numbness anxiety/possible panic attack, left arm numbness/tingling, patient encouraged to go to ER for furthe... Read more
anxiety/possible panic attack, left arm numbness/tingling, patient encouraged to go to ER for further eval, facility staff took her to ER (next door to facility).
26 2021-01-27 weakness chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report fro... Read more
chills; body aches; fever up to 103.8; headache; weakness; malaise; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246) on her left arm, via an unspecified route of administration on 13Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included Asthma and GERD. Concomitant medication included baclofen, buspirone hydrochloride (BUSPAR), paracetamol (TYLENOL). The patient previously took protonix, reglan and ambien; experienced allergies with all. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Dec2020 (first dose). The patient experienced chills, body aches, fever up to 103.8, headache, weakness and malaise; all on 13Jan2021 23:00. No treatment has been received for the events. The outcome of the events was not recovered.
26 2021-01-27 pain in extremity, feeling cold, hot flush severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib... Read more
severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.
26 2021-01-28 discomfort Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection si... Read more
Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)
26 2021-01-28 hot flush Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nur... Read more
Chills; Fever; Hot flashes; Body aches; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiration: 30Apr2021), via injection in left upper arm on 13Jan2021 at 15:00 at a single dose for vaccination. Medical history and concomitant medication reported as none. No family medical history. The patient received her first dose of COVID-19 vaccine via injection to left upper arm on 23Dec2020 at around 1:00pm-2:00pm (Lot: EK5730, Expiry: 31Mar2021, NDC: 59267-1000-2). The patient received her second dose of COVID-19 vaccine on 13Jan2021 in a public health department. She called to report the side effects she experienced since about 06:30 AM on 14Jan2021 which includes chills, fever, hot flashes, body aches, and having a lot of fatigue. She was sent home from work on 14Jan2021 related to the reported adverse events. Chills continued through most of the night from 14Jan2021 to 15Jan2021. On 14Jan2021, she had fever of 102 degrees Fahrenheit that was ongoing throughout most of days. The patient is now feeling fine, all events have improved. She used ice packs for the adverse events and had taken Tylenol 2 rounds of 500mg strength products for total of about 2000mg throughout 14Jan2021 to 15Jan2021. The patient confirmed that there were no concomitant products or other medical conditions to report and has no existing medical condition. She verified that she has had no testing/investigations/lab work/imaging/diagnostic work done relative to the report. No additional vaccines administered on same date of the vaccine. The patient did not require emergency room/physician's office visit. The patient has no prior vaccinations within 4 weeks. The patient did not have adverse event prior vaccinations. No relevant test done. The patient was recovering from the events. The events chills, fever, hot flashes, body aches, fatigue were assessed as related by primary source reporter.
26 2021-01-28 feeling cold Feeling cold in the afternoon 1/28/2021. 101 fever on 1/29/2021.
26 2021-01-28 cold sweat Had a cold sweat; Rapid heartrate; Went to ER on Jan 2 - decreased magnesium; IV therapy - magnesium... Read more
Had a cold sweat; Rapid heartrate; Went to ER on Jan 2 - decreased magnesium; IV therapy - magnesium infusion (January 2st) - ER - Put me on a magnesium supplement; the symptoms resolved a few days later; Saw Dr on January 5th After 2nd dose of - had rapid heartrate for second dose but it was only periodically for two days and I didn't seek medical care
26 2021-01-28 pain in extremity Tachycardia first 10 minutes, soreness in arm for 3 days and fatigue following day.
26 2021-01-29 tingling, facial pain, numbness I received Botox injections on 1/21/21 to both jaw muscles. On the evening of 1/29/21, the left side... Read more
I received Botox injections on 1/21/21 to both jaw muscles. On the evening of 1/29/21, the left side of my face became swollen and felt tingly, numb, and painful. My lips also became swollen when I woke up the morning of 1/30/21.
26 2021-01-29 feeling hot Pfizer COVID- 19 Vaccine Pt received Pfizer COVID vaccine lot #EL3249. Pt sat for about 10 minutes, ... Read more
Pfizer COVID- 19 Vaccine Pt received Pfizer COVID vaccine lot #EL3249. Pt sat for about 10 minutes, arm became itchy, gave diphenhydramine x 1 dose. Pt continued to sit for assessment for another 15 min. Pt stated she felt hot, but is typical for her to feel warm. No chest pain, SOB, blurred vision. Pt cleared to leave facility.
26 2021-01-30 pain in extremity Arm pain, left leg pain, back pain, neck pain, shooting pain on side, chest pain when breathing, fev... Read more
Arm pain, left leg pain, back pain, neck pain, shooting pain on side, chest pain when breathing, fever, headache
26 2021-01-31 pain in extremity Body aches Arm Soreness Headache Stuffiness/Congestion
26 2021-01-31 pain in extremity Fever; chills; headache; myalgia; fatigue; sore arm; This is a spontaneous report from a Non-contact... Read more
Fever; chills; headache; myalgia; fatigue; sore arm; This is a spontaneous report from a Non-contactable Consumer (Patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at Left arm on 17Jan2021 14:00 at single dose for covid-19 immunization. Patient was not pregnant. Medical history included COVID-19 prior vaccination. The COVID-19 vaccine was administered at Hospital. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's received the first dose of BNT162B2 on 26Dec2020 at left arm for covid-19 immunization. The patient experienced Fever, chills, headache, myalgia, fatigue, sore arm on 17Jan2021 23:00. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 17Jan2021. No treatment received for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
26 2021-01-31 tremor I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection... Read more
I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection site right after it was administered. I then experienced severe chills in the evening, starting at about 7pm. The next morning I woke up fatigued and alternated between sweating and having the chills and shaking.
26 2021-01-31 pain in extremity Slight body aches the day after, getting more prominent by 3:00 and worse in the evening. Pain was b... Read more
Slight body aches the day after, getting more prominent by 3:00 and worse in the evening. Pain was both widespread and often sharp. Bad continual leg pain late evening and bedtime. Was able to fall asleep without too much trouble and pain was gone by morning. Did not take Advil or other pain relief medication.
26 2021-02-01 discomfort Got second dose COVID-19 vaccine 1/29/2021, and it looked like it was given very high and she immedi... Read more
Got second dose COVID-19 vaccine 1/29/2021, and it looked like it was given very high and she immediately had pain and discomfort. 2 hours later she had excruciating pain in her shoulder and had difficulty moving the shoulder. She is taking ibuprofen and it better. She still has pain and has occasionally shooting pains. She can move it normally now however and began taking ibuprofen prn
26 2021-02-01 weakness Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, f... Read more
Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, feeling unwell, fatigue.
26 2021-02-01 pain in extremity sore arm; joint pain that started in the left elbow and moved down to the wrist/hand and eventually ... Read more
sore arm; joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pai; body aches all over; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0140, expiration date was not reported), intramuscular in left arm on 18Dec2020 12:00 at a single dose for COVID-19 immunization. Medical history included headaches of an unknown origin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not pregnant. She did no receive any other vaccine four weeks prior covid vaccine. She did not have covid prior to vaccination. She was not tested for covid post vaccination. She had no known allergies. The patient reported adverse events for the first shot: Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain; and body aches all over for the next 2 days. The events' onset was on 18Dec2020 at 07:00 PM. Outcome recovered for events 'Sore arm, joint pain that started in the left elbow and moved down to the wrist/hand and eventually joint pain' was recovered in Dec2020, while body aches all over was recovered on 20Dec2020.No treatment received for the events.
26 2021-02-02 feeling hot, tremor, pain in extremity About 2 minutes after injection, I had a sudden rush of warmth throughout my body starting in my abd... Read more
About 2 minutes after injection, I had a sudden rush of warmth throughout my body starting in my abdomen then causing my pulse to feel like it was pounding out of my neck. Got light headed. EMS came and my blood pressure raised to 155/95 and my pulse was up in the 150s and I was shaking. Started to go down but felt crappy for over 2 hours. Happened again 30seconds after the second injection. Pulse up to almost 160. 02 stats stayed normal. Post first injection had sore arm and lots of fatigue and brain fog. Following the second injection 12 hours post started having nausea, and diarrhea. Continued to have joint pain, muscle aches, headaches for days, and my lymph nodes swelled up and were extremely painful.
26 2021-02-02 feeling hot Employee got 2nd dose of pfizer vaccine on 1/12/21 and on 1/13/21 she started having tachycardia res... Read more
Employee got 2nd dose of pfizer vaccine on 1/12/21 and on 1/13/21 she started having tachycardia resting 120, walking 150. she did not have this at the time of her first dose. She also feels warm, chills and fatigue but those are improving. She was urged to go to urgent care to get evaluated.
26 2021-02-02 tingling I am a pharmacist for pharmacy and received my first dose of Pfizer Covid-19 vaccine while at work b... Read more
I am a pharmacist for pharmacy and received my first dose of Pfizer Covid-19 vaccine while at work by another pharmacist. Vaccine given around 2:15 PM on 2/2/21 Less than 5 minutes after vaccine - arm tingling at site of injection, arm tingling spread from injection site to fingers, tingling and pins/needles traveled through underarm area and moved across left side of chest, slight chest pain on left side, whole body started tingling, dizziness, racing heart. While experiencing all of these symptoms, I sat on the ground, took two tablets of 25mg Benadryl, drank water, and tried to breath steady to make dizziness go away. Working in this healthcare setting, I was aware I was having an adverse reaction to the vaccine and was prepared with an epi-pen in case of any severe anaphylaxis shock - I did NOT have to use the epi-pen. Less than 15 minutes after vaccine - the chest pain, arm pins/needles stopped, I felt lightheaded still, another co-worker checked my blood pressure which had risen to 178/120 and pulse of 120. About 1 hour after vaccine - still felt light headed, blood pressure still elevated at 158/107, pulse of 107. Around 5:45 PM - After consulting personal friend physicians, I was instructed to go to ER and have an EKG of my heart since my blood pressure and pulse had spiked so high and suddenly. I was able to find coverage at work so that I could leave my shift and get a ride to the emergency room. After 6 PM (admitted into ER) - upon admission blood pressure of 176/117 and pulse of 113
26 2021-02-02 pain in extremity, weakness Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for... Read more
Sore arm after injection. I could bearly move it. Fever chills, weakness headache and body pains for 24 hours. I did not seek treatment but I will be letting my OBGYN know at the next appointment.
26 2021-02-03 tremor Headache; severe chills; severe shivering/shakes; This is a spontaneous report from a contactable he... Read more
Headache; severe chills; severe shivering/shakes; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9261), intramuscularly in the left arm, on 21Jan2021 10:30 (at the age of 26-years-old) at a single dose for COVID-19 immunization. Medical history included latex allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included ethinylestradiol, etynodiol diacetate (KELNOR) taken as a contraceptive and fexofenadine hydrochloride (ALLEGRA). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL0142), intramuscularly in the left arm, on 31Dec2020 at 17:00 (at the age of 26-years-old) for COVID-19 immunization. The patient experienced headache, severe chills, and severe shivering/shakes on 21Jan2021 at 21:00. The events were reported as non-serious. The clinical course was reported as follows: Less than 12 hours after getting vaccinated, the patient experienced headache, severe chills, severe shivering/shakes that didn't stop. Being under blankets didn't help but using heating pad helped a lot. The shaking stopped the next morning, but patient still had a bit of chills and headache the next day. Therapeutic measures were taken as a result of the severe chills and severe shivering/shakes as aforementioned. The patient did not receive any treatment for headache as reported. The clinical outcome of headache and chill was recovering and of severe shivering/shakes was recovered on 22Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
26 2021-02-03 hot flush Hot flashes; chills; This is a spontaneous report received from a non-contactable Nurse. A 26-year... Read more
Hot flashes; chills; This is a spontaneous report received from a non-contactable Nurse. A 26-year-old female received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231 and Expiration date was unspecified) on 30Dec2020 14:00 as single dose, (at 26 years of age), intramuscular left arm for COVID-19 immunisation. Medical history included allergic to shellfish. Concomitant medication was none. The Patient is not pregnant. The patient did not have Covid prior to vaccination. The patient was not tested post vaccination for Covid. No other vaccine was taken within four weeks. The patient did not have treatment. The patient experienced Hot flashes and chills 24hrs after receiving vaccine (31Dec2020 16:00). Outcome of event Hot flashes was recovered and chills was recovered. No follow-up attempts are possible. No further information expected.
26 2021-02-03 numbness, tingling Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and low... Read more
Numbness and tingling in both feet and lower extremities; Numbness and tingling in both feet and lower extremities; This is a spontaneous report from a contactable Registered nurse reporting for herself. A 26-years-old female patient received the first dose BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3302, via an unspecified route of administration in right arm on 19Jan2021 at 17:30, at 26 years of age, at single dose for COVID-19 immunization as she was a front line worker. The vaccine was administered at the facility where the patient works. The patient had no relevant medical history and no concomitant medications. On 19Jan2021, about 20 minutes after receiving the vaccine dose (also reported at 18:00) she started having nonstop numbness and tingling in both feet and lower extremities, which has been going on for 46 hours straight. The events were assessed as medically significant, although a visit to emergency room or physician office was not required. The nurse reported that a doctor mentioned Guillain-Barre Syndrome which can lead to progressive muscle weakness and damaged nerves and she is severely concerned, although she has no health history. At the time of the report the reported events had not recovered yet. The reporter assessed the event related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (Method of assessment: Global Introspection).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-02-03 numbness, tingling Patient presented to emergency department at Hospital on 2/03/21 with chief complaint of numbness an... Read more
Patient presented to emergency department at Hospital on 2/03/21 with chief complaint of numbness and tingling over entire left side of body with pain level 9 out of 10. Patient reported that she received first dose of COVID vaccine on 1/25/21. On 1/31/21 numbness began in left lower extremity and progressed to left upper extremity over course of several days. Patient was afebrile, alert and ortiented. Circulation, range of motion and sensation intact. Lumbar puncture performed and appeared normal. Fentanyl 50mg IVP, Zofran 4mg IVP administerd and symptoms improved. Patient discharged home per doctor. Prescription provided for gabapentin 300mg 3 times daily. Follow up with PCP in 2-3 days recommended
26 2021-02-03 feeling cold reported nausea, feeling chilled, lightheaded
26 2021-02-04 pain in extremity Left side Swollen Lymph nodes was reported as worsned.; Left Forearm hurting and swelling; forearm h... Read more
Left side Swollen Lymph nodes was reported as worsned.; Left Forearm hurting and swelling; forearm hurts super bad; the lymph nodes were really tender, she would push it and it would hurt; lymph nodes on her arms got swollen to softball size/ Left side Swollen Lymph nodes/ the lymph nodes getting bigger; This is a spontaneous report from a contactable consumer reporting for herself. A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 19Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. Concomitant medication included etonogestrel (NEXPLANON) for contraceptive implant. The patient received the first dose of BNT162B2 on 29Dec2020. The patient reported a side effect from receiving the vaccine, lymph nodes on her arms got swollen to "softball size" since 19Jan2021 when she received the second dose of the vaccine and wants to know if this was normal. She understands that the arm was going to hurt, but she was noticing that her forearm hurts super bad and it a bit swollen, just on the side of the forearm its swollen, but under that arm her lymph nodes are swollen, she can barely pick up the arm and it just hurts on 20Jan2021. She noticed yesterday (19Jan2021), the lymph nodes were really tender, she would push it and it would hurt. Then when she got home from work, she lifted the arm to look at it, and she could see the swollen lymph nodes, the longer she kept the arm up, she could see the lymph nodes getting bigger. She wants to know how long this will last. She was talking to her mom and she was freaking out saying that people are dying from covid and the swollen lymph nodes, and that's why she has called today. She also stated that her left side swollen lymph nodes was worsened on an unspecified date. The outcome of the event swollen lymph nodes was not recovered, left forearm hurting and swelling and forearm hurts super bad was recovering while other events were unknown. Information on the Lot/Batch number has been requested.
26 2021-02-04 pain in extremity Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature... Read more
Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature of 99.7
26 2021-02-05 tingling The vaccine was inadequately administered, too deep and too high, into the shoulder bursa. The patie... Read more
The vaccine was inadequately administered, too deep and too high, into the shoulder bursa. The patient developed sharp pain soon after which persisted for two days. Soon after she started with neurological symptoms including increased sweating in the affected arm, pain in the branchial plexus region, including arm and forearm, paresthesias in arm, forearm, and fingers, sensation of scapula being dislocated, and tightening sensation in the lateral aspect of the chest. Symptoms are worsening every day. There is a high suspicion that she is developing Parsonage-Turner syndrome.
26 2021-02-06 pain in extremity Sharp left arm pain from fingertips to neck. Most significant pain in medial arm above elbow with ra... Read more
Sharp left arm pain from fingertips to neck. Most significant pain in medial arm above elbow with radiating pain to pinky and ring finger to the shoulder and neck. Pain lasted 5+ days (pain worsened until day 3 and began to diminish on day 4). Also experienced body aches and tiredness on day after vaccine was administered.
26 2021-02-07 tenderness Late Saturday (02/06/2021) night /early Sunday (02/07/2021) morning I noticed a lump on my chest nea... Read more
Late Saturday (02/06/2021) night /early Sunday (02/07/2021) morning I noticed a lump on my chest near my left collar bone (received both doses in my left arm). It is noticeably sore and tender to touch
26 2021-02-07 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA -increasingly sore arm starting about three hours after injecti... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA -increasingly sore arm starting about three hours after injection -fatigue, body aches, headaches starting around 10pm the night of the injection
26 2021-02-07 feeling cold, migraine, inability to speak mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of... Read more
mental confusion; inability to speak/tried to say things and it was a jumbled, meaningless string of words; felt very cold; tingling around the mouth; aura like a bad migraine; bright spotty vision in the peripheral right field; bright spotty vision in the peripheral right field; thought she was having a stroke; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; EKG showed peaked T waves, common with dehydration and high potassium; likely a severe migraine; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EK9231, expiration date was unknown), intramuscularly on the left arm on 30Dec2020 at 14:45 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included COVID-19, which was diagnosed prior to vaccination and migraines (before). The patient had no allergies to medications, food, or other products. Concomitant medication included melatonin. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020 at 15:45 or 1 hour after the vaccine injection, the patient had an aura like a bad migraine and she had bright spotty vision in the peripheral right field for 15-20 minutes; the patient has had migraines before, but they're not common for her. Two hours after the vaccine, on 30Dec2020 at 16:45, the patient had mental confusion and an inability to speak; she tried to say things to her husband and it was a jumbled, meaningless string of words. She also felt very cold and she had tingling around the mouth. Her husband thought she was having a stroke and called 911 on 30Dec2020. All her vitals were stable, and within 10 minutes she could speak again. On 30Dec2020, the patient's electrocardiogram (EKG) showed peaked T waves, common with dehydration and high potassium. She was encouraged to go to the emergency room (ER). Instead of taking the ambulance, she drove herself several hours later. The patient wanted someone to tell her it wasn't a stroke. After a brief neurological exam on 30Dec2020, the doctor said it was likely a severe migraine and wrote the reason for her visit as a vaccine reaction. This took place in the late evening to early morning, and she missed one day of work. The events did result in an emergency room/department or urgent care visit. The reporter assessed the events as non-serious. The patient did not receive any treatment for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient recovered from all the events on 31Dec2020.; Sender's Comments: Based on the close temporal relationship, the association between the event stroke with BNt162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-02-08 weakness 1st dose vaccine 1/21/21; developed nausea, weakness, vomiting, diarrhea, and chills on 2/4/21; seen... Read more
1st dose vaccine 1/21/21; developed nausea, weakness, vomiting, diarrhea, and chills on 2/4/21; seen at ICC 2/5/21.
26 2021-02-09 migraine Complex Migraine and triggered trigeminal neuralgia event.; Complex Migraine and triggered trigemina... Read more
Complex Migraine and triggered trigeminal neuralgia event.; Complex Migraine and triggered trigeminal neuralgia event.; Complex Migraine and triggered trigeminal neuralgia event.; This is a spontaneous report from a contactable other healthcare professional. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el8982; expiry date: unknown) intramuscular in the right arm, on 22Jan2021 at 11:15, at a single dose, for COVID-19 immunisation. Medical history included ongoing trigeminal neuralgia and polycystic ovaries (PCOS). The patient had no known allergies. Concomitant medication included gabapentin. The previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ek9231) intramuscular in the left arm, on 31Dec2020 at 10:30 AM for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 23Jan2021 at 09:30, the patient experienced complex migraine and triggered trigeminal neuralgia event. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
26 2021-02-09 numbness My radial nerve was hit during the injection and I have had little to no feeling in my left pinky fi... Read more
My radial nerve was hit during the injection and I have had little to no feeling in my left pinky finger since receiving the shot.
26 2021-02-10 migraine After the first vaccine, I had a severe migraine for over 48 hours. I had to contact my neurologist ... Read more
After the first vaccine, I had a severe migraine for over 48 hours. I had to contact my neurologist for rescue medication. After the second dose, I had chills, sweats, body aches, migraines, nausea, and dizziness for 24 hours.
26 2021-02-10 pain in extremity Arm pain, nausea, vomiting
26 2021-02-10 numbness and pain in extremities Fever, joint pain, headaches, neuropathy in hands and feet
26 2021-02-10 pain in extremity Severe arm pain, nausea, fatigue, body ache, headache
26 2021-02-10 bell's palsy When pt was administered the 1st dose several hours later pt was seen in the ED for bells palsy symp... Read more
When pt was administered the 1st dose several hours later pt was seen in the ED for bells palsy symptoms, made aware about symptoms returning for the second dose, cleared by personal physician and neurologist.
26 2021-02-14 tingling, nerve pain The following day, 02/07/2021 around 3:30pm I started feeling extreme fatigue, mild sore throat and ... Read more
The following day, 02/07/2021 around 3:30pm I started feeling extreme fatigue, mild sore throat and chills. The following days after I was okay, with a sore throat only occurring in the evening after 4pm, along with vertigo and slight disorientation for approximately 8 days. Starting Saturday, 02/13 around 8pm I noticed a tingling sensation in my right middle finger, that continued to Sunday and through to today. As of this morning, 02/15, I still have the nerve pain in my finger that is now spreading to the palm of my hand.
26 2021-02-17 tingling Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tinglin... Read more
Spike in blood pressure - BP 178/120; Spike in pulse 120; Dizziness; slight chest pains; Arm tingling, turned into full arm pins/needles/Tingling spread through my left underarm and across left side of chest; This is a spontaneous report from a contactable pharmacist (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302), via an unspecified route of administration into the left arm on 02Feb2021 14:15 at a single dose for covid-19 immunisation. Medical history included allergies to penicillin and mushrooms. Patient was not pregnant. Concomitant medication included desogestrel, ethinylestradiol (APRI) for birth control. The patient previously took azithromycin and experienced drug allergy. On 02Feb2021 14:15, patient experienced spike in blood pressure (BP) 178/120 (unit unspecified), spike in pulse 120 (unit unspecified), dizziness, slight chest pains and arm tingling, turned into full arm pins/needles then tingling spread through her left underarm and across the left side of chest. The patient was treated with potassium tablets in the emergency room. Outcome of events was recovered on an unspecified date.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event blood pressure increased cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
26 2021-02-18 tingling, pain in extremity neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most co... Read more
neurological symptoms most consistent with Parsonage-Turner syndrome.; neurological symptoms most consistent with Parsonage-Turner syndrome.; Worsening including increasing pain extending to all the arm; paresthesias throughout arm and hand,; feeling of dislocated scapula; tightening of the lateral aspect of the chest; sharp pain; The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient (daughter) (not preganent) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3302 and Expiration Date unknown) via Intramuscular on 18Jan2021 (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EH9899 and Expiration Date unknown) via Intramuscular on 30Dec2020 (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history was reported as none. The concomitant medications were not reported. No other vaccine in four weeks. The injection was incorrectly done too high and too deep into the joint/bursa. She developed sharp pain and started with neurological symptoms most consistent with Parsonage-Turner syndrome, which includes pain in the brachial plexus with weakness, paresthesia which might never resolve. This is an autoimmune disorder. Patient was worsening including increasing pain extending to all the arm, paresthesias throughout arm and hand, feeling of dislocated scapula, tightening of the lateral aspect of the chest. Onset date for all events was 18Jan2021 and resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with treatment of oral steroids and nonsteroidal anti-inflammatory drugs (NSAID). No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the neurological symptoms, Parsonage-Turner syndrome and other reported events in the clinical context of wrong injection technique due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
26 2021-02-18 tingling tingling to right arm and face, then throat itchiness and nausea
26 2021-02-19 tingling Pfizer-BioNTech Covid-19 Vaccine EUA 15 minutes after receiving the vaccine, when I stood to leave t... Read more
Pfizer-BioNTech Covid-19 Vaccine EUA 15 minutes after receiving the vaccine, when I stood to leave the facility, I felt light-headed which went away after a few deep breaths. 20 minutes after receiving the vaccine, having left the facility, my right hand hand had tingling. I took ibuprofen. The tingling lasted until 1:20 P.M. (at least 3 hours from receiving the vaccine).
26 2021-02-22 feeling hot Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadry... Read more
Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.
26 2021-02-24 grand mal seizure Patient presented for second dose of covid vaccine. She was administered Pfizer vaccine. Patient fai... Read more
Patient presented for second dose of covid vaccine. She was administered Pfizer vaccine. Patient fainted approximately 1 minute after administration of vaccine. Started as syncopal episode then patient started seizing - tonic/clonic. Patient was still seated in chair and seizing lasted about 1 minutes. 911 called. BP 138/78. P 115. Patient moved to cot after she was alert and oriented. By the time paramedics arrived patient was awake and oriented. She refused transport by EMS. She left with fiancé who was driving patient.
26 2021-02-24 pain in extremity Symptoms of swollen, sore, and red throat. Body aches, arm soreness, fever.
26 2021-02-25 tingling "Staff member received 2nd dose Covid vaccine at 1355, began experiencing what she described as "sim... Read more
"Staff member received 2nd dose Covid vaccine at 1355, began experiencing what she described as "similar to first dose"" (unreported) tingling in left arm approx. 10 minutes after receiving vaccine in Left arm. This progressed to tingling in her left leg/foot and 'weakened' left arm and left chest tightness 25 minutes after receiving vaccine. She reported s/s to IOH Lead at that time and monitoring began, Benadryl 25mg given P.O. BP at 1435 135/84, HR 90, Pox 100%, At 1445 Staff members reported improved s/s in arm, but right foot tingling. BP 124/79, HR 90, Pox 100%. At 1455 No s/s left arm or leg, no further chest tightness. BP 123/83, HR 95, Pox 100%. 1500 After standing for 5 minutes, BP 126/90, HR 96, Po 99%. Staff member stated she was ready to return to work. She will call fiancé to pick her up from work."
26 2021-02-25 numbness I waited my 15 minutes after getting the shot and then spent maybe another 10 finding my car and lea... Read more
I waited my 15 minutes after getting the shot and then spent maybe another 10 finding my car and leaving the lot. I had only been driving for a few minutes, maybe less than five when I felt like my arm I got the shot in started to go numb and soon followed a feeling of lightheadness. I thought about pulling off to the side but didn't make it in time because the next thing I knew I woke up pressed against the median on the other side of the freeway I was driving on. I completely blacked out while driving. I had to call an ambulance because I was freaked out and wanted to be looked at and my car needed to be towed.
26 2021-02-25 tremor That night my fever 102 took Tylenol to bring it down, shakes, chills , nausea, muscle aches and swo... Read more
That night my fever 102 took Tylenol to bring it down, shakes, chills , nausea, muscle aches and swollen lymph nodes (right armpit).The symptoms lasted to Sunday. My estimated date of delivery was Sept.14 I miscarried at 5 wks.
26 2021-02-25 pain in extremity, numbness tongue/face numb. Shaky/dizzy while sitting. reported arm pain. Refused ED. Rapid response evalu... Read more
tongue/face numb. Shaky/dizzy while sitting. reported arm pain. Refused ED. Rapid response evaluated. pt ambulated from cafeteria to home
26 2021-02-26 burning sensation, numbness, slurring 830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensati... Read more
830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.
26 2021-02-28 hot flush Fever on 2/27 AM (99.9F after ibuprofen was taken an hour before for headache; very mild chills/naus... Read more
Fever on 2/27 AM (99.9F after ibuprofen was taken an hour before for headache; very mild chills/nausea/hot flashes; subsided later that night), Headache 2/26 PM and 2/27. I also had a headache on the day of the first vaccine dose from Pfizer (2/4/21; EM9809 dose in AM; headache in PM).
26 2021-03-01 pain in extremity, migraine About an hour after receiving my first dose I had a sore arm but just a normal amount for any vaccin... Read more
About an hour after receiving my first dose I had a sore arm but just a normal amount for any vaccine. The next morning I woke up and felt as if I had been hit by a bus. I had an immobilizing migraine, full body aches, I could hardly eat and get out of bed, I also had a mild fever and mild cough. That only lasted about a day and a half. I didn?t find it necessary to seek medical attention and just took some ibuprofen to help ease symptoms. After both doses I noticed some light spotting the two days after. Also I did just have a baby in November but I am not breastfeeding. I work in a Pharmacy and they got me the vaccine before I returned from maternity leave.
26 2021-03-01 pain in extremity, tingling, numbness I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in ... Read more
I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in my arm within 10 minutes of receiving the shot. I didn't think too much of it because I had some stiffness in my arm with the first shot. But this Friday - March 5th will be a month and I am still having arm issues and they have gotten worse. I never had a rash or bruise on the injection site but from the injection site I have a tenderness on my arm and a constant dull and achy pain - sometimes sharp and painful - that starts at the injection site then travels down through my elbow and into my hand. My hand will get tingly and numb as well. My arm will sometimes randomly fall asleep as well. I went to the doctor but they gave me ibuprofen and that didn't do much. I am going back to the doctor soon.
26 2021-03-01 speech disorder It seems like she was drunk; it was almost like disorientation like; Had trouble processing like for... Read more
It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer. Medical history was none. There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
26 2021-03-01 flushing Lightheaded, feeling flushed, dizzy. Evaluated by ambulance. 3:05 pm feeling shaky. Given snack, ... Read more
Lightheaded, feeling flushed, dizzy. Evaluated by ambulance. 3:05 pm feeling shaky. Given snack, feeling better. Discharged at 3:20 pm- symptoms resolved.
26 2021-03-02 tremor 15 minutes after receipt of dose #1 patient developed blurred vision and dizziness. I arrived to th... Read more
15 minutes after receipt of dose #1 patient developed blurred vision and dizziness. I arrived to the patient's side and conducting an abbreviated history as well as a neuro exam. Patient had new onset tremor in upper extremities, positive Romberg, and ataxia. HR ranged from 130-140 w/ SPO2 at 99. No signs of difficulty breathing noted. 911 was called and an ambulance was dispatched. Patient's symptoms remained unchanged upon EMS arrival and she was evacuated to a healthcare facility.
26 2021-03-02 migraine Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; S... Read more
Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.
26 2021-03-02 tenderness headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L ar... Read more
headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L arm (axillary region) at this time I have a golf ball sized lymph node in my L armpit that is tender to the touch
26 2021-03-03 pain in extremity, tenderness High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is sti... Read more
High blood pressure of 150/100; Arm swelling; Arm swelling/The swelling has gone down, but it is still swollen. It is still hurting.; Tenderness; Feeling faint/Felt dizzy; Some trouble breathing; disoriented; Fatigue; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318), via an unspecified route of administration at left arm on 28Jan2021 at 16:55 (reported as 4:55 PM) at SINGLE DOSE for COVID-19 immunisation. It was given at a vaccination clinic. The patient had no prior vaccination within 4 weeks and had no adverse events following prior vaccinations and that was why she thought she would be fine. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included anxiety, peanut allergy, tree nut allergy, and has had anaphylactic reaction in the past. Family history included her dad has heart disease and her half sister has heart disease. There were no concomitant medications. Historical vaccine included flu vaccine on an unspecified date for immunization. The patient stated, "You kind of feel yucky after the flu vaccine, but she has never had this with a flu shot." The patient stated that she hasn't had a flu shot in years. The patient asked if arm swelling was a normal occurrence after vaccination and if side effects can last for 4 days. The patient reported that she received the first dose of the COVID vaccine on 28Jan and afterwards experienced, arm swelling, and tenderness that has last for 4 days. She also reported experiencing feeling faint, high blood pressure of 150/100 and some trouble breathing on an unspecified date and nausea. The patient further reported that she was calling because she got her first dose of Pfizer's vaccine and she was curious if this was normal and if she needs to go see her doctor and she wants to report the symptoms. After she got the injection she felt super faint and got really high blood pressure on an unspecified date. She was not sure if it was because she had anxiety, but she had trouble breathing on an unspecified date. She got nauseated afterwards. Her arm swelled up really big and the swelling has stayed there for four days. Her arm was still swollen on an unspecified date. She has allergies and has had anaphylactic reaction in the past. She was still nauseated and feels super tired. The patient asked how long do the symptoms last. The patient's weight was reported between 122 to 123 pounds. The patient clarified that the nausea started 15 minutes after she got the shot on 28Jan2021. The nausea has lasted through this. She got chills the next day (29Jan2021) after the shot. She has felt super fatigue. The swelling has gone down, but it was still swollen. It was still hurting. She has no idea if that was normal. She also felt dizzy and disoriented after getting the shot. She was not sure if it was because her blood pressure was so high. It was high for her because her blood pressure was normally low. She thinks her blood pressure 150/100 after she got the vaccine. The outcome of all the events was unknown.
26 2021-03-03 feeling cold I was a little tired and cold the first day but the second day i woke up with a swollen lymph node i... Read more
I was a little tired and cold the first day but the second day i woke up with a swollen lymph node in the arm pit that i received my shot in.
26 2021-03-03 flushing, feeling hot Pt received first dose Pfizer vacc approx 1027. Shortly after pt stated to staff she felt, "hot" "w... Read more
Pt received first dose Pfizer vacc approx 1027. Shortly after pt stated to staff she felt, "hot" "weird" . pt appeared flush and left arm was hot to touch. Vitals taken BP 204/148, HR 149, spO2 100% RA, RR 20
26 2021-03-03 bell's palsy, tingling The night I got my first Covid vaccine, the left side of my face started to tingle and my jaw began ... Read more
The night I got my first Covid vaccine, the left side of my face started to tingle and my jaw began to hurt. I took Tylenol and Ibuprofen, but the pain didn't subside. I made a doctor's appointment on 2/25/21, which is when I was diagnosed with Bells Palsy.
26 2021-03-03 weakness Weekness fatigue nausea vomiting for 24 hrs
26 2021-03-03 burning sensation hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, ... Read more
hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, limited to arms. itchy but less severe.
26 2021-03-04 flushing Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 mi... Read more
Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 minutes I had hives on my chest in back. I had high blood pressure 180/120, facial puffiness and mild bottom lip swelling. I developed an onset of increased mucus in my throat causing me to clear my throat frequently. RN on site reported no throat swelling, but increased thickness due to mucus. I received a Benadryl injection on site within 30 minutes and almost immediately symptoms began to lessen. The next day I had mild bottom lip swelling, body itchiness, chest rash, headache and fatigue. Today (24 hours after vaccine) I have a headache, fatigue and body itchiness.
26 2021-03-05 burning sensation Headache, burning in left arm, swelling in left armpit and side along ribcage and left breast (no no... Read more
Headache, burning in left arm, swelling in left armpit and side along ribcage and left breast (no noticeable lumps), fatigue
26 2021-03-05 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Intermittent Chills Intermittent headache I... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Intermittent Chills Intermittent headache Intermittent dizziness Fatigue Soreness in arm of injection
26 2021-03-06 throat numbness Throat numbness, difficulty swallowing. Given Benadryl 25 mg PO. BP 136/85 (pulse 134), O2 sat 96%. ... Read more
Throat numbness, difficulty swallowing. Given Benadryl 25 mg PO. BP 136/85 (pulse 134), O2 sat 96%. F/u BP 127/92 (pulse 131), O2 sat 98%. MD rec'd ED, patient declined.
26 2021-03-07 bell's palsy Classic symptoms of Bell's Palsy- noticed first in my eyes on 2/27 and then also in my mouth on 2/28... Read more
Classic symptoms of Bell's Palsy- noticed first in my eyes on 2/27 and then also in my mouth on 2/28. I was started on valtrex 500 mg TID and a steroid dose pack for 5 days. I am not in pain but full functionality of my eye and mouth have not returned yet as of 3/8/21
26 2021-03-07 weakness, pain in extremity Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, ... Read more
Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, very weak and sore arm. Very little movement or strength. Third day, weak but able to slowly lift arm above head.
26 2021-03-07 migraine Fever, sweating, high level headache/migraine, vomiting, nausea, diarrhea
26 2021-03-07 seizure Patient fainted 2 minutes after receiving the Pfizer vaccine and had 10 second witnessed seizure.
26 2021-03-07 discomfort Patient reports back on the side of spine (right lumbar pressure). Patient reports a lot of pressure... Read more
Patient reports back on the side of spine (right lumbar pressure). Patient reports a lot of pressure, and cannot move. Patient took Tylenol before vaccination at 10AM and was vaccinated at 11AM. Patient reports pain starting when she tried to bend down to get a dress. Then the patient experienced sharp pain thereafter where she cannot stand or move.
26 2021-03-08 tremor Systemic: Lost consciousness-Medium, Systemic: Shakiness-Mild
26 2021-03-08 tremor Systemic: Lost consciousness-Medium, Systemic: Shakiness-Mild, Additional Details: After receiving v... Read more
Systemic: Lost consciousness-Medium, Systemic: Shakiness-Mild, Additional Details: After receiving vaccine, patient lost consciousness briefly while sitting in a chair. Per a witness, the patient slowly fell onto the ground, but did not hit her head against floor or any other surfaces. She regained consciousness after a couple minutes. After resting for about half an hour, the patient was able to stand and leave the pharmacy. I escorted her to her husband's car.
26 2021-03-09 weakness At about 7:30 I started feeling extremely weak followed by coughing. Soon after my throat was tighte... Read more
At about 7:30 I started feeling extremely weak followed by coughing. Soon after my throat was tightened and it became difficult for me to breathe. My eyes have been blurry since and I?ve had a fever, cold, and my entire right side of my body hurts when I move especially from my hips down. My eyes are extremely heavy and I feel better with them being closed
26 2021-03-09 pain in extremity Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the a... Read more
Extreme arm soreness which is getting progressively worse; making it difficult to lift or move the arm entirely; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 29Jan2021 10:30 (at the age of 26-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. It was unknown if patient had any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included gabapentin (MANUFACTUTERE UNKNOWN), fish oil (MANUFACTUTERE UNKNOWN), ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 13:00, the patient experienced extreme arm soreness which is getting progressively worse and making it difficult to lift or move the arm entirely. Seriousness criteria was considered as non-serious. The patient did not receive any treatment for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.
26 2021-03-10 migraine, pain in extremity Extreme soreness in left arm - to the point raising arm to remove clothing was difficult, migraine, ... Read more
Extreme soreness in left arm - to the point raising arm to remove clothing was difficult, migraine, sharp lower back pain, full body chills, feverish, loss of appetite, dizziness, full body fatigue.
26 2021-03-10 seizure like phenomena Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had ... Read more
Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.
26 2021-03-10 tremor Severe chills and shaking, fever, headache, thirst, muscle aches, nausea
26 2021-03-10 pain in extremity Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patien... Read more
Very sore arm; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not available/provided to reporter at the time of report completion), via an unspecified route of administration from 22Dec2020 to 22Dec2020 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other vaccine in four weeks was unknown. Covid prior vaccination and Covid tested post vaccination was unknown. The patient experienced very sore arm (pain in extremity) (non-serious) on 23Dec2020. This report is for the first vaccination only. I will put a second report in for adverse events reported for the second vaccination as well. The outcome of event was recovered on an unspecified date. Information on the lot/batch number has been requested.
26 2021-03-11 tenderness, muscle spasms A week after my shot and I'm still having strange reactions. The day after the shot I started gettin... Read more
A week after my shot and I'm still having strange reactions. The day after the shot I started getting really bad cramps and other PMS symptoms like bloating and tenderness (even though I'm on a type of birth control that means I don't get a period). Then a few days later I started my period and has continued. I also have developed the kind of rash that I get when I eat wheat--all over my body and itchy and it hasn't gone done. Finally, it also caused a lot of digestive issues and bloating and gas. it makes me very nervous to get my next shot.
26 2021-03-11 tingling Red splotches, itching, tingling in face and lips Given Benadryl
26 2021-03-12 flushing Patient had a minor reaction - reported feeling flush and hives. Patient developed symptoms at 30 m... Read more
Patient had a minor reaction - reported feeling flush and hives. Patient developed symptoms at 30 min waiting period. She was given 50mg of diphenhydramine and observed for additional time. Patient reported feeling better after receiving diphenhydramine.
26 2021-03-14 pain in extremity approx 2-5 min after getting vaccine, pt felt faint. pt started to lose vision (only seeing black).... Read more
approx 2-5 min after getting vaccine, pt felt faint. pt started to lose vision (only seeing black). pt was seated and seemed to fade in and out, while staying conscious. RPH stayed with pt for following 5-10 minutes and paramedics arrived on scene. Vitals were taken, and after approx. 15 min with paramedics, they deemed her fit. Pt remained in pharmacy another approx. 30 min while she regained her faculties. She had some pain radiating in her arm and was very anxious. after a total of approx. 90 min, she was comfortable and left the pharmacy.
26 2021-03-15 feeling of body temperature change, night sweats -fever: hot then cold frequently, night sweats and chills -muscle soreness: neck and back - lymph no... Read more
-fever: hot then cold frequently, night sweats and chills -muscle soreness: neck and back - lymph nodes in left armpit/chest area (I received my shot in my left arm)
26 2021-03-15 flushing Patient felt flushed and light headed/dizzy, was given water and Benadryl, recovered in 30 minutes a... Read more
Patient felt flushed and light headed/dizzy, was given water and Benadryl, recovered in 30 minutes and went home after being observed for an additional 15 minutes
26 2021-03-15 pain in extremity Staff member called a Health Office 3-16-2021 10:40am and reported since COVID-19 vaccine #2 on 1-29... Read more
Staff member called a Health Office 3-16-2021 10:40am and reported since COVID-19 vaccine #2 on 1-29-2021 IM to left deltoid, she's had constant dull, aching pain level 3/10 to her left upper arm deltoid area. States pain occasionally radiates to left axilla, but never below her elbow. Denies redness or swelling. States pain relieved with over the counter Tylenol as needed. Has appointment with her doctor 3-16-2021 for evaluation of pain.
26 2021-03-16 tremor 14 hours after vaccination: Fever, full body aches, headache, full body tremors, increased thirst Ne... Read more
14 hours after vaccination: Fever, full body aches, headache, full body tremors, increased thirst Next day: low grade fever, sore muscles, headache, increased thirst
26 2021-03-17 tingling ALLERGIC REACTION Paresthesia of skin
26 2021-03-17 pain in extremity Developed a sore arm around 10pm, woke up with severe 7/10 body aches that quickly worsened leading ... Read more
Developed a sore arm around 10pm, woke up with severe 7/10 body aches that quickly worsened leading to almost fainting, and sick to stomach along with mild headache.
26 2021-03-17 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild
26 2021-03-17 muscle twitching Upon leaving the vaccination site, I began experiencing "twitching" or mouth spasms on the left side... Read more
Upon leaving the vaccination site, I began experiencing "twitching" or mouth spasms on the left side of my face. The exact area was between the corner of the mouth and the cheek area/bone. They were persistent for the remainder of the day on 3/16/21. The twitches/spasms were similar to an eye twitch and lasted into the day on 3/17/21. The twitching subsided today, 3/18/21 but still experiencing them off and on, just not consistent or as frequent.
26 2021-03-17 pain in extremity left arm pain, chest pain, shortness of breath and headache for 2 days
26 2021-03-18 tingling, tremor Patient stated that she received her vaccine in her left shoulder and then noticed a tingling of her... Read more
Patient stated that she received her vaccine in her left shoulder and then noticed a tingling of her left arm. Patient remained seated and then states that the next thing she noticed that she was being woken up by bystanders. Bystanders stated that she lost consciousness fell forward and hit her head on the floor followed by a few shaking/jerking motions and then regained consciousness after approximately 10-15 seconds. Patient denied any prodromal symptoms leading to her fall such as headaches, vision changes, lightheadedness/dizziness, nausea/vomiting, warmth, chest pain or shortness of breath. States that after waking up she noticed pain on the left side of her head where she hit her head. States that after her fall she felt fully aware denies any confused/disoriented state, tongue biting, urination or any other symptoms. Pt had a 4 x 5 cm scalp hematoma on left forehead and tachycardia. Pt was A&Ox3, was able to ambulate, and was discharged from the Emergency Department.
26 2021-03-18 unresponsive to stimuli Patient was 18 min post vaccination when she fainted in the observation area. Nursing staff and EMS ... Read more
Patient was 18 min post vaccination when she fainted in the observation area. Nursing staff and EMS on site attended to the patient. Nurse reports "patient was sitting in observation. Patine rolled out of her chair on to her stomach on the floor. Patient was unresponsive. Time was 16:50. Patient was rolled onto her back. Patient was sternal rubbed. Patient came to 16:52. She was oriented to person, place, and time." Carotid pulse strong and palpable, spontaneous breathing. EMS vital signs; BP 100/80, HR 92, O2 sat 97%. Pt assisted to wheelchair and taken to private EMS area where she was observed, called family for a ride home. Patient refused EMS transport to hospital.
26 2021-03-18 night sweats Within two hours of my shot, I had a headache/muscle aches and felt dizzy/dissociated, and left work... Read more
Within two hours of my shot, I had a headache/muscle aches and felt dizzy/dissociated, and left work early. I started to feel feverish in the early evening, I began experiencing nausea around 3 am that night. This became vomiting about twenty minutes later. I vomited four times over the course of the next half hour: 3:30-4:00 am. I also started experiencing diarrhea at about 4:00 am. I had five loose, near-water stools over the course of the rest of the night until around 9 am, two of which I vomited at the same time. By the time the worst of it stopped, I'd vomited 10 times from 3:30 am - 10 am. I also experienced a fever from that afternoon onward, with chills/night sweats throughout the worst of the digestive upset until the morning. I couldn't keep fluids down until midmorning 3/18 and couldn't keep solids down until that evening, around 7 pm. It's 3/19 and I've had two glasses of water and a piece of toast and still feel nauseous. A friend of mine had some Zofran, which I took one dose of around 10 am 3/18, which allowed me to keep fluids down and not have to return to the hospital.
26 2021-03-19 flushing Patient approached RN in observation complaining of dizziness. RN sat patient down, EMT put on ecg, ... Read more
Patient approached RN in observation complaining of dizziness. RN sat patient down, EMT put on ecg, pulse ox, and took a BP. initial vitals of 141/91, HR: 121, pulse ox: 97. Patient developed flushing in the face. IM Benadryl administered 50mg. repeat VS: 156/91, HR: 114, pulse ox: 97. Patient started to feel better, repeat vitals of 118/91, HR: 97, pulse ox: 98.
26 2021-03-21 feeling hot c/o feeling hot and nauseated after 25 minutes post vaccination.
26 2021-03-22 facial paralysis Paralysis on the right side of the face, numbness inside the mouth, swelling of face, lips, throat, ... Read more
Paralysis on the right side of the face, numbness inside the mouth, swelling of face, lips, throat, and neck.
26 2021-03-22 pain in extremity, tingling Patient complained of tingling to left arm at 10:05, no dizziness or lightheadedness, vital signs no... Read more
Patient complained of tingling to left arm at 10:05, no dizziness or lightheadedness, vital signs normal. Per patient, she has history of anxiety. Patient drank water and orange juice with improvement to tingling noted at 10:17. At 10:22, patient still complaining of pain/tightness/tingling in arm, so Tylenol 325 mg was given. Patient left at 10:34 stable and was advised to follow up with PCP if symptoms persist.
26 2021-03-22 muscle spasms, tingling, muscle twitching Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Approximately 4 minu... Read more
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Approximately 4 minutes after receiving the vaccine, patient reported tingling of the left hand (left deltoid is the site of administration), left eye twitched once, left side of neck spasmed once and left hand tingling remained. Patient remained in the pharmacy in store clinic for 20 minutes. Patient was contacted via cell phone to follow up but no answering machine answered phone call.
26 2021-03-22 pain in extremity soreness in arm, nausea
26 2021-03-23 migraine, tension headache For the last 7 weeks Ive had persistent tension headaches with migraines. In addition, jaw pain, ear... Read more
For the last 7 weeks Ive had persistent tension headaches with migraines. In addition, jaw pain, ear pressure, photophobia. Have gone to the ER, urgent care, and neurology. Have tried various medication with no luck - todarol, Advil, acetominophen, methylpresidone. Notably, at the 6 week mark on 3/18/21 I received a semi quantitative antibody test specific to the spike protein which came back negative. I have previously reported to VAERS but symptoms have continued so I am filling out another form.
26 2021-03-23 pain in extremity, night sweats Night sweats, body aches, disrupted sleep, bruised/very sore arm
26 2021-03-24 speech disorder 1/15 vaccination Early afternoon, fatigue set in. That night i spiked fever over 100 and chills feve... Read more
1/15 vaccination Early afternoon, fatigue set in. That night i spiked fever over 100 and chills fever broke 1/16 pre syncopal episodes. Did pass out while sitting down. By noon, I had fever and chills, fatigue. broke that afternoon. By 7pm I got another fever, chills, and had abdominal pain with GERD. Was not due to food as hadn't ate. Couldn't speak due to the pain. No medication taken. Husband called PCM worried about hydration. Took Tylenol and kept fluid down. Big inflammatory response. Symptoms lasted for 48 hours
26 2021-03-24 seizure She fainted, employee stated she saw her seize, EMS called and she was transfered. Intial reactiom 1... Read more
She fainted, employee stated she saw her seize, EMS called and she was transfered. Intial reactiom 15:37 pm.
26 2021-03-24 feeling hot, flushing Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minu... Read more
Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.
26 2021-03-25 tingling Vision change 20-30 seconds Nausea/vomiting Lightheaded Sweaty Warm Paresthesia in hands
26 2021-03-26 pain in extremity As soon as the vaccine was injected my arm hurt through my neck to the back of my shoulder blade. I ... Read more
As soon as the vaccine was injected my arm hurt through my neck to the back of my shoulder blade. I was immediately feeling woozy and dizzy. I sat for 20 minutes and took a Tylenol. I left the site and about 30 minutes later I was feeling extremely tired, and out of breath. Talking was difficult and taking too much energy, my shortness of breath was alarming. It went away within 4 hours. 2 days later I was feeling fine, and was sitting having a coffee. Out of nowhere I had a rapid heartbeat and started feeling woozy and light headed again. I didn't have as much shortness of breath but it felt like if I were to try and do anything it would exhaust me. I took Tylenol again and things calmed down in about 2-3 hours.
26 2021-03-27 flushing Less than 3 minutes after administration, I began having tingling in my throat. My heart began to ra... Read more
Less than 3 minutes after administration, I began having tingling in my throat. My heart began to race. I grabbed a medically professional who assessed me, she stated I was beginning to flush and then had EMS respond. Vital signs indicated a peak heart rate in the 160?s, O2 Sats were in the 80?s. I also had a metallic taste in my mouth and a tightness in my airway. Later in my hour observation I had a period of facial flushing and itching. I had ice packs placed on my skin, given a fluid bolus and monitored by an RN and EMS personal. A Doctor assessed me and contemplated transporting to the ED for management but I was slowly feeling improvement. I was monitored for an hour and felt okay when I left the clinic.
26 2021-03-28 numbness, facial paralysis Weakness in hands, feet and legs; Facial numbness and drooping 30 mins after injection; Facial numbn... Read more
Weakness in hands, feet and legs; Facial numbness and drooping 30 mins after injection; Facial numbness and drooping 30 mins after injection; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 12Mar2021 14:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization at age 26 years old. The patient was not pregnant at the time of vaccination. The patient had covid prior to vaccination. No known allergies. Patient was not tested post vaccination. There were no concomitant medications. No other vaccines in four weeks and no other medication in two weeks. On 12Mar2021 14:30, 30 mins after injection, the patient experienced facial numbness and drooping 30 mins after injection. On 13Mar2021 02:00, weakness in hands, feet and legs starting 12 hours after injection. Treatment was not given for events. The patient had not recovered from the events. Information about lot/batch number has been requested.
26 2021-03-30 migraine Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a ... Read more
Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.
26 2021-03-30 burning sensation Shortness of breath; chest tightness; stated that she got the first shot in her left hip; soreness t... Read more
Shortness of breath; chest tightness; stated that she got the first shot in her left hip; soreness to left hip; burning at her left hip; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received BNT162B2 first dose (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration on 14Jan2021 at 16:20 (Batch/Lot Number: EL3249) as single dose, then via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included rotator cuff injury from 2020, unknown injury from 2018 to 2019 and repeated injuries to her shoulder (occurred before the vaccine) from an unknown date and unknown if ongoing. The concomitant medication was not reported. The reporter stated that she is a healthcare worker with repeated injuries to her shoulder that occurred before the vaccine. Stated that she had rotator cuff surgery in 2020 and the another injury 1-2 years prior to that one. Stated that the first booster that she received was three weeks ago in her hip on 14Jan2021 16:20. Stated that she went to get the second dose today in her thigh. Stated that she was told that it was being given in her thigh because it was conclusive to being effective. Stated that she was told that the first dose may not be effective. Wanted to know the current information where it should be administered. Wanted to know if she should get first dose again. Clarified that the booster is for the Pfizer Covid 19 vaccine. Stated that she got the first one on 14Jan2021. Stated that she gets repeat vaccines every year and had a declination to IM sites to the shoulder/arm area due to her injuries. No further details provided. Later clarified first booster was to her left hip. The reporter stated that with the first shot that she had soreness to left hip and burning at her left hip on 14Jan2021 16:20. Stated four days after the vaccine that she did a lot of cardio and had chest tightness and shortness of breath on 17Jan2021 16:00 within 10 minutes after that lasted for an hour. Stated burning only lasted 15 minutes. The outcome of the events the first dose may not be effective due to being given in her left hip was reported as unknown. The outcome of the events stated that she got the first shot in her left hip and burning at her left hip reported as recovered 14Jan2021. The outcome of the events soreness to left hip, Shortness of breath and chest tightness was reported as recovered 17Jan2021.
26 2021-03-31 facial paralysis, numbness 3 days after receiving the Pfizer COVID-19 vaccination, the patient reported numbness in her bilater... Read more
3 days after receiving the Pfizer COVID-19 vaccination, the patient reported numbness in her bilateral toes that progressed to numbness and weakness of her bilateral legs. 5 days after the onset of her initial symptoms, the patient noted bilateral numbness in her fingers and her mouth, that also progressed to weakness in her bilateral arms. A few days later, the patient noticed a right-sided facial droop that brought her to the ED. Given the patient's symptoms and elevated protein in the patient's CSF (obtained via lumbar puncture), the patient's symptoms are concerning for Guillain-Barre syndrome. The patient was started today on 5 days of immune globulin (PRIVIGEN) 10 % IV infusion 25 g.
26 2021-04-12 feeling hot lost consciousness; Standing and suddenly felt hot; lightheaded/dizzy; This is a spontaneous report ... Read more
lost consciousness; Standing and suddenly felt hot; lightheaded/dizzy; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 30Mar2021 at 07:00 as a single dose for COVID-19 vaccination. The patient's medical history included anxiety, Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient had taken other medication in two weeks are Prozac, Taytulla. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 18:00 patient experienced standing and suddenly felt hot, lightheaded, dizzy and lost consciousness. The patient did not receive any treatment for the events. The outcome of the events was recovering. Follow up information has been requested.
26 2021-04-18 seizure, weakness, weakness, seizure Employee had a seizure and LOC approx. 2 hrs post second vaccine. EMS was called and employee was t... Read more
Employee had a seizure and LOC approx. 2 hrs post second vaccine. EMS was called and employee was transported to the hospital. Employee was hospitalized for observation. Discharged home after 2 days. Employee still reports feeling weak. Following up with primary care MD.
26 2021-04-18 pain in extremity patient with bilateral posterior knee pain, bilateral Achilles tendon pain, and left fourth toe pain... Read more
patient with bilateral posterior knee pain, bilateral Achilles tendon pain, and left fourth toe pain. These were severe enough to cause inability to walk
26 2021-04-20 tingling, numbness arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and... Read more
arm was starting to go numb/get heavy; tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms; then that my vision started getting blurry; heart rate started elevating to a point where I even had to put my bf's hand on my chest to show him; lightheaded feeling; This is a spontaneous report from a contactable consumer or other non hcp reporting for herself. A 26-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:15 (Batch/Lot Number: EW 0150) as single dose for covid-19 immunisation . Medical history included attention deficit hyperactivity disorder (ADHD). Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced drug hypersensitivity, morphine and experienced drug hypersensitivity. The patient experienced arm was starting to go numb/get heavy on 08Apr2021 23:45 with outcome of not recovered , tingling/pins and needles type feeling start migrating to and from my toes, up both of my legs, through my torso, and then into my finger tips and arms on 08Apr2021 23:45 with outcome of not recovered , then that my vision started getting blurry on 08Apr2021 23:45 with outcome of not recovered , heart rate started elevating to a point where i even had to put my bf's hand on my chest to show him on 08Apr2021 23:45 with outcome of not recovered , lightheaded feeling on 08Apr2021 23:45 with outcome of not recovered. All the reported events were considered serious because Important Medical Events. The patient underwent lab tests and procedures which included heart rate: started elevating on 08Apr2021 , sars-cov-2 test: negative on 06Apr2021 (covid test name post vaccination: Sofia SARS Antigen FIA). The patient visited her PCP and a Bloodwork was scheduled. Follow up information has been requested.
26 2021-04-24 feeling hot About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, ... Read more
About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; My throat was also just a little bit tight and breathing was labored/Little tightness around the throat; My throat was also just a little bit tight and breathing was labored; allergic reaction; rash all over my face; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at the age of 26-year-old on 07Apr2021 14:40 (Lot Number: 7131121) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included lung transplant from 2016 (recipient of double lung transplant in 2016), Slight damage to the windpipe, Asthma, immunocompromised. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone; metoprolol; magnesium chloride. The patient previously took cefdinir (OMNICEF) and experienced drug allergy, clarithromycin (BIAXIN) and experienced drug allergy. Patient got her shot at 2:40 pm. Seemed fine, waited at the star for 15 minutes and went on her way. About an hour after patient looked in the mirror and saw that her entire right cheeck was bright red, hot, and itchy on 07Apr2021 15:30. Her throat was also just a little bit tight and breathing was labored on 07Apr2021 15:30. Patient went to the emergency room and was given 25mg of oral Benadryl, 20mg of famotidine, and a dexamethasone shot. Patient was then observed and released once her reaction started to calm down. Consumer stated, she was calling because she had a allergic reaction to her first dose of the Pfizer Vaccine yesterday (07Apr2021). It did occur just after half an hour of the Vaccine on 07Apr2021 15:10. She broke out in a rash all over her face in Apr2021. Little tightness around the throat. Therapeutic measures were taken as a result of 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored'. Adverse events 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored' result in Emergency room/department or urgent care. The outcome of events rash all over my face and allergic reaction was unknown. The outcome of other events was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.
26 2021-04-27 tremor High fever, (103°), headache, dizziness, pain in left side of body, shakiness, fever, chills,
26 2021-04-27 bell's palsy, numbness her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes... Read more
her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; her mouth, her lip, her right eye was not cooperating/noticeable difference between both of her eyes; half of her face is numb; ear infection; Bell's palsy/face droopiness; Ear ache/Ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734 and expiration date not provided), via an unspecified route of administration, administered in Deltoid Left (reported as left shoulder) first dose on 01Apr2021 10:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medication includes Multivitamin at 2 gummies once a day for immune support, bone support, and health reasons. The patient historical vaccine includes flu shot and experienced sore arm. On 03Apr2021, the patient stated that two days after the vaccine the patient experienced earache, went to the ED (emergency department) this Sunday diagnosed bell's palsy. On 11Apr2021, the patient experienced ear pain that she thought was an earache or ear infection, then she went to the ER because she woke up with half of her face numb. She says she was diagnosed with Bell's Palsy and she did some research. She says during the trials people did get Bell's palsy but they didn't know if it was connected to the vaccine. She says she is reporting it and she wants to get more information, she's due to get the second dose next Thursday. She says it was a mild case but she was concerned it will come back and come back worse. She says she has a meeting at 3 pm and it is currently 2:13 pm where she lives. The patient stated that now she was left with the face stuff, the face droopiness. The patient was still taking the Bell's Palsy medications every day, she thinks she is getting better. She says about her face being numb she woke up and felt it in her mouth, her lip, her right eye was not cooperating, there was a very noticeable difference between both of her eyes. She says she went to the ER where they did a couple of tests to see if it was a stroke or something else, they didn't do any imaging, with what they aw on her face and the way they were testing the conclusion was Bell's Palsy. She says she saw her primary care physician today because she needed to follow up and it looks like a mild case of Bell's Palsy. She says her face is getting better with medications. She says she is taking Prednisone 60 mg a day for 7 days. She is also taking Valacyclovir 1000 mg 3 times, she clarifies it says to take 1 tablet 1000 mg total 3 times a day by mouth. The events prompted the patient to Emergency room visit and physician office visit. The outcome of the event facial paralysis, hypoaesthesia was recovering. The outcome of the event ear pain was Recovered with Sequel on 11Apr2021. The outcome of the remaining events was unknown.
26 2021-04-30 seizure breakthrough seizure and frequent seizures; This is a spontaneous report from a contactable consumer... Read more
breakthrough seizure and frequent seizures; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 16Apr2021 13:00 (1:00PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included ongoing epilepsy and known allergies latex, bee stings from an unknown date and unknown if ongoing. No other vaccine in four weeks. The patient had no Covid prior vaccination and not Covid tested post vaccination. The patient was vaccinated at a facility. Concomitant medication included (reported as Other medications in two week): cenobamate (XCOPRI) and zonisamide (ZONISAMIDE); both taken for temporal lobe epilepsy, start and stop date were not reported. The patient previously took bnt162b2 for covid-19 immunisation first dose from 18Mar2021 at 01:00 PM in the left arm. The patient also previously took oxcarbazepine and experienced allergies (reported as Known allergies: Oxcarbazepine). It was reported that the patient has temporal lobe epilepsy well controlled on Xcopri(200mg) and zonisdamide(300mg) and experienced breakthrough seizure and frequent seizures during the last 14 hours (reported as 15Apr2021 at 08:00 PM [20:00]). Previously well controlled for the past 2-3 months, upon titration to current dose of zonisamide/xcopri. The outcome of the event was recovering. No treatment for the reported event. Information on the lot/batch number has been requested.
26 2021-04-30 migraine lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a ... Read more
lost vision; migraine; unable to lift head; chest pain; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, administered at the right arm on 07Apr2021 10:45 (age at vaccination was 26 years) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at pharmacy or drugstore. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient experienced lost vision on 07Apr2021 with outcome of recovered on an unspecified date, migraine on 07Apr2021 with outcome of recovered on an unspecified date, was unable to lift head on 07Apr2021 with outcome of recovered on an unspecified date, chest pain on 07Apr2021 with outcome of recovered on an unspecified date, and nausea on 07Apr2021 with outcome of recovered on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of lost vision, migraine, unable to lift head, chest pain, nausea that included migraine medication, ibuprofen, and nausea medication. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
26 2021-04-30 pain in extremity my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body ach... Read more
my arm slowly became more and more sore; had a hard time sleeping; woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in my entire body); stomach upset; fatigue; Little bit of chills; sluggishness; This is a spontaneous report from a contactable other hcp. A 26-years-old female patient (non pregnant) received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) dose 1 via intramuscularly administered in left arm on 31Dec2020 10:00 AM and dose 2 via intramuscularly administered in left arm on 21Jan2021 12:00 PM (at 26-years-old and non pregnant at the time of vaccination )(Batch/Lot Number: EL3247) both as single dose for covid-19 immunization. Medical history included anxiety, asthma, allergies, irritable bowel syndrome from an unknown date and unknown if ongoing. No known allergies were reported. Concomitant medications included Sertraline HCL 100mg, Junel (birth control), Trazodone within two weeks. prior to vaccination. No other vaccine taken within four weeks prior to vaccination. Patient had no Covid prior to vaccination and not tested for Covid post vaccination. On 21Jan2021 at 05:30 PM, after second dose patient experienced sore arm slowly and became more and more. She had a hard time sleeping and woke up at 4am with full body aches (particularly felt like severe restless leg syndrome, but in her entire body). Also had stomach upset and fatigue/sluggishness. Little bit of chills. All of the symptoms continued throughout the rest of the day. Therapeutic measures taken which included Tylenol at 4am, 10am, and 4pm for it. Outcome of the event was recovered. Follow-up attempts are completed. No further information is expected.
27 2020-12-31 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for great... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Extremely sore arm Ipsilateral neck stifness/soreness for greater than 72 hours Headache for 72 hours
27 2020-12-31 pain in extremity Started to have soreness in the left arm the day after with body aches the next day (12/30). Then de... Read more
Started to have soreness in the left arm the day after with body aches the next day (12/30). Then developed low grade fever up to 99.9F, chills, and body aches on 1/1/21.
27 2021-01-03 discomfort After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better... Read more
After the shot I was very light headed , and was taken to the side. Ate some candy , and felt better after. About 6 days later is when I woke up with really puffy eyes. Then next day I noticed swelling on the bottom of my mouth , on both sides. Also , my whole right side of my face is swollen with a lot of pressure in it.
27 2021-01-03 feeling hot, feeling hot Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burni... Read more
Delayed Moderate. Myalgias several hours later, worsened myalgias in the Evening, Shivering, "burning up" no fever, headache, back pain, palpitations, left axillary lymph node (peach pit size) bilateral inguinal pain next day. Symptoms improved
27 2021-01-03 numbness I received my first dose of the COVID-19 vaccine on 12/22/2020 in the left arm. Immediately at the ... Read more
I received my first dose of the COVID-19 vaccine on 12/22/2020 in the left arm. Immediately at the time of the administration, I noticed numbness in my left pinky & ring finger that extended to my elbow. I figured they may have ?hit a nerve? so I called my PCP afterward. My PCP advised me to take Ibuprofen 600mg and to call the next day with any new or worsening symptoms. When I woke up the next day, I noticed numbness in both of my feet (with continued numbness in my left forearm). I had a visit with my PCP where I had a normal neurological exam except for the paresthesias. I did not sleep well the night before, so I was sent home with a medication to assist in sleeping and to observe over the holidays to see if my condition improved. Otherwise, my PCP would order more testing. Monday after the holidays (12/28/2020), my symptoms didn?t improve. I noticed that I have constant numbness in bilateral hands and feet with periodic episodes where my entire left leg and then my entire right arm had tingling/numbness/crawling sensation. I had some fasting labs done on 12/29/2020: CBC, CMP, CRP, Sed Rate, TSH, Magnesium, eGFR were all within normal limits. My B12 was slightly low at 210 (normal levels are listed as 211-911). I received a B12 injection that same day and started OTC B12 supplements. I am currently waiting on the referral to go through an EMG. Since receiving my B12 injection, I noticed a few more episodes over the New Year holiday break. From 12/31/20-01/02/21, I had this tingling/unpleasant sensation episode on my whole right side. My entire arm and leg were being affected; the episode was constant throughout most of the day with a few moments of relief with hot showers/heating blanket. No weakness noted. I currently have a message out to my PCP to update.
27 2021-01-03 flushing, feeling hot Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection. She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness. Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious. Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious. Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness. Patient had tachycardia and self-reported palpitations. Received IV fluids and observation on telemetry with no rhythm disturbance. Patient discharged 1428 on 12/24. On 12/29, patient returned to ED at 0326 for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation. Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
27 2021-01-03 tingling, tingling received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakene... Read more
received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00
27 2021-01-04 cold extremities, weakness 12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Rep... Read more
12/18/20- reports suddenly got sweaty, hands felt cold, then got nauseous. Reports vomitted x 1. Reports the rest of the day felt tachycardiac for a few hours (HR 120-140) and dizzy. Started getting muscle aches/joint aches. Denies any recent COVID exposure. Tested positive for COVID In 8/2020. Reports hips/knees are throbbing today; Heart rate WNL. /// Presenting today due to intermittent presyncope and palpitations. Also notes generalized weakness. Patient evaluate 2 L of fluid given her Mirena IUD D-dimer was sent which was negative patient with no pleuritic symptoms or dyspnea to suggest pulmonary embolism. Otherwise hemodynamically stable on exam ambulates with no difficulty no focal neurologic deficits. Patient did describe on her initial presentation that she noted some weakness of her bilateral legs. Given her possible viral reaction and description of weakness it is possible the patient is developing an early autoimmune reaction however she has no evidence of GuillainBarré or transverse myelitis on my exam. We will plan to discharge with neurology follow-up as outpatient.
27 2021-01-04 feeling cold I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild... Read more
I remainder of the day I rested. The next day I rested all day as well and was fatigued, had a mild headache, muscle aches and felt the cold shivering feeling but had no fever.
27 2021-01-04 feeling hot Rapid heart rate ten minutes after administration, anxiety attack and a hot face. Lasted 25 minutes ... Read more
Rapid heart rate ten minutes after administration, anxiety attack and a hot face. Lasted 25 minutes in total.
27 2021-01-04 weakness Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday ... Read more
Saturday night headache took Tylenol, Sunday body aches chills headache dizzy nauseous weak, Monday vomiting headache dizzy heart palpitations body aches, Tuesday continued headache body aches
27 2021-01-04 pain in extremity Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female pati... Read more
Sore arm; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 28Dec2020 at 08:30 AM at a single dose; and the first dose via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination, had no known allergies, and did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient experienced sore arm on 28Dec2020 at 09:00. The patient received no treatment for the event. The outcome of the event was unknown.
27 2021-01-05 tremor Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly as... Read more
Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.
27 2021-01-05 migraine Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer ... Read more
Diarrhea; throwing up; very bad migraines; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on 27Dec2020 at single dose shot left arm once for COVID-19 immunization in hospital. The patient's medical history and concomitant medications reported as no. Patient stated that she got her Covid vaccine on Sunday (27Dec2020) and had experienced very bad migraines on 27Dec2020, diarrhea and throwing up as well on 29Dec2020. Stated that the diarrhea was not as common as the migraines. Stated that she had not thrown up but did last night (30Dec2020) at 2 AM. Investigation Assessment reported as no. No treatment was received for the events. The outcome of event migraines was unknown, outcome of the other events was recovering.
27 2021-01-05 pain in extremity EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include T... Read more
EE report symptoms of left arm pain, fever of 101 , chills, and mild body aches. Treatment include Tylenol with symptom improving.
27 2021-01-05 weakness, tremor Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted... Read more
Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.
27 2021-01-05 weakness Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vac... Read more
Unspecified general vertigo, general weakness, and occasional nausea starting from morning after vaccination that has been steadily improving day by day. Have tried meclizine OTC to no effect. Vertigo is mild and not impairing. Able to keep balance fine.
27 2021-01-05 weakness, discomfort WEAKNESS, HEAVY FEELING , FEELING LIKE GOING TO PASS OUT, CHEST HEAVINESS
27 2021-01-06 tingling Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days la... Read more
Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.
27 2021-01-07 pain in extremity Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. ... Read more
Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.
27 2021-01-07 pain in extremity Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: i... Read more
Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches
27 2021-01-07 flushing Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by ... Read more
Got 1st shot at 1430 1/4/21. Was sent back to my unit (OR). At 1455 got full body flush followed by tingling lips, tight throat, trouble swallowing and SOB. No obvious signs of swelling of the lips. Used inhaler for SOB which helped marginally. After 1.5 hrs tingling in lips and flushed skin went away. Throat tightness and SOB still remained but weren't progressing so went home after my shift. Later that night around 2100 took 1 25mg Benadryl. Tightness in throat and SOB improved. The next morning 1/5/21, I reported to work for my shift. Tightness and SOB was manageable at this point. At 0800 the tightness in my throat, trouble swallowing and SOB got significantly worse. I was scrubbed into a surgery and had to call for a replacement so I could take Benadryl. I took 1 25mg tablet and 2 puffs of my inhaler and went back to my case. After the Benadryl and inhaler, the tightness in my throat and SOB became slightly more manageable. At 1240 the symptoms came back and I took another Benadryl and 2 puffs of my inhaler with slight relief of symptoms. Stayed the rest of my shift continuing my inhaler as needed and a Benadryl every 4 hrs. At 1600 I developed a headache at the front of my head above my eyes like a weight was sitting there. The next day when I woke up 1/6/21, the tightness in my throat, SOB and headache were worse so I had to call into work. The headache that morning had progressed to 7 out of 10 pain and the pain then included my neck where it attaches to the skull. At 0830 I called employee health and they advised my to go to an urgent care. I was checked over by a PA and was prescribed prednisone 40 mg for 5 days along with Benadryl every 4 hrs and inhaler as needed. I was also nasal swabbed for Covid. After taking the steroid, the headache and neck pain, tightness in throat went away. The SOB also improved. Currently taking the steroid, Benadryl (every 4 hrs) and inhaler 2 puffs as needed. Symptoms are mostly controlled. 1/7/21 tried to cut back the Benadryl to every 6 hrs. Noticed a huge difference in my breathing and had an increase in SOB so went back to every 4 hrs. 1/8/21 still taking steroid and Benadryl every 4 hrs and inhaler. SOB is worse today even with taking Benadryl. Have an appointment with my PCP to talk about getting the 2nd shot.
27 2021-01-07 tremor Hives, Redness, itchy, leg tremors, nervous 25 mg Benadryl PO administered
27 2021-01-07 weakness lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, pai... Read more
lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.
27 2021-01-08 hot flush Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle ac... Read more
Headache, nausea, diarrhea, hot flashes, mild fever, loss of concentration/focus, fatigue, muscle aches. 12/23-1/9 (present) 2 virtual dr visits, recommended Tylenol and rest
27 2021-01-08 tenderness I woke up the morning after my shot and I had some pain around my left clavicle when putting pressur... Read more
I woke up the morning after my shot and I had some pain around my left clavicle when putting pressure on it (turning in bed, etc. ) and I felt around and there was a small lump. Seems like a swollen lymph node. Today (2 days later), the area is more tender and a little larger upon palpation.
27 2021-01-08 weakness chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection ... Read more
chills, muscle pain, join aches, elevated heart rate, weakness, headache @ 12 hours after injection took 650mg tylenol, able to fall asleep awoke again with sweats (did not take temperature) able to fall asleep, slept a total of 18 hours still with headache, weakness, fatigue on wakening, took 325 mg tylenol and 200 mg advil symptoms resolved approximately 25 hours after injection
27 2021-01-09 night sweats Chills, headache, night sweats 2 days post shot and enlarged lymph node 4 days post vaccine.
27 2021-01-09 flushing, feeling hot Patient complained of feeling hot, flushed and nausea.
27 2021-01-10 numbness, tremor, tingling 14 minutes post injection, patient laid head on table and started shaking. Complained of severe head... Read more
14 minutes post injection, patient laid head on table and started shaking. Complained of severe headache, h ands, arms and legs numb. No resp problems. 7:50am given 12.5mg of Benadryl IM. 0800 shaking slowing down, but headache, tinglig in arms, legs still numb. 8:04another 12.5 mg of Benadryl IM given. 8:15 shaking stopped but headache continues. Legs remain "heavy" but arms normal. Patient complains of copper taste in mouth. 8:20 legs mostly back to normal. 8:30 able to walk with no symptoms at this time except for headache. Husband arrives to take patient home.
27 2021-01-10 weakness Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain a... Read more
Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***
27 2021-01-10 weakness I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended... Read more
I woke up in the middle of the night with chills, body aches, nausea, and over all weakness. I ended up throwing up. I only got 4 hours of sleep.
27 2021-01-10 migraine Migraine, body aches, chills, nausea beginning at 0300 the next day after receiving vaccine
27 2021-01-10 pain in extremity Nausea, fatigue, left arm pain that sometimes shoots up my shoulder
27 2021-01-10 weakness, numbness, feeling hot Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weaknes... Read more
Vaccine: 12/30/2020 0900 AM Symptoms started: 12/30/2020 0925 AM Symptoms: tachycardia 150s, weakness, feeling extremely hot, lip and facial numbness, tightness on throat, difficulty swallowing, shortness of breath Duration: 1 hour Frequency post vaccination: QDAY but less severe ED Visit: 12/31/2020 prescribed Zyrtec and Pepcid Symptoms still occurring going on week two post vaccination
27 2021-01-10 muscle spasms, muscle twitching, muscle spasms, muscle twitching her muscles have been spasming in her legs and arms since Saturday, she had her second COVID vaccine... Read more
her muscles have been spasming in her legs and arms since Saturday, she had her second COVID vaccine that day and then that night is when she started having the muscle spasms, she got the Pfizer vaccine, both doses were in the left arm, it is mostly in her legs but a little in her arms, she is not having a single spasm that lasts a long time, she describes it as a "muscle twitch" that happens once in any given location and then goes away, no muscle cramps/pain, no fever, no chills, no previous similar symptoms, she has been under more stress for the last few weeks, the only other recent change she can think of is that her OCP changed to a different generic 8 days ago
27 2021-01-10 facial pain, numbness numbness in toes itchy arm hurts face swelling all over swelling of the body
27 2021-01-10 tremor she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, hea... Read more
she left a message that she had a second vaccine on Jan. 7 and on 1/8 was very sick with chills, headache, shaky, and vomiting. She reports 1/9 that it is now gone (lasted about 24 hours).
27 2021-01-11 hot flush At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep deliri... Read more
At 2am that next morning January 8th (almost 12 hours post vaccine) I woke up out of my sleep delirious, light headed, heart was racing, diarrhea, and felt like I was falling in and out of almost passing out, hot flashes, couldn't think straight. It wasa very scary experience for me. This lasted about 15 or 20 minutes I'm guessing (hard to say for sure because I was too worked up to watch the clock) but I ended up making myself fall back asleep. The next day January 8th I had diarrhea multiple times in theafternoon and felt strange, somewhat lightheaded and some what felt like anxiety.
27 2021-01-11 tingling Heaviness and tingling in bilateral arms. No other symptoms. She was monitored for a total of 60 min... Read more
Heaviness and tingling in bilateral arms. No other symptoms. She was monitored for a total of 60 minutes. No decrease or increase in feeling. She called her mother to come and pick her up. She was escorted out of the clinic walking.
27 2021-01-11 hot flush, night sweats, flushing, tingling Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain... Read more
Poor sleep, dry cough and wheeze, flushing of cheeks, hot flashes, night sweats, chills, muscle pain like cramps and pins and needles if skin rubbed, joint pain, sharp brief headache that comes and goes in random spots of head, fatigue, malaise, mental fog
27 2021-01-12 tremor Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This... Read more
Fever; body aches; joint pain; headache; diarrhea; dizzy spells; uncontrollable shakes; chills; This is a spontaneous report from a Non-contactable Other Health Professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06Jan2021 13:45 at single dose for COVID-19 immunization. Medical history reported as none. Known allergies: NO (Allergies to medications, food, or other products: No). The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination: No. The patient experienced Fever, body aches, joint pain, headache, diarrhea, dizzy spells, uncontrollable shakes, chills, all on 06Jan2021 21:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. No treatment received for the adverse event. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Covid test post vaccination: Nasal Swab on 07Dec2021 with result negative. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
27 2021-01-12 flushing Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, ... Read more
Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.
27 2021-01-12 flushing Malaise, chills, flushed, temperature of 99.1 with concurrent antipyretics (acetaminophen 1000mg PO ... Read more
Malaise, chills, flushed, temperature of 99.1 with concurrent antipyretics (acetaminophen 1000mg PO Q6H) starting approximately 20 hours post-vaccination
27 2021-01-12 flushing PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVI... Read more
PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.
27 2021-01-12 pain in extremity, weakness Pain in arm, difficulty moving arm, fever, chills, weakness, fatigue
27 2021-01-12 pain in extremity Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle ach... Read more
Received 2nd dose Pfizer lot EL0142 on 1-12-2021 in left arm. She has been having fever, muscle aches, arm pain and chills.
27 2021-01-12 numbness Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt ... Read more
Reported decreased sensitivity to touch in mouth and on face, mixing heat and cold (hot shower felt cold, cold raindrops felt scalding, trouble thermoregulating) couldn't tell where arms were, dizziness, passed out.
27 2021-01-12 feeling hot, facial pain, numbness left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on n... Read more
left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
27 2021-01-12 pain in extremity sore arm
27 2021-01-13 cold sweat Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry m... Read more
Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all lasting over 36 hours.
27 2021-01-13 weakness Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (dat... Read more
Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, and seeing dark spots (date/time of onset symptoms 1/13/2021 at 3:00PM) Headaches, heart palpitations, dizziness, fatigue, weakness, lightheaded, swollen lymph nodes, and hard to swallow ( date/time of onset symptoms 1/13/2021 at 4pm and still ongoing).
27 2021-01-13 migraine I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, ... Read more
I received my 2nd shot 1/12 @3:30pm. 1/13 @5:00 I started having severe stomach cramps, a migraine, and vomiting that is still occurring 1/14 @ 8:10 am.
27 2021-01-13 facial pain, muscle spasms, pain in extremity Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my... Read more
Sudden severe arm and shoulder pain (left side) along with severe neck pain. I was unable to move my neck for about an hour. As well as left sided facial pain. Worst migraine of my life. Right leg/foot spasms. Heart palpitations, difficulty catching breath, Following day-moderate neck pain, headache, and very sore left arm, nausea, left shoulder pain
27 2021-01-13 flushing The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fa... Read more
The morning after getting the 2nd COVID-19 vaccination, I walked to work and started to feel more fatigued than usual within about 40 minutes after starting to walk from my apartment at 0600. I had a hard time staying awake, started to become flushed and feeling feverish at 0700 at work, and began to develop a headache and nausea around 0745. I went to sick call on my ship after realizing I couldn't power through the symptoms around 0800, and my Senior Chief mentioned earlier in the report) sent me home with motrin, tylenol, and mucinex for any congestion that may come up. Today (14JAN21) I seem to be a little more active and have an easier time staying awake, the headache and nausea have dissipated completely. However, I am still feeling more fatigued than I have been lately, and I began to feel flushed and feverish again around the same time in the morning.
27 2021-01-13 pain in extremity felt numbness at the injection site; moderate upper arm pain from just below the injection site to a... Read more
felt numbness at the injection site; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line; Throughout the day (Dated) it became increasingly difficult to turn my head in any direction and is very painful to move it to the left; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration from 06Jan2021 14:15 (reported as "02:15 PM") at single dose on the left arm as COVID vaccine. The COVID-19 vaccine was administered in a workplace clinic. Medical history included gastrooesophageal reflux disease (GERD), Acid Reflux Disease, Pseudo Tumor and known allergies reported as "Known allergies: Sulfate Drug, Pertussis". The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient reported that directly after the shot, she felt numbness at the injection site and stated "I realize this is normal and the shot was given properly and painlessly in the upper left arm) at approximately 2 am (12 hours after receiving the vaccine)". Patient woke up with moderate upper arm pain from just below the injection site to all the way up the left side of my neck to the jaw line. Throughout the day on 07Jan2021, it became increasingly difficult to turn her head in any direction and was very painful to move it to the left. The events occurred on 07Jan2021 -2:00 AM. Events were assessed as non-serious. No treatment was received for the events. No Covid prior vaccination. The patient was not tested for COVID after/post vaccination. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
27 2021-01-13 pain in extremity redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; ... Read more
redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on 07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
27 2021-01-14 numbness After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could n... Read more
After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl
27 2021-01-14 night sweats Body aches, chills, joint pain, night sweats
27 2021-01-14 numbness Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pa... Read more
Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better
27 2021-01-14 tremor, weakness Seizure like reaction after COVID-19 vaccine, experienced weakness and shortness of breath.
27 2021-01-14 pain in extremity arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contact... Read more
arm soreness (minor) day after; Headache (minor) day of; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1618; expiry date: unknown) via an unspecified route of administration (left arm), on 07Jan2021 at 12:15, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient has no known allergies (NKA). Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), naproxen sodium (NAPROSYN). It was unknown if the patient is pregnant at the of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 07Jan2021, at 13:00, the patient experienced headache (minor) day of. The patient experienced arm soreness (minor) day after (08Jan2021). The patient received naproxen as treatment for the events. Outcome of the events was recovered.
27 2021-01-15 discomfort, pain in extremity I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lympha... Read more
I had a mildly sore arm on Saturday 1/9/21. I awoke Sunday 1/10/21 and had suspected axillary lymphadenopathy on the same arm as my injection. No palpable lymph nodes on affected armpit. Mild discomfort with palpating the edema in the affected armpit. Took 600mg ibuprofen. Swelling continued into Monday 1/11/21, but had decreased in size
27 2021-01-15 hot flush Stomach pain, chills, low grade fever, body aches, joint pains, headache, hot flashes, fatigue
27 2021-01-15 numbness arm and leg numbness
27 2021-01-16 feeling hot Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous a... Read more
Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.
27 2021-01-17 tingling, pain in extremity Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my ... Read more
Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.
27 2021-01-17 difficulty speaking Throat swelling and chest tightness three days after administration of vaccine. Symptoms were manage... Read more
Throat swelling and chest tightness three days after administration of vaccine. Symptoms were managed with over the counter antihistamines until 1/11 when the antihistamines were not working and my throat was swollen and tight, my chest was tight and my voice was horse. I got prescribed prednisone on 1/11 and have been on a long taper of that, with scheduled benadryl, pepcid and zyrtec.
27 2021-01-17 hypersensitivity of all senses When I went to get the shot, I had a firm bump with what looked like a white head on my left arm fr... Read more
When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.
27 2021-01-18 speech disorder Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling,... Read more
Dizziness/light-headed, difficulty speaking, difficulty swallowing, mild tongue and throat swelling, constant need to clear throat, tingle/tickle in throat
27 2021-01-18 weakness, numbness, tingling Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. ... Read more
Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. Then I became dizzy and pale. I was laid down and vital signs were taken. My heart rate was in the 110s and 120s and stayed elevated for about four hours. The hives resolved and did not spread to the bilateral arm or anywhere else. The following two days I felt incredibly weak and had urinary frequency. I was told to go to the hospital by the health clinic staff but I declined.
27 2021-01-18 pain in extremity Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redn... Read more
Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redness of bandaid mark 3 days later with multiple washes.
27 2021-01-18 weakness almost had syncopal episode from weakness; almost had syncopal episode from weakness; after my secon... Read more
almost had syncopal episode from weakness; almost had syncopal episode from weakness; after my second dose, I had no until hour 12. I woke up middle of night to severe fatigue; myalgia; low grade fever; headache; swollen lymph node in L armpit; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; first dose on 19Dec2020 12:00 pm, second dose on 08Jan2021 02:00 pm; This is a spontaneous report from a contactable physician reporting for herself. A 27-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not reported) on 08Jan2021 14:00 via an unspecified route of administration in the left arm for COVID-19 immunization. There was no other relevant medical history. No unknown allergies. The patient previously received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not reported) on 19Dec2020 12:00 pm in the left arm for COVID-19 immunization and experienced some arm pain which lasted several hours and mild. Concomitant medication included sertraline, ascorbic acid (VIT C), ergocalciferol (VIT D), zinc, cetirizine hydrochloride (ZYRTEC). No other vaccine was received in four weeks. The patient had not had COVID prior vaccination, and COVID was not tested post vaccination. After the second dose on 08Jan2021 at 02:00 pm, the patient had no symptoms until hour 12. On 09Jan2021 at 12:00 am she woke up middle of night to severe fatigue, myalgia, low grade fever, headache, swollen lymph node in left armpit (injected left arm). On 10Jan2020, the patient was 36 hours out and she still had these symptoms but slowly improving, relieved more with ibuprofen vs paracetamol (TYLENOL). She also reported she did not receive treatment for the events. She stated that the myalgia, fatigue, headache were severe and she almost had a syncopal episode from weakness. The events were non-serious as reported. The outcome of the events was reported as not recovered.
27 2021-01-18 pain in extremity, weakness injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weak... Read more
injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.
27 2021-01-18 pain in extremity tested positive after receiving the vaccine; tested positive after receiving the vaccine; she did no... Read more
tested positive after receiving the vaccine; tested positive after receiving the vaccine; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; This is a spontaneous report from a contactable consumer (patient herself). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. EH9899 and expiry date Mar2021), via an unspecified route of administration on 05Jan2021 on her left arm at a single dose for covid-19 immunization. Medical history included leg pain. There was no reported concomitant medications. On an unspecified date, patient received COVID vaccine. She stated that she was symptomatic during the vaccine and somewhere after confirmed that she was COVID-positive. She wanted to know if there are any health concerns with getting the vaccine while COVID positive. She added that this was her first dose. she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst but did not think that it was a symptom. She stated that she does not recall the first time ever that she had leg pain but stated that the leg pain was really bad the night before the vaccine. She added that she was isolated until 14Jan2021. Outcome of the events drug ineffective, COVID-19 virus test positive and leg pain were unknown.; Sender's Comments: Leg pain is considered intercurrent and unrelated to suspect BNT162B2.
27 2021-01-18 weakness, migraine tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report fr... Read more
tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report from a non-contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration (left arm) on 01Jan2021 10:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that immediately after receiving vaccine (01Jan2021), the patient felt tingle in throat, severe left arm pain, dizziness, weakness, and migraine. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. No further information is expected.
27 2021-01-19 feeling hot 1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning ... Read more
1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride
27 2021-01-19 pain in extremity Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swel... Read more
Approximately 12 hours after vaccine dose: fever that lasted for 48 hours, fatigue, and extreme swelling of lymph nodes in throat, armpit, and groin. Swelling in lymph nodes of arm that received vaccine was so severe that I could not let my arm rest down by my side without throbbing pain. Pain went away after about 48-72 hours but swelling persisted for 1 week.
27 2021-01-19 numbness Facial Numbness
27 2021-01-19 hypersensitivity of all senses Fever, body aches, fatigue, sensitive to touch, headache
27 2021-01-19 pain in extremity I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine.... Read more
I started having body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine. My symptoms lasted about 12 hours and I feel completely fine now.
27 2021-01-19 flushing Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizz... Read more
Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%
27 2021-01-20 tingling 30 minutes after vaccine pt developed rash on arms and had tingling in right arm. No other symptoms... Read more
30 minutes after vaccine pt developed rash on arms and had tingling in right arm. No other symptoms. Gave 1 dose of 50mg benedryl and within 15 minutes the tingling had stopped and the rash went down. Monitored for 30 minutes and the pt was then released.
27 2021-01-20 tingling After having vaccine, had flu like symptoms. These worsened into dizziness, vertigo, nausea, cough,... Read more
After having vaccine, had flu like symptoms. These worsened into dizziness, vertigo, nausea, cough, and tilgling/palpatations. Describes brain fog and disorientation/vertigo that persists until today - day of reporting.
27 2021-01-20 pain in extremity, muscle spasms Arm pain, headache, body aches, leg cramps, fatigue
27 2021-01-20 burning sensation Bottom lip swelling with right side tongue swelling and burning Lip swelling and tongue resolved by... Read more
Bottom lip swelling with right side tongue swelling and burning Lip swelling and tongue resolved by the time of awakening next morning but left slight numbness with burning at site of lip swelling as if I had novacain from dentist.
27 2021-01-20 tenderness, hot flush I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I receiv... Read more
I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I received the vaccine I noticed some injection site tenderness, minimal swelling; has been present since. Symptoms are very mild. I started having chills and hot flashes intermittently, more hot flashes than chills, have been present since 6pm yesterday. About 9pm I had a headache, muscle aches, joint pain as well. I felt feverish but temperature was 98.6F. I also noticed some axial lymph node swelling as well on the Left side where I received the vaccine. Tender to touch, not too painful though. Since received the vaccine I have had intermittent dizzy spells as well all throughout the day. I decided to go to sleep at 10:30pm and all night I tossed and turned with a headache and hot flashes. I woke up at 7:30am and was so stiff I could barely get out of bed. I called into work as I could not stand up without have dizziness. All day so far I have had dizziness upon standing, headache, myalgia, arthralgias, hot flashes/felt feverish, swollen axial lymph nodes and all I have wanted to do today is sleep. I took a nap and when I woke up I had been sleeping for 6 hours. I finally was able to get up and drink a 32ounce cup of water and take some ibuprofen. Ate some cereal. I still have a headache and dizziness upon standing that limit my ability to do normal daily functions.
27 2021-01-20 pain in extremity Mild headache, mild dizziness, fatigue, moderate joint and muscle pain mainly in neck, shoulders, up... Read more
Mild headache, mild dizziness, fatigue, moderate joint and muscle pain mainly in neck, shoulders, upper extremities. Currently managing with rest and did not seek medical care.
27 2021-01-20 migraine Pfizer-BioNTech COVID-19 Vaccine EUA Migraines
27 2021-01-20 tingling, burning sensation Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side f... Read more
Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side face and dull tingling following three days and tinnitus bilateral worse on right ear and day four pain in both ears and TMJ and front of ear pain and sinus congestion day 6. She went to Telehealth twice personal nurse practitioner and gave Amoxil for ear pain and ENT evaluated ears,nose and throat and hearing test and covid test which exam and test normal. She stilll suffers today intermittently dull tingling right side sided of face and tinnitis both ear and headache.
27 2021-01-20 burning sensation, tingling Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side f... Read more
Reports on 1/14/2021 had Pfizer vaccine left arm and at night notice burning sensation right side face and dull tingling following three days and tinnitus bilateral worse on right ear and day four pain in both ears and TMJ and front of ear pain and sinus congestion day 6. She went to Telehealth twice personal nurse practitioner and gave Amoxil for ear pain and ENT evaluated ears,nose and throat and hearing test and covid test which exam and test normal. She stilll suffers today intermittently dull tingling right side sided of face and tinnitus both ear and headache.
27 2021-01-20 pain in extremity Sore arm right after shot and throughout the next day. Woke up in the middle of the night (around 11... Read more
Sore arm right after shot and throughout the next day. Woke up in the middle of the night (around 11:45pm)with very bad chills, nausea, and headache. Temperature at the time was 99.7. Several hours later (around 3:45am) woke up again with less chills and temperature 101.6-101.8 with headache continuing. Woke up again at 5:45am with continued fever 101.7 and headache. Took ibuprofen around 6:30am and fever dissipated around 9am. Headache still continuing but not as severe.
27 2021-01-20 pain in extremity, muscle spasms Sore arm, left axilla pain, body aches, leg cramps, headache, fatigue, neck pain. Started 12 hours a... Read more
Sore arm, left axilla pain, body aches, leg cramps, headache, fatigue, neck pain. Started 12 hours after vaccine
27 2021-01-20 burning sensation, tingling The night of my second covid 19 Pfizer shot, I began experiencing a strange sensation on the right s... Read more
The night of my second covid 19 Pfizer shot, I began experiencing a strange sensation on the right side of my face near my mouth, cheek, under my eye and on my forehead. It started as a burning sensation and then turned into a dull tingling. It was consistent for 3 days and then began to become intermittent and I still have it today 1 week post vaccine. On day 4 it progressed to tinnitus right more than left ear. Day 4 evening to day 5 was all the above plus ear pain and fullness in my right ear and just pain in the left. I contacted my PCP at this point twice ( once about the initial face symptoms day 1 and to tell her about the ears day 6) and she prescribed me amoxicillin. That night I began having sinus pressure and pain, headache, and malaise. I followed up with an ENT this morning who said everything looked structurally well and could not find a reason for the tingling. She also covid tested me which was negative. Advised me to submit this form at this time due to ongoing symptoms. I will be following up with them within the next few days for further examination.
27 2021-01-20 migraine fever; pulsating migraine; joint and muscle aches and pains; joint and muscle aches and pains; dizzi... Read more
fever; pulsating migraine; joint and muscle aches and pains; joint and muscle aches and pains; dizziness; fatigue; First dose on 21Dec2020, second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular at Left arm on 06Jan2021 15:15 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included swine flu. Concomitant medications included buspirone, venlafaxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR), ethinylestradiol, levonorgestrel (AVIANE) for birth control, plantago ovata fibre (FIBER SUPPLEMENT), probiotics and women's multi-vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historic vaccine included first dose of BNT162B2 (lot number: EL0140), Intramuscular at left arm on 21Dec2020 15:15 for covid-19 immunization. On 07Jan2021 11:00, the patient experienced fever, pulsating migraine, joint and muscle aches and pains, dizziness, fatigue - absolutely could not have went to work if she was scheduled that day - just moving from her left side onto her right side took immense effort and tears - haven't experienced anything like it since she had swine flu. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events fever, pulsating migraine, 'joint and muscle aches and pains', dizziness, fatigue was recovered on an unknown date in Jan2021.
27 2021-01-20 weakness flu; HR was higher than normal; fever; felt weak; dry cough; headache; muscle and joint pains; muscl... Read more
flu; HR was higher than normal; fever; felt weak; dry cough; headache; muscle and joint pains; muscle and joint pains; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received the second dose of bnt162b2, intramuscular in the left arm, from 12Jan2021 09:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at vaccination. Medical history included GERD (gastroesophageal reflux disease) and barrett's esophagus. Historical Vaccine included 1st dose of BNT162B2 on 24Dec2020 via intramuscular in the right arm for COVID-19 immunization. Concomitant medications included melatonin, pantoprazole sodium sesquihydrate (PROTONIX), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS), and algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON). On 13Jan2021 03:00, the patient felt like she had a flu; her HR was higher than normal, felt like she had a fever, felt weak, developed a dry cough, headache; and muscle and joint pains. The outcome of events was recovered. The patient did not receive any treatment for the events. Information on the lot/batch number has been requested.
27 2021-01-20 numbness left arm started tingling; roof of my mouth started tingling then my tongue started tingling and fel... Read more
left arm started tingling; roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger; heart palpitations; lower half of my face went numb; Right eye also felt weird like vibrating; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 23Dec2020 15:30 at single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing prior to vaccination of BNT162B2. Concomitant medication included ibuprofen (ADVIL), ibuprofen and escitalopram oxalate (LEXAPRO). The patient stated, "my left arm started tingling and it was very strong by my finger tips" on 23Dec2020 03:45 PM. The patient stated, "then the roof of my mouth started tingling then my tongue started tingling and felt like it was getting a little larger. Then I got heart palpitations. The mouth tingling went away in ten minutes but then 15 minutes later the lower half of my face went numb and that lasted about 10 minutes. Right eye also felt weird like vibrating" on 23Dec2020. No treatment received for the adverse events. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events were considered non serious as it did not result in death, were not life threatening, did not cause/prolonged hospitalization, were not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovered on unspecified date.
27 2021-01-20 weakness, pain in extremity low grade fever of 99.4; sore joint pain on my knuckles and my wrist; felt kind of off and weak; fel... Read more
low grade fever of 99.4; sore joint pain on my knuckles and my wrist; felt kind of off and weak; felt kind of off and weak; Arm was a bit sore for 3 days; mild headache; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on the left arm on 20Dec2020 16:15 at a single dose for covid-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Patient is not pregnant. Concomitant medication included fluoxetine taken from an unspecified date for an unspecified indication. On the second day of the vaccine (21Dec2020 10:00), the patient had a low grade fever of 99.4 (no unit reported), had sore joint pain on her knuckles and her wrist, felt kind of off and weak, her arm was a bit sore for 3 days and she also had a mild headache that would come and go. No treatment was received for the reported events. The outcome of the events was recovered.
27 2021-01-21 tremor Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), m... Read more
Chills, headache, nightmares, low fever, plantar fasciitis, shaking, low 02(94), high pulse (120), muscle pain, eye pain, fatigue, fogginess
27 2021-01-21 tingling, numbness, weakness Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING... Read more
Neuropraxia of Left Arm; A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS This is a report from an interventional study source for Protocol C4591001 sponsored by BioNTech, managed and reported by Pfizer on the sponsor's behalf. The subject is in open-label phase of the study when the event occurred. A 27-year-old female with a medical history of seasonal allergies (Mar2006 and ongoing not taking any medications to treat) who received the first dose of blinded therapy (BNT162;PLACEBO) (dose 1) on 14Aug2020 at 10:34, second dose of blinded therapy (BNT162;PLACEBO) (dose 2) on 04Sep2020 at 09:27. The first dose of BNT162B2 (dose 3) on 23Dec2020 at 09:25, and the second dose of BNT162B2 (dose 4) on 11Jan2021 at 09:48. All intramuscularly in the left deltoid as a single dose for COVID-19 immunization. Concomitant medications included ethinyl-estradiol/norethisterone acetate (LOESTRIN) for birth control from May2014 and ongoing. There was no family medical history relevant to AE and no concomitant vaccine administered on the same date of investigational vaccine or other prior vaccine within four weeks. The subject experienced neuropraxia of left arm on 11Jan2021 at 09:51 considered an important medical event requiring a visit to physician office. The clinical course was the following: At 9:51, 3 minutes after receiving the second dose of BNT162B2 in left deltoid, the subject complained of left arm numbness and tingling starting at elbow and extending to fingers, weakness, and a weak grip in that hand. She also reported a decreased range of motion on the left side including her arm, shoulder joint, elbow, wrist, and metacarpophalangeal. Subject was afebrile with a normal vascular exam, no bruising, capillary refill time was less than 3 seconds. No antipyretic medication was administered. The investigator requested the subject to return to site the following day. On 12Jan2021, the investigator noted some improvement to symptoms but the subject was unable to return to work for several days after event. An appointment was scheduled with a neurologist for 13Jan2021. The action taken with BNT162B2 for the event was not applicable. The clinical outcome of the event was recovering. The investigator considered there was a reasonable possibility that the event neuropraxia of left arm was related to the second dose of BNT162B2 (dose 4) and clinical trial procedure (vaccination administration in the left deltoid, investigator did consider the location was appropriate), but unrelated to first and second dose of blinded therapy (BNT162;PLACEBO), first dose of BNT162B2 (dose 3) or concomitant medications. Per investigator, it was not likely that the event was related to the investigational product (IP) itself, however, that could not be 100% determined until neurologist had evaluated the subject.; Sender's Comments: The event "Nerve Injury" is unlisted in the Single Reference Safety Document (SRSD) of the Investigational Product therapy vaccine (BNT162B2). There is a reasonable possibility for the event "Nerve Injury" to be related to the procedure of vaccine (BNT162B2) administration (needle trauma) rather than to the product administered. The event would not be considered a unique response to this specific vaccine (BNT162B2). The case will be reassessed upon reception of neurological advice. Pfizer's safety database was reviewed for cases reporting PF-07302048 or blinded therapy through 31-DEC-2020 for adverse events encoding to MedDRA (v.23.1J) Preferred Term(s) of Nerve injury. Review of the database for the PT Nerve injury had the following results: 0 serious clinical trial cases and 1 non-clinical trial case. The impacts of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committee and Investigators, as appropriate.
27 2021-01-21 weakness Pt received dose#2 and c/o allergic reaction with faster onset. Pt reported dizziness/neck stiffness... Read more
Pt received dose#2 and c/o allergic reaction with faster onset. Pt reported dizziness/neck stiffness and right sided headache, nausea. States feels weak on the right side but no numbness. No slurred speech. No facial asymmetry. Pt denies any SOB/throat tightening. Dizziness less severe this time per patient. She was dizziness for 3 days with dose #1. Patient was discharged at 2112.
27 2021-01-22 feeling hot, cold sweat Had itching at site immediately rash above site developed later in the day. About 10 minutes after i... Read more
Had itching at site immediately rash above site developed later in the day. About 10 minutes after injection developed nausea then felt very hot became clammy and sweaty. Felt lightheaded became pale had to played down on the ground.
27 2021-01-22 feeling cold I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about... Read more
I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about 20 minutes, I developed a burning sensation at the injection site. Approximately 30 minutes following the vaccine, I began experiencing an intense itching and hives of my opposite forearm. Then shortly after, my shins and front of ankles started itching. I began getting little bumps with an itch to several other areas of my body, also including redness and itchiness of one side of my face. At about 40 minutes, I also experienced a cold sensation felt at the injection site, almost like what it feels like after removing an ice cube from the skin. The itching of my skin on several areas of my body persisted for about an hour and a half. The welts and itchiness almost completely subsided at about the 2 hour mark. I did take two benedryls once I got home which was about an hour and a half after the injection. Today, the following day after injection, the bumps and itchiness are still no longer present. I have been experiencing a very sore arm at injection site and extreme exhaustion today though.
27 2021-01-23 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA I got the first dose on 1/20/2021, and the side effects occurre... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I got the first dose on 1/20/2021, and the side effects occurred on 1/21/2021. My left arm was so painful that I couldn't raise it. I felt dizzy and got a fever in the afternoon. The temperature is around 101?. Then I took some Ibuprofen and I recovered the next day.
27 2021-01-24 hot flush SEVERE shortness of breath (basically hyperventilating) for 2-3 hours, very sharp pains/heartburn in... Read more
SEVERE shortness of breath (basically hyperventilating) for 2-3 hours, very sharp pains/heartburn in the chest when trying to take a deep breath, nausea, vomiting, diarrhea, joint pain, fatigue, chills/hot flashes, sudden uncontrollable fatigue (deep sleep for 2-3 hours after)
27 2021-01-25 pain in extremity Body aches, low grade fever, nausea, vomiting, diarrhea, HA, arm soreness
27 2021-01-25 migraine I developed a migraine the evening of Jan 20 and began to experience chills before bed around 8-9pm.... Read more
I developed a migraine the evening of Jan 20 and began to experience chills before bed around 8-9pm. At that time, my temperature was 99.8. I took my daily PM and migraine medication as prescribed, with no relief. Approximately 2 hours later I took the second dose of my migraine medication and rechecked my temp, it read 101.2. Around 8am Jan 21 I felt fatigued, still had a migraine, and my temp was up to 101.8. I took 2 tablets of Tylenol to reduce my fever. I did not go into work. Around 12pm my fever reached 102.1 and remained there throughout the day and I took Tylenol as described on the bottle. My migraine was greatly diminished by the evening and I did not take more migraine medication. On Jan 22 I again did not go into work. At approximately 9am my fever was at 101.2 and I called my primary care's office to seek advice about a COVID test. I did not request additional care, but the nurse recorded my symptoms and advised I was able to get tested even with the slight fever. At 2pm both fever and migraine were gone. I was tested on Jan 22 at 10am at a site, my results were negative.
27 2021-01-25 pain in extremity Systemic: Generalized Body Aches -Mild, Systemic: Other- injection given in left arm and patient com... Read more
Systemic: Generalized Body Aches -Mild, Systemic: Other- injection given in left arm and patient complained of muscle soreness of right thigh. Patient had also reported side effects to previous vaccines but did not note it on the consent form.
27 2021-01-25 feeling hot Warm sensation all over and itching 25 minutes after vaccine given
27 2021-01-26 flushing, feeling jittery Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with sym... Read more
Felt dizzy and jittery and flushed. HR elevated by NSR. Monitored for greater than 1 hour with symptoms occurring on and off during that period. At 1025 she felt flushed again with report of scratchy throat. No distress noted. Oxygen sats 100%. No itching or hives noted. No swelling of the face or airway but since she continued to have symptoms she was placed in wheelchair and taken to the ER.
27 2021-01-26 numbness, facial pain, face paralysis I had sudden onset moderate left facial pain then mild weakness and numbness on the left side of my ... Read more
I had sudden onset moderate left facial pain then mild weakness and numbness on the left side of my face. It?s slightly better now but has not resolved. It started about 3 hours after my vaccine. No other symptoms.
27 2021-01-26 pain in extremity Severe L arm pain starting the day of injection. Additionally, L arm weakness. Worse pain and weakne... Read more
Severe L arm pain starting the day of injection. Additionally, L arm weakness. Worse pain and weakness for the first week after injection, but pain and weakness still present at the time of submission (>2 weeks from injection)
27 2021-01-26 pain in extremity Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pai... Read more
Sore arm for 3 days, chills for 7 hours, and uncontrollable lower back, hip joint, legs and neck pain/ache for 24 hours straight.
27 2021-01-26 pain in extremity The only symptom that I noticed was a lot of pain in my joints, especially in my right hand. after t... Read more
The only symptom that I noticed was a lot of pain in my joints, especially in my right hand. after three days symptom disappeared.
27 2021-01-28 tremor, feeling hot, feeling cold, flushing Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore thro... Read more
Feeling hot and flushed then suddenly so cold I was shaking. Massive headache, body aches, sore throat, cough, congestion, and sinus pressure.
27 2021-01-28 feeling hot Myalgias several hours later . Evening worsened myalgias, shivering, "burning up", no fever, head... Read more
Myalgias several hours later . Evening worsened myalgias, shivering, "burning up", no fever, headache, back pain, palpitations, left axillary lymph nodes pain, next day "peach pit size", this has improved . bilateral inguinal pain "a week for symptoms to resolve"
27 2021-01-28 tingling, feeling cold Staff described feeling tingles and coldness in extremities especially arms. Also became tachycardic... Read more
Staff described feeling tingles and coldness in extremities especially arms. Also became tachycardic. Emergency service called and epi-pen administered per instruction. Staff left via ambulance for evaluation. Appeared stable at time of departure.
27 2021-01-29 difficulty speaking While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling... Read more
While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling, and tingling of tongue and lips. Redness was in face, chest and right arm. Client denied difficulty breathing or throat tightness. Client reported at this time "significant hx of anaphylactic reaction." This was not noted clearly on screening form signed by client. Client given 50 mg Benadryl per standing order due to symptoms. Epinephrine was not given. 911 was called. Client vitals remained stable with slightly elevated blood pressure ate 140/102. EMS arrived before repeat vitals were taken. Lung sounds were clear and equal bilaterally. Report was given to EMS and care transferred.
27 2021-01-30 feeling cold, tremor, hot flush, pain in extremity Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as ... Read more
Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.
27 2021-01-31 weakness 1/27 , 13 hours after vaccination (dose #2), 2:30am- strong rigors. Temp 102 1/27-1/28 SEVERE pain... Read more
1/27 , 13 hours after vaccination (dose #2), 2:30am- strong rigors. Temp 102 1/27-1/28 SEVERE pain on the top and back of head, neck pain, and back pain. Pain untouched by consistent 1000mg tylenol and 600mg iburpofen. Also, generalized joint and muscle pain + weakness. I was unable to sit up these days. 1/27-1/29 Fevers for 3 days straight. Unable to get temperature below 99.8 even with Tylenol. Alternated 600mg Ibuprofen and 1000mg Tylenol. 1/28-1/29 Diarrhea - 5-6 bowel movements
27 2021-01-31 difficulty speaking ?Pfizer-BioNTech COVID-19 Vaccine EUA? Pt had red streaking to arm near injection site approximatel... Read more
?Pfizer-BioNTech COVID-19 Vaccine EUA? Pt had red streaking to arm near injection site approximately 10 minutes after injection, then also had chest tightness and felt like her voice had changed. Was given 50mg of benadryl by EMS with near immediate improvement of her symptoms but pt referred to ED. Pt arrived at ED and felt improved, no redness noted to site, no hives or rash noted on exam. Discharged home
27 2021-01-31 tremor Headache right after vaccine was administered. Approximately 40min after vaccine was administered I... Read more
Headache right after vaccine was administered. Approximately 40min after vaccine was administered I had severe dry mouth, inability to swallow, at about an hour after vaccine was administered my lips tongue and throat were swelling. Diarrhea, chills, dizziness, severe tremors.
27 2021-01-31 numbness, tingling RECEIVED 2ND DOSE OF PFIZER COVID VACCINE TODAY AT 4:15PM. APPROX 5 MINUTES LATER REPORTED NUMBNESS/... Read more
RECEIVED 2ND DOSE OF PFIZER COVID VACCINE TODAY AT 4:15PM. APPROX 5 MINUTES LATER REPORTED NUMBNESS/TINGLING IN 2 FINGERS (PINKIE AND RING FINGERS). NO ALLERGIES, ON NO MEDICATIONS, NO REPORTED USE OF CAFFINE TODAY, NO H/O ADVERSE REACTIONS AFTER 1ST DOSE OR OTHER VACCINATIONS. 5 MIN LATER SENSATION HAD ADVANCED TO ALL 5 FINGERS. ABOUT 4:35PM HAD ADVANCED TO WRIST BUT THE NUMBING/TINGLING SENSATION WAS "MUTED" OR REDUCED. EXAMINED INJECTION SITE AND NO REDNESS. PERFECT DELTOID PLACEMENT SO NO SUSPECTED NERVE DAMAGE DUE TO INJECTION. NO H/O CIRCULATORY DISEASES OR NERVE IMPAIRMENTS. H/O 2 MIGRAINES. NO REPORTED SHORTNESS OF BREATH OF ORAL NERVE CHANGES. MIGRAINES CAN HAVE TINGLING IN HANDS AS A SYMPTOM OF "AURA". PT HAS ONLY HAD 2 MIGRAINES IN LIFE AND NO REPORTS OF PRODROMAL/AURA SYMPTOMS. REVIEWED TREATMENT IF HEADACHE ONSET TO TAKE TYLENOL AND IBUPROFEN. PT ASKED ABOUT EXCEDRIN AND WE DISCUSSED POSSIBLE WORSENING OF H/A W/ CAFFINE IF H/A IS DUE TO VASOCONSTRICTION. MONITORED PT UNTIL 4:55PM. SHE FELT COMFORTABLE LEAVING AND WOULD REPORT WORSENING TO URGENT CARE. WILL CALL AND F/U W/ PATIENT TOMORROW. REPORTS OF TINGLING PT REPORTED NO ISSUES W/ BREATHING DURING MONITORING PERIOD BUT WOULD CALL URGENT CARE IF DEVELOPED. TINGLING IN HANDS ALSO REPORTED W/ ACTUAL COVID INFECTION. PT HAS NO H/O INFECTION AND TESTS WEEKLY IN NURSING HOME. AS TINGLING IN HANDS CAN ALSO BE SIGN/SYMPTOMS OFANXIETY DISCUSSED H/O ANXIETY. SHE REPORTS ONLY MINOR ANXIETY LIKE BEFORE TESTS. NO DIAGNOSIS OF ANXIETY. SHE INQUIRED ABOUT CAMOMILE TEA AND I SAID THAT WOULD BE FINE AND WARM FLUIDS COULD DILATE AND HELP WITH BLOOD FLOW.
27 2021-01-31 feeling of body temperature change Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt lik... Read more
Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt like she was running a fever but was not. She was hot and cold during the night; it burns; felt hot and cold; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 at single dose at left arm for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. On 17Jan2021, the patient experienced skin feels like she rubbed icy hot all over her body, like if she scratched or touch it, it burns. There is no redness or rash. Her work just sent her home because she is required to wear an N95 mask. Her breath against the mask makes it feel like her face is on fire and she cannot wear it. She felt like she was running a fever but was not. She was hot and cold during the night, but her temperature was 98 degrees Fahrenheit. She just took Benadryl and they sent her home. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination. Information on lot/batch number has been requested.
27 2021-02-01 pain in extremity Arm soreness, Emesis, Nausea, Urge to vomit for 24 hours, Insomnia, Lethargy, Body aches, Diarrhe... Read more
Arm soreness, Emesis, Nausea, Urge to vomit for 24 hours, Insomnia, Lethargy, Body aches, Diarrhea
27 2021-02-01 numbness Left eye being swollen almost shut with some clear discharge; Left eye being swollen almost shut wit... Read more
Left eye being swollen almost shut with some clear discharge; Left eye being swollen almost shut with some clear discharge; Half of the right side of her face was swelling and being numb; Half of the right side of her face was swelling and being numb; On and off chills; Sweating; Headache; Fever; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1685), via an unspecified route of administration in left arm, on 31Dec2020 at 09:30, at a single dose, for COVID-19 immunization. The patient's medical history included enlarged thyroid (normal for her), painful menstruations, allergies to cats, dogs, and dust, seasonal allergies, and birth control. The patient's concomitant medication included ethinylestradiol/ norethisterone acetate (JUNEL) as birth control. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 12Jan2021 at 06:15 AM, the patient woke up from sleep with her left eye being swollen almost shut with some clear discharge and half of the right side of her face was swelling and being numb. This persisted for about 3 days with on and off chills, sweating, headache, and a fever on 12Jan2021 (06:15). The symptoms completely dissipated on 22Jan2021. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the events. The patient got a COVID-19 test on 13Jan2021 just to be safe which came back as negative. The patient recovered from the events on 22Jan2021.
27 2021-02-01 flushing the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist. A 27-y... Read more
the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 10Jan2021 at single dose for COVID-19 immunization; and diphenhydramine hcl, via an unspecified route of administration from an unspecified date at unknown dose for premedication. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2, lot number: EL0140, via intramuscular in left arm on 20Dec2020 at single dose for COVID-19 immunization and experienced itching. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was pre-medicated with diphenhydramine prior to the second dose of the COVID-19 vaccine. 9 minutes after the vaccination on 10Jan2021, the patient felt itchy and flushed then received oral dexamethasone as treatment for the events. The patient was sent out with oral dexamethasone home. The outcome of the events was recovering. The action taken in response to diphenhydramine hcl for the events was unknown.
27 2021-02-02 numbness Instant facial numbness on left , head rush, and chest pain. fever began 12 hours after injection co... Read more
Instant facial numbness on left , head rush, and chest pain. fever began 12 hours after injection coupled with body pains and general feelings of being unwell.
27 2021-02-02 feeling hot Patient complains of feeling hot and feverish but chilled. Pt states she has some mild tightness in... Read more
Patient complains of feeling hot and feverish but chilled. Pt states she has some mild tightness in her right chest and feels dizzy. She is diaphoretic. BP 136/88; HR 81; RR 15; Oxygen 100%; Temp 99.2 F
27 2021-02-02 tingling Severe headache that made face and neck and arms tingle, stiff neck, pressure in face, head, eyes, n... Read more
Severe headache that made face and neck and arms tingle, stiff neck, pressure in face, head, eyes, neck and arms; bodily aches; fatigue (these symptoms do happen to me occasionally due to pre-existing fibromyalgia, however after the 2nd vaccine dose these symptoms were the most intense I had ever experienced); nausea
27 2021-02-03 muscle twitching Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; Arm that was... Read more
Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; Arm that was injected feels weaker with muscle twitching over 1 week after vaccination; menstrual cycle was lighter and shorter than usual; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK9231/expiration date: not provided), via an unspecified route of administration, on 10Jan2021 (at the age of 27 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included GERD. The patient previously received the first dose of BNT162B2 on 20Dec2020 at 02:30 PM (at the age of 27 years old) as a single dose via intramuscular route of administration in the left arm for COVID-19 IMMUNIZATION. Concomitant medications included vitamin D3, cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), and fluticasone propionate (FLONASE). The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jan2021, the patient experienced her arm that was injected feels weaker with muscle twitching over 1 week after vaccination and her menstrual cycle (that is usually regular each month) beginning 17Jan2021 was lighter and shorter than usual. The patient did not receive any treatment for these events. The outcome of the events arm that was injected feels weaker with muscle twitching and menstrual cycle was lighter and shorter than usual was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
27 2021-02-03 pain in extremity, weakness Body aches ( lower leg pain) Chills Weak Mild Headache
27 2021-02-04 discomfort By 10am the day after vaccine the fever broke and I was just left with fatigue; 10 hours after vacci... Read more
By 10am the day after vaccine the fever broke and I was just left with fatigue; 10 hours after vaccine I started with a fever that climbed to 103.3F overnight; This was joined by chills; This was joined by chills and body/joint discomfort as well as headache; body/joint discomfort; headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection lot number: EL8982), intramuscular at left arm on 21Jan2021, 08:15 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism, penicillins allergy and COVID-19 diagnosed on an unspecified date prior to vaccination. The patient's concomitant medications included levothyroxine, minerals nos, vitamins nos (PRENATAL VITAMIN), and riboflavin. The patient was not pregnant at the time of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK9231) on 30Dec2020, 12:30 PM at left arm for COVID-19 immunization. The patient has not been tested for COVID-19 since vaccination. On 21Jan2021 18:00 (10 hours after vaccine), the patient started with a fever that climbed to 103.3F overnight. This was joined by chills and body/joint discomfort as well as headache. By 10am the day after vaccine (22Jan2021), the fever broke and she was just left with fatigue. No treatment was given for the events. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events were recovering. The events were non-serious.
27 2021-02-04 pain in extremity Intense body aches, pain from arm caused to wake from sleep, difficultly raising arm above head, str... Read more
Intense body aches, pain from arm caused to wake from sleep, difficultly raising arm above head, strong headache that did not go away with Tylenol
27 2021-02-04 pain in extremity Sore right arm Headaches Muscle aches Right armpit painful Tiredness Irritability Lack of appetite
27 2021-02-04 pain in extremity The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp bef... Read more
The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp before taking antifebrile medication at 100.8 F. At the site of injection on my left arm there was a red mark and slight swelling, left arm felt weak and sore. Overall sense of unwell lasted for two days.
27 2021-02-04 pain in extremity arm soreness, body aches, neck/back pain, headache, chills/sweats and fatigue
27 2021-02-05 flushing Client upper arms flush red and chest. Is complaining of feeling warm and headache. EMS evaluated B... Read more
Client upper arms flush red and chest. Is complaining of feeling warm and headache. EMS evaluated Bp122/90, lung sounds clear. Instructed to either see PCP or go to ER. Client called Dermatologist and showed her doctor her chest in between EMS check. Derm. doctor instructed her to take benadryl Client to be driven home by family. Instructed if does not improve with benadryl to go to ER.
27 2021-02-05 feeling cold, feeling hot Patient had a hot/cold sensation. She felt both hot and cold at the same time. She had chills and fe... Read more
Patient had a hot/cold sensation. She felt both hot and cold at the same time. She had chills and felt "off." This occurred less than three minutes after receiving the Pfizer vaccine. These symptoms lasted for approximately 30 minutes. A couple of years ago she passed out after receiving the HPV vaccine.
27 2021-02-05 tingling body wide parastesias
27 2021-02-06 tingling, pain in extremity Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swell... Read more
Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swelling began near elbow, redness and pain followed and immobility. Visited ER on 2/3/21 and diagnosed with superficial thrombophlebitis
27 2021-02-08 muscle spasms, pain in extremity lower back pain, worsened to thighs, spasms developed. Unable to walk, Ketorolac injection, predniso... Read more
lower back pain, worsened to thighs, spasms developed. Unable to walk, Ketorolac injection, prednison, and flexeril. 2 days later on 12/25/2021, symptoms resolved.
27 2021-02-09 bell's palsy, numbness, facial pain first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles... Read more
first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info
27 2021-02-10 numbness About forty minutes after receiving vaccine the patient noticed numbing starting in her pinky finger... Read more
About forty minutes after receiving vaccine the patient noticed numbing starting in her pinky finger. The numbing radiated up her whole arm up to her jaw. This lasted about two hours and then stopped. Patient did not seek any additional treatment. No numbing has continued or started since the first incident.
27 2021-02-10 pain in extremity Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the n... Read more
Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the night that traveled up my forearms. On a scale from 1-10 the pain was about a 7. After the first dose, the pain went away in the morning and I was fine. On the third day after the second dose, I woke up with a rash all over my body and again had pain throughout the night only this time I woke up with swollen hands. It?s now been two weeks since my second dose and I am still experiencing hand pain, though improving. My hands feel sore and tight.
27 2021-02-11 feeling cold I took my second dose of the vaccine (Pfizer) on February 8, 2021. I started to get a headache later... Read more
I took my second dose of the vaccine (Pfizer) on February 8, 2021. I started to get a headache later that evening and later that night I started to get chills and feel very cold with aches. I was exhausted and still had a headache as well. That morning on the 9th I had to call out, I still felt achy with a headache that lasted all day. I contacted my supervisor and also employee health. I then again had to call out on the 10th because of nausea and a headache that persisted that morning. It wasn't until later that day on the 10th that I felt better than the previous day. I also contacted my supervisor again and employee health.
27 2021-02-14 feeling of body temperature change, feeling cold, pain in extremity 12 hours after shot, woke up in the middle of the night with chills, body aches, very sore/swollen a... Read more
12 hours after shot, woke up in the middle of the night with chills, body aches, very sore/swollen arm, headache, slight fever (100.4 degrees), fatigue. 12 hours after the symptoms first started, the headache, body aches, fever, chills ceased but intense fatigue, sore/swollen arm, and body changing from hot to cold to hot persisted. I also noticed at about 30 hours when I was showering that I had swollen lymph nodes the size of golf balls in my left armpit when I raised my arm above my head. Now, 45 hours later I feel more like myself but the sore arm and swollen lymph nodes still persist.
27 2021-02-14 feeling jittery, flushing scratchy throat; Felt dizzy; jittery; flushed; HR elevated by NSR; This is a spontaneous report from... Read more
scratchy throat; Felt dizzy; jittery; flushed; HR elevated by NSR; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247), intramuscularly at the right arm, on 25Jan2021 08:45, at single dose, for covid-19 immunization. Medical history included ongoing acne; no known allergies. Concomitant medication included a prescription medicine for acne. The vaccine was received in a workplace clinic. The patient felt dizzy, jittery, flushed and, heart rate (HR) elevated by normal sinus rhythm (NSR). All these adverse events happened on 25Jan2021 09:15. She was then monitored for greater than 1 hour with symptoms occurring on and off during that period. At 10:25 on 25Jan2021 she felt flushed again with report of scratchy throat. No distress noted; oxygen sats was 100% on 25Jan2021; no itching or hives noted; and no swelling of the face or airway. Since she continued to have symptoms, she was placed in a wheelchair and taken to the emergency room (ER). No treatment was received for these adverse events. At the time of the report, the patient recovered from the adverse events on Jan2021.
27 2021-02-15 pain in extremity 1st dose- left arm pain, especially when lifting arm, starting 6 hours later and most intense at 12 ... Read more
1st dose- left arm pain, especially when lifting arm, starting 6 hours later and most intense at 12 hours later, pain gone in 24 hours; 2nd dose- pain under left armpit/ lymph node, started 24 hours after 2nd dose, ongoing
27 2021-02-15 burning sensation Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade... Read more
Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade on the side where the vaccine was injected). Painful sunburn sensation for the first day or two after presentation, but has lessened to more of an irritation 11 days later. Definitely still present though. No visible rash or marks.
27 2021-02-17 feeling hot, discomfort fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling ... Read more
fever 120; vomit to dehydration point; vomit to dehydration point; a lot of discomfort; hot feeling inside of my body like I was burning; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot unknown: true) via an unspecified route of administration at arm right on 03Feb2021 at a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: brand: Pfizer; lot unknown: true) at left arm on 13Jan2021 at 04: 45 PM at a single dose for COVID-19 immunization. Other medical history included asthma and known allergies: penicillin. Concomitant medications the patient received within 2 weeks of vaccination included ascorbic acid (VITAMIN C) and multivitamins for women. No other vaccine in four weeks. 2 hours after vaccination the patient started with fever 120 (no units specified) and a lot of discomfort; early morning she had vomit to dehydration point, hot feeling inside of her body like she was burning. She went to urgency room. Treatment received for the adverse event included received electrolytes for dehydration and ondansetron (ZOFRAN, reported as Zofram). The event start date was reported on 03Feb2021 at 01:15 PM. The outcome of all events was resolving. No COVID prior vaccination and no COVID tested post vaccination.
27 2021-02-22 numbness After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left finger... Read more
After receiving the first dose of the Covid-19 vaccine, I started feeling numbness in my left fingers within seconds. The injection site with in my left arm. Within 5 minutes, I felt some numbness in my lower lip on the right side. Within a few days, the numbness decreased along with my other, more common symptoms, such as fatigue and headache.
27 2021-02-24 tingling A few minutes post vaccination, patient complained of her ears burning, left arm was tingling. Vita... Read more
A few minutes post vaccination, patient complained of her ears burning, left arm was tingling. Vitals taken, MD on site assessed patient, oral Benadryl given. Patient remained in clinic for approx. 45 minutes. Symptoms improved somewhat, reassessed by MD and was discharged to home via personal vehicle with spouse.
27 2021-02-25 feeling hot Chest tightness, warm throat, chills
27 2021-02-25 muscle spasms Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week pa... Read more
Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week passed, was admitted to hospital for dehydration and to make sure GI problems were nothing more serious
27 2021-02-25 feeling cold, facial paralysis Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freez... Read more
Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.
27 2021-02-25 flushing anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, ... Read more
anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, nausea, dizziness,
27 2021-02-27 numbness Approximately 2 hours after vaccination, patient went to lunch and noted her face was numb, and coul... Read more
Approximately 2 hours after vaccination, patient went to lunch and noted her face was numb, and could not feel when she chewed. Denies shortness of breath, chest pain, wheezing, or rash
27 2021-02-27 flushing Nausea, emesis, facial flushing, HA. Cleared by EMS
27 2021-02-27 pain in extremity arm soreness 3 hrs after vaccination; fatigue, chills, and frontal headache, and body aches began 6-... Read more
arm soreness 3 hrs after vaccination; fatigue, chills, and frontal headache, and body aches began 6-8 hours after vaccination; sweats and fevers began 10-12 hours after vaccination and lasted 24hours after start of fevers; lightheadedness and near syncopal event 20hrs after vaccination; severe nausea around 20 hours after vaccination. Took 500mg Tylenol every few hours with very minimal relief. Fevers remained around 100-102 with medication.
27 2021-02-28 flushing, weakness, cold sweat Headache, Cold sweats, flushing, weakness, painful joints, extreme fatigue starting 2 hours post vac... Read more
Headache, Cold sweats, flushing, weakness, painful joints, extreme fatigue starting 2 hours post vaccine lasted 24 hours All symptoms have subsided except for worsening constant headache and joint pain more than 2 weeks post vaccine.
27 2021-02-28 numbness Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus ... Read more
Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus causing loss Of blood flow to my hand and feeling
27 2021-02-28 pain in extremity body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable cons... Read more
body aches; headache; chills; arm soreness; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on Jan2021 12:00 PM for covid-19 immunization on the left arm, also at age of 27-year-old. The most recent COVID-19 vaccine facility type was Workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headache, chills, arm soreness on Feb2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
27 2021-03-01 pain in extremity After the vaccine client started c/o seeing spots, feeling dizzy and "almost passing out". She was g... Read more
After the vaccine client started c/o seeing spots, feeling dizzy and "almost passing out". She was given water to drink, a snack and to relax. She was not given any medications. Vital signs stable. No problems since except a sore arm.
27 2021-03-01 cold sweat, tremor Shivers and shakes starting 9 hours after 2nd dose (Fri). Fever of 99.9 the next morning (Day 2 - Sa... Read more
Shivers and shakes starting 9 hours after 2nd dose (Fri). Fever of 99.9 the next morning (Day 2 - Sat) with cold sweats and shakes all day. On day 3 (Sun), no fever but still extreme exhaustion and tiredness. Throwing up also started on Day 2 around 2pm and could not keep anything down. On day 4 (Mon), still extreme exhaustion that lasted until about noon. Was finally able to eat something at noon and felt back to normal by 2pm on Monday.
27 2021-03-02 flushing Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled sto... Read more
Angioedema; swelling; Difficulty breathing; Tight chest; Facial flushing; Dry eyes and unsettled stomach; Dry eyes and unsettled stomach; This is a spontaneous report from a contactable nurse. A 27-years-old non-pregnant female patient started treceive bnt162b2 (BNT162B2), Lot number: EL9266, intramuscular in left arm on 15Feb2021 at 0900 (at the age of 27 years-old) for COVID-19 immunzation. The vaccination was administered at a workplace clinic. Medical history included Allergy/Sports-Induced Asthma, Lactose Intolerant and food allergies of Kiwi, Lactose Intolerant, Cherry. The patient had a positive COVID-19 test prior to vaccination on 14Nov2020. There was no other vaccinations given within 4 week and concomitant medications within 2 weeks included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), fish oil (FISH OIL). On 15Feb2021 at 10:00, the patient experienced Angioedema/swelling, Difficulty breathing/tight chest, facial flushing, dry eyes and unsettled stomach. Experienced symptoms of flushing 1hour post-vaccination. The clinical course was as follows: She reported that she experienced symptoms of flushing 1hour post-vaccination. About 4 hours later swelling persisted and took Zyrtec to alleviate symptoms, which provided minimal relief. 24 hours post vaccination resulted in ER admission advised per Occupational Medicine at (name). IV SoluMedrol, Bendaryl and Pepcid administered. Overall stay in ER 3 hours. On 17Feb2021, 24 hours post admission rebound symptoms occurring with facial flushing and swelling. Will repeat allergy medication to relieve symptoms PRN. The clinical outcome of the events was recovered with sequalae (as reported by patient: recovered with lasting effects).
27 2021-03-02 feeling hot My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke ou... Read more
My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
27 2021-03-02 tingling Swelling underneath the chin, initially had tingling in the area before swelling started
27 2021-03-03 flushing, pain in extremity Malaise, fatigue, flushed face, sore arm. Lasted about 12 hours
27 2021-03-04 throat numbness She felt numbness in the throat, the impression was that her throat was closing up. she was also diz... Read more
She felt numbness in the throat, the impression was that her throat was closing up. she was also dizzy/lightheaded. her heart beat was up. she felt her heart racing as she described. Patient took self adminstered benadryl liquid, 20 minutes after the shot, 25 mg, then after 5 minutes she took another 12.5 mg. EPIPEN administered after 40 minutes of vaccine administration. 911 was called. She was shaky for 10-15 minutes after the epipen then the shakiness stopped. paramedics checked blood pressure, was normal: 120/80 as I recall. paramedica checked her oxygen saturation and it was fine. Patient didn't want to go to the hospitals , I stayed for an extra 45 minutes after using the epipen, she was normal.
27 2021-03-06 pain in extremity Arm soreness, tiredness
27 2021-03-06 tremor Shaky, numbness in tongue, tightness in throat, tingling on tongue, evaluated by EMS-transported to ... Read more
Shaky, numbness in tongue, tightness in throat, tingling on tongue, evaluated by EMS-transported to nearest ER.
27 2021-03-07 numbness Shortly after receiving vaccine in left deltoid, pt complained to numbing and pain near the left sho... Read more
Shortly after receiving vaccine in left deltoid, pt complained to numbing and pain near the left shoulder. After a few minutes pt stated numbness had moved down arm and left hand was slightly darker than right hand and wrist. Pt was advised to stay in store for observation. After 20-25 minutes the pt stated that numbness has subsided and pt's left hand/wrist had returned to similar color as right hand/wrist. Pt stated that she felt much better and would leave. Pt was advised to contact pharmacy if numbness returned or if arm was tingly, or if pt had any further questions.
27 2021-03-08 tremor Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 m... Read more
Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 minute, lost voluntary control of bodily function (urinated), woke up, and vomited multiple times. Vomiting lasted from 10:35am - 1:10pm. Also had diarrhea twice in between vomiting, and was shaking occasionally.
27 2021-03-08 tenderness, weakness, pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+ hours as well.
27 2021-03-09 numbness, tingling Client presented back at our clinic 4 hours post-vaccination. She reported that her R arm is feeling... Read more
Client presented back at our clinic 4 hours post-vaccination. She reported that her R arm is feeling numb, similar to when an extremity 'falls asleep'. Reports tingling sensation. Reports that the feeling goes up to her head and behind her eyes. She is able to lift her arm above her head with any pain. Injection site inspected and nothing abnormal at injection site. Took patient to the EMS area at our event for further observation.
27 2021-03-09 weakness, night sweats Extreme fatigue, weakness, myalgias, drowsiness, night sweats, abd pain, bloating, GERD, joint pain,
27 2021-03-09 tingling, numbness L arm numbness, tingling and heaviness feeling. Evaluated by EMS, cleared.
27 2021-03-09 pain in extremity Nausea, fatigue, arm pain, and intense itchiness on arm
27 2021-03-09 tingling Patient feels slight tingling sensation on posterior neck, and slight tinglingsensation on L hand. ... Read more
Patient feels slight tingling sensation on posterior neck, and slight tinglingsensation on L hand. Vitals: 116/69 BP 84 bpm 18 cpm 97% RA #21 pt. stable and sent home
27 2021-03-09 tingling Started as localized tingling/pins and needle sensation by injection site approximately 4 hours afte... Read more
Started as localized tingling/pins and needle sensation by injection site approximately 4 hours after initial injection.; the sensation spread to all extremities (arms, hands, legs, and feet).; This is a spontaneous report from a contactable consumer (patient). This 27-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3247) via an unspecified route of administration on 17Jan2021 at 15:00 (at the age of 27-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient had COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not receive any concomitant medications. The patient previously received cefprozil (CEFZIL) and vancomycin from unknown dates and experienced allergy. On 17Jan2021 at 19:00, the patient experienced localized tingling/pins and needle sensation by the injection site approximately 4 hours after initial injection. Over the course of the next day the sensation spread to all extremities (arms, hands, legs, and feet). It was three weeks since first dose and sensation had lessened but still felt at times. The patient did not receive any treatment for the events. The outcome of tingling by the injection site and sensation spread to all extremities was not recovered. It was also reported the patient had not been tested for COVID-19 since the vaccine. No follow-up attempts are needed. No further information is expected.
27 2021-03-09 hot flush received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and ... Read more
received first dose on 27Dec2020 and second dose on 13Jan2021; received first dose on 27Dec2020 and second dose on 13Jan2021; chills; fever; dizziness; headache; nausea; lack of appetite; fatigue; hot flashes; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, ), intramuscular in the Left arm on 13Jan2021 13:30 PM at single dose for covid-19 immunisation. Patient was not pregnant. Medical history was None. No known allergies. No other medical history. No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899, administrator route=Intramuscular, vaccine location=Left arm) on 27Dec2020 at age of 27 years old for COVID-19 immunization and nothing after the first shot. The night of the second shot (13Jan2021) patient had chills, fever, dizziness, headache, nausea, lack of appetite, fatigue, and hot flashes until the following two days (15Jan2021). Then dizziness, fatigue, nausea, lack of appetite, chills, and hot flashes for about a week (in Jan2021). No treatment for the adverse events. No covid prior vaccination. No covid tested post vaccination. The patient administered vaccine in Doctor's office/urgent care. The outcome of 'received first dose on 27dec2020 and second dose on 13jan2021' was unknown, of other events was recovered.
27 2021-03-10 numbness, pain in extremity First, I had moderate pain in my right arm and near the injection site. After the first dose, my rig... Read more
First, I had moderate pain in my right arm and near the injection site. After the first dose, my right arm and hand became numb with loss of feeling or touch. This lasted for most of the evening, about 12 hours after vaccination. The injection site and the muscle were in a lot of pain, which climbed up into my neck muscle. I did not have any fever or chills. For the past several days, I have become fatigued very easily. Lastly, my lower abdominal area has become sore with discomfort. I have never experienced this before, and I am not currently menstruating either. Tylenol makes it better, and resting on my back and excess movement makes it worse.
27 2021-03-10 pain in extremity I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little ... Read more
I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little bit on my face and arms. Then it went away. I got home around six pm. I had to go to the bathroom and first go was a mix of diarrhea and solid stools. Then as soon as I left the bathroom, I had to go back. It was fully blown diarrhea. Then I kid you not, my period came on at the same time. It is usually unpredictable but I wanted to add it just in case. And my arm became really really sore around 8pm and last night I could barely move it from the pain, or lift it. This morning it is still sore...and hurts to put pressure on .
27 2021-03-11 pain in extremity Only symptom is a mild sore arm. Started hurting through the night.
27 2021-03-11 pain in extremity Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near po... Read more
Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near point of injection on left arm only.
27 2021-03-11 tremor dizziness, nausea, shaky. Evaluated by EMS-Cleared
27 2021-03-12 feeling cold, cold sweat, cold extremities Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vacc... Read more
Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vaccine tent at 1800 stating she had a "splitting headache, was cold, clammy and nauseated." Vital signs SPO2 99% HR 72 and regular, Blood pressure 148/98, skin dry, hands cool, at this time denying nausea, still with complaints of headache. At 1830 HR 75 regular heart rate remains regular, SPOS 99%, denies any airway issues, declined water or crackers, wanted to go home.
27 2021-03-14 seizure Began feeling sick after injection. Low fever, fatigue for day of injection and day after. Day 3 fel... Read more
Began feeling sick after injection. Low fever, fatigue for day of injection and day after. Day 3 felt normal, but day 4 began feeling sick again with no appetite, nausea and chills. At 5:30 I passed out and remained unconscious until my mother found me on the floor and then had a seizure lasting about 2 minutes. I was unconscious for at least 30 minutes. I have had seizures in the past, but never anything close to this.
27 2021-03-15 pain in extremity Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consume... Read more
Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information was provided.
27 2021-03-15 burning sensation Swollen lymph nodes in my armpit that burn and are swollen
27 2021-03-16 muscle spasms Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant... Read more
Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant muscle spasms.
27 2021-03-16 tingling Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and ... Read more
Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and itchy skin on entire torso. No hives noted. No other symptoms. Actions Taken: Vitals taken at 1722 as follows: 135/82, HR 86, Respirations 14. O2 sats on RA 95%. No c/o shortness of breath, throat closing, itchy throat, SOB or stridor. After 15 minutes, Pt feels the same and no changes for the worse. Vitals at 1738 as follows 119/68, HR 85. O2 sat 96% on RA. Pt requests to head home and will take Benadryl upon arrival. Disposition: PT d/c to home per pt request @ 1820
27 2021-03-17 feeling hot About 5 minutes after vaccine, pt feels warmness in her body and sob. It resolved about a few minut... Read more
About 5 minutes after vaccine, pt feels warmness in her body and sob. It resolved about a few minutes. Denies chest pain, dizziness, swelling, rash and itching.
27 2021-03-17 difficulty speaking, pain in extremity, numbness Heart racing, dizzy upon standing, and numbness in face occured within 5 minutes of injection. Sore ... Read more
Heart racing, dizzy upon standing, and numbness in face occured within 5 minutes of injection. Sore arm, fatigue, and feverishness set in around 5 hours after injection. Headache began about 20 hours after injection and has persisted (as of 3/18/21, 3 days after injection). Sore throat, hoarse voice, and feelings of malaise set in around 40 hours after injection.
27 2021-03-17 tingling Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less tha... Read more
Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.
27 2021-03-18 burning sensation Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, followed by cold sores
27 2021-03-18 pain in extremity arm hurt; achy; weird lung pain; splitting headache; This is a spontaneous report from a contactable... Read more
arm hurt; achy; weird lung pain; splitting headache; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 15Jan2021 at (at the age of 27-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified). On an unknown date after the first vaccination the patient experienced, she is achy, her arm hurts, some weird lung pain and a splitting headache. It took until the next day for her arm to hurt. The clinical outcome of the events achy, arm hurts, lung pain and headache was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
27 2021-03-20 weakness Exhaustion Fatigue Weakness Dizziness Itchiness of injection site, face, arms Runny nose Headac... Read more
Exhaustion Fatigue Weakness Dizziness Itchiness of injection site, face, arms Runny nose Headache
27 2021-03-20 pain in extremity pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contact... Read more
pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contactable consumer reporting for herself. A 27-year-old non-pregnant female patient received her first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: 9266, via an unspecified route of administration, administered in left arm on 25Jan2021 at 08:45 (at the age of 27 years old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date, blood triglycerides increased from an unknown date, and drug allergy to cephalosporins from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Six hours after vaccine administration, the patient experienced pain at injection site/ left arm on 25Jan2021, and pain when raising arm on 25Jan2021. The patient did not receive treatment for the events. The outcome of the events pain at injection site/ left arm, and pain when raising arm was recovered on 26Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
27 2021-03-21 muscle spasms Pfizer-BioNTech COVID-19 Vaccine EUA Muscle cramping two weeks after shot. Felt similar to menstrual... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Muscle cramping two weeks after shot. Felt similar to menstrual cramps, but in absence of a period (two weeks before period is due, not pregnant). Charley horse cramps. lasting muscle soreness the day after. Pain traveled around but was primarily in hip joints and pelvis.
27 2021-03-22 night sweats Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Al... Read more
Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Also experienced severe pain at the injection site, that worsened over the evening. All symptoms continued through the evening. Also experienced night sweats. The following morning, headache and mild chills were present, but other symptoms had abated. Had minor brain fog. Those symptoms resolved over the course of the day. All symptoms, except night sweats, have cleared up. Night sweats are ongoing.
27 2021-03-22 migraine Chronic nausea, dizziness, headaches, migraines, food/smell aversion (not pregnant)
27 2021-03-22 migraine Nausea and migraine (began after a couple hours of vaccine receipt and worsened the next day)
27 2021-03-23 weakness, cold sweat, pain in extremity 03/23/21 -sore arm -body aches -headaches -weakness -fatigue -chills 7:00pm -102.5 fever -ras... Read more
03/23/21 -sore arm -body aches -headaches -weakness -fatigue -chills 7:00pm -102.5 fever -rash surrounding injection site -slight swollen armpit -cold sweats -headaches -body aches 03/24/21 -101 fever -body aches -chills -cold sweats
27 2021-03-23 seizure PT HAD A REACTION 10 MINUTES AFTER RECEIVING THE COVID VACCINATION. PT STARTED HAVING SEIZURE LIKE ... Read more
PT HAD A REACTION 10 MINUTES AFTER RECEIVING THE COVID VACCINATION. PT STARTED HAVING SEIZURE LIKE ACTIVITY THAT LAST 30 SECONDS ABOUT 10 MINUTES POST COVID SHOT; PT WAS SENT TO THE ED BY RAPID RESPONSE TEAM. PT WAS CHECKED OUT, DR THOUGHT IT TO BE A BASAVAGAL RESPONSE,BUT MONITORED HER IN THE ED. SHE WAS GIVEN NS BOLUS. AFTER MONITORING PT SHE WAS DISCHARGED.
27 2021-03-24 numbness, facial paralysis, bell's palsy I week after the second dose around lunch time, I started feeling numbness in my face. I went home a... Read more
I week after the second dose around lunch time, I started feeling numbness in my face. I went home and took my mask off and had facial drooping on my right side and the numbness on the left side. I went to the Dr. and diagnosed me with Bals Palsy and gave me prednisone, and lasted about a month.
27 2021-03-24 facial paralysis March 14th developed numbness, tingling of tongue March 21 developed pain under L jaw, L face droop,... Read more
March 14th developed numbness, tingling of tongue March 21 developed pain under L jaw, L face droop, drooling, and increased numbness of tongue no history c/w Lyme exposure, or hiv exposure
27 2021-03-25 pain in extremity, discomfort, seizure At 11:00 pm I had an extremely intense seizure that caused me to convulse on the floor while arching... Read more
At 11:00 pm I had an extremely intense seizure that caused me to convulse on the floor while arching my back. My partner thought I was dying as it was much more intense and extreme then normal. I am still having increased seizures in both pain and severity daily. Typically my seizures last 20 minutes and are from 4-5 in discomfort in pain out of ten. Now they are around 7, even a week later. The first severe seizure was a 10 level pain and diabling. I also got severe swelling in my arm of the site, extreme pain in the my arm lasting four days, and two large cold sores. Typically my cold sores small and last for two days. Mine are still active and gave me a fat lip. I also have extreme fatigue but could be caused by the increased seizures and pain of them. I been unable to perform my normal duties and responsibilities, which my seizures typically do not interfere with.
27 2021-03-25 cold sweat Brought to observation area on wheel chair @ 12:07 PM, she was clammy , dizzy, pale. Layed on stretc... Read more
Brought to observation area on wheel chair @ 12:07 PM, she was clammy , dizzy, pale. Layed on stretcher. @ 12:08 PM, PR 77, RR 16, BP 91/55, O2% 100, apple juice x1.@ 12:18 pm , PR 65, RR 18, BP 102/70, O2% 100. @ 12:32pm, PR 62, RR 18, BP 107/71, O2% 99 , apple juice x1. @ 12:44 PM, PR 71, RR 16, BP( Sitting) 106/70, O2% 99. Pt stated she is feeling better and she can walk out. Walked out to Exit.
27 2021-03-27 weakness, pain in extremity 27 year old female comes in 3/27/21 at 4:15pm to get Pfizer COVID vaccine. She has no family doctor.... Read more
27 year old female comes in 3/27/21 at 4:15pm to get Pfizer COVID vaccine. She has no family doctor. On her VAR form she states no seizure or history of seizure but does have reaction to HPV vaccine where her throat swelled up and her MD had to give her oxygen year ago. I asked about any other reactions to any other vaccinations and she said no and was willing to get this vaccine. I told her to wait 30 minutes after vaccination to make sure no reaction. At 4:25pm her sister and mom tell us that patient is feeling week and dizzy and ask for water, I go out and check and she is pale and is ready to faint. Mother asks for orange juice which she takes a sip. I ask her if she has any health conditions like diabetes, seizures and they say no, then patient has what looks like a petit mal (absence) seizure. While sitting in the chair her eyes flutter, roll back she tenses up and her body freezes for about 20-30 seconds. I tell staff to call 911 and her sister says she's having "another" seizure. We don't move her but make sure she doesn't fall, once the seizure passes we move her to the ground to lie down. She regains consciousness and is coherent but confused. I do not give EpiPen because I witnessed a seizure. The fire and ambulance arrive to assist her and then her family mentions she did have seizures years ago. After 20 minutes or around 4:50pm she feels better and does not want to go to the hospital and walks out assisted by fire/ambulance staff. The next day I call her and she says she feels better and just has a sore arm and will find new doctor check her out.
27 2021-03-27 slurring Brain fog, extremely lethargic, slurred speech, dizziness, loss of balance and coordination,
27 2021-03-28 numbness Patient reported numbness and ringing in ears after recieving vaccine. She stated she felt like she ... Read more
Patient reported numbness and ringing in ears after recieving vaccine. She stated she felt like she was going to pass out. Onsite HR 53 BP 116/67 Patient stated she was a runner, she recovered fully and was free to go home.
27 2021-03-30 pain in extremity Chest pain-radiating pain on right arm; Chest pain-radiating pain on right arm Went to the emergency... Read more
Chest pain-radiating pain on right arm; Chest pain-radiating pain on right arm Went to the emergency room-14Mar2021; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eng199 and expiration date not provided) via an unspecified route of administration, administered in left arm on 12Mar2021 10:30 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient is not pregnant. The patient has no known allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC) and ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI FE 1.5/30). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced chest pain-radiating pain on right arm on 14Mar2021 19:30 and went to the emergency room. The event resulted in Emergency room/department or urgent care. The patient underwent EKG, Chest X-Ray, Blood work on an unspecified date with unknown results. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
27 2021-04-01 pain in extremity, weakness, seizure like phenomena passed out; experienced seizure like activity; low fever; arm pain; fatigue; chills; feeling very we... Read more
passed out; experienced seizure like activity; low fever; arm pain; fatigue; chills; feeling very weak and sick; feeling very weak and sick; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 11Mar2021 at 15:45 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers-Danlos syndrome, known allergies to red food dye and sulfa; all from unspecified dates. The patient was not pregnant at the time of vaccination. Concomitant medications included celecoxib (CELEXA), lorazepam (ATIVAN), VITAMIN D NOS (VITAMIN D), cyanocobalamin (VITAMIN B12), curcuma longa (TURMERIC); all taken for unspecified indications, start and stop date were not reported. The patient previously took gabapentin, escitalopram (LEXAPRO), and promethazine and experienced known allergies to all drugs. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. It was unknown if the patient had Covid prior to vaccination. The patient was not Covid tested post vaccination. After receiving the first shot, the patient felt the expected side effects (low fever, arm pain, fatigue and chills) but they worsened over the next several days. After feeling very weak and sick all day, she passed out for approx 30+ minutes, she was alone but was found on the floor by her mother after she attempted to call her multiple times and she didn't respond. She experienced seizure like activity and was advised by her primary care doctor to go to the emergency room, and was seen there. Start date for the adverse events reported as 15Mar2021 at 16:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. There was no treatment received for the events. The outcome of the events was recovering. Information on the lot/batch number has been requested.
27 2021-04-07 seizure Cold sores lip; Swollen Left Arm; Seizures; This is a spontaneous report from a contactable consumer... Read more
Cold sores lip; Swollen Left Arm; Seizures; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration administered in arm left on 19Mar2021 12:15 (Batch/Lot Number: ER2613) at age of 27 years old as single dose for covid-19 immunisation (To not die from Covid). Medical history included functional neurological disorder from Nov2019 and ongoing. There was not any history of all previous immunization with the Pfizer vaccine considered as suspect. There were no vaccines administered on same date of the Pfizer suspect. There were not any prior vaccinations within 4 weeks. There were no adverse events following prior vaccinations (she did not have any vaccines since she got the seizure disorder). The patient's concomitant medications were not reported. The vaccination was given: 12:15, kept 30 minutes because of disorder (24 hour clock). The patient experienced seizures from 19Mar2021 to 24Mar2021, swollen left arm from 20Mar2021 to 23Mar2021, Cold sores lip from 21Mar2021 and ongoing. Cold sores lip was reported as worsened. The patient stated that she had a seizure disorder and a lot of people online were saying that they had questions about seizures and the vaccine on the epilepsy site, but there wasn't much information. She had seizures for four days after her first dose. She did not have epilepsy, she had functional neurological disorder. She normally had seizures that cause her to freeze or fall or have a kick. She stated that this time though, she had the ones that most people get, falling on the floor and convulsing. She would be getting the second one but she wanted to let us know. She stated she got that Covid weight. She had seven seizures over four days. She was back to her normal with her disorder and she was not losing consciousness. She also reported a swollen left arm. She reported getting 2 cold sores. She got them when her immune system struggling. She had two on lip and that had never happened. She stated they were really inflamed and it looked like someone punched her in the lip. She usually had them for a week. She got them once a year if she was really sick, had a fever or the flu. The patient Took 2 Ativan as treatment. She stated that it kind of helped but not really. She took it on 20Mar2021. She also took alcohol because it usually lowered the seizure threshold and she won't get any but it wasn't helping. The patient was having an increase and change in type of seizures after receiving the first Covid vaccine. She had an increase in her normal seizures. They were normally 3-4 minutes and she medicates them away. Those started around 16:00. She stated they then got too powerful and too many for too long around 18:00. At 20:00 she had seizures where she would lose consciousness and fall to the ground. She had 6-7 of those. She stated that each day they were getting weaker and weaker. She stated the one at 20:00 was 10/10 painful and scary and people thought she was dying but she was not. The events did not require a visit to emergency room or physician office. She stateds that they were in a different state, they went to an island and decided if she had second one that night then would go but she didn't. She stated that she was not supposed to go [to the emergency room] unless they last 5 minutes or longer and hers lasted 3 minutes. The outcome of event seizures was recovered on 24Mar2021. The outcome of event swollen left arm was recovered on 23Mar2021. The outcome of event Cold sores lip was not recovered. Follow up attempts are needed. Further information has been requested.
27 2021-04-11 pain in extremity Arm pain for 12 hours, fever for 4+ days, aches and chills for 4+ days, sore throat for 4+ days, fat... Read more
Arm pain for 12 hours, fever for 4+ days, aches and chills for 4+ days, sore throat for 4+ days, fatigue for 4+ days
27 2021-04-15 tingling About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. thro... Read more
About 15 minutes after injection patient reporting shortness of breath , difficulty swallowing. throat felt swollen and tingly sensations. On assessment patient clear but diminished breath sounds, thready/weak pulse, swollen lips , BP 130/80. At 1359 pharmacy gave first dose of Epi in left leg, pt symptoms only mildly improved, then second dose of epi given at 1406. ER rapid response on site to take patient to ER and assume care.
27 2021-04-15 pain in extremity Woke with up chest, arm and jaw pain on 03/21/2021. Presented to the ED. Her initial EKG was negativ... Read more
Woke with up chest, arm and jaw pain on 03/21/2021. Presented to the ED. Her initial EKG was negative for any acute changes but her troponin was elevated. Cardiology was consulted. Her echo was negative for cardiomyopathy or hypertrophy. But after her troponin continued to rise she was taken to the cath lab to look for ischemia. Her cardiac angiography was negative for obstructive disease, and coronary arteries were completely normal. Had low magnesium and potassium- so started on oral supplementation. Discharged on 03/22/2021 with nitroglycerin (which was not helpful and made her feel worse/nauseated) and to follow up with outpatient cardiac MRI and cardiology. This imaging revealed significant myocardial edema consistent with myocarditis. 04/01/2021 Per Cardiology: -Given that the patient had covid 19 back in November 2019 I believe she may have had a low yield subacute myocardial infection at that time that was somehow exacerbated by her 1st covid vaccine. Therefore, after some consideration and careful discussion I am advising against the 2nd vaccine at this time. -No physical exercise for 6 months given her current myocarditis and family hx of sudden cardiac death -May trial PRN NSAIDS for pain relief -Recommend birth control and no pregnancy until at least after her follow up cMRI -Follow up in 6 months with cMRI prior
27 2021-05-05 feeling jittery AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITAT... Read more
AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITATIONS AND WAS JITTERY. SHE DEVELOPED RASH ON CHEST. 911 WAS CALLED AND EMS CAME AND TOOK PATIENT AWAY FOR OBSERVATION
27 2021-05-05 involuntary muscle movements I received the first dose of the Pfizer/BioNTech vaccine on April 15, 2021 at 3:00PM. On April 17, 2... Read more
I received the first dose of the Pfizer/BioNTech vaccine on April 15, 2021 at 3:00PM. On April 17, 2021, I began experiencing involuntary body jerks. They initially felt like hypnogogic jerks, but I was fully awake. The body jerks primarily occur in my trunk (seldomly in my lower extremities) and are visibly noticeable. These myoclonic jerks increased in frequency over the course of a few days since they first began on April 17th (up to 7-10 times within a 15 minute span). It has been 3 weeks since my first Pfizer vaccine dose. I have not received a second Pfizer vaccine dose. The jerks are persistent; they have not decreased in frequency or intensity. As an aside, I am concerned about these body jerks because I am a medical student who plans on going into a surgical specialty and this will severely disrupt my career. I received one dose of the Janssen Covid-19 vaccine at 6:45 PM on May 5, 2021.
27 2021-05-05 pain in extremity, tingling, numbness Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on aff... Read more
Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on affected side. No treatment appears to improve conditions.
27 2021-05-07 migraine Fever; Chills; Body aches; Migraine; Nausea; Dizziness; This is a spontaneous report from a contacta... Read more
Fever; Chills; Body aches; Migraine; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9269) at 13:15 at single dose for COVID-19 immunisation. The relevant medical history included fibromyalgia. Concomitant medications included spironolactone. The patient previously received the first dose of BNT162B2 on 13Jan2021 (lot number: EL3249, administration time: 12:45PM, vaccine location: Left arm) at the age of 27 years old for COVID-19 immunisation. The patient experienced fever, chills, body aches, migraine, nausea, dizziness on 04Feb2021 at 09:00 AM. No treatment received for the events. The outcome of the events was recovered on an unspecified date in Feb2021.
28 2020-12-31 difficulty speaking tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. ... Read more
tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.
28 2021-01-03 tingling AT 10:38, patient reports feeling anxious and tingling sensation at the occipital area / behind her ... Read more
AT 10:38, patient reports feeling anxious and tingling sensation at the occipital area / behind her ears. She denied any flushing, dizziness, headaches, cough, sob, numbness sensation around her mouth, chest discomfort
28 2021-01-03 hot flush Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated fe... Read more
Hot flash and dizzy next thing she knew she was in a stretcher. Gave her an ice pack and elevated feet. Went to ED, per patient did not receive any medications, just had an EKG.
28 2021-01-03 tingling Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain.... Read more
Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; Left sides shock like pains in head. Lasts 3-5 seconds and go away. It's a stabbing shock like pain. Started on Thursday 17Dec2020 at 7:45 pm; This is a spontaneous report from a contactable nurse reported for herself. A 28-year-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in left arm on 16Dec2020 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient experienced left sides shock like pains in head, lasted 3-5 seconds and went away. It's a stabbing shock like pain. The events started on Thursday 17Dec2020 at 19:45. It was unknown whether treatment was received for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible time association, the event left sides shock like pains in head is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-01-03 tingling Patient developed SOB, wheezing, tongue swelling, facial tingling.
28 2021-01-03 burning sensation, feeling hot She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate e... Read more
She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.
28 2021-01-03 flushing within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushe... Read more
within 10 minutes patient became pale and lightheaded, heart rate elevated, continued to have flushed feeling. Rapid response called observed, provided water and ice. Felt dizzy when tried to walk. Observed for 45-60 mins.
28 2021-01-04 feeling hot Day of administration around 2100 I started feeling a little off, got a little bit of a headache and... Read more
Day of administration around 2100 I started feeling a little off, got a little bit of a headache and felt warm. While sleeping I could feel that I had chills and felt very warm. Woke up at about 0200 to take my temperature. Felt dizzy when I got up, still had a headache and a fever of 101.0 (taken orally). Contacted a nurse triage line to ensure I can take t=Tylenol to bring the fever down and get rid of the headache. She said yes, which is when I took 500mg Extra Strength Tylenol rapid release. Continued to feel not so well, and broke my fever around 0630 timeframe. Once I woke up around 0900 (day after administration) still felt a little warm (99.5) and a mild headache. Will keep an eye on any other adverse reactions.
28 2021-01-04 pain in extremity Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physi... Read more
Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
28 2021-01-04 tremor Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous r... Read more
Nausea; racing heart rate; restlessness; Dizziness; Shaking; breathlessness; This is a spontaneous report from a contactable consumer reporting for herself. A 28-years-old female patient received bnt162b2 (BNT162B2 ; Lot # EK9231) vaccine , via an unspecified route of administration on 27Dec2020 at single dose for Covid-19 immunisation . Medical history included drug hypersensitivity to amoxicillin sodium on an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced about one minute and a half after receiving the vaccine racing heart rate on 27Dec2020 with outcome of recovered , restlessness on 27Dec2020 with outcome of recovered , dizziness on 27Dec2020 with outcome of recovered , shaking on 27Dec2020 with outcome of recovered , breathlessness on 27Dec2020 with outcome of recovering , nausea on 28Dec2020 with outcome of recovered. The patient underwent lab tests and procedures which included heart rate: racing on 27Dec2020. The patient received diphenhydramine (BENADRYL) to treat dyspnea.
28 2021-01-04 numbness Numbness in right cheek of face almost immediately after injection.
28 2021-01-04 feeling hot Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minu... Read more
Red hive like rash and felt hot. She was also feeling dizzy Epinephrine given IM After 5 minutes, her symptoms returned and another Epinephrine given IM
28 2021-01-05 pain in extremity Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a conta... Read more
Arm sore/upper arm sore; itching surrounding vaccine site; This is a spontaneous report from a contactable nurse, the patient. A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EJ1686, via an unspecified route of administration in the right arm on 30Dec2020 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. The patient's medical history included an allergy to tegaderm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), naproxen, zinc, methocarbamol (ROBAXIN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took chlorhexidine and experience allergies. On 30Dec2020 at 21:30, the patient experienced arm sore/upper arm sore, itching surrounding vaccine site. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the arm sore/upper arm sore, itching surrounding vaccine site was unknown.
28 2021-01-05 discomfort I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of br... Read more
I received my vaccine at 1215 on 12/31/20. At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230. At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.
28 2021-01-06 tingling, numbness After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, sync... Read more
After receiving vaccine, woke up around 3 am experiencing nausea, loss of vision x 1-2 minutes, syncope, difficulty breathing, numbness & tingling in hands and feet. Measured temperature of 102 F. Slept most of the next day and missed work x 1 day. The following day was improved but still with moderate fatigue and nausea. Took ibuprofen with some improvement.
28 2021-01-06 pain in extremity Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were re... Read more
Arm soreness, fever (101.5F), chills, rigors, headache, and body aches. The fever and chills were refractory to ibuprofen and required both ibuprofen and Tylenol to break. The fever and chills continued for 24 hours and the headache/body aches continued for 36 hours, the arm soreness has improved but is ongoing.
28 2021-01-06 pain in extremity Significant arm soreness and generalized body aches about 9-10 hours after the vaccine. Lasted about... Read more
Significant arm soreness and generalized body aches about 9-10 hours after the vaccine. Lasted about 24 hours and prevented me from performing daily activities or working.
28 2021-01-06 pain in extremity had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included c... Read more
had a 102 degree fever for about 15 hours which started the evening of 1/5/21, which also included chills and muscle aches. The muscle aches lasted about 24 hours. The injection site was my left arm and I now have swelling in my left axilla which started the evening of 1/6/21 and is still currently swollen. I am an ultrasound technologist and was able to scan myself this morning when I came back to work. It appears I have a cluster of reactive lymph nodes in the area of swelling within my left axilla, the largest measuring 3.0 cm. It is very tender in the area of swelling and the pain radiates down my left arm. I had a lot of pain at the injection site that lasted for about 24 hours, it is now subsiding. However, for the last 24 hours it has been very painful to bend my arm. Any time I tried to bend my arm it sent a throbbing pain down to my left hand, it is still occurring today.
28 2021-01-07 tingling, numbness, feeling cold 15 minutes post injection had numbness and tingling in left arm, complained of feeling cold, tinglin... Read more
15 minutes post injection had numbness and tingling in left arm, complained of feeling cold, tingling started in her back too. Called for rapid response and patient was transported to ED>
28 2021-01-07 pain in extremity Chills and 99.7° fever 26 hours after injection. Very painful arm.
28 2021-01-07 pain in extremity Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection s... Read more
Fever the morning after; sore arm; headache; chills; body aches; developed a rash around injection site, chest, neck, and face; developed a rash around injection site, chest, neck, and face; This is a spontaneous report from a contactable other HCP (patient). A 28-years-old female patient (pregnant: No) received first dose bnt162b2 (BNT162B2 lot number: EH9899), intramuscular on Left arm on 30Dec2020 12:00 at single dose for covid-19 immunisation. Medical history included known allergies: Penicillin, Sulfa, Other-medical-history: Allergy induced asthma. No other-vaccine-in-four weeks. No other-medications-in-two weeks. Since 30Dec2020 13:00 Started with sore arm and headache shortly after injection. Since 30Dec2020 6-8 hours later chills and body aches started. At some point in the same time range, developed a rash around injection site, chest, neck, and face. Fever the morning after on 31Dec2020. AE-resulted-in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for AE included Steroid and Benadryl Injection. The event outcome was recovering. No-covid-tested-post-vaccination. The events were non-serious.
28 2021-01-07 feeling hot, cold sweat Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling... Read more
Headache, Myalgia, Fever, fatigue, feels hot but temp is normal. Narrative: 12/28 onset of "feeling crummy" - fatigue and "really bad" headache. She went home after work and went to sleep. 12/29 onset of feeling "hot" but her temperature is normal. Body aches, slight headache, and feeling "clammy". She took ibuprofen on 12/29 and is currently at work. Employee reports she usually feels mildly ill the day after a flu vaccine but this adverse reaction is much worse than that. 12/30 - employee reports she developed diarrhea and a temp to 99. Continues to have body aches and mild headache. 12/31 all symptoms resolved.
28 2021-01-07 tingling, numbness I have like tingling and it is not really numbness but feels like my hands are asleep; I have like t... Read more
I have like tingling and it is not really numbness but feels like my hands are asleep; I have like tingling and it is not really numbness but feels like my hands are asleep; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on at single dose for preventive measure for Covid. Medical history included postural orthostatic tachycardia syndrome, migraine, cardiac disorder and ventricular tachycardia. Concomitant medication included sertraline hydrochloride (ZOLOFT), topiramate (TROKENDI XR) and nadolol. The patient stated that on 31Dec2020, "I have like tingling and it is not really numbness but feels like my hands are asleep". The patient underwent lab tests and procedures which included weight: 130 lbs on an unspecified date. The outcome of the events was unknown.
28 2021-01-07 feeling hot Patient began experiencing itching at the injection site and then all over her body. She started fee... Read more
Patient began experiencing itching at the injection site and then all over her body. She started feeling very warm and developing hives. She was given diphenhydramine 25mg by mouth. 911 was called and she was taken to the ER. The ambulance arrived about 5 minutes after 911 was called.
28 2021-01-07 tingling, numbness Patient experienced numbness and tingling around 15min after dose was received.
28 2021-01-07 pain in extremity, flushing Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling ... Read more
Some nausea; Got a pulsating headache; Shortly after receiving the vaccine I felt a flushed feeling in my cheeks.; My left arm also was extremely hard, sore, and tender/swollen.; My left arm also was extremely hard, sore, and tender/swollen.; This is a spontaneous report from a contactable nurse. A 28-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899), intramuscular on 22Dec2020 16:00 at single dose at arm (for confirmation) for COVID-19 immunization. Medical history included anxiety. The patient's concomitant medications were not reported. On 22Dec2020 17:00, Shortly after receiving the vaccine the patient felt a flushed feeling in her cheeks. The patient's left arm also was extremely hard, sore, and tender/swollen. About an hour afterwards, 18:00 I got a pulsating headache that lasted for 3 days. It was only mildly relieved with Tylenol and ibuprofen. It felt similar to a migraine and accompanied with some nausea on 23Dec2020 day 2. The patient received treatment for the events. The outcome of the events was recovered on an unspecified date in Dec2020.
28 2021-01-07 weakness, hot flush, tingling Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; ... Read more
Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Sudden development of hot flashes with sweating and blurry vision- felt like I was going to faint.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; Tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache.; This is a spontaneous report from a contactable nurse. A 28-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), Lot number= ELO140, via an unspecified route of administration, in the right arm, on 31Dec2020 at 13:45 (at the age of 28 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included polycystic ovarian syndrome. There were no concomitant medications. The patient had not received other vaccines in 4 weeks nor taken any other medications in 2 weeks. Prior to the vaccination the patient was not diagnosed with COVID-19. On 01Jan2021 at 0700 the patient experienced hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The clinical course was as follows: Sudden development of hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. The vision blurring and hot flashes resolved within 15-20 minutes but the fatigue, headache and nausea persisted throughout the day. The patient was not hospitalized for the event nor was treatment administered. The clinical outcome of the hot flashes with sweating and blurry vision- felt like she was going to faint, tingly sensation in arms and then some nausea and general feeling of weakness with persistent headache. Since the vaccination, the patient has not been tested for COVID-19.
28 2021-01-07 flushing Sxs started 2 hours post vax with flushing, palpitations, chest pressure. Presented to ED. Sxs reso... Read more
Sxs started 2 hours post vax with flushing, palpitations, chest pressure. Presented to ED. Sxs resolved after 2 hours of observation.
28 2021-01-07 burning sensation Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tong... Read more
Symptoms started around midnight on 1/7/2021 Symtpoms: Burning red face, entire body was itchy, tongue and inside of the mouth was itchy, rash on upper body and swollen inflamed painful lips.
28 2021-01-07 pain in extremity The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I... Read more
The day after my first vaccine, I felt overall achy and chills, this only lasted approx 6 hrs then I went to bed. The day after my second vaccine, the entire day I felt extreme arm pain, full body aches, chills and had a fever. It was hot in my room and I was wearing multiple layers of clothing and laying under my blankets, shivering. It was very uncomfortable and lasted much longer but I had heard the second vaccine was a bit more intense so I figured this was to be expected. The following morning I woke up feeling like brand new.
28 2021-01-08 pain in extremity Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 h... Read more
Arm soreness starting the next day after injection and lasting for 4 days Fatigue starting about 6 hours after injection and lasting for 2 days Brain fog starting about 6 hours after injection and lasting for 2 days Mild headache starting about 6 hours after injection and lasting for about 4 days
28 2021-01-09 pain in extremity - Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myal... Read more
- Mild arm muscle pain about 5 min after the vaccine (second dose). - 6-30 hours - progressive myalgias and arthralgias, fatigue - 24 hours max temp 99.9, chills, sweats - Symptoms all resolved by 36 hours after vaccine
28 2021-01-09 pain in extremity 1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Feve... Read more
1/8/21 at 0830 sore arm 1/9/21 at 0200 chills 0800 fever, muscle aches, fatigue 1/10/21 at 1000 Fever resolved. Fatigue and muscle aches still noted
28 2021-01-09 weakness Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours aft... Read more
Soreness in left arm by injection site 6-24 hours after shot Chills, fever, weakness 12-30 hours after shot
28 2021-01-09 tingling Systemic itching, systemic tingling, Hypotension, syncope, Bradycardia, injection site swelling
28 2021-01-10 pain in extremity About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grad... Read more
About 2 hours after vaccine, experienced soreness down entire left arm. Later that evening low grade fever of 99.9, chills, headache, nausea and fatigue that persisted until Friday evening. Saturday I experienced a headache and nausea, loss of appetite and whole body fatigue and soreness in back, neck and arm. Headache, fatigue, loss of appetite and nausea persists till now (Monday/Day 4)
28 2021-01-10 numbness Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability... Read more
Approximately 10 minutes after receiving the vaccine she started experiencing numbness and inability to move all 4 extremities. No difficulty breathing or swallowing. Benedryl 25 mg was administered with no relief. EMS was called, she was transported to the ED and admitted to the hospital for evaluation. She was given Ativan 0.5 mg IV with some mild improvement in symptoms. She has had gradual improvement in her symptoms, now able to move her arms normally. She has persistent weakness and discomfort in both lower extremities and is unable to ambulate without assistance.
28 2021-01-10 pain in extremity Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30... Read more
Immediate arm soreness after injection but otherwise felt fine until about 2130 when over about a 30 minute period onset of fever, myalgias, chills, and nausea. Called off work from my job as a flight nurse at midnight. Tried to sleep it off until about 0430 when the body aches became unbearable. Ate a few bites of yogurt and took 400mg of ibuprofen. No change in symptoms until 0530 when I took a hot shower which helped relieve some muscle pain. Took 400mg ibuprofen again at 1030 with a small snack with no change in pain or fevers. Took hot shower again which helped briefly. Nausea subsided around 1630, enough that I had a small meal of bland food and another 400mg of ibuprofen. By 1700 more tolerable myalgias and fever came down some. 2230 another 400mg dose of ibuprofen, fitful night of sleep waking again at 4am with shooting lower back pain and fever. Took another dose of 400mg ibuprofen and a hot shower. Woke up at 1000am sweaty with mild myalgias and low grade fever. Took another dose of ibuprofen 400mg, 30 minutes later profusely sweaty but afebrile. Fatigued all day and poor appetite until late evening. Woke up next day after better night of sleep at 0730. Mild fatigue and bad heartburn all day and night. Left arm still sore to touch. This morning (1/11) feeling mild heartburn but better.
28 2021-01-10 muscle twitching, facial paralysis On 01/05/21 at 6:30 A.M. the patient woke up and noticed facial right side quivering. On 01/08/21 t... Read more
On 01/05/21 at 6:30 A.M. the patient woke up and noticed facial right side quivering. On 01/08/21 the patient noticed right side of mouth raised on Sat. 01/09/21 the patient noticed at 4:30 P.M. right side drooping of right mouth corner. The patient went to to the emergency room at Medical Center at 2:30 P.M. The patient was treated with prednisone 20 mg 3 times a day for 5 days.
28 2021-01-10 tenderness Patient reported a tender lump on the left side of neck that was tender to the touch. The lump pres... Read more
Patient reported a tender lump on the left side of neck that was tender to the touch. The lump presented exactly 1 week after the 1st vaccine dose, and it was noticeably swollen. At the time of 2nd dose, the lump was no longer visually noticeable, but could still be felt to the touch. The residual lump is no longer tender to the touch.
28 2021-01-10 weakness fever, chills, headache, extreme body aches, nausea, weakness.
28 2021-01-11 weakness Patient became pale, felt weak, dizzy. Vital signs stable, 100% O2 on Room air
28 2021-01-12 pain in extremity I had a sore arm for two days after vaccine.
28 2021-01-12 flushing Injection site pain, tingling, swelling, redness. Flushing of face. Diarrhea. Improving.
28 2021-01-12 weakness My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles w... Read more
My arm became tender, I got chills at 330am on 1/12, my temp never got above 99.7F, my leg muscles were achy, felt weak, my neck was sore and I had a knot at the injection site. I took 400 mg of ibuprofen around 7am on 1/12 and my symptoms subsided until around 3pm and started getting chills and leg aches. My arm developed redness right where the knot is on my arm and I still have the knot today (1/13). I have had no other symptoms since 3pm 1/12.
28 2021-01-12 cold sweat Systemic: Chills, Systemic: Fever, Systemic: Nausea, Systemic: clammy
28 2021-01-12 feeling hot dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and brok... Read more
dizziness; nausea; joint pain; itching and broke out in rash around injection site; itching and broke out in rash around injection site; pain and stinging on injection site location; heat and redness as well as a raised rash; heat and redness as well as a raised rash; Both ears got, rot and itchy, stomach itchy; Both ears got, rot and itchy, stomach itchy; fever of 100.7; sever heart burn; severe body aches; head ache; raised rash; This is a spontaneous report from a contactable other Health Care Professional (HCP) who is the patient. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown, expiration date unknown) via an unspecified route of administration on 04Jan2021 at 10:00 AM (at the age of 28-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included removal of a metastatic carcinoid tumor from an unknown date and unknown if ongoing. The patient's allergies include minor hive breakouts from "several things." The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 17-DEC-2020 at 14:00 (at the age of 27-years-old) at an unspecified dose in the right arm. The patient was not pregnant at the time of this vaccination. The patient was administered the vaccine in the hospital. Prior to this vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included drospirenone;ethinylestradiol;levomefolic acid (reported as "generic form of Beyaz") and acetaminophen.The patient did not receive any other vaccines within four weeks prior to the first vaccination. On 04Jan2021 at 10:00 PM the patient experienced severe body aches and head ache, through out that night. She had dizziness and nausea with increased joint pain and body aches with the head ache increasing as well. On the morning of 05Jan2021 she experienced a fever of 100.7 and body aches. On that same day in the afternoon these symptoms subsided. She also experienced severe heart burn on 05Jan2021 that did not subside with Tums. On Wednesday 06Jan2021 she was feeling much better, and she had a "normal day." At 12:00 AM on 07Jan2021 the patient started itching and broke out in a rash around the vaccination site, and pain and stinging at injection site. She also had heat and redness as well as a raised rash. Both ears got, hot and itchy, her stomach was itchy but not red or swollen, same for the right leg and foot. She took one allergy pill, and twenty minutes later was still having a bad reaction so she took another allergy pill. She stayed awake to fill out this form, and she was hoping the reaction would stop spreading. Treatment was reported as having taken Tums for the severe heart burn and the patient also took an unspecified "allergy pill" for the itching, vaccination site rash, pain and stinging, the heat, redness and raised rash, the red, hot itchy ears, and the itchy stomach. The clinical outcome of the events severe body aches and fever was reported as recovered on 05Jan2020. The clinical outcome of headache, dizziness, nausea, joint pain, heartburn, vaccination site rash, vaccination site pruritus, vaccination site pain, feeling hot, redness, itchy, ear disorder and raised rash was reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
28 2021-01-13 burning sensation About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly b... Read more
About 27 hours after my vaccine (at about 9 pm on 01/12) I began having 8-10/10 chest pain. Mostly burning sharp pain, but some restricting tight pain as well, radiating to my back mostly. It would be relieved for maybe 10 minutes at a time but then flare back up for about 5 hours. I went to the emergency room, where they did a cardiac work up including blood work and EKG, vitals and a chest X-ray, all which were unremarkable. At about 0200 am on 01/13, the pain subsided. Previous to the chest pain, during the morning and afternoon of 01/12, I had a low grade fever (99.9 F), an intense headache, and fatigue. 01/14/21 sore swollen lymph node under L arm.
28 2021-01-13 pain in extremity Chills, sweating, throbbing headache, terrible body aches, fatigue, malaise, sore left arm
28 2021-01-13 speech disorder, difficulty speaking Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Ben... Read more
Day after vaccine : mild shortness of breath, sensation of swelling in my throat/neck area. Took Benadryl 50mg before bedtime. 2 days after vaccine: woke up with voice changes, coughing/choking with speaking. Used epipen once, felt full relief for about 1-2 hours. Trouble speaking again. Then went to ER, had epipen again twice, over two hours, Benadryl 50IV and Pepcid and steroids. Sitting in the ER now debating admission. Likely being admitted., home epipen are too expensive to treat q2h by myself.
28 2021-01-13 pain in extremity Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after ... Read more
Fatigue on the same day of the vaccine and the next day. Left arm soreness for about 2-3 days after the vaccine.
28 2021-01-14 weakness Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back... Read more
Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
28 2021-01-14 night sweats Fever, chills, myalgia, muscle weakness, night sweats x3 days
28 2021-01-14 feeling cold, tremor I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violen... Read more
I was awoken from sleep with violent chills and an sensation of severe cold. My chills became violent and coarse rigors, severe enough to contract the spine into hyperextension if I kept my body in a neutral position. I could still activate each muscle group to keep in a fetal prostration pose. I was knowledgeable of the event, did not loose any bowel, bladder, or smooth muscle function, and the intensity of the rigors was focused on the most developed skeletal muscles (thighs, calves, upper arms, forearms, paraspinal muscles, hands, respectively). Jaw and muscles of the head/face seemed unaffected. Fingers and toes not distinctly affected. I was not sweating at this time and there were NO other symptoms to report; I remained lucid and able to self-reflect the entire time. Home temperature is kept to consistent 66F, no malfunctions to thermostat. No recent changes to bedding (sheet and quit on top of mattress); it is even optimized for me as I tend to overheat as I sleep. At 50 minutes, I felt "less frozen" and confident enough to stand/ambulate for 220mg naproxen + 500mg APAP , cautiously and successfully swallowed. Robe was donned over existing pajamas and thick comforter was pulled from hallway closet. Rigors continued, but it appeared that intentional activation of the muscle groups could still overpower the rigors for safe (but shaky) ambulation. Greatest risk was coarsely shaking hands a bringing cup to mouth to swallow pills. Above activity was completed in 5 minutes. I then sat upright in bed under layers above. I could feel the muscles calm and relax, with episode completely ending in 5 minutes. Total time of event: 60 minutes. Post-event details: There was a mild sensation of muscle tension in the posterior cervical spine akin to whiplash, but no residual symptoms. I debriefed with my husband shortly thereafter (he has been in another room the whole time) and fell asleep by 23:30. Awoke to alarm at 05:00 and able to stretch, accomplish 30 min run, vacuum/mop the floors, and present to work by 08:00am without deficit. Time of documentation: 11:22 am 1/15/2021
28 2021-01-14 tingling Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin... Read more
Injection site pain, malaise, headache, chills, fatigue, low grade fever, swollen lymph nodes, skin tingling, joint pains, muscle aches
28 2021-01-14 tremor The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen ... Read more
The unexpected reaction was localized constant left chest pain. It is believed to be due to swollen lymph nodes in the pectoral area (as all other testing at the ER was normal). Also sharp pain when breathing in deeply.
28 2021-01-14 feeling hot Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and ... Read more
Thursday night started with body aches, shot area started to hurt. The next morning woke up hot and sweaty with a headache and body aches
28 2021-01-14 pain in extremity headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (p... Read more
headache; arm pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 18Dec2020 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included Postural orthostatic tachycardia syndrome. Concomitant medication included spironolactone and metoprolol. The patient experienced headache and arm pain on an unspecified date after first dose (reported as "First dose: headache, arm pain"). No treatment received for adverse events. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/ batch number has been requested.
28 2021-01-15 tremor Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, f... Read more
Got vaccine at noon with no pain. Was completely fine until 1:30am then began with chills/tremors, fever, headache, nausea and 1 episode vomiting, myalgia throughout body, dizzy/lightheaded ness and extreme fatigue. The next day Jan 16 had diarrhea all morning
28 2021-01-15 weakness Muscle aches, low grade fever of 99.8 F, vomiting, weakness and fatigue.
28 2021-01-16 numbness, migraine, tingling 2 hours after the administration of the vaccine, the left side of my face briefly started to tingle.... Read more
2 hours after the administration of the vaccine, the left side of my face briefly started to tingle. I slept for 6 hours, and when I woke up, the left side of my face was noticeably having pins and needles. I took 25 mg of oral Benadryl and slept for another 7 hours, and when I woke up, my left arm and leg were experiencing pins and needles. The left side of my face was completely numb, and I felt like that side was being pulled down toward the floor. The left, posterior side of my head felt very tingly, and I had a pounding headache behind the left eye that worsened with light. My boyfriend noticed my smile being different, and after looking in the mirror, I decided to go to ED. They were concerned about Bell's Palsy, but with the extremity involvement, they changed my plan of care to a migraine response from the vaccine. I received an MRI, IV Compazine and IV Toradol. My headache went from a 6/10 to a 2/10 after that treatment, but it came back soon after my discharge.
28 2021-01-16 numbness Numbness in left side of face including lips cheek and forehead
28 2021-01-17 pain in extremity, feeling hot After 1st dose, feeling of fatigue and extreme heat, soreness in left arm and headache After 2nd do... Read more
After 1st dose, feeling of fatigue and extreme heat, soreness in left arm and headache After 2nd dose, headache, soreness of left arm, and night fever 24 hours later
28 2021-01-17 feeling cold After almost 15 minutes of receiving vaccine, my mouth, inside and outside, tongue and face wer very... Read more
After almost 15 minutes of receiving vaccine, my mouth, inside and outside, tongue and face wer very tingly and cold. It came from no where. I could even feel it on the top of my mouth. I did not have any trouble breathing or swallowing, it felts like everything fell asleep and that I chugged ice cold water. It lasted for about 40 minutes.
28 2021-01-17 pain in extremity, weakness I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my lef... Read more
I received the dose at 12:00pm Saturday and by midnight I was awoken with severe 9/10 pain to my left arm radiating up my left side of my kneck to my ear and down to the middle of my back. This follows Sunday morning with muscle aches, joint pain, headache and nausea. Continuous nausea occurs until vomiting starts sunday mid afternoon. This all continues until Tuesday morning when a Phenergan shot IM is able to be administered at urgent care where I return home and sleep for 24 hours. Tiredness and weakness continue until the morning of Saturday 16th where I wake up feeling "normal" in a sense.
28 2021-01-17 flushing, feeling hot Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calmi... Read more
Pt. felt hot and flushed, she c/o itching of arms and back, also itching of throat but felt it calming down after 10 minutes and drinking water. Her face did appear flushed but she also said it was flushed before she got the injection. No difficulty breathing, no obvious urticaria. She was emotional about losing her mom to anaphylaxis at age 10, stated that her sister also has similar allergy profile. She questioned if she should et the second vaccine dose.
28 2021-01-17 pain in extremity Starting 6 hours post vaccine - arm started to feel sore, unable to lift straight up without sorenes... Read more
Starting 6 hours post vaccine - arm started to feel sore, unable to lift straight up without soreness 8-10 hours after - headache began, treatable with tylenol -- Tylenol dose lapsed Overnight arm increased in soreness, could not sleep because if arm moved it woke me up First thing the next morning - could not lift arm past shoulder, body felt stiff/sore/ very fatigued, headache -- tylenol helped get through the work day -- Extreme fatigue - took a 2 hour nap after work and still had to go to bed by 9p The following day (48 hrs after): dull headache + sore arm but significant improvement - took tylenol to help Arm stopped feeling sore after 72 hrs and no longer had headache.
28 2021-01-17 weakness difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchines... Read more
difficult breathing; Pain on the chest; Not being able to move my upper neither lower body; itchiness all over my body; unconscious; Headaches; major anxiety; depression; very light-headed; weak; almost faint; This is a spontaneous report from a contactable Other HCP (patient). A 28-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 12:00 at single dose on Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history was none. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced Not being able to move my upper neither lower body, Headaches, major anxiety, and depression, unconscious, very light-headed, weak, almost faint, Pain on the chest, difficult breathing, itchiness all over my body on 08Jan2021. AEs resulted in Emergency room/department or urgent care, Hospitalization. Received injected fluids as treatment. The outcome was Not Recovered. No COVID prior vaccination. No COVID tested post vaccination. Information on the lot/ batch number has been requested.; Sender's Comments: Based on a close temporal association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-01-18 pain in extremity, numbness 1/14/21 severe chills , fever of 101.9, treated with ibuprofen throughout entire day, sweats, head... Read more
1/14/21 severe chills , fever of 101.9, treated with ibuprofen throughout entire day, sweats, headache, fatigue, body aches, nausea, soreness at injection site 1/15/21 headache, fatigue, body aches, nausea, dizziness, soreness at injection site, numbness and soreness of right 5th metacarpal; took ibuprofen for headache 1/16/21 headache, dizziness, fatigue, nausea, body aches, numbness and soreness of right 5th metacarpal 1/17/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal; took Tylenol for headache 1/18/21 headache, dizziness, nausea, body aches, tiredness, numbness of right 5th metacarpal 1/19/21 tiredness, nausea, numbness of right 5th metacarpal
28 2021-01-18 hot flush Feeling hot/flushed, throat tightness, Benadryl 25mg po given and transported to ED
28 2021-01-18 tingling Got the second dose vaccine around 1:45 and was feeling completely fine. I was about to leave at 2:0... Read more
Got the second dose vaccine around 1:45 and was feeling completely fine. I was about to leave at 2:00pm when my heart rate started to increase. I took some deep breathes and started to feel better. Then as I walked out to my car and on my drive home, my whole face felt like some type of electricity was racing through it. I would touch my face and wherever I touched, the skin would feel tight and tingling. This lasted for 30-40 minutes and never came back.
28 2021-01-18 tingling Pt. described feeling as if her cheeks and front of tongue were slightly swollen. She also noted tin... Read more
Pt. described feeling as if her cheeks and front of tongue were slightly swollen. She also noted tingling of lower legs. She denied any throat tightening, no trouble swallowing or difficulty breathing, no chest tightness as she has experienced in exercise induced asthma. (Note: forgot to add under chronic conditions with only rare use of rescue inhaler).
28 2021-01-18 numbness, tingling numbness/tingling in R arm, intermittent not constant last 2-3 weeks prior to 2nd administration
28 2021-01-19 migraine Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection s... Read more
Deep muscle aches. Migraine headaches. Skin pain (hurts to be touched, anywhere, no just injection site)
28 2021-01-19 migraine R SIDED MIGRAINE, CHILLS, FEVER, MUSCLE ACHES, FATIGUE
28 2021-01-20 feeling cold Alternating sweating and cold; Alternating sweating and cold; stomachache; Nausea; Fatigue; Headache... Read more
Alternating sweating and cold; Alternating sweating and cold; stomachache; Nausea; Fatigue; Headache; This is a spontaneous report from a non-contactable healthcare professional (reporting for herself). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 10:45 in right arm at single dose for COVID-19 immunization. Medical history included hypothyroidism and major depression from an unknown date and unknown if ongoing. The patient had no allergies to medication, food, or other products. The patient had first dose of BNT162B2 on 18Dec2020 15:00 via intramuscular in left arm at single dose for COVID-19 immunization. Concomitant medications included levothyroxine, bupropion hydrochloride (WELLBUTRIN), "birth control" (not further specified, and escitalopram. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 08Jan2021, the patient experienced alternating sweating and cold, stomachache, nausea, fatigue, and headache at 1:00 AM. She was not hospitalized, and the events were reported as non-serious. Therapeutic measures taken as a result of the headache and included acetaminophen. The outcome of the events was resolving. The patient underwent lab tests and procedures which included nasal swab: negative in Nov2020. The facility where the most recent COVID-19 vaccine was administered was in the hospital. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. No follow-up attempts are needed, information about lot/batch number cannot be obtained. Follow-up (14Jan2021): This is a follow-up report combining information from duplicate reports 2021013335 and 2021015838. The current and all subsequent information will be reported under manufacturer report number 2021015838. Additional information included: reaction data (alternating sweating and cold, stomachache, nausea, fatigue, and headache). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
28 2021-01-20 pain in extremity Arm pain which lasted 3 to four days - I Got a headache a week after the vaccine. I saw my neurolog... Read more
Arm pain which lasted 3 to four days - I Got a headache a week after the vaccine. I saw my neurologist and she prescribed a prednisone 50 mg for seven days. It resolved it for that week.
28 2021-01-20 pain in extremity, weakness, tremor, feeling cold Fevers, uncontrollable shaking, chills, sweats, muscle aches, chest tightness, painful enlarged left... Read more
Fevers, uncontrollable shaking, chills, sweats, muscle aches, chest tightness, painful enlarged left axillary lymph node, left arm pain, fatigue, weakness, and nausea. Adverse effects started approximately 12 hours after vaccination and lasted up to 48-72 hours.
28 2021-01-20 cold extremities Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 V... Read more
Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM. After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo; additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.
28 2021-01-21 speech disorder 12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOS... Read more
12/23/20 1ST DOSE (AFTERNOON/EVENING): CHILLS, BODY ACHES, TEARING/CRYING. BACK PAIN 1/12/21 2ND DOSE (AFTERNOON/EVENING): WORDS/CHALLENGES COMMUNICATING FOR 24 HRS
28 2021-01-21 pain in extremity At approximately 9pm the night of the vaccine 2nd dose, I developed a fever. As the night progressed... Read more
At approximately 9pm the night of the vaccine 2nd dose, I developed a fever. As the night progressed, I also developed severe R arm pain, joint pain, muscle aches in my back, chills, a headache, and fatigue. The fever was as high as 103.1 and improved with tylenol, but lasted for 2 days. Since onset of the back pain, it has persisted and gradually worsened over the past 2 weeks since the injection. I contact my physician, received a prescription for a muscle relaxant, and a referral for physical therapy.
28 2021-01-21 migraine Body Aches, Chills, Sweats, Migraine, light sensitivity
28 2021-01-21 numbness, burning sensation, tingling I just wanted to report an incident that occurred after receieving the first dose of the covid vacc... Read more
I just wanted to report an incident that occurred after receieving the first dose of the covid vaccine. It was not one of the possible reaction from covid vaccine but rather administrator error in injecting the vaccine. The symptoms appeared about 3 hours after receiving the vaccine, now have numbness, tingling, pain and burning sensation on my left pam in the arm of given vaccine. Obviously, the person giving the vaccine, hit the nerve.
28 2021-01-21 numbness, inability to speak One hour after vaccination patient experienced Left facial and tongue numbness that impacted her abi... Read more
One hour after vaccination patient experienced Left facial and tongue numbness that impacted her ability to speak clearly (similar to experience with numbing for a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. Dexamethasone 10mg given intramuscularly in ER.
28 2021-01-21 numbness, speech disorder Patient experienced left facial and tongue numbness which impacted her ability to speak clearly (sim... Read more
Patient experienced left facial and tongue numbness which impacted her ability to speak clearly (similar to numbness experienced with numbing prior to a dental procedure). She was given 25mg diphenhydramine orally and taken to the ER. She was given 10mg dexamethasone intramuscularly in the ER.
28 2021-01-21 tingling Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Developed rash that spread over chest, back and left arm after vaccine given. Patient also noticed stiffness in neck, feeling of pins and needles and some skin burning. Additionally endorses feeling a dry mouth sensation.
28 2021-01-21 pain in extremity Sore arm
28 2021-01-23 bell's palsy, numbness, face paralysis, migraine, tingling Bells Palsy diagnosed after 8 days from start of symptoms. Initially, I went to ED for left sided fa... Read more
Bells Palsy diagnosed after 8 days from start of symptoms. Initially, I went to ED for left sided facial numbness and weakness, along with left sided headache and upper/lower parasthesias. They half treated me with 1L Sodium Chloride bolus, Compazine IV and IV Toradol for a migraine. This took 4 hours. It was my PCP who I saw 8 days later that started me on Imitrex for the migraine and a 13 day treatment of tapered Prednisone, along with 10 days of 5x a day acyclovir. I am currently on day 4 of this treatment.
28 2021-01-24 feeling hot 13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135... Read more
13:21 -vaccine administered 13:40-c/o HA, nausea, dizziness, "hot, sweaty," diaphoretic HR116 BP 135/80 13:45-HR 107 BP 126/74 with worsening HA, persistent nausea.
28 2021-01-24 discomfort, feeling hot, pain in extremity Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and... Read more
Covid Vaxx #2 1/20 0815 - shot 12:15 - sore arm 1600 - mild aches and fatigue 1800 - 2cm nodule and redness at injection site 2015 - moderate aches and fatigue, feel like fever is coming 98.2 2130 - severe aches and fatigue, feels like flu 99.2 fever and chills 2300 - can?t sleep, extremely uncomfortable 100.5 1/21 0030 - hot, more uncomfortable and exhausted, need sleep 101.0 took 600mg Advil 0500 - slept ~4 hours, woke up uncomfortable again, temp 99.5 with chills 0730 - woke up hot and uncomfortable, temp 100.0 0930 - woke up hot and uncomfortable, headache and chest tightness, severe back pain, temp 100.5, took Tylenol and ate sandwich 1130 - woke up, hungry, still uncomfortable but okay, temp 98.5 1355 - sudden severe chest pain 1455 - showered and laid down, chest pain subsided, took nap temp 98.5 1610 - woke up hot achy and uncomfortable, temp 101.0 1630 - took Tylenol 2145 - sudden severe chest pain, went to bed, no fever 2330 - chest pain subsided, haven?t slept yet 1/22 0200 - slept for an hour or two, woke up slightly warm, temp 99.7 0500 - woke up sweating, feeling slightly better, temp 98.7 0900 - No more fevers after this point, injection site swollen and raised ~5 cm circle, red and hot to touch, itchy Benadryl helps 1/23 99% better, only symptoms left are injection site soreness and itchiness, and intermittent right sided neck pain relieved with ibuprofen
28 2021-01-24 feeling cold Fever 101, headache, chills and diarrhea
28 2021-01-24 tingling, feeling hot, hot flush Pt started feeling hot and tingly after getting your first series COVID-19 vaccine. lately started h... Read more
Pt started feeling hot and tingly after getting your first series COVID-19 vaccine. lately started having hot flashes and tingly scratchy throat. Pt was administered 04 Epi pens (0.30 mg IM) and 01 Diphenhydramine (50MG IM L Deltoid). Pt was transported to Hospital via ambulance.
28 2021-01-24 tingling Reporter received the first COVID-19 vaccine on 12/30/2020 and waited the recommended 15 minutes for... Read more
Reporter received the first COVID-19 vaccine on 12/30/2020 and waited the recommended 15 minutes for observation. After the observation period, she left the facility and started to notice tightness and what she describes as a "bubble" at the top of her throat. She also noticed a tingling sensation in the top of her lip, but did not notice any swelling. Reporter took 25 mg of liquid Benadryl and within an hour the sensation in her throat began to go away. Reporter received the second COVID-19 vaccine on 1/20/2021 at 08:25 AM. She had proactively taken diphenhydramine following the reaction to her first dose. Around 08:40 AM, she began to feel tightening in her throat and some heaviness in her chest. She was evaluated by a nurse who took her blood pressure (normal), however, her heart rate was elevated (noted this could be that she was nervous following initial reaction and repeat tightness in throat). Around 08:55AM, she began to feel like her tongue was swelling and that she had a "bubble" on the top of her throat. She was taken to the Emergency Department for evaluation. She was given hydroxyzine, famotidine, and dexamethasone in the ED and was discharged and felt stable. She reported a continued odd sensation in her throat the evening of the second vaccination. This feeling resolved the next day, and she reports no additional side effects from the vaccine.
28 2021-01-24 seizure, tremor Severe shaking about 12 hours after injection. Started as shivering and turned into full body convul... Read more
Severe shaking about 12 hours after injection. Started as shivering and turned into full body convulsions lasting just over an hour. Bundling up in blankets did not help as shaking intensified. Only other side effect was a sore arm at injection site.
28 2021-01-24 pain in extremity Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work ... Read more
Very sore arm the following day (difficulty using and lifting) and tired. Then two days later work up with headache and nausea.
28 2021-01-24 pain in extremity WOKEN UP BY SEVERE ARM PAIN APPROXIMATELY 12 HOURS AFTER INJECTION. PAIN DID NOT CHANGE ENTIRE NEXT... Read more
WOKEN UP BY SEVERE ARM PAIN APPROXIMATELY 12 HOURS AFTER INJECTION. PAIN DID NOT CHANGE ENTIRE NEXT DAY. SLIGHTLY BETTER SECOND DAY AFTER, HOWEVER I WENT TO WRING OUT A WASHCLOTH IN THE AFTERNOON AND EXPERIENCED EXTREME HORRIBLE PAIN THAT RADIATED IN MY LEFT WRIST. I HAVE NEVER FELT A PAIN LIKE THAT, I WAS AFRAID SOMETHING WAS REALLY WRONG. IT SLOWLY SUBSIDED, AND SINCE THEN I HAVE BEEN CAREFUL WITH HOW I USE MY WRIST AND ARM, BUT IT IS STILL SOMEWHAT PAINFUL AND DOESN'T FEEL RIGHT. I AM AFRAID I WILL FEEL THAT PAIN AGAIN IF I MOVE/PUSH/LIFT ANYTHING IN A CERTAIN WAY.
28 2021-01-24 numbness, tingling [Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID... Read more
[Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID vaccine on 12/18/20 at 10:50. I began experiencing numbness and tingling from my knees to my toes 40 minutes following the vaccine in both legs. I am still experiencing tingling and numbness in my legs at times.
28 2021-01-24 pain in extremity, weakness weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more ... Read more
weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night. She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021. The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
28 2021-01-25 migraine Dizziness, shortness of breath, severe migraine, and stiff neck.
28 2021-01-25 weakness Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (pati... Read more
Fatigue; Body aches; Headache; Weakness; This is a spontaneous report from a contactable Nurse (patient). This 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek4176) intramuscular on 12Jan2021 11:15 at single dose on Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. The patient medical history and the concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=Ej1685) intramuscular on 22Dec2020 at single dose on Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient experienced Fatigue, Body aches, Headache, Weakness on 13Jan2021 12:00 AM. The outcome was Recovering. No treatment received for the adverse event. All the events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.
28 2021-01-25 burning sensation I had a fever in the middle of the night, but no pain at the injection site. On Monday, January 25 ... Read more
I had a fever in the middle of the night, but no pain at the injection site. On Monday, January 25 my arm and part of my back felt like they were burning/itching and were sensitive to clothing and clothing tags. Not anything major or that i'm too concerned about, but wanted to know if any others have experienced this as well. My skin isn't red and there's no rash- it is only hypersensitive to touch. I don't have any food allergies or any allergies to medicines. I've never had adverse reactions from a vaccination before and my skin is typically not sensitive to anything.
28 2021-01-25 pain in extremity Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in ... Read more
Upon administration of the vaccine, patient reported 4/10 pain in injection arm, muscle soreness in their neck, and dizziness. Care was managed on-site by EMS and patient refused transport to hospital. Signed refusal of EMS transport states non-urgent acuity at time of discharge.
28 2021-01-25 numbness Vaccine was administered not even 1 finger width below shoulder. Bruising noted where vaccine was ad... Read more
Vaccine was administered not even 1 finger width below shoulder. Bruising noted where vaccine was administered. Patient had feeling of shoulder area being 'asleep'.
28 2021-01-25 tremor Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms... Read more
Vertigo. Patient presented with lightheadedness and dizziness with associated body tremors. Symptoms started 5-10 minutes after patient received her 2nd Pfizer vaccine dose. Patient has h/o vertigo and reported vertigo, headache, nausea, and emesis following the first vaccine dose. Unsure if syncope 2/2 vaccine vs vaccine adminitration anxiety vs h/o vertigo. NS bolus, Benadryl, Ativan, Tylenol, and Motrin were given. Normal EKG. Symptoms improved and patient discharged from the ED.
28 2021-01-25 pain in extremity arm soreness for 2 days after injection, lips swelling and numbness for couples hours on the second ... Read more
arm soreness for 2 days after injection, lips swelling and numbness for couples hours on the second day after injection, consistent headache on second day, significantly decrease in breastmilk supply starting 2-3 days after injection and hasn't recovered (I'm breastfeeding my baby completely since birth in July 2020).
28 2021-01-26 numbness ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way thr... Read more
ADR to COVID-19 vaccine - moderate in severity headache and upper extremity numbness all the way through the fingers lasting for 2 hours.
28 2021-01-26 weakness, inability to speak, slurring, tingling, pain in extremity, muscle spasms My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was ad... Read more
My arm started to hurt , tingled and then turned into feeling very heavy as soon as injection was admitted. I suddenly became light headed and felt very abnormal. Broke out in hives on my neck and face . They took me to the ER department and by the time they wheeled me down the hall I was white , very disoriented. Couldn?t open my eyes and went from slurred speech to I couldn?t speak at all and couldn?t swallow. My throat and closed and I was having a anaphylactic reaction . They administered epi pen , pepcide and steroids. Since then I have been very weak , running a fever , tired , dizzy . Can hardly walk and I get out of breath from standing or walking .My muscles are very sore and have spams . Almost last night I went to the ER due to theses symptoms lingering. I have been unable to work since the vaccine was administered to me .
28 2021-01-26 bell's palsy Patient received Pfizer BioNTech on 12-23-20 & 1-13-21. She woke upon 1-21-21 with Left side Bell's ... Read more
Patient received Pfizer BioNTech on 12-23-20 & 1-13-21. She woke upon 1-21-21 with Left side Bell's palsy, She did go to the ER and report attached. She also reported a tennis ball size swollen lymph node in R underarm (armpit) on 1-14-21 for a day or two. very tender to touch.
28 2021-01-26 migraine, weakness Severe chills, fever -103, nausea, chest pain (felt like I had a bubble in the center of my chest), ... Read more
Severe chills, fever -103, nausea, chest pain (felt like I had a bubble in the center of my chest), abdominal pain, body pain all over, weakness, loss of appetite, migraine Symptoms started yesterday and still ongoing. Taking ibuprofen
28 2021-01-26 tremor chills, shaking, fatigue
28 2021-01-26 pain in extremity sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy tha... Read more
sore arm, headache, muscle aches, fatigue. Also breastfeeding and baby seems slightly more fussy than usual unsure if related.
28 2021-01-27 pain in extremity Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigu... Read more
Fevers, severe chills, headaches, nausea, arm pain and swelling of left arm (injection site). Fatigue
28 2021-01-27 hot flush She immediately started having hot flashes after receiving vaccination, that have not resolved since... Read more
She immediately started having hot flashes after receiving vaccination, that have not resolved since time of patient reporting ADR on 1/14/21 (~12 days in duration). She also experienced a bad headache with blood vessel rupturing in her eyes.
28 2021-01-28 flushing Dizziness, Flushing Denies trouble breathing. Escorted to stretcher to lie down. BP 157/88, HR 98 R... Read more
Dizziness, Flushing Denies trouble breathing. Escorted to stretcher to lie down. BP 157/88, HR 98 RA 100%. Snack/juice given. BP rechecked 130/84 and HR 86.
28 2021-01-28 pain in extremity, tingling Headache started 20-30 minutes after administration, off and on the last 24 hours. Sore left arm wit... Read more
Headache started 20-30 minutes after administration, off and on the last 24 hours. Sore left arm with pain in armpit/lymph node area. Tingling pain down to left elbow and hand. Sore back and shoulder. Chills throughout night sleeping and into next night
28 2021-01-28 migraine Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous ... Read more
Headache/headache feels like migraine; Headache/headache feels like migraine; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 (19:00) (Lot number: EH9899; Expiration date was not reported), and then the second dose on 12Jan2021 (18:45) (Lot number: EK4176; Expiration date was not reported), both intramuscularly on the left arm at a single dose for COVID-19 immunization at the hospital. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On an unspecified date, after the first dose of vaccination, the patient had a headache/headache that felt like migraine. The patient had experienced a similar headache (headache that felt like migraine) on 17Jan2021, after the second dose of vaccination. The patient had received bultalbital, acetaminophen, caffeine (FIORICET) as treatment for the events. The outcome of the events, headache/headache that felt like migraine, was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination. No follow-up attempts are possible. No further information is expected.
28 2021-01-28 tenderness, pain in extremity Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fe... Read more
Sore arm (and got really red; tender and really swollen) and body aches and muscles aches; slight fever; severe headache and chills -counted get warm - lasted about 48 hours. But my arm was really sore for another 2 days after all the other symptoms cleared. Treated with Tylenol around the clock throughout.
28 2021-01-28 facial pain This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patien... Read more
This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response. She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.
28 2021-01-28 tingling, weakness Within 24 hours after administration of 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, patient be... Read more
Within 24 hours after administration of 2nd dose of Pfizer-BioNTech COVID-19 Vaccine EUA, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours.
28 2021-01-28 pain in extremity headache, severe fatigue, arm soreness, myalgias
28 2021-01-28 weakness high fever 102.6, severe body aches, chills,sweats, headache, neck pain,weakness, fatigue, nausea, r... Read more
high fever 102.6, severe body aches, chills,sweats, headache, neck pain,weakness, fatigue, nausea, runny nose, 48 hrs and going
28 2021-01-29 hot flush Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye p... Read more
Nausea, headache, joint pain, back and neck pain, pain at injection site, chills, hot flashes, eye pain when looking at light
28 2021-01-29 tenderness supraclavicular painless lymphadenopathy noted ~ 1 week after first injection. lymphadenopathy was o... Read more
supraclavicular painless lymphadenopathy noted ~ 1 week after first injection. lymphadenopathy was on same side that injection was delivered to. after second dose, lymphadenopathy became slightly tender to palpation and noted additional palpable lymph node next to first one. three weeks after second dose, lymph nodes still palpable but smaller and nontender.
28 2021-01-30 pain in extremity, cold sweat 10:30am- 2nd dose received 1:30pm -fatigued/ headache (Advil taken, symptoms subside) 6pm - fatigue... Read more
10:30am- 2nd dose received 1:30pm -fatigued/ headache (Advil taken, symptoms subside) 6pm - fatigue/ sore arm/ headache (Tylenol, symptoms worsen) 11:30pm- chills, body/ muscle aches, clammy 1:30pm- worsening chills, worsening aches, insomnia, restless legs, panic attack 5am- nausea, aches, chills, fever (Tylenol & Zofran- helped minimally) continued lack of appetite Symptoms subside Approx 48 hrs after 2nd dose.
28 2021-01-30 weakness Had a low fever of 99.9 throughout the day, chills, severe headache, joint pain and weakness, dizzin... Read more
Had a low fever of 99.9 throughout the day, chills, severe headache, joint pain and weakness, dizziness, nausea.
28 2021-01-30 flushing Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and t... Read more
Pfizer COVID-19 Vaccine EUA Event Description: Felt light headed and slight numbness in tongue and throat about 10 minutes post Covid-19 vaccine (Pfizer EL9261, exp. 5/1/21). History of vasovagal reactions. Also said numb tongue made her think of trouble swallowing. Given water, Benadryl 25mg PO, Zyrtec 10mg PO, and Famotadine 20mg PO and felt better. Heart: RRR without mrg Lungs: clear Skin: blotchy and slightly flushed in spots Throat clear No problems swallowing medications, also given Ginger Ale
28 2021-01-31 tremor On 12/30 I developed neck pain, a headache, chill and shaking but no fever, diarrhea, ear pain and n... Read more
On 12/30 I developed neck pain, a headache, chill and shaking but no fever, diarrhea, ear pain and nasal congestion. I had a virtual visit with the NP and was advised if the symptoms got worse to take tylenol and ibprophen. I was advised I could take mucinex and recommended a COVID test. It was performed on 12/31 which was negative so I took mucinex for the congestion and after 2 or 3 days I began to feel better.
28 2021-01-31 speech disorder Swollen lymph nodes, hard to swallow, talk.
28 2021-01-31 flushing, pain in extremity nausea vomiting and painful flush feeling in chest and extremes. improved after vomiting but naus... Read more
nausea vomiting and painful flush feeling in chest and extremes. improved after vomiting but nausea and flush feeling persisted for 3 hours
28 2021-02-01 face paralysis, bell's palsy Bell's Palsy. Symptoms include right sided facial weakness, eye drooping. Onset was around 12:30 on ... Read more
Bell's Palsy. Symptoms include right sided facial weakness, eye drooping. Onset was around 12:30 on 1/28. Went to walk in clinic where MD confirmed Bell's Palsy and prescribed Valacyclovir and Prednisone. Started medications around 5pm on 1/28.
28 2021-02-01 muscle spasms, seizure, weakness Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous re... Read more
Seizure; muscle spasm; weakness; hard to breathe at time; can't stay awake; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3346), via an unspecified route of administration at Left arm on 15Jan2021 08:00 at single dose for covid-19 immunization. Medical history included seizure, asthma, known allergies to penicillins and NSAIDs. Concomitant medication included levetiracetam, escitalopram, phenytoin, lamotrigine. The patient previously took naproxen, azithromycin, clindamycin; all experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 08:30, the patient experienced seizure, muscle spasm and weakness, hard to breathe at time, can't stay awake. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the seizure and other reported events due to temporal relationship. Of note, the patient has a medical history of seizure disorder. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-01 tingling Within 24 hours of second dose- Fever, dizziness, arm tingling, headache
28 2021-02-02 numbness, tingling 28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots." Pt notes had f... Read more
28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots." Pt notes had facial/nose/lip tingling with prior vaccines, requiring steroids and oral Benadryl. Patient received the covid vaccine at approx 1715 on 21 Jan 2021. At approx 15 minutes, pt developed numbness and tingling to her nose and lips. pt notified Rapid Response Team, who notified Physician. monitored patient for 5-7 min, pt noted that her symptoms were worsening, to include numbness and tingling affecting most of her face, cheeks, lips and nose. No trouble breathing. no lip swelling or tongue swelling. HR 78. Gave oral benadryl - gave her 4 ml of po benadryl (12.5 mg/5ml) at approx 1735, and another 4 ml po benadryl (12.5 mg/5ml) at approx 1740. pt prefers to be treated with steroids because a similar previous episode resolved with benadryl and steroids. pt symptoms persisted with facial numbness and tingling ... and subjectively were worsening. no coughing, no tongue swelling. no lip swelling. no shortness of breath. FM physician arrived - prepped for 60 mg im solumedrol. at approx 1750, FM physician gave IM Solu-Medrol in R shoulder. pt waited for approx 15 min - felt better. numbness and tingling of face and nose were lessening, almost gone - only tip of nose was affected. no facial swelling. no lip or tongue swelling. no trouble breathing. no shortness of breath. physician gave return parameters - benadryl prn overnight called patient the following monday - stated she slept that night (from benadryl), felt better the next day. no further concerns
28 2021-02-02 feeling cold Fever Chills Headache Body Ache Nausea Tiredness Insomnia
28 2021-02-02 bell's palsy bells palsy right sided, started on 2/1/2021
28 2021-02-03 pain in extremity Hypotension; fever; chills; body aches; severe arm soreness/tenderness; This is a spontaneous report... Read more
Hypotension; fever; chills; body aches; severe arm soreness/tenderness; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received second single dose BNT162B2 (Solution for injection, lot number: EL3248, exp date not reported), intramuscular (vaccine location: left arm) on 12Jan2021 10:30 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took first single dose of BNT162B2, lot number: EL1284, intramuscular (vaccine location: left arm) on 23Dec2020 23:00 for COVID-19 immunization. On 12Jan2021 23:00, the patient experienced hypotension, fever, chills, body aches, and severe arm soreness/tenderness. The events were considered as non-serious by the reporter. No treatment was given for the adverse events. On 20Jan2021 Nasal Swab was negative. The patient recovered from the events on Jan2021.
28 2021-02-03 inability to speak Rash (scaly spots appeared over the left upper extremity and back - this isn't an uncommon autoimmun... Read more
Rash (scaly spots appeared over the left upper extremity and back - this isn't an uncommon autoimmune response for this patient) Brain fog Word finding difficulties Suspected decreased seizure threshold - unclear if partial seizure was elicited Intense fatigue Increased sleep Treatment: monitored for 30 minutes status post vaccine injection without any notable concerns; routine observation and monitoring given seizure history Time course: Rash lasted for 1 week; Brain fog/word finding difficulties last fully for 10 days, then started to dissipate; Fatigue and increased sleep lasted 1 week
28 2021-02-03 migraine body aches; chills; sweats; migraine; light sensitivity; This is a spontaneous report from a contact... Read more
body aches; chills; sweats; migraine; light sensitivity; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on left arm on 20Jan2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not allergic to medications, foods, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and multivitamin. The patient was not pregnant at the time of vaccination. The vaccine was administered at the patient's workplace clinic. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches, chills, sweats, migraine, and light sensitivity, all on 21Jan2021 at 09:00. She did not receive any treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Jan2021. No follow-up attempts are possible. No further information is expected.
28 2021-02-03 cold sweat post covid vaccine symptoms included, fatigue, lightheadedness, cold sweats, brain fog, severe neck ... Read more
post covid vaccine symptoms included, fatigue, lightheadedness, cold sweats, brain fog, severe neck and back aches.
28 2021-02-04 pain in extremity 101 fever with tylenol, severe arm pain, throbbing headache-sharp
28 2021-02-04 pain in extremity After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue... Read more
After Dose 1 - mild headache, fatigue, arm soreness for 2 days After Dose 2 - mild headache, fatigue, arm soreness for 2 days. Appendicitis resulting in appendectomy 4 days later
28 2021-02-04 feeling cold, tremor In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over... Read more
In the evening had chills, shaking, could not get warm, low grade fever, 01/13/2021next day all over body aches, 99.9 and then arm pain at injection site nausea and diarrhea 01/14/2021 nausea and diarrhea disappeared on 01/14 or 01/15/2021. Nausea and diarrhea with first dose for two days.
28 2021-02-04 pain in extremity Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same da... Read more
Sore arm for 3 days, headaches same day until current, chills same day to current, dizziness same day till current, fatigue, diarrhea increased heart rate
28 2021-02-05 tremor 3:00pm headache 10:30pm start of fever 101.8 followed by intense body aches all over the body but w... Read more
3:00pm headache 10:30pm start of fever 101.8 followed by intense body aches all over the body but worse in the lower extremities. Cold chills developed as well with mild to moderate body shaking. Symptoms lasted for 18 hours before totally stopping.
28 2021-02-06 pain in extremity Episode of palpitations and tachycardia to the 120s the night of my shot. Took my PRN Propanelol 20... Read more
Episode of palpitations and tachycardia to the 120s the night of my shot. Took my PRN Propanelol 20mg with resolution. Arm soreness x2-3 days
28 2021-02-06 slurring Extreme body aches, nausea, headache, trouble walking and speaking, severe kidney/lower back pain
28 2021-02-07 discomfort, feeling hot, feeling cold 6pm: body aches, feeling cold, not hungry or able to finish my dinner, drowsy. I went to bed around ... Read more
6pm: body aches, feeling cold, not hungry or able to finish my dinner, drowsy. I went to bed around 7pm. All that night, I was hot and sweating and freezing cold. I had a lot of pain in my lower back and would have to position myself in fetal position. There was no position that felt comfortable. 24 hours after the shot, still fatigue, stayed in bed for most of the day. No appetite. 48 hours: limited appetite, I was hungry, but when eating just felt bloated and not interested. Would feel stomach aches if I attempted to eat more. The monday following the vaccine, I had eaten lunch and noticed I had a burning feeling in a lower area of my throat. My stomach felt slightly upset.
28 2021-02-07 feeling cold Chills were the first symptom. The next day, I also experienced feeling very cold and some chills. I... Read more
Chills were the first symptom. The next day, I also experienced feeling very cold and some chills. I passed out briefly after getting out of bed and threw up right after that. I had body aches. I was nauseous but was able to take ibuprofen in the late morning. After the ibuprofen wore off, my body aches returned as well as a lethargic feeling. The next morning, I experienced nausea again until in the afternoon.
28 2021-02-07 migraine Fatigue and mild headache starting 24 hours after the injection. Approximately 30 hours after inject... Read more
Fatigue and mild headache starting 24 hours after the injection. Approximately 30 hours after injection, headache progressed to severe headache with migraine features (sensitivity to sound and light) Symptoms resolved within 48 hours.
28 2021-02-07 hot flush Itching in tongue/mouth/throat, hot flashes, dizziness, sweating, tongue swelling, tachycardia
28 2021-02-07 tingling, burning sensation Itchy throat; left side of face burning; left side of face burning/tingling sensation; burning/tingl... Read more
Itchy throat; left side of face burning; left side of face burning/tingling sensation; burning/tingling sensation left side of lip; burning/tingling sensation and left side of lip; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration second dose (lot number: EL3302) on 21Jan2021 17:00 at single dose on right arm for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: E11284, on 29Dec2020 13:30 on right arm. Medical history included asthma and seasonal allergies. The patient did not test for COVID post vaccination. The patient is not pregnant. The patient experienced itchy throat, left side of face burning/tingling sensation and left side of lip on 21Jan2021 17:45. The patient took Benadryl as treatment for the events. The outcome of the events was recovering.
28 2021-02-07 discomfort, tingling, weakness Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her bo... Read more
Passed out; fell; became disoriented and weak; became disoriented and weak; could not control her body, all muscles felt heavy and weak; could not control her body, all muscles felt heavy and weak; Felt tingles in feet and lower legs; This is a spontaneous report from a contactable consumer(patient). The 28-year-old female patient(not pregnant) received first dose BNT162B2(COVID 19, lot number: EL9262), via an unspecified route of administration at left arm on 22Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included none. She had no known allergies. Concomitant medication included spironolactone, amfetamine aspartate/amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate (ADDERALL), vitamin b complex (VITAMIN B), ergocalciferol (VIT D), ZINC, omeg(omeprazole). There was no other vaccine in four weeks. About 11 hours after receiving(23Jan2021), she very quickly became disoriented and weak, could not control her body, all muscles felt heavy and weak. She fell once and then presumably passed out - she came to after falling again. She felt tingles in feet and lower legs. After sleeping about 9 hours, she felt better. There was no treatment received, no covid prior vaccination, covid tested post vaccination. Events were assessed as non-serious. Outcome of events was recovering.
28 2021-02-07 tingling Usual tiredness & adverse effect on PRN medication. I take sumatriptan for onset of migraine attacks... Read more
Usual tiredness & adverse effect on PRN medication. I take sumatriptan for onset of migraine attacks. Ever since I received the 1st dose on 1/22/21, when I take this medication, my face starts to itch & has a tingling sensation (pins & needles feeling). I have been taking this medication for 10yrs & not once have I ever had this kind of reaction. I am a little scared.
28 2021-02-07 tingling, feeling hot itching rash, tingling and warming sensation in arm radiating down within 15 min of shot. Pt has his... Read more
itching rash, tingling and warming sensation in arm radiating down within 15 min of shot. Pt has history of several allergic reactions to foods and medications. Stated that this felt like a similar reaction. Provided OTC Benadryl and patient stated that it resolved fairly quickly after initial dose, but had to continue w/ Benadryl for 2 days afterwards otherwise rash would reemerge.
28 2021-02-08 flushing, tingling She felt panicky prior to injection. Felt flush and panicky after injection. Had ginger-ale and ic... Read more
She felt panicky prior to injection. Felt flush and panicky after injection. Had ginger-ale and ice pack to help with flushing. Left injection room approximately 35 minutes post-injection. When walking down the hall, she said she started to feel more panicky and felt paresthesias near lower jaw--stated she doesn't normally feel that way during a panic attack. Physical assessment normal. Vitals signs normal. Dexamethasone 4mg IM given. Paresthesias stopped about 10 minutes after dexamethasone. Went home and stated all had resolved by the time she got home and nothing has happened since.
28 2021-02-09 feeling hot, muscle spasms Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, che... Read more
Left side of body felt very warm and felt like it was melting; red rash on left side face, neck, chest, arm; Facial spasms; Fever; Confusion/lightheaded; Confusion/lightheaded; Palpitations; Feeling of being unwell; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on right arm single dose for COVID-19 immunization on 22Jan2021, 05:45 PM, at 28-year-old. Medical history included: COVID-19. No allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included: daily vitamins, lisdexamfetamine mesilate (VYVANSE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient left side of body felt very warm and felt like it was melting. The patient had red rash on left side face, neck, chest, arm. The patient had facial spasms, fever, confusion/lightheaded, palpitations, feeling of being unwell, fatigue. All on 22Jan2021, 06:45 PM, and was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit, no treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving. Information on the lot/batch number has been requested.
28 2021-02-09 pain in extremity Pt called to report pain radiating down her arm and up her neck.
28 2021-02-09 migraine fever; migraines; Chills; This is a spontaneous report from a contactable consumer (patient). A 28-y... Read more
fever; migraines; Chills; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (Weight: 150 lbs, Height: 5'10) received first dose bnt162b2 (Batch Number: EL3248, expiry date: Apr2021), via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunization. Medical history included ongoing migraines. The patient's concomitant medications were not reported. The patient experienced chills in Jan2021, fever on 23Jan2021, migraines in Jan2021. Developed low grade fever (100.8) and chills after receiving the first dose of the Covid-19 vaccine. First does giving 22Jan2021. Fever started late evening 23Jan2021. Developed migraine approximately 6 hours after the shot. The patient underwent lab tests and procedures which included body temperature: low grade fever (100.8) an unspecified date. The outcome of events was unknown. No follow up attempts are possible. No further information is expected.
28 2021-02-10 tremor About twelve hours after getting the vaccine I got a fever which is fine and expected but then my wh... Read more
About twelve hours after getting the vaccine I got a fever which is fine and expected but then my whole body started shaking. It has not stopped. I s not painful but making it hard to do my job
28 2021-02-10 numbness, cold extremities, tingling After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is prot... Read more
After my 2nd dose administration, I sat in an observation tent with 4 resident doctors. This is protocol at my hospital to assess for any adverse reactios. About 10 minutes later, I started to feel both of my arms (from should all the way to tips of my fingers) start to get tingly with an intense vibrating sensation. I tried to calm myself down, however numbness began to occur to both BUE seconds after. Next thing that happened, bilateral fingers became visually contracted however numb and I could not move my fingers. I also got a tingly/prickly sensation to my cheeks all the way down to my chin after the hand numbess. The resident doctors quickly took me by wheelchair to a private room where they checked my vital signs. BP was elevated with systolic in 190's, HR around 120s, and my limbs were all cold. By this time it was around 6pm and they were trying to calm me down as I started to have a panic attack. My parents came to pick me up at 7pm when my vitals were stable. I rested at home, and the contraction to my fingers/numbess did not subside until 8:30pm. The following day, my left arm (injection site) had a soreness level of 9/10. Tylenol was used to relieve pain.
28 2021-02-14 speech disorder, tingling, slurring, discomfort Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pal... Read more
Arm was tingling; heavy; Became dizzy; Felt very weird; Broke out in rash on neck and face; Went pale; Couldn't open my eyes; Slurred speech; I couldn't breath; couldn't speak; couldn't swallow; My throat had closed up; I am still very sick and unable to work; This is a spontaneous report from a contactable other healthcare professional (patient). A 28-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left leg on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient has no medical history. The patient had not had covid prior to vaccination. patient is not pregnant. Concomitant medication included isotretinoin (ACCUTANE). On 21Jan2021 14:30, immediately after administering vaccine the patient reported arm was tingling, heavy, patient became dizzy, felt very weird, broke out in rash on neck and face, went pale, couldn't open her eyes, slurred speech, then patient couldn't breath, couldn't speak and couldn't swallow. The patient added that her throat had closed up. The patient was administered with Epi pen. The patient reported that she was still very sick and unable to work. The patient underwent a covid test post vaccination via nasal swab on 25Jan2021 and 26Jan2021 with negative result. The outcome of the events was not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the time association and product's safety profile, the reported serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-02-14 weakness, feeling hot, feeling cold Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke a... Read more
Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; Awoke around 11pm 1/28 with aches, chills, severe headache, weakness, dizziness, and nausea; could not regulate my temperature; fluctuated between being diaphoretic and cold to being overheated; fluctuated between being diaphoretic and cold to being overheated; fluctuated between being diaphoretic and cold to being overheated; I did experience an episode of nearly passing out sometime during the night; Fatigue throughout the day increased.; This is a spontaneous report from a contactable other Health Professional reported for herself. A 28-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included SLE (systemic lupus erythematosus), asthma (mild), PTSD (post-traumatic stress disorder), anxiety, ADHD (attention deficit hyperactivity disorder), allergy to egg whites, allergy to bee stings and diagnosed with COVID-19 prior to vaccination. Concomitant medication included desvenlafaxine succinate (PRISTIQ), methylphenidate, hydroxychloroquine sulfate (PLAQUENIL), clonidine received within 2 weeks. The patient previously took escitalopram oxalate (LEXAPRO) and experienced Allergy to lexapro, sertraline hydrochloride (ZOLOFT) and experienced Allergy to Zoloft, quetiapine fumarate (SEROQUEL) and experienced Allergy to seroquel, erythromycin and experienced Allergy to erythromycin. On 28Jan2021, the patient experienced fatigue throughout the day increased. The patient developed headache. Awoke around 28Jan2021 23:00 with aches, chills, severe headache, weakness, dizziness, and nausea. She did not feel she could move safely to retrieve OTC medications for these symptoms which were far worse than any illness she can recall having. She likely would have went to the ER for help but she couldn't have driven herself and her kids were home. She did not want to call 911. On 28Jan2021 23:00, she did experience an episode of nearly passing out sometime during the night when she attempted to sit up on the edge of the bed to take some Tylenol. She could not regulate her temperature as she fluctuated between being diaphoretic and cold to being overheated. In the morning she finally felt well enough to go to her medicine cabinet downstairs and decided to essentially sedate herself for the day with Benadryl, Xanax, zofran, Tylenol, and ibuprofen. She then slept from about 10am until about 5pm. She felt considerably better upon waking up, with just fatigue, nausea, and headache. The report was reported as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue, nausea and headache was not resolved and the outcome of the other events was resolving. Information on the lot/batch number has been requested
28 2021-02-15 tingling Blindness (loss of vision); Neurocardiogenic syncope; Tingling in hands and feet/lower legs; Panic a... Read more
Blindness (loss of vision); Neurocardiogenic syncope; Tingling in hands and feet/lower legs; Panic attack/unable to breathe; Nausea; Vomiting; Dehydration; Tiredness; Body aches
28 2021-02-15 pain in extremity Extreme fatigue; headache; heart was racing; nausea; diarrhea and body aches. These lasted until 06:... Read more
Extreme fatigue; headache; heart was racing; nausea; diarrhea and body aches. These lasted until 06:00 AM the next day. A little headache and arm soreness still that next day - by noon that day I was feeling myself again.. I took ibuprofen for the headache and that helped.
28 2021-02-15 tremor Headache 5am, hurts to lift head or move neck; Nauseous since 1am; Chills since 1am; All over muscle... Read more
Headache 5am, hurts to lift head or move neck; Nauseous since 1am; Chills since 1am; All over muscle aches and pains 530 am; Fever 100.4/feeling feverish 6am; Shaking/shivering since 3am
28 2021-02-15 numbness, tingling L arm, some numbness and tingling, "tongue feeling fat", toes tingling". Patient was taken to triage... Read more
L arm, some numbness and tingling, "tongue feeling fat", toes tingling". Patient was taken to triage, tongue and oral membranes assessed, no signs of swelling, lungs clear, v.s. taken, patient given 25mg of benedryl IM., patient also given orange juice, continued to monitor for 30 minutes, symptoms subsided. Patient was walked out and driven home by her co-worker.
28 2021-02-15 tingling throat closing, peri-oral tingling, and erythema on chest
28 2021-02-16 inability to speak stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day th... Read more
stroke; a thunder clap headache; limbs stiffened up; eyes crossed; lost speech; She is now on day three of a coma on life support from a brain aneurysm; Mood swings; irate; Body aches; This is a spontaneous report from a Contactable Consumer, the patient. This 28-year-old non-pregnant female consumer (patient) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration in the left arm on 01Feb2021 as a single dose, for COVID-19 vaccination. Historical vaccination includes BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Dose 1. The facility in which the second vaccine was administered was a hospital. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. No Medical history reported ('No health issues, At all'). The patient has no known allergies. There were no concomitant medications. On an unspecified The Patient Experienced became irate. Mood swings. Body aches for couple days; On 07Feb2021 at 13:45, The patient experienced Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm (hospitalization, disability, life threatening), Treatment was given for the events of stroke, a thunder clap headache, limbs stiffened up, eyes crossed, lost speech, and brain aneurysm. The Adverse Event resulted in an Emergency Room Visit. Treatment was given for the events. 'Patient on Life support still'. The Clinical Outcome of the events Stroke a thunder clap headache, limbs stiffened up , eyes crossed, lost speech, now on day three of a coma on life support from a brain aneurysm not recovered, while Mood Swings, Anger and Pain was unknown. Information on Lot has been requested.
28 2021-02-17 numbness, tingling, weakness tingling and numbness in hands and feet; tingling and numbness in hands and feet; weakness; fatigue;... Read more
tingling and numbness in hands and feet; tingling and numbness in hands and feet; weakness; fatigue; muscle and joint pain; muscle and joint pain; chills; fever of 100.4 F; headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 26Jan2021 18:00 at a single dose on the left arm for COVID-19 immunization. Medical history included asthma, fibromyalgia, ADHD, GERD, IBS, and allergies to pollen and yellow onions. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), diltiazem, and topiramate. Patient is not pregnant at the time of vaccination. The patient received the first dose of bnt162b2 on 05Jan2021 15:00 (lot number: EL1284) on the left arm. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 post-vaccination: Tempus iC SARS-CoV-2 RT-PCR on 28Jan2021 with result negative. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021 14:00, within 24 hours after administration of second dose, patient began experiencing tingling and numbness in hands and feet, weakness, fatigue, muscle and joint pain, chills, fever of 100.4 F, headache, and nausea, in that order developing over the next 48 hours. Patient has not recovered from the events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes Tylenol. Events reported as non-serious.
28 2021-02-18 pain in extremity Evening of the vaccine, Sunday, had left arm soreness, and vomited that night. I woke up Monday morn... Read more
Evening of the vaccine, Sunday, had left arm soreness, and vomited that night. I woke up Monday morning with a fever of 101.6, extreme fatigue, nausea, vomiting, aches and pains and chills. Monday went to get a COVID nasal swab test as required by my work-place, was negative. Tuesday, I had continued nausea, fatigue, chills, fever of 99-100. Went to see Healthcare Professional, they ran labs (detailed below), only found low eosinophils, and leukopenia. Received nausea medication. Was able to eat on Wednesday, severely fatigued Wednesday, temperature remained 99-100. Thursday had major fatigue, headache, nausea. Was feeling better on Friday.
28 2021-02-18 migraine Fever (99.7 degrees F), chills, muscle aches, joint aches, severe dizziness, significant fatigue, se... Read more
Fever (99.7 degrees F), chills, muscle aches, joint aches, severe dizziness, significant fatigue, severe migraine. All symptoms started at 4:00 am 2/13 and were present throughout the entire day 2/13. Migraine and dizziness persisted until 2/15 but lessened in intensity each day. managed symptoms with Aleve
28 2021-02-18 migraine, pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA injected into left arm at 10:15 am on 17 Feb. Soreness at the injection site was the only symptom immediately following the injection. At about 3:00 am the next morning, I experienced extreme nausea and chills. I fainted when I tried to get out of bed to go to the restroom. All of 18 Feb, I experienced the following symptoms: headache/migraine, fatigue, dizziness, loss of appetite, muscle aches/soreness, fever, and severe pain in my left arm. As of today, 19 Feb, I am experiencing headache, lightheadedness, and mild pain my left arm.
28 2021-02-21 pain in extremity Chills, body aches, sore arm
28 2021-02-22 hypersensitivity of all senses Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection s... Read more
Fever 101-102, body chills, body aches, generalized skin sensitivity, sore eyes, sore at injection site, headache, fatigue
28 2021-02-23 facial pain About 30 hours following injection, observed slow to full facial pain on the right side of face and ... Read more
About 30 hours following injection, observed slow to full facial pain on the right side of face and head. Face was mildly inflamed and in pain for approximately 6 hours, then gradually the pain and inflammation subsided. No ibuprofen or other pain relievers were taken at the near the time of adverse event. Ibuprofen (400 mg) was taken at approximately 9 pm the previous evening to reduce arm pain/pain at the injection site.
28 2021-02-23 tingling Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered,... Read more
Left arm with fingers tingling, tongue feeling "fat" and numb, toes tingling, Benadryl administered, No EMS, resolved during extended observation.
28 2021-02-23 pain in extremity, muscle spasms Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine.... Read more
Pain began as a "crick" in the left side of the neck two days after receipt of second covid vaccine. It has now been three weeks and pain has been continuous in the left shoulder and left neck. Pain radiates down the arm and up into the ear, making the ear hurt and making it painful to swallow. The skin is also tender/painful to touch in the same areas, as if nerve damage has occurred. Swelling is visible in the upper back and neck.
28 2021-02-23 pain in extremity Sore arm/arm felt sore; This is a spontaneous report from a contactable consumer (patient). A 28-yea... Read more
Sore arm/arm felt sore; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: EL3247), via intramuscular route of administration, on 26Jan2021 10:15 AM (at the age of 28 years old) as a single dose in the left arm for COVID-19 immunization at work clinic. Relevant medical history were anxiety, depression. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), aripiprazole (ABILIFY), iron, ascorbic acid (VITAMIN C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 at 04:00 PM, the patient experienced sore arm/arm felt sore. No treatment was received for the event arm/arm felt sore. The outcome of the event arm/arm felt sore was recovering. Since the vaccination, the patient had not been tested for COVID-19.
28 2021-02-23 pain in extremity, numbness Walking around house doing chores after working from 9-6 with 90 minute lunch break as a dental hygi... Read more
Walking around house doing chores after working from 9-6 with 90 minute lunch break as a dental hygienist. Could feel left foot start to go numb and tingling and feel very cold. Took thin sock off foot, pinky toe was purple. Took pictures. Could not get foot to warm up with warm/hot compresses. Started having slight discomfort in lower back/butt with pain going down leg to toe within the hour. I believe this could be coincidence and have sciatic pain, but thought I should report just in case there are few other reported cases on this. Purple discoloration was gone when woke in morning on 2/23/2021 It is now 2/24/2021 and I am still having sciatic pain and numb pinky toe.
28 2021-02-24 slurring, bell's palsy Ballspalsy, right side Eye and facial movement issues, it started gradually a week and a half after ... Read more
Ballspalsy, right side Eye and facial movement issues, it started gradually a week and a half after my dose my eye was not blinking in sync with my left eye, gradually started to go down to my face where my lips my cheek or my eyebrows were not moving when I was talking all my words were slurred and off to the side of my mouth. When smiling one side trip the far far left the other side stay still. My job had me go to a doctors up where they diagnosed me with Bell?s palsy it and the doctor advised me to report this. My treatment plan is antiviral medication and steroids, Valacyclovir 1gm tid, methylprednisolone 4grams qid. I am very upset and heartbroken every time I look in the mirror I cry because I cannot recognize my face I did read online that Pfizer did have side effects of bells palsy but I never thought I would get it given my age and good medical history. I would love for someone to reach out to me I need to know what happens from here. As a result I have been off of work for a couple days.
28 2021-02-24 tingling Numbness on lips, tingling.
28 2021-02-25 speech disorder 3-5 minutes after receiving the vaccine, I felt a sense of panic and a tingling on my lips, that the... Read more
3-5 minutes after receiving the vaccine, I felt a sense of panic and a tingling on my lips, that then spread to my mouth, throat, and tongue. I asked the nurse if my lips were swollen, and she said no. A few minutes later my heart rate increased and I felt really lightheaded. After 7-10 minutes I felt my tongue tingling and it had become swollen. I told the nurse that I think my tongue was swollen and she said it looked okay. I had a hard time talking because I wasn't used to be tongue being so large. The nurses stayed and talked to me for the rest of the 30 minute waiting period. I was able to talk and breath while making a conscious effort. I wasn't sure whether the high heart rate and lightheadedness were associated with my condition, Postural Orthostatic Tachycardia Syndrome. I kept checking my tongue to see how swollen it was. After the 30 minutes, the nurses had me stand up to see if I could. Once I could, they said I was all set to go. They did not get an Epi-pen for the swollen tongue or give me instructions on how to treat it. They were insensitive and dismissive of my symptoms. they kept repeating "I think your just nervous." Once I got home, I still had the swollen tongue and tingling, but was able to go up and down stairs and go about my day. It was a little difficult to swallow one of my pills when I got home, but I was able to. I checked my blood pressure around 4:30 p.m. and it was 121/84 and my pulse was 79 bpm sitting. I did not take anything to treat my swollen tongue. The swollen tongue and tingling feeling in my throat continued for another 2.5 hours, until 6:00 p.m. Once the swelling was down, my tongue felt like I burnt it on a hot beverage, almost a numb feeling. I also experienced more common side effects such as body aches, fatigue, and feeling feverish. After this episode I had extremely high anxiety where it was difficult for me to sleep the following night. I called a 24/7 nurse line and she said to talk to my doctor. I had less than 4 hours sleep the night after I had my vaccine. I called my doctor's office this morning and I spoke to a nurse who worked as a nurse on the COVID Vaccine hotline. She relayed the message to the doctor who was covering for my doctor while she's on medical leave. I received a call around 9:30 a.m. saying that the doctor on leave recommend I should talk to my PCP but that she thought I had an allergic reaction to the Pfizer vaccine and that I should not get the second dose. She said they were not sure how I would react with the second dose, and they're afraid that my allergic response might be more severe and life threatening. I hope this report helps other people who experience these symptoms.
28 2021-02-25 pain in extremity Fever, arm pain/swelling/erythema.
28 2021-02-25 tingling Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes le... Read more
Fever; Chills; Muscle aches; Swollen PAINFUL lymph nodes left armpit; Swollen PAINFUL lymph nodes left armpit; tingling left wrist; headache; fatigue; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: el9261) via an unspecified route of administration on the left arm on 25Jan2021 14:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included drospirenone, ethinylestradiol (NIKKI) for birth control. The patient previously received first dose of BNT162B2 on 04Jan2021 for COVID-19 immunization (lot number: ej1685, left arm, 02:00 PM). On 26Jan2021 04:00 AM, the patient experienced fever, chills, Muscle aches, swollen painful lymph nodes left armpit, tingling left wrist, headache, fatigue. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Post vaccination, the patient has been tested for COVID-19, nasal swab on 25Jan2021: pending result. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The facility where the vaccine was administered was in a Public Health Clinic/Veterans Administration facility. Outcome of the events was not recovered.
28 2021-02-26 flushing HA, nausea, facial flushing, evaluated by EMS, refused transport.
28 2021-02-27 muscle spasms Muscle spasms at the site of vaccination
28 2021-02-28 breast pain Extreme armpit pain/breast pain on side of the injection that lasted 3 days. Lymph nodes were able t... Read more
Extreme armpit pain/breast pain on side of the injection that lasted 3 days. Lymph nodes were able to be palpated and a bit swollen.
28 2021-03-01 migraine Migraine lasting for 10 hours, vomiting, diarrhea, nausea, chills. Took ibuprofen, stayed in bed. S... Read more
Migraine lasting for 10 hours, vomiting, diarrhea, nausea, chills. Took ibuprofen, stayed in bed. Still have nausea and migraine today. Tested positive for Covid 03/01/2021. Also had Covid 11/19/2021
28 2021-03-01 tremor, flushing Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushin... Read more
Pfizer-BioNTech COVID-19 Vaccine: Thirty minutes after receiving vaccination developed trunk flushing, nausea, and tiredness. Flushing quickly resolved but patient reports nausea, abdominal pain, mild headache, and tremors since vaccination. Six days after vaccination noticed hip bruising in the absence of falls or trauma and a cut on the hand that bled more than expected. No respiratory distress or rash noted on exam. Vital signs all within normal ranges. Patient left clinic visit stable and advised to avoid non-steroidal anti-inflammatory medications.
28 2021-03-02 numbness L arm numbness, L arm heaviness, chest tightness, itchy throat-cleared by EMS
28 2021-03-03 seizure, unresponsive to stimuli Patient was seated during her mandatory 30 minute wait, where she stated she began to feel light hea... Read more
Patient was seated during her mandatory 30 minute wait, where she stated she began to feel light headed and had a headache. Stated that she has a history of pseudo seizures and that she had one with her first vaccine. Patient then became unresponsive, slumped back in her chair and began to seize. She was lowered to the floor while she was seizing and monitored by paramedics who were on site until the seizure was over. The seizure lasted approximately 4 minutes. Patient was postictal and elected to be transported to the ED for further evaluation. ED discharged her home.
28 2021-03-03 weakness client has compliant of dizziness, feeling weak.
28 2021-03-04 pain in extremity "the next day [after vaccination] the injection site was extremely sore and the pain went up to my n... Read more
"the next day [after vaccination] the injection site was extremely sore and the pain went up to my neck and down into my hand. From what I heard this is pretty normal so I had no concerns. Over the next couple days the injection site pain was gone along with the neck pain but the wrist/hand pain persisted. It?s now been a week since the pain started and my wrist/hand/forearm are still really sore/achy. I?ve been icing it multiple times a day but the pain persists. It?s especially bad when typing or doing any repetitive motions with my hand. "
28 2021-03-06 pain in extremity 5 hours post vaccine- sore arm, low grade fever, 12 hours post vaccine cold symptoms (stuffy nose, s... Read more
5 hours post vaccine- sore arm, low grade fever, 12 hours post vaccine cold symptoms (stuffy nose, sneezing, coughing), 24 hours post (severe cold symptoms listed above, fever, body aches). Also- I'm pregnant (5 weeks).
28 2021-03-06 tingling Right after vaccine injection, patient started having tingling in her face and feeling sob. Episode... Read more
Right after vaccine injection, patient started having tingling in her face and feeling sob. Episode last about 5 mins. Afterwards, pt felt fine. Denies chest pain, rash, itching or dizzy. RR 18 BP 120/73 HR 74 and oxygenation of 99%.
28 2021-03-08 breast pain I am breast feeding an d I got mastitis from a breast duct. I was put on a 14 day Clindamycin. My d... Read more
I am breast feeding an d I got mastitis from a breast duct. I was put on a 14 day Clindamycin. My doctor did not think this was related to the vaccine but that I had to report it. I had chills and breast pain and pain at the plugged duct. I saw my doctor through telemedicine.
28 2021-03-08 numbness Pt mother states that Pt is having a panic attack, pt verbal, but kept repeating that her hands were... Read more
Pt mother states that Pt is having a panic attack, pt verbal, but kept repeating that her hands were numb, seated and agitated. Evaluated by EMS-Cleared
28 2021-03-09 flushing Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneo... Read more
Muscle aches (back); Injection site pain; Headache; Flushing in face; Brain fog; This is a spontaneous report from a contactable other hcp (reporting for herself) A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1283), via an unspecified route of administration single dose on 06Feb2021 10:15 (at the age of 28) left arm for covid-19 immunisation. The first dose (lot# EL12849) was taken on 15Jan2021 10:15 am, left arm. The patient medical history was not reported. There were no concomitant medications. No other vaccine was received in four weeks. The patient experienced muscle aches on 06Feb2021 19:00, injection site pain on 06Feb2021 19:00, headache on 06Feb2021 19:00, flushing in face on 06Feb2021 19:00, brain fog on 06Feb2021 19:00. No treatment received. The events outcome was not recovered.
28 2021-03-10 feeling hot Est DD: 08/07/2021 Patient reported feeling hot and light headed within 5 minutes of receiving injec... Read more
Est DD: 08/07/2021 Patient reported feeling hot and light headed within 5 minutes of receiving injection. Assisted into on the cot. Reports feeling shaky and anxious. States worried because of being pregnant, nausea as well. 1240 BP 147/89 HR Spo2 99% 1245 BP 126/86 HR 104 Spo2 100% 1255 BP 142/87 HR 96 Spo2 99% ( edge of bed) 1305 All symptoms have subsided. Standing on side of bed. 1310 No further issues . Accompanied out by family member.
28 2021-03-10 throat numbness Metallic taste in mouth, then following with numbness, tightening, and tingling in throat and mouth.... Read more
Metallic taste in mouth, then following with numbness, tightening, and tingling in throat and mouth. First treated with Benadryl, then decadron and Pepcid. After reaction did not stop, I was taken to the ER and given IV steroid(s). On discharge I was given epinephrine and prednisone. This occurred over a four hour period.
28 2021-03-10 weakness Nausea, vomiting, fever 100.3, pounding headache, weakness, chills
28 2021-03-10 tremor Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and ... Read more
Shortly after receiving the shot at work, I developed worsening dizziness as well as a headache and internal tremors, which resolved. I later developed generalized itching, worse on the back of my hands and feet, which resolved. The following day, I developed palpitations while at rest and mild shortness of breath. I also had a brief bout of nausea, which resolved, but I still have palpitations and mild shortness of breath.
28 2021-03-12 weakness Client stated that she had prior history of vaso-vagal response to vaccinations, finger pricks and b... Read more
Client stated that she had prior history of vaso-vagal response to vaccinations, finger pricks and blood draws, that usually they have her lay down when she gets shots. She also has had nausea and dizziness after other shots. She felt nauseous within 2 minutes and was pale and faint, weak. Checked her bp was between 100/60 and 120/80 pulses 40-60. she was"passing out" between answering questions, called EMS and asked her about what she had eaten this morning. she stated some of a bagel but not all. F/U on 3/12 states she felt better with normal BP/pulse while in ambulance and the EMS released her with out transfer, she sat in her vehicle for 1 hour before driving home. she felt weak with sore shoulder on 3/11
28 2021-03-12 migraine Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fa... Read more
Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fatigue, migraine, un-productive coughing, chest tightness, difficulty breathing.
28 2021-03-13 pain in extremity First dose: Had a very slightly sore arm a few hours after injection through the following morning. ... Read more
First dose: Had a very slightly sore arm a few hours after injection through the following morning. Then had a very slight headache for a couple hours. Then the day after that my neck was very sore on the side the vaccine was given. I watched TV on my laptop and had my elbows on my thighs for maybe 30 minutes and I often watch TV like this. When I went to the bathroom, I saw my thighs had multiple bruises where my elbows were (3 spots) while I was watching TV. The bruises and sore neck lasted another 2 days and I was fatigued more quickly during this time. After that I was fine, though 1 bruise spot still remains today 11 days after vaccination. The easy bruising and lasting bruising is not normal for me. I have dark color skin and also rarely bruise.
28 2021-03-13 unresponsive to stimuli, weakness Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unkn... Read more
Symptoms: Fainting, Unconciouness (repeatedly), Profusive Sweating, Low Blood Pressure (60 over unknown number), Nausea, Dizziness, Unable to stabilize quickly, not able to get an IV, extreme thirst Signs: Immediately felt unwell within 5 minutes of the vaccine. Time Course: Injection (1st dose - Pfizer) at 4:00pm. Adverse Reaction at 4:05/4:10 (est.) Released at 5:00pm (est.) Description of Incident: On March 8th, at 4:00 pm, I received my first dose of the covid vaccine. Within 5 to 7 minutes, I felt unwell while sitting in the waiting area. I walked towards a worker to inform them that I was feeling unwell and that I was going to pass out. I became unresponsive and laid on the ground. My husband was with me at the time. I was unconscious for a bit and when I regained consciousness, my legs were being raised. I regained consciousness and was able to recall my name, DOB, and address. After I was done recalling my information, I began to lose consciousness again. They brought a wheelchair and took me to the medical room. As I moved from the wheelchair to the bed, I began to lose consciousness again. They told me to lay down. I overheard a woman ask my husband if I had diabetes or heart problems. He answered ?No.?. She explained to him that my body did not know how to accept the vaccine and was trying to regulate back to normal. She explained that my body was going through ?homeostasis? (?). While I laid on the bed, some workers took my blood pressure and tried to start an IV. One of them made a comment and said I was extremely dehydrated. This was odd to hear because I normally drink 3 to 4 liters of water daily. During this entire medical event, I felt the water pushing out through my pores. I was drenched in sweat. He tried to start an IV on my left arm and was unsuccessful. He tried to start an IV on my right hand, which was also unsuccessful. He stated they were unable to start IV liquids because my veins kept popping/collapsing. My blood pressure was reading 60. They checked it again, still at 60. I laid in the bed and basically waited it out. After a few minutes, they checked my blood pressure at it was at 120. They said that was good and I was good to go. No report was given to me nor my husband about the event that occurred. Even after they agreed to let me use a wheelchair (due to feeling weak), one was not provided to me. They basically stated that I was ?good to go?, after doing a series of hand squeezes and walking a few steps upright. I am currently trying to obtain a copy of the report I saw the gentleman fill out at the time. I was given Zofran to help with my nausea, it was placed under my tongue. After going home, I felt weak, tired and somewhat lightheaded. My husband drove me home and I got some rest. I set an appointment with my doctor on Friday March 12th to determine what happened to me during my vaccine and to record the incident. After describing the incident, she determined that it was anaphylaxis. She recommended for me not to get my second dose due to the anaphylactic shock I experienced with the first dose. She was shocked to learn that they did not transport me to the hospital or provided an Epi Pen injection. When asked why I didn?t drive myself to the hospital, I let her know that they told me I was ?good?. They did not explain what had occurred to me, no mention of anaphylaxis was explained. I was not aware that is what had occurred. The incident occurred from 4:00pm (injection time) to 5:00pm (left location).
28 2021-03-13 seizure, numbness dizzy, feeling numb, convulsions per spouse. Evaluated by EMS-Refusal to transport.
28 2021-03-14 numbness Blurred vision, numbness on left side of body, restlessness
28 2021-03-14 tenderness Strong pain in deltoid muscle beginning the evening of the first injection (3/12) and the day after ... Read more
Strong pain in deltoid muscle beginning the evening of the first injection (3/12) and the day after (3/13). Impossible to sleep on that arm, difficult to lift arm, severe pain when touched. Diminished pain 3/14-3/15.
28 2021-03-15 feeling hot Progress Notes Expand AllCollapse All Patient: ... Read more
Progress Notes Expand AllCollapse All Patient: DOB: 9/4/1992 Date: 3/12/2021 MRN: Subjective Patient is a 28 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and feeling faint and hot. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , collapse, hypotension, rapid progression of symptoms and skin changes. Past Medical History: Diagnosis Date ? Acne ? Acute gastritis ? ADD (attention deficit disorder) ? Allergy ? Anxiety ? Depression ? Migraines ? Shingles 2017 ? Wears glasses in the past ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, vomiting, abdominal pain, dizziness and headaches Previous Reactions: She reports hx of fainting with vaccines in the past. She didn't have problem with 1st dose of Pfizer. Today she is here for 2nd dose. Objective Vitals Vitals: 03/12/21 1437 03/12/21 1450 BP: 115/70 124/64 Pulse: 70 76 SpO2: 98% 100% Physical Exam Constitutional: Appearance: She is obese. She is diaphoretic. Comments: flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is moist. Neurological: General: No focal deficit present. Mental Status: She is alert, oriented to person, place, and time and easily aroused. Gait: Gait normal. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Behavior is cooperative. Thought Content: Thought content normal. Judgment: Judgment normal. Pt wheel chaired to the medical bay. Pt given ice packs x 2 and brought to the bed and placed in trendelenburg position. Pt vs taken and is stable. Pt feels better in this position. Slowly inclined to sitting position. Tolerating well. Skin dry. Assessment/Plan Treatment included: water, snacks and ice packs Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) She reports having improvement of symptoms after observation in medical bay for 40 mins. She is to be taken home by dad who was able to come in to pick her up. Pt wheeled to front by this provider and able to stand and walk w/o assistance to car. Monitor symptoms at home and follow up with pcp as needed.
28 2021-03-15 muscle spasms day after vaccine, expereinced severe cramping and menstrual bleeding very heavily. I was two weeks ... Read more
day after vaccine, expereinced severe cramping and menstrual bleeding very heavily. I was two weeks before my period which is VERY abnormal. lasted for five days
28 2021-03-16 numbness I tested positive for COVID-19 on 12/16/20. I got my first shot (Moderna) on 1/28/21. The next day m... Read more
I tested positive for COVID-19 on 12/16/20. I got my first shot (Moderna) on 1/28/21. The next day my right arm and my whole body hurt. After 24 hrs, I went back to normal. On 2/4/21, I went back to get my second dose of (Moderna). I didn't know I was not suppose to go 28 days later, since i only remember them telling me to go back on a Thursday at 3:30 PM. I gave my vaccine card to a lady in the registration table. She did not see my name on their roster, therefore she wrote my name on the bottom of her sheet. She then asked the pharmacist "Do you have a spot for one more?". I went and he asked me on which arm do I want the vaccine and I said the "right arm". I don't remember him telling me which vaccine I was going to receive. He told me to wait outside in my car for 15 minutes. The next day both of my arms started feeling numb. I noticed that I received both vaccines (Moderna and Pfizer), when one of my coworkers asked me if I was ready to go and take the second dose on 2/22/21. That was when I checked my card and saw that I received both vaccines and my date for my second dose was on the back of my card 2/25/21. I called where I got the shot, and they said that they were not with the people in charge of giving the vaccines. I told my coworker to give them my number and tell them my situation, when she went to get her second dose (2/25/21). I never received a call from them. Staff from vaccine provider called me on 3/8/2021 to see if I wanted to schedule my second dose of Moderna. I had to explained my situation with her, since she did not know about it. She told me to go to my Family Doctor. I went to see him on 3/10/21. He said I will be ok and the symptoms will go away. He told me to take Claritin. I feel both of my arms less numb as of today. I hope this goes away soon. Other than that I feel healthy.
28 2021-03-16 tingling I was 33 weeks and 7 days pregnant on the date of shot, estimated due date 4/24/21, previous pregnan... Read more
I was 33 weeks and 7 days pregnant on the date of shot, estimated due date 4/24/21, previous pregnancy delivered preterm at 34 weeks and 3 days due to preeclampsia, currently no indication of preeclampsia in this pregnancy Approximately 15 minutes after receiving the vaccine the right side of my face begin to tingle. It tingled off and on for the rest of the evening and in the morning the right side of my face was noticeably swollen for the first 3-4 hours of the day. It went away and I took no medication and have experienced no more symptoms.
28 2021-03-16 pain in extremity Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid ... Read more
Lung pain; splitting headache; could not sleep; feels run down; developed bubbles filled with fluid all over her lips; feels bad; achy; arm hurt; swelling and tingling sensation around my lip; swelling and tingling sensation around my lip; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 09Feb2021 at (at the age of 28-years-old) as a single dose in the deltoid (unspecified) for COVID-19 vaccination. Medical history included asthma, Meniere's disease, cold sores and she had COVID-19 with symptoms of splitting headache, all on an unknown date. Concomitant medications included formoterol fumarate, mometasone furoate (DULERA) for asthma from an unknown date and ongoing and supplements (unspecified) for Meniere's disease. The patient previously received the first dose of BNT162B2 on 15Jan2021 and experienced achy, arm hurts, weird lung pain and splitting headache. Within minutes of receiving the second dose on 09Feb2021 the patient experienced swelling and tingling sensation around the lip and arm hurt. On 10Feb2021 the patient experienced bubbles filled with fluid over her lips in the morning, she felt bad and is achy; from an unknown date the patient experienced feels run down, weird lung pain, a splitting headache and she could not sleep. Therapeutic measures were taken as a result of the headache which included Aleve and she drank a bunch of water with her daily vitamins. The clinical outcome of the events lip swelling, tingling lips, lung pain, insomnia, fatigue was unknown; lip blister, feels bad, achy and arm hurt was not recovered; and headache was recovered The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
28 2021-03-16 pain in extremity Nausea, vomiting and bodyaches. Employee states her Left arm is swollen from injection site down to... Read more
Nausea, vomiting and bodyaches. Employee states her Left arm is swollen from injection site down to her hand. Arm is very painful to move.
28 2021-03-16 feeling cold Patient consent form shows no allergies to medications or vaccines and was given Pfizer covid shot. ... Read more
Patient consent form shows no allergies to medications or vaccines and was given Pfizer covid shot. She was not on any medications, and no known allergies to food. After roughly 10 mins she said she felt tired, her head was feeling heavy, her heart rate increased. Patient stated she was able to breath fine, alert of surroundings. Alert x 4. Felt cold and shivering. Heart rate was 110, came down to 90, and then increased to 99. 02 level was 99. Temp 97.3. BP 134/72. Ambulance was called out of caution and patient transported to hospital.
28 2021-03-16 tingling, burning sensation Pt had chest pressure and slight pain starting 10 minutes after the injection. Patient then had wors... Read more
Pt had chest pressure and slight pain starting 10 minutes after the injection. Patient then had worsening chest pressure and pain, slight nausea, dizziness, palpitations, and left upper extremity paresthesia which lasted a few minutes. The symptoms resolved but hen recurred later when she was in the post-vaccine monitoring area. Pt also felt pre-syncopal and was then sent to the emergency department. Her symptoms resolved shortly thereafter but she had an additional episode while waiting in the ED. She reports she currently feels some chest pressure and LUE burning. No exacerbating or alleviating factors. Not associated with shortness of breath.
28 2021-03-17 pain in extremity, facial pain I had chills, body aches; headaches; I felt feverish but I don' t know if I had a fever. Body aches ... Read more
I had chills, body aches; headaches; I felt feverish but I don' t know if I had a fever. Body aches were really intense - I didn't sleep the whole night. I had swelling a little on my arm - at injection site. My arm was sore. In general, my body was really sore and I couldn't get up from bed for 24 hours. I still had a bit of a headache and chills after the 24 hours so I stayed home from work 48 hours. I have been seen by a doctor -after the second vaccine, I had a flare up with my rash on my face (had been experiencing a rash on face prior to vaccine but this was a flare). My face flare up was that I broke out in a rash after finishing doxycycline. Didn't put me on another antibiotic because they wanted to wait and see with the rash - and the tests. Flare up - I couldn't eat; painful to wear a mask to work; couldn't sleep on my face. I was put on doxycycline again - on March 10th or 11th again because I couldn't handle the pain anymore. And it is getting refilled for another round. I have had to take a leave a absence from work the last two weeks.
28 2021-03-18 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out after receiving the P... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out after receiving the Pfizer covid vaccine from a sitting chair position.
28 2021-03-18 difficulty speaking tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bi... Read more
tachycardia HR 135; shortness of breath; Mild Angioedema (local throat and tongue); Hoarse voice; Bilateral wheeze/ bronchospasm; Upper airway swelling; Tachypnoea: RR28; Sensation of throat closure; Irregular heart arrhythmia; Dry cough; This is a spontaneous report from a contactable other hcp (patient). A 28-years-old female patient receive dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL3249, intramuscular left deltoid on 08Jan2021 07:35 at the age of 28 years as a single dose for covid-19 immunisation. Medical history included asthma from 04Apr2005 to an unknown date, obesity from an unknown date, seasonal allergy from 20Dec2007 to an unknown date , food allergy from 20Dec2007 (allergic to walnuts, peanuts, hazelnuts, palm oil) to an unknown date. Concomitant medication included fexofenadine hydrochloride (ALLEGRA), docusate sodium (COLACE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), iron (IRON), calcium (CALCIUM) , diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), on 08Jan2021 07:05 and acetaminophen on 08Jan2021 07:05 for antipyretic prophylaxis. The patient previously took sunflower seed oil base and experienced hypersensitivity. The patient carries EPI pen but never used, received allergy shot for 6 years only uses drug allergy season. Historical vaccine dose 1 of BNT162B2 for covid-19 immunisation on 18Dec2020, Left deltoid, intramuscular, Batch/lot number: EJ1685 at 08:45 am at age 27 years. The patient experienced mild angioedema (local throat and tongue) considered medically significant on 08Jan2021 08:00 with outcome of recovered 14:30 , hoarse voice on 08Jan2021 with outcome of unknown , shortness of breath on 08Jan2021 09:05 with outcome of recovered , tachycardia HR 135 on 08Jan2021 09:07 with outcome of recovered , bilateral wheeze/ bronchospasm on 08Jan2021 with outcome of unknown , upper airway swelling on 08Jan2021 with outcome of unknown , tachypnoea: RR28 on 08Jan2021 with outcome of unknown , dry cough on 08Jan2021 with outcome of unknown , sensation of throat closure on 08Jan2021 with outcome of unknown , irregular heart arrhythmia on 08Jan2021 with outcome of unknown and "Vacematter 08:45". Lab data all reported on 08Jan2021 included heart rate: 135 and 130, oxygen saturation: 98 %, respiratory rate increased 28. Therapeutic measures were taken as a result of mild angioedema, hoarse voice, shortness of breath, tachycardia HR 135, bilateral wheeze/ bronchospasm, upper airway swelling, tachypnoea: RR28, dry cough, sensation of throat closure, and irregular heart arrhythmia. The patient took Benadryl 50mg at 09:10 and experienced irregular heart arrhythmia.
28 2021-03-19 pain in extremity SWOLLEN, RED, PAINFUL LEFT ARM FOLLOWING ADMINISTERATION OF VACCINE.
28 2021-03-19 pain in extremity, nerve pain Sudden and continued nerve pain in the little finger and ring finger of the left arm at about 10:15p... Read more
Sudden and continued nerve pain in the little finger and ring finger of the left arm at about 10:15pm
28 2021-03-21 facial paralysis, cold sweat At 12:35 PM mother hollered for help, patient was pale, skin was cold and clammy, and slight left si... Read more
At 12:35 PM mother hollered for help, patient was pale, skin was cold and clammy, and slight left side facial droop, facial droop resolved pretty quickly, Patient was given soda to drink and a squad was called for further evaluation, squad arrived at 12:57, vital signs was taken, BP 106/72, Spo2 100%, Pulse 76, Patient refused to go to hospital, patient left with family.
28 2021-03-21 numbness At 4:15 pm, While under observation for 30 minutes, pt c/o heaviness in the eyes., and slight chest... Read more
At 4:15 pm, While under observation for 30 minutes, pt c/o heaviness in the eyes., and slight chest pain. pt. also c/o nausea and vomiting symptoms. pt. c/o numbness in the left arm. Pt. was encouraged to take deep breaths. Pt. was helped to the ground in a supine position. BP=140/90, HR=88, RR=18 . Pt was alert and oriented X4. 2 minutes after deep breaths, patient reported that all symptoms had subsided except numbness in the left arm.
28 2021-03-21 feeling hot Patient describes feeling dizzy and hot through top of the body. Patient had a low grade (99.8) tem... Read more
Patient describes feeling dizzy and hot through top of the body. Patient had a low grade (99.8) temp and was advised by Physician to monitor temp for the next 4-6 hours. Consider a Covid test if temp goes over 100.4 degrees. Advised Patient to rest.
28 2021-03-21 migraine, burning sensation Severe migraine, and burning sensation on entire body. Especially in back/neck, ribs and vaginal ar... Read more
Severe migraine, and burning sensation on entire body. Especially in back/neck, ribs and vaginal area (even when I pee).
28 2021-03-21 slurring Slurred speech event for 15 seconds while working. Continued elevated DDimer and other various cloth... Read more
Slurred speech event for 15 seconds while working. Continued elevated DDimer and other various clothing labs post event. TIA event with continued hypercoagulation
28 2021-03-22 weakness Felt weak and racing heart post vaccination. Transported to ER via EMS.
28 2021-03-22 weakness fever, aches, chills about 7-8 hours after the shot. Lasted about 10 hours, and then a weakened leve... Read more
fever, aches, chills about 7-8 hours after the shot. Lasted about 10 hours, and then a weakened level for another 12
28 2021-03-23 flushing Low grade fever for six days (and counting) post vaccine; flush cheeks
28 2021-03-24 weakness, tingling Collapsed; difficulty breathing; weakness; Pain in chest; tingling all over body.; This is a spontan... Read more
Collapsed; difficulty breathing; weakness; Pain in chest; tingling all over body.; This is a spontaneous report from a contactable consumer (parent). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 10Mar2021 at 12:15 (Lot Number: EN6206) (at the age of 28-year-old) as single dose for COVID-19 immunisation. Medical history included bipolar from an unknown date and unknown if ongoing. Concomitant medications included lamotrigine (LAMICTAL); amphetamine aspartate/ amphetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) and alprazolam (XANAX); all taken for an unspecified indication, start and stop date were not reported. On 10Mar2021 at 12:15, the patient collapsed and experienced difficulty breathing, weakness, pain in chest and tingling all over body. The events resulted in physician office visit. No therapeutic measures were taken as a result of the events. The patient outcome of the events was not recovered.
28 2021-03-24 grand mal seizure Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech a... Read more
Generalized Tonic-Clonic Seizure; feeling unwell; slightly nauseous; still a little slow in speech and gait; still a little slow in speech and gait; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration, administered in arm right on 05Mar2021 08:00 as a single dose (at the age of 28-years-old) for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included epilepsy, hypopituitarism, central diabetes insipidus, neoplasm of brain, irregular menses, short-term memory loss, elevated LDL, and myopia w/ astigmatism. The patient had known allergies to surgical tape and contrast dyes. Concomitant medications included desmopressin acetate (DDAVP), lamotrigine (LAMICTAL), levetiracetam, and zonisamide; all were taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug allergy. On 08Mar2021 at 06:15 PM, the patient experienced generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait. Therapeutic measures were taken as a result of generalized tonic-clonic seizure, feeling unwell, slightly nauseous, still a little slow in speech and gait as Nayzilam 5 mg two doses was administered. Clinical course details as reported: the patient finished dinner and evening medications before 6 pm and started feeling unwell and slightly nauseous soon after. Laid on sofa, started to sit up at 6:20 pm, and went into a Generalized Tonic-Clonic Seizure. The patient's father administered Nayzilam 5 mg (2 doses); seizure ended and the patient went into a deep sleep until 8:00 pm. The patient was largely recovered, but still a little slow in speech and gait. The outcome of the events was recovering as reported. Information on the lot/batch number has been requested.
28 2021-03-24 feeling hot feeling faint and hot; feeling faint and hot; the patient began to experience lightheadedness; Syste... Read more
feeling faint and hot; feeling faint and hot; the patient began to experience lightheadedness; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable other health care professional. A 28-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6206 and expiry date was not provided), via an unspecified route of administration on 12Mar2021, as SINGLE DOSE for COVID-19 immunisation. Medical history and concomitants were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The reporter stated that, during her 15-minute waiting period after the injection, the patient began to experience light-headedness and feeling faint and hot. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. The patient received water, snacks and ice packs as the treatment. On an unknown date in Mar2021 the patient had differential diagnosis systemic reaction (hypoglycemia, hypotension, generalized rash). The reporter stated that that the patient having improvement of symptoms after observation in medical bay for 40 mins. She was to be taken home by her father who was able to come in to pick her up. The reporter stated that the patent wheeled to front by this provider and able to stand and walk assistance to car and she was monitored symptoms at home and follow up with PCP as needed. Outcome of the events was recovering. No follow-up attempts are possible. No further information available.; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
28 2021-03-25 facial paralysis 28 yo female received second dose of Pfizer COVID-19 vaccine 3/19 at 0933. Around 1130 pt reports nu... Read more
28 yo female received second dose of Pfizer COVID-19 vaccine 3/19 at 0933. Around 1130 pt reports numbness and tingling in her mouth and right sided facial drooping. Presents to ED. History of right frontal cavernous malformation, removed in 2013. PMH significant for migraine headaches and vestibular disorder. Evaluated by neurovascular with low suspicion for stroke. Symptoms improving. Received diphenhydramine, ketorolac and prochlorperazine in the CDU. CT brain and angio brain and neck without acute findings. Recommended pt to complete brain MRI with and without contrast to rule out possibility of stroke or underlying lesions to be performed outpatient. Pt discharged later that day with symptoms fully resolved.
28 2021-03-25 flushing, tingling Dizzyness, nausea, flushed, tingling in the legs. VR reported typical reaction to all vaccines minus... Read more
Dizzyness, nausea, flushed, tingling in the legs. VR reported typical reaction to all vaccines minus leg tingling.
28 2021-03-27 numbness, pain in extremity My left hand in the pinkie finger and ring finger are numb ,as well as my right hand is sore and har... Read more
My left hand in the pinkie finger and ring finger are numb ,as well as my right hand is sore and hard to grip very painful, my throat glands are swollen, today I went to pass a bale movement and much strain so I removed it only to discover blood in it. I'm very worried about these health issues that have never been experienced,. March28,2021 Sunday morning bale pass blood seen and noticed around 9:30 am.
28 2021-03-27 pain in extremity Sore arm, headache
28 2021-03-28 feeling hot Patient reports sudden onset of severe nausea, sweating. C/o "not feeling well and feeling hot". Pat... Read more
Patient reports sudden onset of severe nausea, sweating. C/o "not feeling well and feeling hot". Patient was assessed by onsite clinic EMS, vitals were taken and evaluated. Patient was monitored for 30 additional minutes. Patient's symptoms resolved, never vomitted. Patient disposition: went home and recovered feeling fine.
28 2021-03-29 facial pain gradual facial pain; mild inflammation on the right side of face; This is a spontaneous report from ... Read more
gradual facial pain; mild inflammation on the right side of face; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 19Feb2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa drug allergy, penicillin allergy, and evergreen allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medications included vitamin C and vitamin B complex, both from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that about 30 hours post-injection, she experienced gradual facial pain and mild inflammation on the right side of the face. The pain and inflammation lasted 6 hours and gradually decreased; she reported no droop or numbness. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of gradual facial pain and mild inflammation on the right side of the face were recovered in Feb2021. It was also reported that since vaccination the patient had been tested for COVID-19 on 23Feb2021 via polymerase chain reaction (PCR) nasal swab, and the results were pending (as of 24Feb2021).
28 2021-04-17 tremor Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling wor... Read more
Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling worse; Some feverish feelings; Hives all over my body, especially on my face; Chills; Couldn't stop shaking; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in arm left, on 26Mar2021, at 14:00 as single dose for COVID-19 immunisation. Patient medical history was not reported. She did not have any known allergies. Concomitant medications included estradiol valerate, progesterone and cyanocobalamin (VITAMIN B12). Patient stated that she first experienced some feverish feelings, chills and hives 30 minutes following her vaccination. She drove home from the hospital and was feeling a bit off, but mostly okay. By the time she got back, she was feeling worse, around 4 PM. By 5 PM she had broken out in hives all over her body, especially on her face, swelling her eyes significantly and having her tongue go somewhat numb, starting to make it difficult to swallow. She also had significant chills, and couldn't stop shaking, and ended up being admitted to the ER. After being given antihistamines, the swelling went down and eventually the chills stopped after monitoring in the hospital. The patient was hospitalized for the events on an unknown date in Mar2021. Treatment received for the events. The patient was not diagnosed with COVID prior vaccination. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. Outcome of the events was recovered on an unknown date in Mar2021.
28 2021-04-17 pain in extremity, tingling This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (... Read more
This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 11:15 AM (Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation. Historical bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 12:15 PM (Lot Number: EN6199) as SINGLE DOSE for covid-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD). No covid prior vaccination, no known allergies and no covid tested post vaccination. The patient's concomitant medications included unspecified drug and not enough space. There is no other vaccine in four weeks. Patient experienced adverse events on 02Apr2021 included Arm Pain right after 02:00 AM, Headache around 2am, Nausea around 2:15am, Fainted around 2:20am, Weak Legs around 2:30am, Tingling in hand & feet around 2:30am, ringing in ear around 2:30am, Light fever around 7am, Headache persisting until just now after getting some sleep finally from 12pm-2pm now.AE resulted in Doctor or other healthcare professional office/clinic visit. There was unknown treatment were received for adverse events. The outcome of headache was not recovered. The outcome of other events was recovering.
28 2021-04-17 hot flush This is a spontaneous report from a contactable other health professional (patient) reported that a ... Read more
This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot be excluded. Case will be reassessed if additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-04-20 pain in extremity DVT in my right calf; I felt pain in my calf between 10-20 hours before second vaccine dose. The pai... Read more
DVT in my right calf; I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant; I felt pain in my calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 28-year-old female patient received second dose of BNT162B2 (Lot Number: ER8734), via an unspecified route of administration, administered in the left arm on 02Apr2021 as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EP7534) for COVID-19 immunization. Medical history included corneal abrasion and pain in my calf, both from an unknown date and unknown if ongoing. Concomitant medications included tetryzoline hydrochloride (EYE DROPS [TETRYZOLINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced DVT in her right calf on an unspecified date and 'felt pain in my calf between 10-20 hours before second vaccine dose. the pain went away but came back 5 hours after second vaccine dose. in the next 10 hours, the pain became severe and constant' on 02Apr2021. The clinical course was reported as follows: The patient felt pain in her calf between 10-20 hours before second vaccine dose. The pain went away but came back 5 hours after second vaccine dose. In the next 10 hours, the pain became severe and constant. At 40 hours after second vaccine dose, she went to the ER and was diagnosed with a DVT in her right calf. The adverse events result in Emergency room/department or urgent care. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of both events which included blood thinners. The outcome of the events was recovering.
28 2021-04-27 pain in extremity Exposure during pregnancy; Sore arm; This is a spontaneous report from a contactable consumer or oth... Read more
Exposure during pregnancy; Sore arm; This is a spontaneous report from a contactable consumer or other HCP (Patient) via Pfizer-sponsored program reported for both mother and foetus. This is a mother case. The mother reported she was pregnant while taking BNT162B2 . A 28-year-old (pregnant) female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EJ1685) via an unspecified route of administration on 08Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EJ1685) via an unspecified route of administration on 27Jan2021 (at the age of 28-year-old) as single dose for COVID-19 immunisation. The patient medical history included induced labour, live birth-induced at 38.5 weeks for gestational hypertension- no other complications, Ehlers-Danlos syndrome (Father Side- sister has Ehlers-Danlos syndrome), mast cell activation syndrome (maternal aunt-Mast cell activation, none on mother side), alcohol use. Prenatal vitamins (once a day) from Oct2020. Concomitant medication included meclizine HCl (25 mg once/day) taken for nausea, motion sickness (car sick) from 27Dec2020 to 20Jan2021. The patient was 12 weeks pregnant (off label use, product use issue) on 08Jan2021. She was wondering if data was being collected, she knows that pregnant women cannot be studied for ethical reasons and was happy to be a part of any data sharing. The mother was 12 weeks pregnant at the onset of the event. In the first trimester of pregnancy, the patient was admitted to the hospital due to exposure during pregnancy and was fine later. Estimated due date was 08Feb2021 and for the first dose she was 10.5 weeks pregnant and for the second 13.5 weeks. She had no side effects except for a sore arm (pain in extremity) and so far no complications in her pregnancy. No other products were taken together. First day of last menstrual period was 25Oct2020, estimated date of conception was 10Nov2020 and estimated delivery date was 02Aug2021. The mother did not smoke, use illicit drugs nor drink alcohol during this pregnancy. Number of previous pregnancies were one and number of other children were one. History of sub-fertility included live birth-induced at 38.5 weeks for gestational hypertension, no other complications. No treatment for infertility, Negative results for serology tests and on 16Jan2021, first ultrasound showed all normal, left ovary-corpus luteum cyst. No problems before pregnancy. No drugs were taken by the father during the mothers pregnancy. The father did not smoke nor used illicit drugs but drank alcohol socially during the mother's pregnancy. Outcome was unknown for all the events. Information about lot/batch number has been requested. Follow up (12Feb2021): This is a follow-up spontaneous report from a contactable nurse. This 28-year-old female nurse reported in response to Non HCP letter sent which included lot number, adverse events, pregnancy due date. Follow up (16Feb2021): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to Non-HCP EDP follow-up questionnaire sent which included pregnancy information and drug details.
28 2021-04-27 pain in extremity, seizure Low grade fever; seizure; Passed out; syncope/ fainted; Blood pressure drop; Sore arm; This is a spo... Read more
Low grade fever; seizure; Passed out; syncope/ fainted; Blood pressure drop; Sore arm; This is a spontaneous report from a contactable consumer (patient's parent). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 28-years-old, via an unspecified route of administration in left arm on 07Apr2021 at single dose for COVID-19 immunization. Medical history included autism, being nervous, passed out, and anxiety. Concomitant medications included sertraline hydrochloride (ZOLOFT), quetiapine fumarate (SEROQUEL), gabapentin, bupropion hydrochloride (WELLBUTRIN), and lorazepam (ATIVAN) for being nervous. The patient received the Pfizer vaccine last Wednesday (07Apr2021) and immediately after that, at about 1:30 (unspecified), she just started having a seizure. They thought that it was more of a major response she was just having, fighting and was nervous about it, but it was kind of a different situation. The reporter has seen the patient passed out before. She did some blood test on 07Apr2021 and her sugars were fine. The reporter's concern was that they didn't know whether she should get the second one. The reporter didn't believe she got a seizure but was not sure about it. It's just that what immediately happened after she got the shot was that she passed out and they called the ambulance. After she passed out, she went to the emergency room and they did blood work on her. The reporter just did not know if they were going to let her go for the second dose because they couldn't relay if it was a seizure or a bizarre response where she just syncope and fainted. They were just thinking it was a bizarre response as it was just blood pressure drop but they were just not sure where to go from here. The patient was told to rest and intravenous fluid and something through the blood were given. The patient also experienced sore arm from 07Apr2021 for 2 days and had a low-grade fever the following day (08Apr2021). The outcome of the event sore arm was recovered on 09Apr2021 and recovered on Apr2021 for all other events. Information about the lot/batch number has been requested.
28 2021-04-30 pain in extremity, tremor, feeling hot, muscle twitching fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shak... Read more
fainted; dizzy; warm; arms had seized up and were twitching; leg and body had also briefly been shaking; eyes were dilated; vomiting; arm is sore; sweaty; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 11:00 (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination Medical history was reported as none. There were no concomitant medications. The patient previously had first dose of BNT162B2 (Lot number: ER8727) on 28Mar2021 01:00 PM in the left arm at 28 years old for COVID-19 immunisation and experienced fainted. On 18Apr2021 11:15 AM, the patient fainted about 10 minutes after second dose was vaccinated. The patient became dizzy and very warm and then woke up about 5-7 seconds after had fainted. The patient's arms had seized up and were twitching and leg and body had also briefly been shaking. The patient was very sweaty and warm. The patient's eyes were dilated when woke up according to the overseeing nurse. The patient said it was scary. Half hour after, the patient felt fine but then began vomiting when got home. The patient's arm is sore but nothing else has happened. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. No treatment was given to the patient for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
28 2021-05-03 unresponsive to stimuli Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was feeling dizzy and put the pt on t... Read more
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt was feeling dizzy and put the pt on the floor she was breathing and concious called 911 and the felt better and put her on a sitting position to rest. Her husband said she has dizzinees and fainting problem. we get help they came and assessed her and pt was ok and walked to her car accompanied by her husband. Called her around 5:40p to make sure she is doing ok but no answer
28 2021-05-04 migraine Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is... Read more
Migraine to the point of a blackout; Migraine to the point of a blackout; Shingles Breakout; This is a spontaneous report from a contactable nurse (patient). A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 10Apr2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient experienced shingles breakout migraine to the point of a blackout on 18Apr2021. There was no treatment received for the events. The outcome of the events was not recovered. Information about lot/batch has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the report migraine to the point of a blackout and the use of BNT162B2 cannot be fully excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
28 2021-05-06 numbness Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down tw... Read more
Seeing black, spotty eyesight, almost passing out but was able to make it back to bed to lay down twice. Cannot stand or walk for longer than a couple of minutes unassisted (holding onto something) without breathing becoming shallow and dizziness setting in. Intermittent dizziness and inability to focus eyesight occurred throughout the day even if sitting down. Issues have been consistent throughout entire day. Not sure if this is adverse but also started having circulation issues in toes/fingers turning white & numb when either standing, walking or lying down. Experienced chills but only until ceiling fan was turned off. Circulation slightly improved except in feet.
28 2021-05-07 night sweats headaches; severe kidney infection; drenching night sweats; Fever; This is a spontaneous report from... Read more
headaches; severe kidney infection; drenching night sweats; Fever; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 31Mar2021 12:00 as single dose for COVID-19 immunization in an hospital. Medical history included irritable bowel syndrome-constipation (IBS-C) from an unknown date. No known allergies. Unknown if with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. Concomitant medications included plecanatide (TRULANCE) for an unspecified indication and unspecified generic birth control both start and stop date were not reported. On 31Mar2021, the patient experienced fever and drenching night sweats. On 01Apr2021 the patient developed headaches. On an unspecified date on Apr2021, 4-5 days post vaccination of the first dose, the patient developed severe kidney infection treated with ciprofloxacin. The events required doctor or office/clinic and emergency room visit. The outcome of the events was recovered. The patient received the second dose on bnt162b2 (lot number: EW0164) on 19Apr2021 left arm for COVID-19 immunization.
28 2021-05-10 pain in extremity, numbness and pain in extremities, tingling, numbness On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air p... Read more
On and off neuropathy in hands and feet; Right ear sensitivity / "popping", like with changing air pressure,; Slight woozy/dizziness; Injection site soreness; tingly outside of left arm / left pinky; Very mild headache; tiredness; Stiff / sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; sore neck (including upper shoulder area) Left side of left arm and leg including hand; slight numbness/ Slight numbness in pinky fingers on both hands, and left toes; General "not feeling good"; nausea; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. Medical history included developmental trauma disorder, drug allergy, allergies certain adhesives, borderline personality disorder, and irritable bowel syndrome. Patient is not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient experienced very mild headache, and mild tiredness were on 06Apr2021. On 07Apr2021 (day 2), patient was experienced injection site soreness, tingly outside of left arm/ left pinky. During day 6-7 (in Apr2021), patient experienced headache, stiff / sore neck (including upper shoulder area) left side of left arm and leg including hand and foot, tingly and slight numbness, general "not feeling good", slight nausea/ need to lie down, but not fatigue / wooziness. No fever. On 13Apr2021 (day 8), patient experienced slight woozy/dizziness, in waves. Slight numbness in pinky fingers on both hands, and left toes. On 14Apr2021 (day 9), on and off neuropathy in hands and feet, specifically left leg from knee down (outside of left toes and bottom of left foot) and pinky fingers, most notably when falling asleep/ waking up, or after being on my feet for a while. Right ear sensitivity/ "popping", like with changing air pressure, but on and off (most likely unrelated, but during same period). Adverse event result in doctor or other healthcare professional office/clinic visit. No treatment for events. The patient underwent lab tests and procedures which included saliva test: negative on 13Apr2021. The outcomes of events were unknown.
28 2021-05-12 bell's palsy Bell's palsy/droopiness on the left side of her face; This is a spontaneous report from a contactabl... Read more
Bell's palsy/droopiness on the left side of her face; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Apr2021 (at the age of 28-years-old) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Apr2021, she had drooping on the left side of her face. On the 25th, she went to the ER and it was Bell's Palsy. Her second dose will be on Thursday, 29Apr2021, and is wondering if she should get the second dose. On 27Apr2021, she reported the droopiness in her face is staying about the same. She had blood work done in the emergency department and her bloodwork was all normal. The patient underwent lab tests and procedures which included blood test: normal on 25Apr2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.
29 2020-12-31 migraine, tingling Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches an... Read more
Immediate tingling to face, then on 12/23 migraines and smell adversions, 12/24 chills body aches and skin burned, 12/25 no taste or smell with chills body aches diarrhea skin burned and brain fog, 12/26 positive rapid covid test and symptoms continue
29 2020-12-31 pain in extremity Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wedn... Read more
Tuesday: headache and sore arm came around evening time then at night a fever of 102 kicked in. Wednesday: 102-101 fever took only ibuprofen Thursday: called doctor fever 99-101. Tyenelol and antibiotics and immune boosters Friday: doctor oncall told me to continue meds and she will call me back on Saturday. Fever still 99-101 range.
29 2021-01-02 feeling hot Throat tightness Hot Dizzy Nausea
29 2021-01-03 hot flush Elevated heart rate within the first five minutes after injection. Went away in about one minute. Ca... Read more
Elevated heart rate within the first five minutes after injection. Went away in about one minute. Came back for about one minute in five minute intervals for a duration of about 40 minutes after injection. Feeling flushed with the first 15 minutes after injection. Soreness at injection site 24-48 hours after injection.
29 2021-01-03 migraine developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she de... Read more
developed a migraine; nausea; sensitivity to light and sound; sensitivity to light and sound; she developed significant loss of mental clarity (brain fog); On 18Dec in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the the touch. This lasted about a total of 36 hours and progressively improve; brain fog; retroorbital headache/intermittent mild tension type frontal headache; This is a spontaneous report from a contactable physician (patient). A 29-year-old female patient received first dose BNT162B2 (lot number EH9899), via an unspecified route of administration on 17Dec2020 12:00 at 29 years old at single dose at Left arm for COVID-19 immunization. Medical history included Mirena IUD, personal and family history of retinal migraines (without headache). The concomitant medications were magnesium citrate, melatonin, ademetionine (SAME) and fish oil. On 18Dec2020 in the AM, developed progressive severe soreness at injection site, worse than any other vaccine, hurt even just the touch. This lasted about a total of 36 hours and progressively improved. There was no swelling, redness, or other local symptoms. In the afternoon on 18Dec2020, she developed significant loss of mental clarity (brain fog) while at work. In the evening on 18Dec2020, developed mild retroorbital headache (this was actually the first headache of my life). All day 19Dec2020 and about half the day of 20Dec2020 developed a migraine (also the first of my life), experienced as retroorbital pounding headache, sensitivity to light and sound in 19Dec2020, nausea without vomiting in 19Dec2020, and loss of mental clarity. She had intermittent mild tension type frontal headache on 20Dec2020 PM with all other symptoms resolved, all symptoms resolved by 21Dec2020 AM. The patient used naproxen 440 mg and Tylenol 1000 mg on 19Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not Allergic to medications, food, or other products. The outcome of the events was recovered on 21Dec2020. The information on the batch number has been requested.; Sender's Comments: Based on information available, the reported loss of mental clarity together with other events was likely related to the first dose BNT162B2 due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-01-04 tingling All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell... Read more
All of a sudden I did not have any taste or smell; All of a sudden I did not have any taste or smell; Tested positive; Tested positive; This is a spontaneous report from a contactable nurse reported for herself. A 29-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot EH9899), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included seasonal allergy. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient was taking a multivitamin a day. The patient experienced typical symptoms no taste, smell on 22Dec2020, Slight tingling, body aches, chills, all the other symptoms for Covid and now positive for Covid in Dec2020. Outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for Covid based on the known safety profile.
29 2021-01-04 numbness Left hand feels sleepy; This is a spontaneous report from a contactable health care professional nu... Read more
Left hand feels sleepy; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE); Lot Number: EK5730), intramuscular in the left arm on 30Dec2020 at 14:00 as a single dose, for COVID-19 vaccination. The patient had no known medical history or allergies. Concomitant medication included amoxicillin (AMOXICILLIN). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 30Dec2020 at 16:45, the patient experienced left hand feels sleepy. No Treatment was given for the event. The clinical outcome of left hand feels sleepy was not recovered.
29 2021-01-04 numbness Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began ... Read more
Started with numbness to the whole body, palpitation, Dyspnea, and increased heart rate. This began 20 minutes after the injection. Lasted about 25 minutes. After this episode subsided, I continued to have persistent Dyspnea, chest pain, palpitations and heart racing. Was unable to speak in full sentences, exercise. Walking short distances caused extreme SOB. These symptoms lasted about a week.
29 2021-01-04 tingling Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypne... Read more
Sudden onset of tachycardia and palpitations; Sudden onset of tachycardia and palpitations; tachypnea without SOB; Sudden elevation of BP 178/100; Dizziness; Nausea; skin tingling; This is a spontaneous report from a contactable other healthcare professional, who is also the patient. A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EJ1685), via an unspecified route of administration in the left arm on 30Dec2020 at 12:30 (at the age of 29-years-old) as a single dose for COVID-19 vaccination. Medical history included Psoriasis, psoriatic arthritis, exercise induced asthma (no inhalers or treatment for >10 years). The patient had known allergies to methotrexate and chlorhexidine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications received within 2 weeks of the vaccination included apremilast (OTEZLA) 30mg BID (twice a day), bupropion hydrochloride (WELLBUTRIN XL) 300 QD (once a day), and buspirone hydrochloride (BUSPAR) 5mg. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 30Dec2020 at 12:30 the patient experienced sudden onset of tachycardia and palpitations and tachypnea without SOB within 3-5 minutes of injection. The patient also had sudden elevation of BP 178/100, dizziness, nausea, and skin tingling. The patient's BP gradually came down over 60 minutes. The dizziness lasted about 50- 60 minutes. No medication or medical assistance required. The patient was able to drive home. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 27Dec2020, with Test: Nasal Swab and Result: Negative.
29 2021-01-04 cold sweat, weakness, pain in extremity, flushing, feeling cold Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness,... Read more
Within 10 minutes following vaccine administration, patient had vomiting, lightheadedness, weakness, and verbalized feelings of being cold along with a very flushed appearance. Skin was slightly moist and very warm to touch. Complained she felt the same as when she was diagnosed with the coronavirus infection in March of 2020. Patient continued to experience ongoing weakness in all extremities, dizziness followed by complaints of some changes in her sense of the light with her eyes closed. Shortly thereafter patient began complaining of her heart "speeding" up. Medic arrived and transported patient to the local emergency room. On 1-2-2021 patient provided additional information including that later on the evening of the adverse event the arm where the injection was given became painful and itchy. Patient stated the pain and itching extended into Friday 1-1-2021 and then on into Saturday, 1-2-2021 she developed a sore throat, and some difficulty swallowing (described it as feeling something "stuck" in her throat) along with hoarseness. The patient also verbalized she remained weak, with a very sore arm and some small blisters which had formed on the same arm as where the injection had been given. A couple of the blisters the patient described where on the thumb of her hand as well her arm.
29 2021-01-04 flushing feeling flushed; facial swelling; This is a spontaneous report from a contactable physician reported... Read more
feeling flushed; facial swelling; This is a spontaneous report from a contactable physician reported for self. This 29-year-old female (No pregnant) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 14:30 at single dose for COVID-19 immunization. No COVID prior vaccination, No COVID tested post vaccination. No known allergies or other medical history. No other vaccine in four weeks, No other medications in two weeks. The patient got the vaccine Wednesday afternoon (on 23Dec2020 14:30), then Thursday evening (>24h, 24Dec2020 07:45 PM) started feeling flushed and had facial swelling after dinner. No other symptoms. Resolved with Benadryl. Then again Saturday morning while brushing teeth and Saturday evening after dinner. One more time Sunday morning during breakfast. Each time the symptoms were milder than before. Took Benadryl as needed. No new foods, meds etc. The outcome of event was recovered.
29 2021-01-05 feeling hot 1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain... Read more
1/4/21 12 hr after vaccine fever of 101.3 bodyache and chills . On 01/05 Joint pain ,chest pain hot sweat chills and diarrhea
29 2021-01-05 pain in extremity Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned in... Read more
Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; Arm pain that gradually turned into body pain, joint pain, chills; This is a spontaneous report from a contactable health care professional nurse, the patient. A 29-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 29DEC2020 09:15 as a single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing, and Covid-19 on '17th of this month ' and unknown if ongoing. The patient had no known allergies. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), spironolactone (SPIRONOLACTONE), desogestrel, ethinylestradiol (KARIVA). No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. On 29Dec2020 16:30, the patient experienced Arm pain that gradually turned into body pain, joint pain, chills. The pain was so extreme. Patient had Covid on the 17th of this month and was not told that you should wait 90 days after to get the vaccine. The patient reported her response was worse than the side effects of Covid. The events result in a Physician Office Visit The patient was treated for Arm pain that gradually turned into body pain, joint pain, chills with Heating pads, Ibuprofen (Manufacturer Unknown) and Tylenol alternated. The clinical outcome of arm pain that gradually turned into body pain, joint pain, chills was recovered. Information regarding lot number has been requested.
29 2021-01-05 tremor, muscle spasms Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and ... Read more
Experienced minor chills about 11 hours post vaccination (7:00pm) and took 1000mg acetaminophen and went to bed at 9:30pm. Woke at 11:30pm with uncontrollable chills, nausea, headache and muscle spasms (shaking). Took 1000mg acetaminophen and was able to get back to bed at 2:30am. Had a vivid/stressful dream ongoing off and on all night about completing a task I couldn?t understand, was irrational, and completion would lead to the symptoms subsiding. Woke back up at 4:00am with chills and shakes and a headache and took another dose of acetaminophen. Relaxed at 5:00am and got out of bed. Took 600mg ibuprofen for significantly sore injection site that feels very deep and even goes into the arm pit.
29 2021-01-05 flushing Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. H... Read more
Tachycardia, palpitations, flushing, and dizziness 1-2 hours after the vaccination administration. Has persisted since.
29 2021-01-06 inability to speak 5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore ... Read more
5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat
29 2021-01-06 pain in extremity Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely so... Read more
Fever to 101.4F, headache, nuchal ridigity, tachycardia low 100s, nausea, muscle aches, extremely sore arm with injection site.
29 2021-01-06 feeling hot, cold extremities Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site sorene... Read more
Headache,Myalgia, chills, felt hot all over but temp normal, nasal congestion, injection site soreness Narrative: 12/29 got vaccine. 12/30 feet and hands felt cold. then she felt hot all over. her temp was normal. Then she developed nasal congestion and a headache. Later in the evening she developed body aches and injection site soreness. She took tylenol. 12/31chills have resolved. She has ongoing body aches, feels hot, headache. She called in sick 12/31. Symptoms resolved as of Jan 2.
29 2021-01-06 migraine Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobi... Read more
Joint pain; loss of balance; increased drowsiness; Headaches induced by allergies; Limited neck mobility/lessened neck pain but still limited mobility; Scalp tenderness and sensitivity; Significant migraines/debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness); Sharp pains in neck/Neck pain; Sharp pains in neck, ear, head pain (similar to an ear infection pain); head pain/sharp pains in lower head/covers whole head, pulsating, sharp pain/Increase in headaches but no longer centralized to back of head/ headaches induced by allergies; Nausea; Neck stiffness; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection, lot number was unknown, via an unspecified route of administration in the right arm on 22Dec2020 07:30 at a single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient received vaccine in Tuesday (22Dec2020). The following Sunday (27Dec2020) at 12:00, she had nausea and neck stiffness. On Monday (28Dec2020), she had sharp pains in neck, ear, head pain (similar to an ear infection pain), and nausea. She used teledmed appt and got antibiotics (unspecified). On Tuesday (29Dec2020), she had significant migraines, limited neck mobility, sharp pains in neck and lower head, scalp tenderness and sensitivity which felt like whiplash when she moved her head w/ her head feeling "swimmy". She tried to see urgent care but was to go to ER. On Wednesday (30Dec2020), there was lessened neck pain but still limited mobility, increased in headaches but no longer centralized to back of head. She went to ER and they said that she had headaches induced by allergies. She mentioned that she never had migraines or allergies in her life. They also reported no ear infection. She did complete CT Scan with no concerning results on 30Dec2020. On Thursday (31Dec2020) & Friday, she no longer has neck pain but with continued nausea, joint pain, debilitating migraines (light & noise sensitivity, covers whole head, pulsating, sharp pain, loss of balance, increased drowsiness). The events were reported as non-serious. The treatment received for the adverse events included fluids, pain & nausea meds. The patient was not diagnosed with Covid prior to vaccination. She was tested for covid post vaccination on 30Dec2020 through a nasal swab with negative result. The outcome of the events neck stiffness, ear pain, scalp tenderness and sensitivity, and 'Headaches induced by allergies' was unknown; while neck pain was recovered on 31Dec2020. The outcome of the events 'significant migraines/debilitating migraines', nausea, limited neck mobility, head pain/Headache, joint pain, loss of balance, and increased drowsiness was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the event migraine cannot be excluded based on a compatible temporal relation between vaccination and onset of event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
29 2021-01-06 migraine Migraine started about 24 hours after getting the 2nd shot on 1/4 at 9:20
29 2021-01-06 pain in extremity Next morning, I woke up with severe positional headache (headache with standing or sitting up, resol... Read more
Next morning, I woke up with severe positional headache (headache with standing or sitting up, resolved completely with ibuprofen and tylenol within 20 minutes). The next morning I also had a sore left deltoid, and soreness extending into my left chest and shoulder, which diminished throughout the day after ibuprofen and tylenol. I also had a left swollen armpit, which I interpreted as swollen lymph nodes. My left armpit was sore and was visibly swollen compared to the right. The left lymph node is still visibly swollen as I report this (approximatley 36 hours after vaccine administration), and is sore but less sore than initially. Of note, when I received the first vaccine in this series, my left deltoid was more sore than with the second administration, but soreness was limited to the deltoid and resolved within 3 days.
29 2021-01-06 discomfort Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feelin... Read more
Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feeling faint and a bit of heaviness. Assisted patient to the floor with head supported with jacket in supine position with feet elevated. Patient did not faint. Obtained vitals 1914 BP: 103/68, HR: 67., o2: 97%. Patient denies being pregnant, but states that she has started a diet. Pt states eating yogurt prior to receiving the vaccine. Continued to monitor patient, no change in status. 1920 BP 129/75, HR: 80, o2: 98%. Patient states feeling better, asked to sit up, still on the floor. 1930 BP: 119/77, HR: 71, o2: 98%. Offered patient apple juice, pt able to tolerate PO liquids. 1940 patient assisted to sit up in chair BP: 134/89, HR: 72, o2: 100%. Patient continued to remain stable with improvement, no feeling of faint or heaviness. 1950 patient transitioned to standing position BP: 118, HR: 75 , o2: 95%. Pt walked around clinic to see if she could tolerate walking. Pt states having to drive home, asked if a ride was available, pt stated no. Pt states feeling fine to drive home. Pt discharge @ 2000 in stable condition.
29 2021-01-07 throat numbness 25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 m... Read more
25 minutes after injection numbness of throat and tingling/prickling at back of tongue. Another 10 minutes later entire tongue tingling/prickling. Another 5 minutes lips began tingling/prickling. Epi-pen administered by military staff present for vaccination. Taken to ER and received a dose of Benadryl and prednisone.
29 2021-01-07 difficulty speaking, tremor, speech disorder 29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and na... Read more
29-year-old previously healthy female presenting today with difficulty sleeping, sore throat, and nausea after receiving the second Pfizer COVID-19 vaccine around 10 AM. Patient says that after her first dose of the vaccine she had mild sore throat and hoarse voice that resolved spontaneously. She had her vaccine around 10, several hours later before coming to the emergency department between 2--230 she had the sudden onset of difficulty speaking with associated sore throat and nausea. She has had dry heaving but no large amounts of vomiting. She has not had stridor, wheezing, shortness of breath, syncope, or the development of a rash or hives. She has not had a reaction to her prior vaccines she does not have any other allergies in general. She has otherwise been well recently without infectious symptoms including fevers, chills, cough, and has not been exposed to Covid to her knowledge. Medications administered in ED included diphenhydramine 50 mg IV once, dexamethasone 10 mg IV once, famotidine 40 mg IV once, ondansetron 4 mg IV once. Had brief episode of shaking and R arm rigidity in the ED. Patient denies LOC during the episode, did not have a post ictal state, no tongue biting or episodes of incontinence. Given single event without LOC, less concern about episode being a seizure. Patient has had no further episodes of shaking since admission. CT brain was wnl, no FNDs noted on exam.
29 2021-01-07 pain in extremity Arm soreness, chills, achiness, lymphadenopathy
29 2021-01-07 weakness Fever, chills, weakness, body aches
29 2021-01-07 breast pain, tingling Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards ... Read more
Pain in left arm in injection site and under arm, armpit and side of breast. Pain feels like shards of glass. By day 3, swelling in left arm and lymph nodes under arm, armpit, and side of breast. Tingling in left arm down to fingertips and "dead arm" feeling.
29 2021-01-07 cold sweat, tremor Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, cl... Read more
Tachycardia-160 for about 10-20 minutes about 10-15 after injection, HR 120-130 for about 1 hour, clamminess, shaky, dizziness
29 2021-01-07 pain in extremity, tenderness dizziness, body pain in arm chest and back, painful to touch.
29 2021-01-07 pain in extremity fever 99.6 for 12 hours, soreness in upper arm and injection site
29 2021-01-07 pain in extremity myalgias, fever, headache, left arm pain, chills
29 2021-01-07 pain in extremity, tremor strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extre... Read more
strange feeling in my throat; Shaking; I felt like a fever was coming on/temp of 102; fatigue; extremely sore arm; This is a spontaneous report from a contactable nurse, who is also the patient. This 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via an unspecified route of administration in the left arm on 17Dec2020 at 09:00 at single dose for COVID-19 immunisation. Vaccination facility type: workplace clinic. The patient did not receive other vaccines in four weeks. Relevant medical history included asthma, hypothyroidism, seasonal allergy, allergy to pine nuts and almonds and past drug history included allergy to levofloxacin (LEVAQUIN). Concomitant medications included ethinylestradiol/norethisterone acetate (LOESTRIN), levothyroxine sodium (SYNTHROID), fluticasone furoate (VERAMYST), levocetirizine dihydrochloride (XYZAL) and montelukast sodium (SINGULAIR). On 17Dec2020, within a few minutes of receiving the vaccine, the patient noticed a strange feeling in her throat. The patient stated that it was difficult to describe, but only lasted a minute or so. That night (17Dec2020), as she was getting ready for bed, she felt like a fever was coming on, but she checked her temperature and it was 97.6 (her normal temperature). She woke up around midnight shaking, with a temperature of 102. She took ibuprofen and it came down to 100.8 before she fell back asleep. In the morning, her temperature was down to 98.5 and she did not experience any additional fevers. The only other symptoms she experienced were fatigue and an extremely sore arm. These lasted about two days. The patient recovered from the events strange feeling in her throat on 17Dec2020 and she recovered from the fever on 18Dec2020; the patient recovered from the other events in Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was tested for COVID-19 with a nasal swab on 31Dec2020 which was negative.
29 2021-01-08 flushing, tingling Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only las... Read more
Arm tingling, more prevalent in right arm, face tingling R>L. Tingling started at 0030 1/8, only lasted a few hours. Intense body aches, chills, low grade temp, started at 00:30 and ended by 1800. Still experiencing intermittent chills, flushing, and sweating.
29 2021-01-08 pain in extremity Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatig... Read more
Low grade fever, fatigue, chills, sore arm. Narrative: Low grade fever, sore arm, chills, and fatigue developed after administration of covid vaccine. Resolved by 1/1/21.
29 2021-01-09 tenderness Exquisitely tender right sided epitrochlear, axillary, and supraclavicular lymphadenopathy. Began ab... Read more
Exquisitely tender right sided epitrochlear, axillary, and supraclavicular lymphadenopathy. Began about 16 -20 hours after receiving vaccination. Still present at 36 post vaccination, but seems to be improving.
29 2021-01-09 flushing Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccinatio... Read more
Flushed face, light headedness, shortness of breath, and chest tightness 20 minutes after vaccination. Needed albuterol inhaler and benadryl to stop reaction. Redness swelling at injection site up to 1/2 dollar in size now, still increasing in size. Even after 3 days since shot
29 2021-01-09 muscle spasms, tingling Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body ac... Read more
Muscle spasms and pain (pins and needles sensation), extreme fatigue, headache, debilitating body aches for 24+ hours, abdominal pain for 2 hours.
29 2021-01-10 hypersensitivity of all senses Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph no... Read more
Fever, lethargy, headache, muscle + joint ache, skin sensitivity, hair sensitivity, swollen lymph nodes. 3 days out axillary lymph nodes still swollen with joint pain, all other symptoms subsided on day 2.
29 2021-01-11 pain in extremity, flushing 1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my... Read more
1/8/21 - 15 minutes after second dose of COVID19 vaccine I had flushing (warm rash like) all over my chest and neck that lasted for about an hour. No itching or hives. 1/9/21 at 3am my heart rate started to increase to about 110bpm while sleeping and continued till 4am. 1/9/21 at 4am my apple watch alerted me to my heart rate was above 120bpm while resting. This is when I realized I was sweating and felt like I had a fever. I drank water and went back to sleep. 1/9/21 5am heart rate was at 135. then 6am 148bpm. 7am around 161bpm. Kept trying to go back to sleep. 1/9/21 8am got up and took an adult benadryl tablet and drank plenty of water. Tried to relax to lower my heart rate. 1/9/21 9am took another adult benadryl tablet and was able to get my heart rate just below 120 while sitting. Then ate breakfast and went back to bed. If heart rate was not going to lower, I was planning on going to the ER. 1/9/21 10am till next day. Heart rate was then under 100bpm. I was then so tired that I slept all day and did not eat anything else. 1/10 I experienced severe body aches, chills and headache. This was all day. 1/11 I woke up feeling mildly nauseous for about 3 hours and then dizzy for about an hour. after that I just had a sore arm. 1/12 Had a mildly sore arm.
29 2021-01-11 weakness Deep cough, muscle soreness throughout entire body, weakness, congestion and pressure in head
29 2021-01-11 burning sensation, cold sweat During the first few hours following vaccination, I had soreness at the injection sight and a mild h... Read more
During the first few hours following vaccination, I had soreness at the injection sight and a mild headache. About 10hours later, I started to experience more severe symptoms including a fever of 101-102deg, chills/cold sweats, a moderate headache, and body aches. This continued throughout the night and into the next day. In addition, I began to experience a burning sensation in my chest, similar to heart burn. I have consistently been taking Tylenol and recently took Tums to aide with the heartburn feeling.
29 2021-01-11 feeling hot, flushing Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began ... Read more
Patient began to feel light headed, hot, and flushed. Over the next few minutes, the patient began to start breathing rapidly and become short of breath. Also, red blotches started to develop around her neck. Epi 0.3 mg IM given along with diphenhydramine 50 mg orally.
29 2021-01-11 pain in extremity Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day.... Read more
Received the vaccine 11:20am, experienced expected arm soreness and fatigue for the rest of the day. Went to sleep with no issues. Woke up at 2:00am uncontrollably shaking with chills/goosebumps, sweating with shortness of breath. Extreme headache and all over body soreness also at that time. This continued in waves for the next several hours. I finally slept for a short time and woke with continued headache and muscle/joint soreness. This was accompanied by dizziness, nausea and decreased appetite. This persisted throughout the entire next day following vaccination. The day after that was slightly better and the subsequent day I felt relatively back to normal. I checked for fever many times throughout the symptoms but was always afebrile.
29 2021-01-11 tremor, pain in extremity, feeling hot body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle... Read more
body feels like a furnace; shaking from her core; All main muscle groups sore/tense; All main muscle groups sore/tense; mild chills; arm hurts so bad, like deep in her arm pit bad; Shooting headache; Vivid stressful dreams; Nauseous; This is a spontaneous report from a non-contactable pharmacist. A 29-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at the right arm on 05Jan2021 08:45 at a single dose for COVID-19 immunization at a hospital. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) on 17Dec2020 16:45, at the right arm for COVID-19 immunization. On 05Jan2021, the patient experienced mild chills at 19:00 and took acetaminophen (TYLENOL) and went to bed, at 23:30, patient reported shaking from her core and all main muscle groups sore/tense. In addition, patient stated her arm hurts so bad, like deep in her arm pit bad, had shooting headache, vivid stressful dreams, & was nauseous on the same day of 05Jan2021. On 06Jan2021 04:00, the patient also stated her body feels like a furnace. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for it since the vaccination. The patient was recovering from the events. No follow up attempts are possible. No further information is expected.
29 2021-01-11 pain in extremity she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was ... Read more
she is having a hard time sleeping; swelling; She developed a knot on the side of her neck that was very painful; She does not know if it is a swollen lymph node; right arm pain; pain started traveling up her neck to the shoulder area.; pain started traveling up her neck to the shoulder area; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscular on 24Dec2020 08:30 at the first single dose for covid-19 immunisation. Medical history reported as none. There were no concomitant medications. The patient received vaccine in Right arm. She got the Pfizer Covid19 vaccine on 24Dec2020. The right arm pain started two hours after getting the vaccine and the arm pain got progressively worse and the pain started traveling up her neck to the shoulder area on 24Dec2020. The patient experiencing Right neck pain and swelling on 26Dec2020. She developed a knot on the side of her neck that was very painful, along with arm pain that went up to her neck on 26Dec2020. The knot developed about 2 days after she got the vaccine and now the knot is getting larger. She does not know if it is a swollen lymph node but she has never had a swollen lymph node in that area, states it is above her collar bone and the knot is very painful. She is thinking to go to urgent care since it is bothering her to where she is having a hard time sleeping. On 26Dec2020 she noticed it was painful in the particular spot where she found the knot. Her arm pain went away by the 27Dec2020 and it was not too painful any more, she clarifies her arm pain recovered completely as of 27Dec2020. The painful knot has gotten worse. The patient did not receive any treatment for the events. The outcome of event right arm pain was recovered on 27Dec2020; outcome of event knot on the side of her neck was not recovered; outcome of other events was unknown.
29 2021-01-12 pain in extremity Arm pain and neck pain, body aches, fever, headache
29 2021-01-12 pain in extremity Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme f... Read more
Employee was vaccinated on 1/12 prior to start of shift. Called this am to report feeling extreme fatigue and arm soreness. Stated she was not able to tie her hair or use arm without pain. Denies fever, body aches at this time.
29 2021-01-12 pain in extremity Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on... Read more
Fever 101.0F; chills; headache; fatigue; arm soreness; second dose on 05Jan2021 15:30 /first dose on 18Dec2020; This is a spontaneous report from an other hcp. A 29-year-old female non-pregnant patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL1284), via an unspecified route of administration at left arm on 05Jan2021 15:30 at single dose for COVID-19 immunization. Facility type vaccine was Hospital. No known allergies. No other medical history. Concomitant medication included ibuprofen, alprazolam, ergocalciferol (VIT D), clarithromycin (CLARITIN), cranberry. No other vaccine in four weeks. The patient received first dose (lot number= EK5730) via an unspecified route of administration at Left arm on 18Dec2020 at single dose for COVID-19 immunization. The patient experienced Fever 101.0F, chills, headache, fatigue, arm soreness on 05Jan2021 20:00. The patient underwent lab tests and procedures which included body temperature: 101.0 fahrenheit on 05Jan2021. No covid prior vaccination, Covid was test post vaccination via Nasal Swab on 22Dec2020 with result of negative. The events Fever 101.0F, chills, headache, fatigue, arm soreness were recovering. Treatment of acetaminophen received for the events Fever 101.0F, chills, headache, fatigue, arm soreness.
29 2021-01-12 pain in extremity Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. ... Read more
Several hours after vaccination, I developed left arm soreness, which persisted for about 36 hours. Arm soreness was quite severe on 1/8, as it was painful to even lift the left arm for much of the day. I also noted, about 5 hours after vaccination, that my jaw felt slightly tense, bilaterally. On Friday, 1/8, I also experienced headache for the entire day, and I was fatigued for much of the day. I noted clavicular lymph nodes as well. About 18-20 hours after vaccination, I developed soreness in my back, and about 24 hours after vaccination, I noted some myalgia in the left leg. These symptoms were responsive to acetaminophen. The headache, clavicular lymph nodes, arm soreness, and myalgias were resolved by the time I woke up on 1/9. Finally, I noted development of an axillary lymph node during the evening of 1/8, about 28 hours after vaccination. This axillary node persisted until Monday, 1/11.
29 2021-01-12 weakness Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn,... Read more
Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness
29 2021-01-13 tingling, weakness, pain in extremity 1 week history of significantly worsened (previously present "low back strain" lower back pain that ... Read more
1 week history of significantly worsened (previously present "low back strain" lower back pain that had become radicular to both LE and associated with progressively worsening bilateral LE weakness, paresthesias since COVID vaccination last week. see continuation for HPI and assessment/plan from office note 1/13/21 HPI from OV dated 1/13/21 She had presented initially in December 2020 for her annual physical, and we evaluated some low back pain that that time, felt to be a sprain/strain resulting from a fall in the shower earlier December which was aggravated significantly by lifting/transferring a patient at the SNF she works for as a nurse. Presentation at that time was rather benign, no imaging obtained, pt was placed on leave from work for 1 week to avoid the heavy lifting and likely aggravation of back pain, and rx including diclofenac and cyclobenzaprine. She did not FU in the office, but returned to work at SNF a week after I saw her for the back pain. She states she had improved enough to feel like she could go back to work but wasn't 100% without back pain yet. At no time was comp mentioned at the visit in December. She did tell her employer about the injury and was off of work for a week and was encouraged to seek comp. We were never notified. Yesterday 1/12 she followed up in the office for the back pain and was found to have much more severe pain, now radicular to both LE (pain intensity worse on right), with new neurologic impairment including objective weakness bilateral LE (R>L), sensation disturbance bilateral LE (R>L). Xray of lumbar spine obtained in clinic, this was essentially unremarkable, non-acute. Pt was sent for stat MRI of the lumbar spine. MRI last night revealed no findings to explain her severe symptoms - she has mild symmetric disc bulging at L5-S1 nd mild bilateral facet arthropathy with patent canal and foramina, and a mild nonspecific "STIR signal abnormality" within the soft tissues abutting the left lateral aspect of the L5 spinous processes felt to be small and nonspecific. I did discuss the case and the imaging with the radiologist and he feels this is unlikely to be the source of her back pain/radicular symptoms. No obvious signs of apparent discitis or any signficant soft tissue abnormality. Pt contacted last night with initial "normal" results of MRI as formal results were pending - hydrocodone was sent to her pharmacy for pain relief overnight. Pt received 60mg toradol in the office yesterday during her visit. Pt noted significant improvement in her back pain, bilateral leg pain about 30 minuts after that injection. She continued to have pain in the evening but went to sleep. She woke at 3am unable to roll over due to weakness and pain - her sister gave her a hydrocodone and she went back to sleep' she woke this morning feeling much better; today, she has less severe low back pain, less severe right lower leg radicular pain, NO pain radiating into the left LE, lessening of the weakness in her right LE, lessening of paresthesia reported in the right LE (now isolated just to the heel), resolution of the weakness in the left LE, resolution of the tingling of the left knee. Other than the toradol and one dose of hydrocodone, no other medications were given, no other treatments given since presentation yesterday. Upon further questioning, patient does reveal that she received the 1st of 2 COVID-19 vaccinations (pfizer) last week. She received the vaccination at work at nursing home on 1/7/21. She had some relatively quick onset nausea and dizziness within an hour of the injection, but that resolved. She recalls feeling like her low back pain, bilateral lower leg pain, leg weakness and paresthesias all intensified sometime either Wednesday 1/6/21 or 1/7/21, but more obviously worsened over the weekend 1/9 and 1/10. Along with the lower extremity symptoms, she does admit today that she experienced soreness in bilateral upper arms starting the day following the vaccine administration, with left arm/shoulder still feeling sore and tender to the touch now. She also developed some altered sensation of the right thumb and index fingers the day following vaccination (1/8/21) and this has been persistent/unchanged. She is right handed. No prior issues with right hand/fingers. Other than the altered sensation, she denies pain, swelling, or notable weakness. She is right handed, and really hasn't done much with her right hand over the past week since she hasn't been working. Patient denies having significant headache, fever, chills, diaphoresis, fatigue, rashes/injection site erythema since the covid vaccination. She was not told to sign up for or told about the V-safe program and hadn't thought to report her symptoms to work or think to be concerned regarding possible vaccine SE. Pt denies prior hx of low back pain, neurologic symptoms including weakness/paresthesias, previous allergy to or adverse reaction to vaccination or injectable medications. She has a history of latent TB(fully treated) but is otherwise in good health. After gathering much further detailed information/history today from patient, review of chart including the MRI results and xray results from yesterday, my prior OV note, and discussion with radiologist today regarding her MRI - I Discussed with patient and her sister that I believe what is becoming more apparent to me now is that she is likely suffering from an adverse event associated with the COVID-19 vaccination she received on 1/7/21 through her workplace. I'm unable to define this for certain, but I suspect that she developed the progressive worsening of low back pain, development of radicular pain and bilateral LE weakness and paresthesias about 1-2 days following the vaccination administration. She has had notable and rather surprising improvement in both subjective and objective findings Today as compared to yesterday. Only intervention was toradol 60mg IM and one dose of hydrocodone, she had already been taking diclofenac or ibuprofen so I believe the only explanation for the improvement over the past 24 hours is the fact that she is gradually having resolution of the temporary paraparesis, neuralgia, paresthesia brought on by the recent COVID-19 vaccination. I believe she truly had injury to the low back in December, initial injury at home but had improvmenet and then significant worsening/exacerbation when transferring a resident at work. Her presentation following that was consistent with a strain/sprain of the lumbar spine. This was treated appropriately with rest, activity modification, stretching, NSAID, and muscle relaxers. She returned to work w/o restriction likely earlier than she should have but I believe the covid vaccination is likely what caused her condition to so significantly decline; Its also possible that her physically demanding job requiring lifting/transferring/standing for prolonged periods of time on top of an only partially resolved low back strain had aggravated her low back condition. plan from OV dated 1/13/21 Given the improvement since yesterday, I recommended obtaining some labs looking for any sign of alternative explanation including infectious etiology or autoimmune/inflammatory condition, however will hold on further imaging as would be the plan, specifically EMG of the bilateral LEs. Explained to patient that I'm hopeful with continued rest and time, her symptoms (weakness, tingling/numbness, radicular back pain) will completely resolve. She may need some eventual PT for the disc bulge in the lumbar spine and lumbar strain that is likely still lingering. Will contact pt with any change in care plan based on the laboratory findings. I would like to closely follow her, and make sure her symptoms continue to slowly improve /resolve. If at any point she develops worsening symptoms again or any new neurologic signs/symptoms (and we discussed what emergency signs/symptoms would be) then she needs to be in touch with me right away. I will work on reporting this suspected adverse covid vaccine reaction to VAERS / possibly also CDC and see if they have any additional input/suggestions for monitoring/treatment. For pain control, pt may continue with the diclofenac OR ibuprofen, and the hydrococone/APAP as needed for breakthrough severe pain uncontrolled with the NSAID. I have advised pt to remain off of work at this time, resting at home avoiding lots of physical activity as she continues to heal. Suspect will have her follow up in clinic sometime next week for repeat evaluation/examination depending on VAERS/CDC recommendations and of course the lab results and any updated condition reports from the patient in the interim. Will want to make sure she has full resolution of the paresis and adequate resolution of her back pain/radicular pain prior to returning to work, even in a limited capacity. I am informed today that there is light duty available and will keep that in mind. Pt to be contacted regarding follow up. Encouraged to call with questions/concerns/updates. Pt was very thankful for the care.
29 2021-01-13 feeling hot 1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken... Read more
1238 staff member received vaccine, 1245: staff member reported feeling dizzy with vital signs taken: bp-155/97, P-77, O2@98%, R-16. Reported to pharmacist who adm. vaccine, staff member was given water and told to stick around an additional 15 min for monitoring. 1257: Pharmacist rechecks staff member and notices Blotchy redness to her neck and chest, does not report signs of itchiness but does feel warm, window opened nearby, cont. to monitor staff member, 1320: staff member reports she feels better. 1309: staff member rechecked by pharmacist,
29 2021-01-13 pain in extremity Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at... Read more
Chills, Fatigue, left arm pain and fever of 100.3. Treatment include Tylenol with no improvement at this time.
29 2021-01-13 weakness I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I star... Read more
I received my second dose of the vaccine at 03:00pm on 1/12/21. I noticed around 06:00pm that I started feeling a little tired and some pain around the injection site. I had anticipated this as I felt similar symptoms from the first dose of the vaccine. I took a nap and woke up around 09:00pm feeling some of the worst body aches I had felt in a long time. My arm that I received my vaccine in was painful and warm to the touch. I felt dehydrated as well so I drank a pedialyte, took OTC Tylenol extra strength, and laid down again. Around 07:00am on 1/13/21, I still felt achy, sweaty, and felt pain in the arm that I recieved the vaccine in. I went into my bathroom, and noticed two small red and raised areas around the injection site. I took pictures of the site, and continued to closely monitor through out the day. I ended up calling in sick to work on 1/13/21. It is now around 12:00pm on 1/14/21, and I woke up with a pounding headache, muscle aches, dehydration, nausea, and low energy. I feel like I am hungover or have the flu, and am planning on calling in sick to work again. I reported my symptoms to my staffing department at my workplace on 1/13/21 and wanted to file a report here as well.
29 2021-01-13 pain in extremity, breast pain Lymph node swelling to right axillary with pain that radiates to the right breast, down the right ar... Read more
Lymph node swelling to right axillary with pain that radiates to the right breast, down the right arm, and around the back to the right shoulder blade. Pain limited daily activity to the right arm. Pain decreased for about 12 hours and then the pain returned again around 06:00, Thursday 1/14/2021 with lymph node larger than previous day. Area is tender and painful with every day movements. Will consult with primary health care provider if pain/swelling does not improve or gets worse.
29 2021-01-13 cold extremities, numbness, tingling Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, ... Read more
Nausea and vomiting about 12 hours after injection. Followed by fevers, body aches, sinus headache, and fatigue for about 30 hours. Post 3 days after injection all finger tips have been cold, red, numbness, and tingling. Now post 5 days after injection finger tips have improved but still red, cold and difficult to get warm.
29 2021-01-13 weakness Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, s... Read more
Shooting chest pains, delirium, dry mouth/throat with mild difficulty swallowing, severe weakness, severe fatigue, sweating.
29 2021-01-13 migraine nausea migraine unable to move left arm lethargy
29 2021-01-14 burning sensation, tremor, cold sweat Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on ... Read more
Jan.13th- Diarrhea, extreme fatigue, extreme nausea, body aches, congestion, rash under eyes and on nose (itchy and burning). Jan14- extreme fatigue, nausea, loss of appetite, rash continues but no itching, light on burning, body aches, cold, could not get warm, temp stayed around 96.0-97.0 Jan 15- fatigue, nausea, extreme congestion, sweats, symptoms of a fever over night and during day. Cold sweats, shakes, cold then hot, body aches, fatigue. These happened off and on through the day. When started feeling crappy took temp and it was 99.6-99.8. When feeling cold temper drops down to 97.0 scratchy voice voice congestion, runny nose, little sore throat, when swallowing pills or hard texture foods, sometimes drinking something. Overall feeling of a cold. I think it?s important to note that I had Covid-19 in the month of November and received my first vaccine December 22nd. I had side effects after the first shot but not nearly as bad as this time. I am nurse in a doctors office if that matters at all. I am still feeling under the weather but wanted to get these down before I forgot them.
29 2021-01-14 pain in extremity Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Signifi... Read more
Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose; Start Date/Time: 08Jan2021 12:45 PM/ Start Date/Time: 21Dec2020 10:15 AM; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date not reported), intramuscular in the right arm on 08Jan2021 12:45 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. The patient previously took first dose of bnt162b2 (lot number: EJ1685, expiry date not reported) in the right arm on 21Dec2020 10:15 at single dose for COVID-19 immunisation. The patient experienced significant myalgias and moderate arm soreness about 15 hrs after vaccination with 2nd dose. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
29 2021-01-14 pain in extremity whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain wi... Read more
whole right arm is in pain; have a swollen lymph node (i think?) around right clavicle area; Pain with minor touch to clavicle and upper arm (at site of injection); body/muscle aches; body/muscle aches; nausea; At 0230 on 07Jan21 I woke up shivering with a high fever; heart rate of greater than 100BPM all day on 07Jan21; This is a spontaneous report from a contactable Nurse reporting for self. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#: El3248), via an unspecified route of administration in right arm on 06Jan2021 15:30 at single dose for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. At 0230 on 07Jan2021 patient woke up shivering with a high fever. Didn't realize it was a fever until 5am when woke up more, temperature taken at that time was 100.6. Fever stayed all day until 2000, no less than 99.0 even with Tylenol and ibuprofen until that time. Also developed body/muscle aches around 1200 on 07Jan2021, and some nausea. Got sent home from work that day. On 08Jan21 patient synced my (brand withheld) and checked my heart rate for day before. Didn't know it till then, but had heart rate of greater than 100BPM all day on 07Jan2021. Highest it got was 130, my resting heart rate is usually in the 60s. Also on 08Jan2021 no more fever, but whole right arm is in pain and have a swollen lymph node around right clavicle area. Pain with minor touch to clavicle and upper arm (at site of injection). Will be going to visit a doctor to make sure it is just a swollen lymph node since it is now 09Jan08Jan2021 and it's still swollen and there's still a lot of pain to R arm. Outcome of event fever was recovered, of others was not recovered.
29 2021-01-15 feeling hot, pain in extremity Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours ... Read more
Received vaccine around 8 am, arm soreness within 4 hours of administration. At midnight (16 hours after administration), woke up with chills, body aches, headache, hands and feet hot, skin hot to touch/tactile fever.
29 2021-01-16 pain in extremity Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, ... Read more
Approximately 6 hours following the second dose in the two-dose Pfizer COVID-19 vaccination series, I began experiencing nausea, vomiting, moderate body aches, and headaches. I have been unable to keep down liquids (including water, gatorade, and soup broth) and solids. At this time, I have continuous vomiting, with each following the intake of food and/or beverages. Physical exam is negative for redness, swelling or rash at the injection site. Additionally, I have not appreciated any fever or signs of anaphylaxis. Following my first dose in the two-dose series, I did not experience any side effects other than the expected sore arm for 24-48 hours.
29 2021-01-17 muscle twitching, muscle spasms, tingling 10 hours since second vaccination I had muscle aches, chills, myalgia, nausea, headache, and fatigue... Read more
10 hours since second vaccination I had muscle aches, chills, myalgia, nausea, headache, and fatigue. This went on for.36-48 hrs. After flu like symptoms subsided,I started to get pins and needles in both feet, legs, and hands. Then twitching and muscle spasms in my legs.
29 2021-01-17 numbness, tingling Numbness/tingling to bilateral hands for over one week
29 2021-01-17 migraine Twelve hours after receiving vaccine patient began experiencing chills & body aches. The next morni... Read more
Twelve hours after receiving vaccine patient began experiencing chills & body aches. The next morning (24 hours post-vaccine) the patient had a very bad migraine, chills, and body aches. Upon standing felt nauseous & dizzy, then saw black dots and vision went black for several minutes and fell to floor. Relative called 911 and vision had returned by the time medics arrived. Vitals were normal, except for low blood pressure. She took Advil and felt better by the evening.
29 2021-01-18 pain in extremity, burning sensation About 12 hours after the vaccine, I started having arm pain at the site and low back pain which is v... Read more
About 12 hours after the vaccine, I started having arm pain at the site and low back pain which is very unusual for me as well as a dull headache which is not uncommon for me. Around midnight I woke up with chills, and severe arthralgias in all joints down to the toes and fingers, and deep, boring pain in my long bones and neck. My skin and fingertips felt like they were burning. I was nauseated but didn?t vomit. I was up all night because I couldn?t find a position I wasn?t in pain in. Tmax 100.3 F. Took a gram of Tylenol with improvement of symptoms. Felt better in AM but when Tylenol wore off around 9 am, had another wave of the same pain all over. Tylenol improved. Felt almost completely normal by 4 pm with the exception of some lingering low back pain (central not muscular).
29 2021-01-18 seizure Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Ext... Read more
Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Extremely uncomfortable, from neck to back to calves, without improvement with Tylenol or ibuprofen, causing me to be unable to sleep. Around hour 20 post-vaccine, I started to get chills. It wasn?t just feeling cold or shivering, it was full body convulsions that lasted approximately 15 minutes. I became nauseas and dizzy after that for about an hour, unable to stand or walk anywhere. The severe body aches continued, with no improvement from Tylenol or ibuprofen or heating pad. Aches resolved around hour 30 post-vaccine and the only symptom left was pain at the injection site.
29 2021-01-18 flushing Immediately after the vaccine administration, she felt tingling around her lips, swelling of the lip... Read more
Immediately after the vaccine administration, she felt tingling around her lips, swelling of the lips, slight facial and chest flushing. She was given Benadryl 25 mg PO and sent to the ED for further evaluation. In the ED she was given famotidine 20 mg IV push once, methylprednisolone 125 mg IV push once, and a bolus of NaCl 0.9% 1000 mL over 65 minutes. Patient was asymptomatic 3 hours after vaccination.
29 2021-01-18 migraine Second dose of COVID vaccine (Pfzier/BioNTech) received Friday morning around 8:00, I left work abou... Read more
Second dose of COVID vaccine (Pfzier/BioNTech) received Friday morning around 8:00, I left work about an hour early that day due to rising nausea, migraine and fatigue. By the time I got to my car in the parking garage I had thrown up and was so dizzy that I called my boyfriend to come pick me up. When I got home I immediately laid down to take a nap. 3 hours later I woke up very sore and achy and still had a migraine. I remained in bed and later that night I spiked a fever as high as 101.8 fahrenheit. I had severe chills and the aches were so bad that my bones hurt all over and it felt like someone was stabbing me with a metal broom handle. Pain spiked to 8 on the pain scale and with the length of time I had this pain, it was one of the worst experiences of my life. The dizziness and fatigue caused me to need help to get out of bed to use the restroom. I took ibuprofen frequently and Nyquil at night to help relieve the effects without it doing little more than taking the edge off. Saturday night was the same as Friday night with no relief of symptoms. Fever remained around 100.9. Sunday night it dropped to 99.8 with chills, dizziness and fatigue still remaining but aches slightly lessening. Monday night I was still dizzy and weak but not nearly as in much pain and fever had subsided. Tuesday I started to feel more normal by the end of the night, just easily out of breath and off and on again headache.
29 2021-01-18 flushing Symptoms within 15 minutes of vaccination. Staggering, flushed and dizzy. Low pulse. Passed out ... Read more
Symptoms within 15 minutes of vaccination. Staggering, flushed and dizzy. Low pulse. Passed out while sitting in the chair while waiting to go to ED. Regained conscious within 1 minute, disorientated, complaining of chest pain. Taken to ED - thought to be a vasovagal episode.
29 2021-01-19 pain in extremity 01/19/2021 Fever- 102.0 F Headache Chills Sore arm 01/20/2021 Fever 100.1, sore arms, chills
29 2021-01-19 tremor, feeling cold, tingling I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking... Read more
I felt q lump in my throat and tingly in hands qnd feet for a few minutes after. I then was speaking with management and felt faint and short of breath, continued to be tingly. Last night 1/19/21 I had a moment of not feeling well and my heart rate went from 60s to 120s with shortness of breath and nausea qnd tingling. This continued for about 30 minutes, I was debating going to the ED for the SOB. I then became really cold and had such bad shaking I couldn't hold anything for another 20 minutes. Today I continue to have some tingling. All of this on top of the expected side effects.
29 2021-01-20 weakness Fever to 101, body aches, chills, weakness and nausea for 24 hours
29 2021-01-20 tingling I had tingling in the right side , opposite arm of the injection. I felt it from the forarm to my ... Read more
I had tingling in the right side , opposite arm of the injection. I felt it from the forarm to my hand and the top of my foot.
29 2021-01-20 pain in extremity Main reaction: very achy wisdom teeth area (pulled ~10 years ago), all other teeth fine, for ~ 10 da... Read more
Main reaction: very achy wisdom teeth area (pulled ~10 years ago), all other teeth fine, for ~ 10 days Also: headache and dizziness night of vaccine, sore arm ~2 days
29 2021-01-20 migraine Severe bodyaches at 1am, migraine, chills, sweating, fatigue lasted until 9pm.
29 2021-01-20 pain in extremity Sore arm; swollen/tender lymph nodes in armpit of injection arm; swollen/tender lymph nodes in armpi... Read more
Sore arm; swollen/tender lymph nodes in armpit of injection arm; swollen/tender lymph nodes in armpit of injection arm; headache; chills; fatigue; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249 and expiry date: unknown), intramuscular left arm on 10Jan2021 09:45 at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included melatonin, ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient took the 1st dose (lot number: EL4284) on intramuscular left arm on 23Dec2020 10:15. The patient experienced sore arm, swollen/tender lymph nodes in armpit of injection arm, headache, chills, fatigue on 10Jan2021 19:30. Outcome of the events was recovering. No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible. No further information is expected.
29 2021-01-21 slurring, inability to speak Began about 1.5-2 hrs after vaccine Hives, red rash all over face and body. Fever of 103 disoriente... Read more
Began about 1.5-2 hrs after vaccine Hives, red rash all over face and body. Fever of 103 disoriented trouble breathing and speaking and remembering. Dizzy. Alternating high and low blood pressure. Chills. Body aches. Sore tenderness and warmth at injection site. Sluggish speach
29 2021-01-21 feeling hot, night sweats, pain in extremity, tremor First Dose- I had a headache after the shot and tremors started that even and throughout the night.... Read more
First Dose- I had a headache after the shot and tremors started that even and throughout the night. No fevor. Arm very sore, going into neck. Second Dose- Felt find the night. Woke up that morning at 1am and with tremors and in a night sweat. Checked temp and it was only 96, but felt hot and was sweating. Woke up the next morning and my entire body, muscles and joints ached. My knuckles, ached, kept getting sharp pains in my knuckles. My jaw ached, difficulty eating. My entire body, my muscle ached, difficulty moving. I didn't get a headache till that evening. I also had severe heart burn that night, not sure if it was related, but I have never had heart burn that bad. The next morning when I woke up (5am) (now two days after my shot), again my joints hurts, I couldn't even stand. Its like my knees couldn't even support me and I had a massive headache. I went back to bed and woke around 9am, no longer had a headache, muscles still hurt. Around 11am, all of a sudden, muscles and joints felt fine. The only thing (day three) is my arm pit on my left side where i got the shot is bothering my extremely bad. I was able to put an ultrasound probe on my axilla area, and I have swollen lymph nodes in my axilla in the area that is very painful. I also have a dull pain in my elbow.
29 2021-01-21 pain in extremity Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wie... Read more
Hand of arm that vaccination was administered in began hurting, tongue tingling, & mouth feeling wierd, light headache
29 2021-01-21 flushing Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused... Read more
Hypertensive (167/91), tachycardia HR of 126, flushing, dizzy, dry mouth, sweating. patient refused further care and her symptoms improved then left the waiting area at 2:55pm. Before leaving, her vitals were BP 133/69, HR 70 and SpO2 100% on room air.
29 2021-01-21 slurring Severe nausea, vomiting, blood pressure changes, heart rate changes, dizziness, slurred speech. Sent... Read more
Severe nausea, vomiting, blood pressure changes, heart rate changes, dizziness, slurred speech. Sent to ER for monitoring and fluids.
29 2021-01-22 numbness Numbness and tingling in right arm. It started the night of 1/21/21 and is still happening. Intermit... Read more
Numbness and tingling in right arm. It started the night of 1/21/21 and is still happening. Intermittently it feels like my arm and fingers are falling asleep.
29 2021-01-23 pain in extremity -dilated eyes around 8 pm day of injection -extreme soreness in left arm day of injection -extreme ... Read more
-dilated eyes around 8 pm day of injection -extreme soreness in left arm day of injection -extreme body aches, chills, and sweats day of injection -insomnia that lasted from day of injection to early morning the next day. This was not anxiety related. -Frequent burping the night/overnight after getting injection -feeling of being hungover the day after the injection but this could be due to sleep deprivation from the insomnia.
29 2021-01-23 muscle spasms I started to experience back pain and light spasms two to three hours after the second vaccine shot... Read more
I started to experience back pain and light spasms two to three hours after the second vaccine shot. When I woke up the next day I was unable to move. I have had intense back spasms which make it hard to; walk, pick up items, and walk up/down stairs. I have been bed ridden since I received the shot getting up to eat and do light stretching.
29 2021-01-24 migraine About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started ... Read more
About 24 hours after 2nd dose of vaccine received 1/23/21, really intense migraine started. Started about 4pm, lasted through going to sleep at 9pm, and then woke up fine.
29 2021-01-24 pain in extremity Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan20... Read more
Body aches; chills; nausea; headache; arm pain; fatigue; received second dose of BNT162B2 on 09Jan2021; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient received second single dose of BNT162B2 (Pfizer, solution for injection, batch/lot number and exp date not reported), intramuscular (left arm) on 09Jan2021 11:00 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included migraines. The patient was not pregnant. There were no concomitant medications. No other vaccine was received in four weeks. No other medication within two weeks. The patient previously took acetylsalicylic acid (ASPIRIN) wherein patient had known allergies and anaphylaxis. The patient received the first single dose of BNT162B2 on 22Dec2020 15:00, Intramuscular (left arm). The patient received second dose of BNT162B2 on 09Jan2021 11:00. The patient experienced body aches, chills, nausea, headache, arm pain, and fatigue on 09Jan2021 21:00 (09:00 pm). The patient did not have COVID prior vaccination. Patient was not Covid tested post vaccination. Treatment for AE included paracetamol (TYLENOL) OTC every 4 hours x 24 hours. The patient recovered from the events body aches, chills, nausea, headache, arm pain, and fatigue on an unspecified date in Jan2021. Information about lot/batch number has been requested.
29 2021-01-24 migraine Day of vaccine a few hours later I had a migrane start to form and I felt off. Sunday morning the mi... Read more
Day of vaccine a few hours later I had a migrane start to form and I felt off. Sunday morning the migrane had ebbed a bit until about 12 noon. By that point I was in bed almost all day with muscle pain in my torso (back, ribs, abdominal). I also had a severe migrane and a fever that at it's worst was 102.3. It was brought down quickly with ice to 100.7 within an hour. After about 8 hours it subsided for about 20 minutes before the torso pain and migrane came back. The fever stayed around 100.3 when I last checked. I went back to sleep for the rest of the night and felt fine in the morning with no fever.
29 2021-01-24 muscle spasms, nerve pain, bell's palsy, facial pain Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/... Read more
Dose 1 received 12/23/20 - had mild symptoms of fatigue and headache on 12/24/20. Dose 2 received 1/14/21. Initial symptoms of mild/dull dental pain started on 1/19/20. on 1/21/21 and 1/22/21 started getting EXTREME right-sided oral/facial nerve pain/spasms that migrated to head that occurred intermittently every 30-60 min and lasted 2-5 min at a time in the evening. Saw dentist on 1/22/21 to check for issues with teeth, no dental issues were found on exam and on xray. Symptoms similar to trigeminal neuralgia/ bells palsy. Called Teledoc on 1/22 who suspected bell's palsy and prescribed prednisone 50 mg po qday x 5. Nerve pain attacks went always after first dose of prednisone. Currently still left with mild dull right-sided pain.
29 2021-01-24 pain in extremity I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while wait... Read more
I received the COVID Vaccine yesterday (1/24/21) around 12:10pm. I experienced no effects while waiting the allotted 30 minutes. The next morning, January 25th 2021, I started to experience arm soreness and blurry vision. The blurry vision is worse in my left eye. My vision has not improved after waking up, taking a shower and putting saline drops in both eyes. The best way to describe the sensation is hazy, blurry and sometimes double vision.
29 2021-01-24 tingling Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. ... Read more
Residual moderate pain and tenderness at deltoid site with tingling and radiation down to left arm. 3 weeks post injection.
29 2021-01-24 pain in extremity, feeling cold, migraine Severe injection site pain that began around 2 hours and went into the evening, severe in the evenin... Read more
Severe injection site pain that began around 2 hours and went into the evening, severe in the evening and night. Light soreness continued over the next day. 3 hours after receiving the 2nd vaccine, nausea, loss of appetite and general 'unwell' feeling began. Nausea, fatigue, loss of appetite, headache continued the rest of the first day. Symptoms impacted ability to work, went home early from work. Day 2: splitting headache, migraine, sinus pressure, joint pain which began in hips then spread to elbows, ankles, knees; muscle pain began in left calf then spread to shin. Injection site soreness was not severely painful any longer, mild pain. Loss of appetite continued. Nausea decreased, and no longer present by afternoon of day 2. Fatigue, increased sleep, sinus pressure in eyes, and cold chills persisted. Day 3: Migraine was present still upon waking and continued for whole day; loss of appetite remained but improved by late afternoon on day 3. Joint and muscle pain continued for duration of day 3. Fatigue continued. Increased need for sleep most noticeable today. For the first time, ibuprofen was taken for symptoms after receiving the vaccine almost 50 hour prior. Day 4: was able to return to work for the first time. Headache continued throughout day, nausea in the evening. Day 5: Headache continued but went away. Day 6 and Day 7, mild headache.
29 2021-01-25 weakness Body aches, fatigue, HA, weakness, increased BP
29 2021-01-25 pain in extremity Body aches, headache, nausea, vomiting, chills, fatigue, arm tenderness
29 2021-01-26 pain in extremity, feeling hot 1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heig... Read more
1/14 Thursday 8am received vaccine 10am nauseous 11am soreness starts 12pm fatigue 6pm soreness heightens, slight chills, more fatigue 7pm ear itch both sides, all ear involved even lobe and red 9pm soreness, chills, arm pain 1/15 Friday 7:30am nausea, dizziness, sinus pressure, headache, arm pain 1pm extreme fatigue, sleep for afternoon, arm pain 4pm headache intensify, arm pain 6pm both ear swelling, warmth, extreme itch 9pm lingering headache, arm pain improves 1/16 Saturday 7am ear itch and rash spread to back of neck 12pm telehealth - recommended benadryl, Rx prednisone Benadryl ineffective, rash remains 8pm- itch inside ears, red scaly ears, hot after washing, extremely scaly 1/17 Sunday 6 pills of methyl prednisone Hives moved to back of neck following the back of ear 1/18 Monday 6pills prednisone inside ear itch, ear lobes itch, skin very flaky 1/19 Tuesday Go to urgent care 6pills prednisone 1/21 Thursday Rash spreads to collarbone Go to TMC Dermatology prednisone continued 1/24 Sunday Stopped steroid under recommendation of MD Huge flare up around neck, chest, back and down to lower body Itch continues to night, lack of sleep 1/27 Wednesday Placed back on steroid (16 day course) Rash remains, itch subsided Decision to not take second dose
29 2021-01-26 feeling hot, weakness, numbness, migraine 1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressu... Read more
1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness
29 2021-01-26 pain in extremity, tingling Once patient in waiting room, after a few minutes, patient verbalized feelings of dizziness after re... Read more
Once patient in waiting room, after a few minutes, patient verbalized feelings of dizziness after receiving Vaccine in L arm. Given apple juice. Transferred via wheeled chair to private holding/monitoring room. Patient transferred onto gurnee. Pt began to complain of pain and feelings of heaviness in Left arm, given more juice and crackers to eat. Verbalized dizziness occurred with first dose, but one day after receiving. Patient states mild pain began at bridge of nose as dizziness begun. VS at 1845: BP of 126/82 in R arm. Heart rate 83bpm, Pulse ox 97%. HOB lowered to 45 degrees per pt request. At 1900, pulse ox 97%. Heart rate 77; B/P 120/80. Verbalizes lesser feelings of dizziness now, but still present.. At 1915 pulse ox 97%. heart rate 73bpm. B/P 126/80. Pt sat up to 90 degrees. Verbalizes tingling remains L arm. at 1920 patient able to stand up without dizziness, ambulate, and only c/o L arm soreness now. Ambulated in hallway twice before sending home. Patient stated she was Covid+ in October 2021
29 2021-01-26 tingling, pain in extremity, weakness Upon receiving my first shot, I felt weak, and after a few days a tingly feeling in my head. Symptom... Read more
Upon receiving my first shot, I felt weak, and after a few days a tingly feeling in my head. Symptoms lasted for 2 weeks. After receiving the second dose, I had a fever that evening and weakness, it lasted through the next day. My right arm was sore for 2 days. I took Advil, Tylenol, and ibuprofen (at different times). Symptoms of fever lasted two days and were gone, I was left feeling weak, it lasted for a day. Now day 5 after I got my shot (got the last dose 1/22/2021), I have noticed some vaginal bleeding that has been going on for 2 days now (It's not the menstrual period since I had that going on a week before I got my last shot). I am wondering if there are any other women who have experienced the same reaction to their body. Kindly feel free to call me or email me with any answers. I am trying to reach my primary physician who is currently booked till February.
29 2021-01-27 numbness, hypersensitivity of all senses, tingling, migraine Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and f... Read more
Migraine started 2.5 hours after receiving shot (2nd dose). Intense migraine with nausea, hand and facial tingling/ numbness, seeing spots. Went away at just about 24 hours after it started. Got the chills just before it went away, no fever. Skin sensitivity and fever set in around 26 hours in - 102. Heart rate jumped from 130-170. Improved to about 150 with Tylenol and ALOT of fluids as fever improved, remained high until fever was gone around noon the next day. Hip pain, neck pain and back pain throughout. Hip pain first 24 hours. Back pain following that.
29 2021-01-27 weakness Nausea Weak Very tired Headache
29 2021-01-27 pain in extremity, breast pain Swollen lymph node to right axillary; Swollen lymph node to right axillary. Pain radiates to right b... Read more
Swollen lymph node to right axillary; Swollen lymph node to right axillary. Pain radiates to right breast, down right arm and around to the back and right scapula area/ tender to touch; Pain radiates to right breast; Pain radiates to right breast, down right arm; Pain radiates to right breast, down right arm and around to the back; Pain radiates to right breast, down right arm and around to the back and right scapula area; Pain caused inability to do daily activities; This is a spontaneous report from a contactable nurse (patient). A 29-years-old female patient ( received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at right arm on 12Jan2021 07:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN). The patient had allergies to sulfamethoxazole, trimethoprim (BACTRIM), amoxicillin. The historical vaccine included the first dose of BNT162B2 at right arm on 21Dec2020 07:30 for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swollen lymph node to right axillary, pain radiates to right breast, down right arm and around to the back and right scapula area, pain caused inability to do daily activities and area was tender to touch from 13Jan2021 02:00. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. Information on the batch number has been requested.
29 2021-01-27 pain in extremity, feeling hot Within 5 minutes of receiving Covid Vaccine (Pfizer ), second dose..... Employee complains of diffic... Read more
Within 5 minutes of receiving Covid Vaccine (Pfizer ), second dose..... Employee complains of difficulty breathing, warm, sweaty, left arm pain, lips swelling, tachycardia (p=140-100). Team called and sent to ER.
29 2021-01-28 facial pain, nerve pain 1week after second shot started experiencing facial nerve pain. No medical history of any pain befor... Read more
1week after second shot started experiencing facial nerve pain. No medical history of any pain before. Negative etiology from dentist. Received 5 day course of prednisone 50mg daily which resolved pain, however 1 day after finishing course pain returned. Worse at night with bouts of pain every 30 minutes when trying to sleep. Received steroids and carbamazepine from internal medicine doctor but this has not helped for this episode. Max doses of Tylenol and ibuprofen have not helped this episode.
29 2021-01-28 numbness Chest tightness worse with expiration, numbness in hands
29 2021-01-28 tremor, migraine Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature w... Read more
Chills started around 8:30pm, uncontrollable shaking from the chills, my skin hurt. My temperature was 103.5F when I checked it at 12:30am. I removed clothing and put ice on my neck, and took tylenol and the fever came down to 102.5F in 30 min. I had a moderate headache, felt lightheaded and a little disoriented, and nauseous. The following morning and the entire next day I had a moderate to severe headache, malaise, nausea, and a low grade temp 99-99.8F.
29 2021-01-28 weakness Hives developed on the injection arm and spread across her chest; intense heart palpitations; weakne... Read more
Hives developed on the injection arm and spread across her chest; intense heart palpitations; weakness/dizziness; weakness/dizziness; This is a spontaneous report from a contactable Nurse (patient). A 29-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at Left arm on 07Jan2021 13:00 at SINGLE DOSE for COVID 19 vaccination. The patient was not pregnant. Medical history included Shellfish allergy. There were no concomitant medications. Historical vaccine included first dose of bnt162b2 on 17Dec2020 07:00 AM at left arm for COVID 19 vaccination. On 07Jan2021, hives developed on the injection arm and spread across her chest within 5 minutes of receiving the vaccine, along with intense heart palpitations and weakness/dizziness. Resolved spontaneously after 10 minutes without any use of epinephrine or other medications. Oral diphenhydramine was taken afterwards. Treatment drug oral diphenhydramine received for events. The outcome of the events was recovered in Jan2021. No covid prior vaccination, no covid test post vaccination. Information on the lot/batch number has been requested.
29 2021-01-28 pain in extremity Swollen neck, chills, body aches, arm pain. Took benadryl and felt better. Took one tylonal felt muc... Read more
Swollen neck, chills, body aches, arm pain. Took benadryl and felt better. Took one tylonal felt much better. Drinking hot tea seems to help with the swollen neck. The symptoms started about 4 hours after injection.
29 2021-01-28 tremor, seizure Syncope versus seizure with urinary incontinence and shaking. Transported to ED via EMS.
29 2021-01-28 feeling cold The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it... Read more
The date of injection I didn't have any symptoms. The next morning i woke up and my arm felt like it was on fire. I had a rash on the opposite arm that i had the injection. I took benadryl to help with the rash in the morning and at night. That night i was freezing and i woke up in a sweat. This morning i woke up and the rash looks worse.
29 2021-01-28 difficulty speaking raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneou... Read more
raspy throat; red ears; a temperature; Headache; lip swelling; tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3302), via an unspecified route of administration on the left arm, on 14Jan2021 at 05:15, at a single dose for Covid-19 immunization. Medical history included asthma and uses an inhaler, glaucoma, nonsustained ventricular tachycardia for which she takes no medication. When she was a baby she had a reaction to the pertussis vaccine, she thought it was just a rash. Concomitant medications included topiramate (TOPAMAX) and bupropion hydrochloride (WELLBUTRIN). On 14Jan2021, the patient had a reaction after getting the vaccine. She reported that she had lip and tongue swelling. On the day of the report she still has the lip swelling. On 15Jan2021, the patient also had a raspy throat, red ears, a temperature, and headache. The center where she got the vaccine gave her diphenhydramine hcl (BENADRYL) through injection and the swelling went down. She noted she can breath, that has been complete fine. She explained that the lip and tongue swelling had gone completely down last night after the diphenhydramine hcl, but the lip swelling has come back as she has not taken any diphenhydramine hcl yet at the time of the report. She plans on taking some soon. The outcome of the event of tongue swelling was recovered on 14Jan2021 and outcome of other events was not recovered.
29 2021-01-29 weakness "Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan.... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" I received my 2nd dose of the Pfizer COVID-19 vaccine on Jan. 20th, 2021. On Jan. 21st, 2021, I woke up feeling feverish. I went to use the bathroom, and after washing my hands I walked towards the bathroom door and felt light-headed and dizzy. Suddenly, I passed out and hit my head and upper neck on the tile floor. My parents heard the sound of my fall and luckily rushed to the bathroom. They found me lying unconscious on the floor with my eyes rolled up for what felt like more than a minute. I regained consciousness on my own, and I drank water with a bit of sugar and salt mixed in. I felt too weak to get up and walk, and the back of my head and upper neck were in pain. I told my parents to call 911 as I wanted to make sure that there was no serious damage to my brain or neck area. I went to the local hospital in an ambulance. I was taken to the emergency room: Vitals were done and my temperature ranged from then was 99.5-101F and my heart rate was high- it stayed around 112 bpm for some time I was given 2 L of IV Saline Fluids EKG result: no clinical abnormalities CT head/neck/spine: negative 2 different types of COVID-19 tests: results were both negative Bloodwork: CBC/BMP/D-dimer: no clinical abnormalities Chest Xray: negative 2D- doppler ultrasound: negative Holter monitor: negative for irregular heart rhythm I was discharged the same day around 4:30pm
29 2021-01-29 pain in extremity Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain thro... Read more
Constant stomach pains with a continuous loop of constipation and diarrhea. High levels of pain through the left arm and around the injection site.
29 2021-01-30 weakness Fever, rigors, severe nausea, headache, generalized weakness, body and joint aches. These lasted 10 ... Read more
Fever, rigors, severe nausea, headache, generalized weakness, body and joint aches. These lasted 10 hours. Total 4 days of significant fatigue, joint aches, neck stiffness.
29 2021-01-30 facial pain First vaccine I had slight fever/ chills. Second vaccine on 01/27/21 I woke up next day with extreme... Read more
First vaccine I had slight fever/ chills. Second vaccine on 01/27/21 I woke up next day with extreme body aches and a temp of 101.1. Going into today 01/31/21, I still have elevated temp been taking Ibuprofen and Tylenol but now having dizziness, left facial pressure/pain, and nausea with neck stiffness.
29 2021-01-30 tenderness Immunization Admin. COVID-19 30mcg/0.3mL Dosage 1st Dose Pfizer (Z23); ­COVID-19 Vaccine, 30 Mcg/0.... Read more
Immunization Admin. COVID-19 30mcg/0.3mL Dosage 1st Dose Pfizer (Z23); ­COVID-19 Vaccine, 30 Mcg/0.3mL Dosage, Diluent Reconstituted, For Intramuscular (Z23) (IM injection) Manufacturer Pfizer Lot EL3249 Expiring 05/01/2021 ­ Vaccination received on 1-12-21, left deltoid. She had localized stinging in left proximal lateral arm for first 12-24 hrs; then itchy welt at injection site and nearby separate itchy small area on proximal lateral arm on 1-13-21. Progressive increase in size/persistent itching. Evaluated on 1-19-21. Afebrile. There is 2x2.5 cm mildly tender, slightly indurated nodularity surrounded by 10x9 cm confluent erythema demarcated by pen, which has extended to 12x9.5 cm in widest margins. Confluent erythema is slightly warm to touch, nontender, nonindurated, no red streaks. No left axillary adenopathy. Treated with antihistamines.
29 2021-01-31 migraine Body aches, migraine, chills, dizziness, nausea Missed work, treated successfully with APAP
29 2021-01-31 weakness Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, b... Read more
Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, body aches, muscle pain, dizziness, etc.
29 2021-01-31 pain in extremity The lady?s technique was to put needle in with one hand. Switched the hand she was holding the needl... Read more
The lady?s technique was to put needle in with one hand. Switched the hand she was holding the needle with, then plunged the vaccine into my arm. I could feel the needle moving in my arm. It has been sore since!
29 2021-01-31 nerve pain, pain in extremity Within 5 minutes after the vaccination I felt really dizzy and took had to take a couple deep breat... Read more
Within 5 minutes after the vaccination I felt really dizzy and took had to take a couple deep breaths to calm down which went away pretty quickly. Almost immediatly afte,r I got a sharp shooting inside nerve pain from shoulder under the armpit area down to my wrist area. The pain was bad and constant until 1/14, aleve, ibuprophen or tylenol made it better. On 1/10-1/11 the pain was the worst and woke me up from sleeping it hurt so bad with a pain level of a 8/10. The pain was more nerve pain over muscle pain and the intensity never changed whether I moved or not.
29 2021-02-01 pain in extremity Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibupr... Read more
Because of patient's previous reaction, pt premedicated with famotidine 20 mg, benadryl 25 mg, ibuprofen 400 mg 30 min before injection. Received vaccine at 9:15 AM. She initially felt well, but about 20-30 minutes after administration began to feel dizzy. Then had nausea, vomiting, dizziness, severe headache, feeling of her body being heavy, arm pain at site of administration. Vitals were monitored/stable throughout. Pt was given Zofran 4 mg disintegrating tab at 9:50, which did not do much to relieve sx. However, at 10:35 she noted that headache was gone, although still had dizziness, arm pain. By 11:08 no longer had symptoms except for arm pain. By 11:43 still feeling back to normal except for arm pain.
29 2021-02-01 feeling hot, pain in extremity Body ache; Headache; blood pressure was 140/100; left leg swell; severe pain in toes; feel feverish;... Read more
Body ache; Headache; blood pressure was 140/100; left leg swell; severe pain in toes; feel feverish; Chills; Warm body; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 11:00 at single dose for covid-19 immunization. Medical history included asthma. Concomitant medication included salbutamol sulfate (PROVENTIL) for asthma. Patient previously took first dose of bnt162b2 on 30Dec2020 at single dose for covid-19 immunization. Patient got second vaccination on 18Jan2021 and may be around about 11 O'clock on same day patient felt to have a body ache all over which patient knew it was normal. However, it was getting worse throughout the day. And patient couldn't even get up and went to work. Also have very bad headache and patient blood pressure was 140/100. For about 3 hours patient did had left leg swell and caused severe pain in toes, that just subsided. Patient didn't have a fever but patient feel feverish, chills, warm body. Patient had been taking Ibuprofen on and off as treatment. Outcome of events left leg swell and caused severe pain in toes were recovering, and outcome of other events was unknown. Information about Lot/Batch number is requested.
29 2021-02-01 burning sensation Burning sensation in chest
29 2021-02-01 muscle spasms, tremor PT had Covid Pfizer vaccine on 02/01/21 at 8:47 am with no adverse reactions. While working at her d... Read more
PT had Covid Pfizer vaccine on 02/01/21 at 8:47 am with no adverse reactions. While working at her desk at 11:40 am, (employee) patient states had gradual bilateral arms and bilateral legs shaking and back went into spasms. No loss of consciousness. PT walked to vaccination pod where seen by MD Resident and then take to ED for further exam
29 2021-02-01 discomfort, tenderness, burning sensation Received 2nd Covid vaccine dose on 01/31/21 at 07:13 AM. The evening after/bedtime after injection -... Read more
Received 2nd Covid vaccine dose on 01/31/21 at 07:13 AM. The evening after/bedtime after injection - Had severe chills, mild fever (highest temp 100.3F), myalgias/body aches, and aching/pain and burning in collar bone area. 02/01/21 at 04:00AM - still having above plus even more discomfort over collar bone (especially left side) noticed lump over left collar bone which was an enlarged left supraclavicular lymph node which was also very tender. 02/01/21 - called my primary physician, notified them of the above info and Appt scheduled for 2:00PM. Went to Appt for physician evaluation on 02/01/21 at 2:00PM. Follow-up Appt scheduled with Primary Physician for Thursday 02/04/21. Today 02/02/21 - lymph node remains enlarged and tender. Fever chills and body aches have subsided for now. Having headache today as well.
29 2021-02-01 numbness Site: Pain at Injection Site-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Oth... Read more
Site: Pain at Injection Site-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Other- Light-headed, numbness ONLY in lower hand and wrist-Medium
29 2021-02-01 migraine fever; chills; headache; bad body aches; continuous migraine; developed bad body sweats; This is a s... Read more
fever; chills; headache; bad body aches; continuous migraine; developed bad body sweats; This is a spontaneous report from a contactable Other HCP reporting for herself. A 29-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number eL0142), intramuscular on 05Jan2021 10:00 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at hospital. Patient age at time of vaccination was 29 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) intramuscular administered on 16Dec2020 at 03:00 PM at single dose in right arm. Medical history included hypothyroidism, polycystic ovarian syndrome, low vitamin D from Apr2020, was diagnosed with COVID19 in Apr2020. The patient has no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), spironolactone, ergocalciferol (VIT D) birthcontrol pill. On 16Jan2021 at 03:00 PM, all of a sudden developed fever, chills, headache and bad body aches out of nowhere. Fever continued to progress despite Tylenol. Went to the hospital she worked at, and was COVID (Nasal Swab) and respiratory panel tested same night as symptom development at 11pm. Both have since come back negative. The fever and symptoms lasted for another 24 hours and the patient also developed bad body sweats even after fever had been broken. She had no other symptoms like congestion or sore throat that would signify another cause of the fever and symptoms, and ears and throat where checked at the hospital. The headache she had was similar to the headache when she had covid back in Apr2020. The headache was icepick like along with a continuous migraine. The only thing she did differently was the day before symptom onset, she did a pretty high intensity cardio workout for an hour. The events resulted in emergency room/department or urgent care and were resolving. No treatment was given other than Tylenol for fever.
29 2021-02-01 pain in extremity, tension headache moderate L arm pain; intermittent mild moderate retro orbital and tension headache; intermittent mil... Read more
moderate L arm pain; intermittent mild moderate retro orbital and tension headache; intermittent mild moderate retro orbital and tension headache; Difficulty sleeping with multiple awaking; Difficulty sleeping with multiple awaking; This is a spontaneous report from a contactable Physician (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284 and expiration date: 30Apr2021), intramuscular in left deltoid on 08Jan2021 09:00 at a single dose for COVID-19 immunization. Medical history included Menorrhagia. Concomitant medication included ongoing Mirena IUD from 04Jun2020 ('Once placed last 5 yr') for pregnancy prevention and menorrhagia. On 08Jan2021 (at PM), the patient developed moderate left (L) arm pain which improved gradually and resolved 10Jan2021 (at AM), significantly less severe than prior. Patient had intermittent mild moderate retro orbital and tension headache occurred 08Jan2021 (at PM) thru 10Jan2021 (at AM). Patient had difficulty sleeping with multiple awaking on 08Jan2021 to 09Jan2021 overnight. The patient was not admitted to the hospital. The reporter reported a reasonable possibility that the events were related to suspect product. No treatment was required. The outcome of the events moderate left (L) arm pain and retro orbital and tension headache was recovered on 10Jan2021; event difficulty sleeping with multiple awaking was recovered on 09Jan2021.
29 2021-02-02 pain in extremity Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 1... Read more
Blurry Vision, headache,dizziness, armpit pain, increased heartrate ( 165) , high blood pressure ( 195/110 ) leg pain, muscle aches
29 2021-02-02 numbness, tingling Facial numbness and tingling on right side of the face
29 2021-02-02 tremor HAd trembling, heart racing, chest tingling some difficulty swallowing and swelling of the tongue. ... Read more
HAd trembling, heart racing, chest tingling some difficulty swallowing and swelling of the tongue. She premedicated with benadryl.
29 2021-02-02 pain in extremity Sore arm. No treatments. Resolved in 2 days
29 2021-02-03 pain in extremity Arm soreness; pregnant at the time of vaccination (gestational period: 20 weeks); pregnant at the ti... Read more
Arm soreness; pregnant at the time of vaccination (gestational period: 20 weeks); pregnant at the time of vaccination (gestational period: 20 weeks); pregnant at the time of vaccination (gestational period: 20 weeks); This is a spontaneous report from a non-contactable other healthcare professional (patient). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1681), via intramuscular route of administration on 18Jan2021 at 12:00 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies to penicillin. Concomitant medications included prenatal vitamins and cetirizine hydrochloride (ZYRTEC).The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that patient was pregnant at the time of vaccination (gestational period: 20 weeks). On an unspecified date, the patient experienced arm soreness but did not receive any treatment for the event. The event arm soreness was considered non-serious. The last menstrual date was reported as 28Aug2020. The mother was due to deliver on 04Jun2021. The patient underwent lab tests and procedures which included nasal swab test and PCR on 18Jan2021 and both were negative. The outcome of the event arm soreness was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
29 2021-02-03 pain in extremity, muscle spasms Cramping/soreness in upper legs and buttocks, headache, mild sore throat, lethargy. Symptoms started... Read more
Cramping/soreness in upper legs and buttocks, headache, mild sore throat, lethargy. Symptoms started just shy of 24 hours after the second injection and lasted the rest of the day. Symptoms resolved by morning the following day (2 days after vaccine).
29 2021-02-03 numbness Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hour... Read more
Left half of face (same side as injection) from chin/neck to scalp was numb for approximately 8 hours. Felt very similar to the numbness of after dental work. Did NOT have face paralysis like that of Bell's Palsy just face numbness. After approximately 8 hours feeling was restored. As of 2+ weeks later no lasting effects.
29 2021-02-03 feeling cold, breast pain PMH: dx with Grave's disease in 2014, s/p thyroidectomy 2/2 thyroid cancer on 8/10/2020 (now on syn... Read more
PMH: dx with Grave's disease in 2014, s/p thyroidectomy 2/2 thyroid cancer on 8/10/2020 (now on synthroid 150 mcg). 1/26 ED VISIT: P/w chest pain/SOB went to ED. Patient received the COVID vaccination 3 days prior (1/23). Was in NSH the morning of vaccine, then in the afternoon became tired. Then developed a H/A (frontal and right sided, that has resolved) and chills. p/w SS chest pain, radiating to the right shoulder and to the back. Worsened with deep inspiration and difficult to take a deep breath. Took tylenol at 8 pm yesterday (1/25) and advil at 1 pm yesterday (1/25). A/w DOE. Denies birth control use, n/v, abd pain, urinary symptoms, tobacco/etoh/drug use, recent travel, cough, le swelling, hx pe/dvt. Patient had imagining completed - no significant findings and discharged on percocet and ibuprofen. Patient represented to the ED on 2/2/2021: Over the last two days, patient has tender right shoulder pain radiating to neck and chest with ROM and strength limited by pain associated with nausea. Evaluate for rhabdo and myocarditis - negative. Patient seen by ortho (note unable to be obtained). 2/4 Telehealth visit: The patient reports still having a swollen lymph node under her left axillary area. She denies fever. Patient reports pain to her right shoulder. She presented to ortho who said it might be an infected cyst and attempted to drain it unsuccessfully. Patient mentions pain and tingling to her left breast. She notes right shoulder pain to the back of her neck that radiates down to her left arm. She notes a stabbing back pain and rib pain when she takes a deep breath. Patient given levofloxacin and gabapentin
29 2021-02-04 inability to speak After the vaccine was administered, 5-10 minutes later I began to feel a rapid heart rate. One of th... Read more
After the vaccine was administered, 5-10 minutes later I began to feel a rapid heart rate. One of the nurses came to check on me, I described to her my symptoms, and she let me know if they get worse to inform her. In the next 5 minutes, my head began to hurt, as well as, some chest pain. She checked on me again, and said to let her know if things got worse. Within the next 5-10 minutes after, I had difficulty swallowing and speaking. I raised my hand, and the nurse came over, then proceeded to get help. They then took my blood pressure and heart rate. My blood pressure was 185/103 and I believe my pulse was 156 bpm. I was still having a hard time swallowing and speaking. They proceeded to get an epi pen and the doctor on site, as well as suggested to send me over the ER/ call 911. The doctor checked my lungs, and they noticed my blood pressure and heart rate was not decreasing to a normal level. I was then put in a wheel chair and transferred to the ER. At the ER, my blood pressure and heart rate was still elevated, as well as difficulty swallowing. The doctor ordered Benadryl via IV, steroids, and the epi pen. After having a reaction to the Benadryl, the epi pen was put on hold. After about 15 minutes, I began to feel better. I was put on IV fluids and observation. I was able to leave the ER around 12 pm 2/05/21. At this time, 7:22 pm, I am feeling better with mild muscle aches, and fatigue.
29 2021-02-04 numbness Patient arrived to vaccine clinic for her 1st Pfizer vaccine. She received her vaccine at 1606. S... Read more
Patient arrived to vaccine clinic for her 1st Pfizer vaccine. She received her vaccine at 1606. She was then walked out to the waiting room to wait her 15-20 minutes that is strongly recommended after receiving the vaccine. Approximately 5 minutes later, she alerted the reception staff that she was having some sort of reaction. I was then notified immediately and patient was brought back to a private exam area. Patient complained of chest tightness, numbness in fingers and a racing heartbeat. She also felt that she was having difficulty breathing. Vital signs at that time were 96.3 temperature, RR 36, blood pressure 170/100 and a heart rate of 174. Patient received (1) epipen and 911 was simultaneously notified. 2 liters of oxygen via nasal cannula were applied. Shortly after epipen was given and oxygen applied, patients heartrate decreased into the 130s. Oxygen remained stable at 99-100% on 2 liters nasal cannula. Ice pack applied to base of neck for comfort. EMS arrived and report given as patient will be taken to the emergency department for further evaluation.
29 2021-02-06 tremor 15 hours after receiving the 2nd dose of the Pfizer vaccine, I woke up at 1:00 am with severe chills... Read more
15 hours after receiving the 2nd dose of the Pfizer vaccine, I woke up at 1:00 am with severe chills, shakes, body aches and my left arm (injection arm) could hardly lift up. I had water that night. In the morning, about 5 hours after these symptoms (6:30 am), I had a pounding headache and still body aches. I took Tylenol every 5-6 hours. About 3pm, the only symptom I still had was a headache which was mild-mod. By the next morning, I felt back to normal.
29 2021-02-07 pain in extremity Headache, fatigue started same day. Arm soreness that evening, lasted for 2-3 days.
29 2021-02-07 flushing felt flushed; This is a spontaneous report from a contactable Nurse. A 29-year-old female patient ... Read more
felt flushed; This is a spontaneous report from a contactable Nurse. A 29-year-old female patient received the first dose of of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247 with Expiration Date 31May2021), on 18Jan2021 (at 08:30) at 0.3 ml single dose on the left deltoid for COVID-19 immunisation. No relevant medical history was provided. The patient did not have relevant concomitant medications. She was vaccinated at COVID vaccine center where they are administering the Pfizer vaccine. On 18Jan2021 (at 09:05), she felt flushed. She took cetirizine hydrochloride (ZIRTEC) at home in preparation; she was given juice and cookies. At 9:20, patient was feeling better, she was monitored for 30 more minutes in observation area and stated she was feeling fine and left. The patient had recovered from the events on 18Jan2021.
29 2021-02-08 weakness 29F no PMH had COVID-19 almost 1 year ago. On 2/2 received 1st shot of COVID-19 vaccine. Since then... Read more
29F no PMH had COVID-19 almost 1 year ago. On 2/2 received 1st shot of COVID-19 vaccine. Since then with mild headache, body aches, chill. On the morning of 2/3, with prolonged standin, felt weak, abdominal pain, pre-syncopal, grabbed a co-worker and then syncopized. Caught and did not sustain injuries. Rapid response called and she was brought here.
29 2021-02-08 feeling cold Vial had been removed from deep freezer to cooler for longer period of time than recommended by Pfiz... Read more
Vial had been removed from deep freezer to cooler for longer period of time than recommended by Pfizer. By time realized, vaccine had been administered to patient (employee). Pharmacy contacted Pfizer and Infection Disease MDs for counsel. Said wouldn't hurt patient, however not able to guarantee effect; stated could offer 3rd dose in 3-4 weeks. Notified Employee; stated did experience expected side effects of fatigue, chilling, body aches and possibly fever (didn't check) and declined 3rd vaccination offer
29 2021-02-09 numbness Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of b... Read more
Adverse event: Blurred vision, numbness left side head to shoulder, vomiting, chills, shortness of breath, severe headache, oral mycosis swelling Treatment: Benadryl Outcome: Sent to ER by facility MD, treated and observed at hospital for 1.5 hours released no negative outcome
29 2021-02-09 migraine Fever, chills, coughing, sore throat, difficulty breathing, nausea, and migraine.
29 2021-02-10 numbness After second shot had numbness on the left side of face approximately ten minutes after shot, was le... Read more
After second shot had numbness on the left side of face approximately ten minutes after shot, was less numbness than shot one. Approximately 3 hours after shot developed hives on same area of face that was number. Hives last about 2 hours and cleared up with OTC Benadryl. Face numbness stopped about 6.5 hours after injection
29 2021-02-10 feeling hot, tremor Approximately 4 minutes after receiving my vaccine I felt warmth down injected arm. Approximately 20... Read more
Approximately 4 minutes after receiving my vaccine I felt warmth down injected arm. Approximately 20 minutes post injection, I experienced a drop in my blood pressure, heaviness in my legs (like walking through cement), and ringing in my ears. At approximately 12:30-12:45pm I experienced mental fog (I couldn't remember how to turn off my windshield wipers), increased heart rate, rapid onset of feelings of panic, minor shortness of breath, neck/clavicle tightness on side of injection, and sweating. Between approximately 1:30pm and 2:30pm I continued to have extreme sweating, as well as: increased pulse, fatigue, dry throat, muscle weakness/shakiness, brain fog, and headache. At approximately 3:30 I hit my knee on the bed frame and felt like the wind had been knocked out of me and immediately had a severe drop in blood pressure that felt similar to a vasovagal event. I called the vaccine clinic and my symptoms were noted and I was told to seek help if my symptoms worsened or I felt like I was going to pass out. My symptoms have not worsened but I am still experiencing extreme sweating along with shivering, shakiness, blood pressure changes with movement (orthostatic hypotension), and fatigue - time is currently 5:50pm
29 2021-02-10 tenderness Morning of 14th, I woke up and my left arm hurt to move - it wasn't the site itself, it was under my... Read more
Morning of 14th, I woke up and my left arm hurt to move - it wasn't the site itself, it was under my armpit (where the lymph node is). I didn't call my doctor at that point because I read that it was a side effect. Dull/always there pain at that point. On the 15th, shooting pains - this lasted two days. It started getting better again by the 17th. It was resolved by the 18th. 14-17th - Swelling that I could feel and see and that also went back to normal by the 18th. It was just tender to touch for a little while after that....after it didn't hurt to move I didn't pay as much attention to it. I was able to go to work but I had to modify what I could do at work. I could not do my normal swimming exercise until that next week.
29 2021-02-10 night sweats, pain in extremity, tingling anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feelin... Read more
anxiety attack; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; 2 mins after the shot left arm felt heavy and was hard to move, tingling/dead feeling; in the evening arm swelled/swelling went down to size of pin hole; there was a welt at the vaccination site / there was still a little knot on arm; fever; night sweats; body rash/ rash beneath eyes; blister sores; swelling of eyes; arm was painful and is still; This is a spontaneous report from a contactable consumer. A 29-years-old female patient, a registered nurse, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Lot number BK9231, in Hospital, via an unspecified route of administration in left arm on 04Jan2021 at 14:00 at single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of the vaccination. Concomitant medications included ibuprofen and cetirizine hydrochloride (ZYRTEC). The patient reported that 2 mins after the shot, her left arm felt heavy and was hard to move and, on 04Jan2021 at 14:15 she had tingling/dead feeling; in the evening arm swelled and there was a welt at the vaccination site. On an unknown date in Jan2021 she had fever at 102 °F for 48 hours and swelling went down to size of pin hole; her arm was painful and was still sore, there was still a little knot on arm. On 07Jan2021 she experienced an anxiety attack; 20 days after, in Jan2021 the patient experienced night sweats. She also experienced body rash and little blister sores on her body and both arms, swelling of eyes and rash beneath eyes. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was administered to the patients for the events. On 25Jan2021 the patient underwent COVID-19 test via Nasal Swab which showed negative results. The event "Fever" resolved after 48 hours, whereas the outcome of all the reported events was unknown at time of the report.
29 2021-02-14 pain in extremity Left second toe became discolored and stinging/painful, then left 4th toe. Exam c/w pernio/chillblai... Read more
Left second toe became discolored and stinging/painful, then left 4th toe. Exam c/w pernio/chillblains
29 2021-02-14 feeling cold the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was ... Read more
the arm i received the injection felt like it was on fire; The opposite arm had a rash on it; I was freezing at night and i woke up in a sweat; I was freezing at night and i woke up in a sweat; This is a spontaneous report from a contactable Other Health Professional (patient). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old. Lot number was EL9262. Medical history was none. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at 09:45 at single dose in right arm for COVID-19 immunisation at the age of 29-year-old (lot number was EL3248). Concomitant medications included desogestrel, ethinylestradiol (ISIBLOOM) for birth control, ESCITALOPRAM OXALATE (LEXAPRO), vitamin D. On 28Jan2021 at 07:45, the patient woke up and the arm where she received the injection felt like it was on fire; the opposite arm had a rash on it; the patient took benadryl that morning and at night after she got home from work. On 28Jan2021, the patient was freezing at night and he woke up in a sweat. On 29Jan2021, the rash looks worse. The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has not been tested for COVID-19.
29 2021-02-15 tremor PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 ... Read more
PFIZER-BIONTECH COVID-19 . Individual had nausea/vomiting, fever 101.6, fatigue and body aches x 48 hours following first dose on 1/20/21. After second dose of vaccine, reported: itching, stridor, cough, nausea, vomiting, dizziness, tachycardia, acute change in mental status, temp102.5, DBP >100, tremors for 48 hours. Did not see doctor or other healthcare provider.
29 2021-02-16 seizure like phenomena Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly therea... Read more
Difficulty breathing- received EpiPen dose, patient was able to breath normally again Shortly thereafter patient was witnessed to have seizure like activity, EMS was called and administered Ativan and Benadryl in route to ED
29 2021-02-16 pain in extremity Headache, brain fog, tiredness, achy, sore arm started approximately 23 hours after administration o... Read more
Headache, brain fog, tiredness, achy, sore arm started approximately 23 hours after administration of vaccine
29 2021-02-18 pain in extremity I had a small fever; my arm was really sore; I felt really tired and fatigued. I had a small headach... Read more
I had a small fever; my arm was really sore; I felt really tired and fatigued. I had a small headache. The fever was one day. The arm was sore for two or three days. And my fatigue and headache went away after about two days.
29 2021-02-21 facial paralysis Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began ... Read more
Bell's Palsy -loss of muscle movement in left side of face, numbness in tongue, pain in neck. Began on 2/18 with numbness, woke 2/19 with no control of facial muscles Received steroids and antivirals, no improvements
29 2021-02-21 tenderness, cold sweat Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically... Read more
Fatigue, cold sweat/chills, slight headache, muscle/joint pain, skin painful to the touch (typically occurs to me right before getting a fever or becoming sick)
29 2021-02-21 tremor, weakness, muscle spasms, tenderness High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache a... Read more
High fever for 24 hours that couldn't be controlled with OTC meds, chills/sweats, severe headache and dizziness, shaking, muscle cramps (all lasted about 24 hours straight through. Muscle and joint pain and weakness continued through 48 hours. Left arm, under arm and shoulder were very tender and mobility restricted through day 3.
29 2021-02-21 feeling cold, pain in extremity Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes,... Read more
Nausea, fever, chills, aches and pains, fatigue, headache, neck ache, ear pain, swollen lymph nodes, sore arm. These symptoms lasted about 2 days total.
29 2021-02-21 tingling, numbness, weakness Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder... Read more
Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital 01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture. 02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021. PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.
29 2021-02-21 weakness The morning after the vaccine, pt noted low grade fever and general weakness, syncope with loss of c... Read more
The morning after the vaccine, pt noted low grade fever and general weakness, syncope with loss of consciousness for undetermined time period, facial trauma resulting in fractures of maxilla and teeth
29 2021-02-21 numbness numbness and tingling in R arm and neck. Then next day when I followed up with patient the numbness... Read more
numbness and tingling in R arm and neck. Then next day when I followed up with patient the numbness and tingling had resolved and she stated her neck and R shoulder blade area were sore.
29 2021-02-22 feeling hot, weakness Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of t... Read more
Approx 5 minutes after receiving the vaccine, client started c/o feeling hot, sweaty, Left side of tongue numb and she had pressure on the left side of her head, her BP dropped and she felt weak. No medications given. She felt better after 10 minutes. She called her doctor and he gave her an epi pen and told her not to take the 2nd dose of Pfizer. She says she felt dizzy and weak for 3 weeks afterwards, but fine now.
29 2021-02-22 pain in extremity Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to wa... Read more
Itchy red hives and rash all over body and face. Painful joints. Swelling so bad it is Painful to walk on feet and use hands.
29 2021-02-22 numbness Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. Aft... Read more
Left arm experienced a numbness-like feeling from shoulder to elbow, as well as a heavy feeling. After about 20 minutes the numb like feeling had begun to regress back toward the injection site. It had not fully faded away after 30 minutes but did seem to be improving.
29 2021-02-22 weakness Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives... Read more
Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared. Monday redness on face and by Tuesday all hives had resolved. Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.
29 2021-02-23 migraine Fever, swollen lymph nodes, itchy skin, intense body acne (increased swelling and discharge from exi... Read more
Fever, swollen lymph nodes, itchy skin, intense body acne (increased swelling and discharge from existing infections), muscle aches, body pain, prolonged fatigue, brain fog, persistent migraines, sweating, chills. All persisted for about a week.
29 2021-02-23 migraine Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Ir... Read more
Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
29 2021-02-24 feeling cold, numbness, tingling 2 Days post injection started to have left axillary lymph node pain and swelling. Left arm sensation... Read more
2 Days post injection started to have left axillary lymph node pain and swelling. Left arm sensation starting to become cold, tingling, and numbness. 1 week post injection right axillary swelling and pain started. Right arm sensation also started to have cold, tingling, and numbness but not as extreme.
29 2021-02-24 numbness, pain in extremity Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's a... Read more
Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection (which is very rare on me), and was treated with antibiotics. With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.
29 2021-02-24 tremor Pfizer COVID-19 Vaccine EUA Pt received 1st dose of Pfizer COVID vaccine and was scheduled to be mo... Read more
Pfizer COVID-19 Vaccine EUA Pt received 1st dose of Pfizer COVID vaccine and was scheduled to be monitored for 30 minutes afterwards due to her history of anaphylaxis with penicilins. About 10 minutes after vaccination, pt had a sudden onset of headache (frontal and temoral) and an increase in her blood pressure. Within 20 minutes of vaccination, pt had body tremors. At 30 minutes, patient was transferred to convenient care. At convenient care, pt presented with headache, elevated blood pressure, tremors. Denied swelling of tongue or thorat, difficulty swallowing, or breathing. BP was 148/89, pulse 10, respiratory rate 18. Pt received diphenhydramine 25 mg IM x 1, ibuprofen 800 mg PO x 1. Convenent care provider diagnosed reaction as anaphylactic reaction and recommended she follow up with PCP regarding receiving 2nd dose. Pt was discharged to home after 1-1.5 hours of monitoring.
29 2021-02-24 weakness ended up in the ED later that day with a flare up of covid symptoms, I stated hurting all over as ex... Read more
ended up in the ED later that day with a flare up of covid symptoms, I stated hurting all over as expected, but also got lightheaded, nauseated, sugar kept dropping, felt short of breath due to coughing, head started pounding, and got very weak.
29 2021-02-26 feeling hot Patient felt hot, had nausea, and passed out transiently. She woke after approximately 2-3 seconds a... Read more
Patient felt hot, had nausea, and passed out transiently. She woke after approximately 2-3 seconds and felt well after lying down for 1-2 minutes.
29 2021-02-27 pain in extremity Fever-99.9 And stiffness and soreness in right pointer and middle finger
29 2021-02-27 pain in extremity First dose: fatigue with left arm soreness Second dose: chills, whole body soreness and ache, low gr... Read more
First dose: fatigue with left arm soreness Second dose: chills, whole body soreness and ache, low grade fever and an ongoing blurry vision. I went to the ophthalmologist and the ocular ct showed right eye optic nerve is inflamed.
29 2021-02-27 inability to speak Vaccine recieved January 4th and 2nd shot recieved January 26th. Both pfieffer On 2/27/2021 I becam... Read more
Vaccine recieved January 4th and 2nd shot recieved January 26th. Both pfieffer On 2/27/2021 I became aphasic confused could not remember my name or say anything coherent. Husband called 911. MRI EKG CAT EEG done all negative. Speculating a TIA or seizure.
29 2021-02-27 weakness minutes after administration, patient reports head feeling strange, so I asked her to remain seated ... Read more
minutes after administration, patient reports head feeling strange, so I asked her to remain seated so I can observe her prior to getting up to the observation room. Then she reports feeling nauseous and weak. I asked her what medical conditions she has and she told me she is diabetic and has kidney disease. I asked if she ate breakfast, she said she did not, only had something small before heading out in the morning. I gave her am ice pack to place on the back of her neck which helped relieve her symptoms of head feeling strange and the nausea. Once nurse arrived, we checked her pulse and blood pressure, at this time it was around 11:45 am and her pulse was low at 64 and blood pressure at 94/60, which patient states is her baseline normal blood pressure. We opened the windows so she could get some fresh air since the room was very hot and shortly after we took her pulse and blood pressure she seemed to be feeling better. By 11:50 am the ambulance arrived and paramedics asked if she would like to be taken to the hospital to get checked, she said even though she is feeling a lot better, she would prefer to go just in case.
29 2021-03-02 numbness, sensory loss 6 hours after vaccine developed bilateral upper extremity numbness and weakness. R arm symptoms res... Read more
6 hours after vaccine developed bilateral upper extremity numbness and weakness. R arm symptoms resolved in 30 minutes. L arm symptoms persist. Awoke with a headache 2/27/21 with headache-severe R sided temple. Had brief urinary urgency but did not urinate. L arm weakness and numbness persistent. Arm function returned but has persistent inability to move / use L hand and has loss of sensation L hand /forearm in glove distribution to mid forearm.
29 2021-03-02 pain in extremity Arm pain but significantly less arm pain than the first shot. I also have a fever and I feel tired.
29 2021-03-02 feeling hot, pain in extremity Dizziness since 12:30pm March 2nd, nausea, pain and soreness in left arm. Swelling down to wrist. Di... Read more
Dizziness since 12:30pm March 2nd, nausea, pain and soreness in left arm. Swelling down to wrist. Diarrhea 6 times since vaccination, vomiting bile, headache, chills. Feeling feverish. Headache. Took Motrin 6pm March 2nd and 9am March 3rd.
29 2021-03-02 pain in extremity Patient reported sore arm the full day afterwards and it was less on the 2nd day.
29 2021-03-02 pain in extremity sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer... Read more
sore arm; diarrhea; sore rib; lump on neck; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: Ek4176), via an unspecified route of administration in the left arm on 12Jan2021 at 16:45 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, PCOS (polycystic ovaries), and allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination, and was not pregnant at the time of vaccination. Concomitant medications included levothyroxine, metformin, and daily multivitamins (also reported as medication that the patient received within two weeks of vaccination). After the first dose, on 15Jan2021, the patient experienced sore arm, diarrhea starting day 3 through today, sore rib, and lump on neck. It was unknown if the events were treated. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
29 2021-03-03 discomfort 1/12 vaccination 1/13 I woke up, fatigue. Went to work. I could feel my HR increase. Pressure on my... Read more
1/12 vaccination 1/13 I woke up, fatigue. Went to work. I could feel my HR increase. Pressure on my chest, upper right side. It progressed to neck and shoulder, pressure and sharp stabbing pain. Went to lay down in dark room. Vitals stable except pulse. ER; could not keep eyes open I was so fatigued. Fever; 100.4. BP 131/85. Tachycardia, body aches, extreme fatigue, dizzy. Tylenol, COVID test, blood work, chest xray, EKG; short of Toradol. EKG looked normal. Advised to come back if worsened after 48 hours.
29 2021-03-04 tingling Shortly after vaccination had same side hand tingling followed by leg. Resolved after 30 min. No f... Read more
Shortly after vaccination had same side hand tingling followed by leg. Resolved after 30 min. No further complaints
29 2021-03-05 feeling hot, migraine, tremor Beginning 2 hours after vaccine: Headache/migraine, vice grip feeling in front and side of head an... Read more
Beginning 2 hours after vaccine: Headache/migraine, vice grip feeling in front and side of head and down nose Extreme nausea, overheating, dizziness Overheating gets worse, no fever but inability to cool down even after putting ice on body Nausea worsens, shaking begins with whole body shaking The following day: Diarrhea, fatigue Other symptoms resolved
29 2021-03-05 feeling cold Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with pounding heart rate, short of breath, cold forehe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Woke up with pounding heart rate, short of breath, cold forehead. Stood up and walked to next room, pulse continued to rise, ultimately plateauing around 160bpm. Called family doctor, was advised to apply pressure to one side of neck and monitor for the next half hour. Followed advice, sat down with knees bent, and did slow breathing. Pulse slowly decreased and returned to normal rate around half an hour later.
29 2021-03-06 night sweats Night sweats, tiredness
29 2021-03-07 pain in extremity sore arm; fever up to 101.3 (fever dropped to 99 with tylenol, was still at 100 30 hours after injec... Read more
sore arm; fever up to 101.3 (fever dropped to 99 with tylenol, was still at 100 30 hours after injection); full body chills and aches; full body chills and aches; nausea; loss of appetite; 1 instance of vomiting after eating a banana; This is a spontaneous report from a non-contactable healthcare professional. A 29-year-old female patient received second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on the right arm on 04Feb2021 08:00 at single dose for COVID-19 immunisation. Medical history included chronic lung illness and sulfa allergy. Patient has unspecified concomitant medication. The patient previously took BNT162B2 on 13Jan2021 first dose (lot number=EL3249) on the right arm; Allergies: CEFZIL, amoxycillin and NEOSPORIN. The patient experienced sore arm, fever up to 101.3 (fever dropped to 99 with TYLENOL, was still at 100, 30 hours after injection), full body chills and aches, nausea, loss of appetite, 1 instance of vomiting after eating a banana on 04Feb2021 04:00. Other events does not received treatment. The outcome of the events were recovered on Feb2021. No follow-up attempts are possible. No further information is expected.
29 2021-03-10 unresponsive to stimuli Approximately 3 to 4 minutes after receiving vaccine, patient stated she was not feeling good and pa... Read more
Approximately 3 to 4 minutes after receiving vaccine, patient stated she was not feeling good and patient turned red and fainted. She was sitting in chair so mom stood behind her with an ice pack behind neck and holding patient head while dad stood in front of patient. Her body became limp and mom was shaking her body on right side in attempt to wake patient up. Her eyes opened but was still unresponsive and she was breathing heavily for 30-40 seconds. After placing patient on floor and elevating her legs, patient stated she felt better but still fills nauseated. Paramedics were called.
29 2021-03-10 feeling hot, hot flush Hot flashes. Body is hot. Itchy skin. Scratchy throat. Fuzzy tongue.
29 2021-03-11 muscle spasms, tingling About 36 hours after shot, my lymph nodes in my left arm pit became swollen and painful. This progre... Read more
About 36 hours after shot, my lymph nodes in my left arm pit became swollen and painful. This progressed to the lymph nodes around my chest and neck, and I developed a lump of swollen lymph nodes on the back of my neck about 48 hours after my shot that lasted about a day. My lymph nodes in my chest arm and underarm stayed swollen for about a week. About 48 hours after my shot, I began experience minor muscle spasms in my right foot, then in the arm muscle where I was injected. Throughout that day and the next week, I experienced minor muscle spasms throughout my entire body. They were most prominent on my left side of my body where I got the injection. I also felt weakness and tingling in my left arm for about a week. The muscle spasms throughout my body and weakness in my left arm continued slowly subsided over about 3 weeks after my shot. They were minor spasms, but were persistent across the three weeks.
29 2021-03-11 tremor Symptoms: Nauseated and shaking hand Treatment: education, water and snack, had patient wait an extr... Read more
Symptoms: Nauseated and shaking hand Treatment: education, water and snack, had patient wait an extra 15 min. When she left she stated she felt great.
29 2021-03-12 migraine I felt like I was having major flu like symptoms. I had chills, cough, migraine and was very congest... Read more
I felt like I was having major flu like symptoms. I had chills, cough, migraine and was very congested. This lasted for about a week. I seen at Dr. he told me I was having a reaction to the vaccine.
29 2021-03-13 numbness Numbness in left hand, first dosage never had any numbness. 2nd dosage on 3/14/21 @10:35 when my lef... Read more
Numbness in left hand, first dosage never had any numbness. 2nd dosage on 3/14/21 @10:35 when my left hand went numb. Had a few of the gentlemen ask if i had any swelling or any other symptoms. If did monitor for 30min to an hour and if any more symptoms popped up or worsen call 911 or go to prompt care or see primarycare doctor
29 2021-03-14 numbness, pain in extremity, tingling During the first fifteen minutes after receiving the vaccine, the right side of my face started ting... Read more
During the first fifteen minutes after receiving the vaccine, the right side of my face started tingling and became numb. The left side of my face was not affected and there was no respiratory involvement. In the following few hours, my right eye had transient pain and my cheek felt swollen. The next day, I had chills, arm soreness, mild headache at times, and while my facial symptoms were still present, they had improved. The second day I only had mild numbness and tingling on my face with some lip tingling. Day three, four, and five I had slight numbness of the right side of my face and tingling lips, no further symptoms. As of day 6, I have slight eye pressure around my right eye and mild lip tingling.
29 2021-03-14 muscle spasms, tingling Tingling starting in feet three days after vaccination, now w/ muscle spasm in back, feet and leg ti... Read more
Tingling starting in feet three days after vaccination, now w/ muscle spasm in back, feet and leg tingling and feeling of weakness in legs.
29 2021-03-15 unresponsive to stimuli, migraine, numbness Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on lef... Read more
Immediately following vaccination, started having itchy tongue, ears and mouth. Rash emerged on left chest and shoulder with muscle pain. Left arm became numb, rash at injections site, migraine, numb lips and mouth. Persisted and progressed to vomiting and diarrhea, tachycardia and tachypnea. On 1/14, petechiae around both eyes, widespread muscle and joint pain, tachycardia and tachypnea persist, unable to lift left arm, itchy face, nose and throat. 1/15 Tachycardia persists, migraine, diarrhea, sudden onset vaginal bleeding. 1/16 elevated blood pressure, tachycardia and tachypnea, found unresponsive in bed by my husband and taken to the emergency room.
29 2021-03-15 pain in extremity Sore arm for about 48 hours. 25 weeks pregnant with a due date of June 3, 2021. Have had in depth gr... Read more
Sore arm for about 48 hours. 25 weeks pregnant with a due date of June 3, 2021. Have had in depth growth ultrasounds since then and baby is still measuring right on track now at almost 29 weeks.
29 2021-03-15 weakness heart racing, throat feels like its closing, hard to breathe, generalized weakness. Evaluated by EM... Read more
heart racing, throat feels like its closing, hard to breathe, generalized weakness. Evaluated by EMS-Cleared
29 2021-03-16 pain in extremity " Heart rate went up and my lips, tongue and throat started swelling"" I took 3 Benadryl and had t... Read more
" Heart rate went up and my lips, tongue and throat started swelling"" I took 3 Benadryl and had taken Allegra that morning. It seemed to work and the swelling went down. Bad back pain, arm pain headache, general muscle aches, fatigue and my grip strength is very weak"
29 2021-03-16 muscle spasms Gradual increase in fever (started at 99 and went up to 101.8 within 36 hours) Severe leg cramps Chi... Read more
Gradual increase in fever (started at 99 and went up to 101.8 within 36 hours) Severe leg cramps Chills Fatigue but couldn?t sleep
29 2021-03-17 seizure Approximately 5 minutes after receiving first dose of Pfizer COVID vaccine, patient had syncopal epi... Read more
Approximately 5 minutes after receiving first dose of Pfizer COVID vaccine, patient had syncopal episode with brief seizure activity noted
29 2021-03-17 weakness Flu like symptoms. Nausea, chills, diarrhea, fatigue, weakness. Felt back to normal by next morning.
29 2021-03-17 numbness Onset within minutes: dizziness, confusion, and facial numbness in both cheeks, eyes, nose, jaw and ... Read more
Onset within minutes: dizziness, confusion, and facial numbness in both cheeks, eyes, nose, jaw and muscle stiffness in the face which lasted until the following day. Following morning, there was sharp pain at the injection site and I was unable to lift my arm at all. In the evening I can lift it half way. Still experiencing 32 hours later: headache and brain fog and dissociated feeling, fatigue, and body aches. Neck remains stiff. Never had any adverse or allergic reaction to anything before and didn't become fully aware that something wasn't right until after I left the facility yesterday.
29 2021-03-17 tingling c/o tinging to face. 25 mg oral benaryl given. Pt reported feeling better. 0920 co lips tingli... Read more
c/o tinging to face. 25 mg oral benaryl given. Pt reported feeling better. 0920 co lips tingling. 25 mg Benadryl given.
29 2021-03-18 feeling cold, pain in extremity 29 weeks pregnant. Intense shivering, coldness started around 2am, woke up at 5:30 with fever of 101... Read more
29 weeks pregnant. Intense shivering, coldness started around 2am, woke up at 5:30 with fever of 101.2 and threw up. Sore arm and headache also present. Baby?s movements are unchanged
29 2021-03-18 discomfort Fever of 101.3 across 24 hours, alternating chills and sweats, severe muscle and joint pain and disc... Read more
Fever of 101.3 across 24 hours, alternating chills and sweats, severe muscle and joint pain and discomfort, fatigue, nausea, loss of appetite.
29 2021-03-18 migraine Migraine; Nausea; joint pain/specifically in a joint that had a previous injury (not all joints).; T... Read more
Migraine; Nausea; joint pain/specifically in a joint that had a previous injury (not all joints).; This is a spontaneous report from a contactable consumer, the patient A 29-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 16Feb2021 at 13:15 (at the age of 29-years-old) as a single dose, for COVID-19 immunisation. Medical history included Osteoarthritis of the knee due to an injury, Known allergies to cats. No concomitant medications. Historical Vaccination includes BNT162B2 Dose 1, lot number=EL3247, administration date=26Jan2021 at 13:15 in the left arm for COVID 19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Feb2021 at 03:00, The patient experienced Migraine, nausea, and joint pain specifically in a joint that had a previous injury (not all joints). No treatment was given for the events. The clinical outcome of the events migraine, nausea and joint pain was recovering. :
29 2021-03-18 weakness Patient reported history of queasiness after injection. Patient fell weak, diaphoretic after injecti... Read more
Patient reported history of queasiness after injection. Patient fell weak, diaphoretic after injection. Patient was escorted to a chair when she fainted and became unconscious for approximately 1 minute, had an episode of incontinence. EMS service was ordered. Patient's BP was recorded by the EMS and was hypotensive. Patient refused to go to ER and was escorted to the car where her family member was waiting to take her home.
29 2021-03-18 tingling, numbness on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; ... Read more
on the legs, hands: nerve damage; Left side: sharp shooting pains,Constant pain; fatigue; numbness; tingling; bruising; rash; This is a spontaneous report from a contactable consumer (patient herself). A 29-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), via an unspecified route of administration in the left arm, on 01Feb2021 08:30, at a single dose, for covid-19 immunization. Medical history included kidney stones, BPD2 (bipolar II disorder), and anxiety; there were no known allergies. Concomitant medications included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; and imipramine taken for an unspecified indication, start and stop date were not reported. The patient had no Covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The vaccine was given at the hospital. The patient experienced left side: sharp shooting pains, constant pain; fatigue; numbness; tingling; bruising; rash and; on the legs, hands: nerve damage. All the adverse events happened on 02Feb2021 which resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had not recovered from all the adverse events at the time of the report despite having an unspecified medication and ongoing treatment received for them. The patient also had imaging and labs on Feb2021 for these adverse events with unknown results. The patient has not been Covid-tested post vaccination.
29 2021-03-19 feeling hot My face and neck turned bright red and became very hot. I have pictures for the progress of the redn... Read more
My face and neck turned bright red and became very hot. I have pictures for the progress of the redness if needed too.
29 2021-03-19 tingling tingling all over body, high heart rate, waited 15 minutes, resolved.
29 2021-03-20 tingling, numbness, speech disorder Her hips and her knees everything was as stiff as a board and she could not bend her knee's; tinglin... Read more
Her hips and her knees everything was as stiff as a board and she could not bend her knee's; tingling; blood pressure was 169/101; speech was real slurred; numb in her arm and hand; she could not pick up or hold anything; This is a spontaneous report from a contactable consumer (patient herself).A 29-years-old non- female patient received receibed second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 28Jan2021 as intramuscular, administered in Arm Right on 07Jan2021 as SINGLE DOSE for covid-19 immunisation.The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced numb in her arm and hand (hypaesthesia) on 28Jan2021 10:00 and she could not pick up or hold anything on 28Jan2021 and, speech was real slurred on 30Jan2021 and , her hips and her knees everything was as stiff as a board and she could not bend her knee's on an unspecified date and tingling (paraesthesia), blood pressure was 169/101 (blood pressure abnormal) on an unspecified date and The patient underwent lab tests and procedures which included blood pressure measurement: 169/101 on ,blood test: normal on 30Jan2021 ,computerised tomogram: no stroke on 30Jan2021 ,urine analysis: normal on 30Jan2021.The events were considered as non-serious by the consumer The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
29 2021-03-20 tingling Lip and facial tingling, R ear pain started right after vaccination was given. Benign exam, unremark... Read more
Lip and facial tingling, R ear pain started right after vaccination was given. Benign exam, unremarkable vitals. Sensation intact. Suspected anxiety, pt observed in car for 30 minutes, drank Pedialyte, discharged home
29 2021-03-20 muscle twitching Muscle twitching randomly in shoulder or leg started the day after receiving the vaccine.
29 2021-03-20 migraine On the first day, a little over 12 hours after the first vaccine, I felt light headed and was nauseo... Read more
On the first day, a little over 12 hours after the first vaccine, I felt light headed and was nauseous. By noon of that day I had a persistent migraine like headache that remained the entire day and into the next (3/21/2021). On the 3/21/2021 I also experienced dull chest pain and a feeling of tightness throughout the entire day
29 2021-03-20 difficulty speaking sore throat, sensation of throat closing, hoarse voice
29 2021-03-21 muscle spasms Extreme body soreness/cramping nausea extreme chills mild fever loss of appetite tiredness
29 2021-03-21 feeling jittery Sunday 3/21 (2 days after vaccine): itchy rash on entire neck, shoulder, ears and left abdomen - too... Read more
Sunday 3/21 (2 days after vaccine): itchy rash on entire neck, shoulder, ears and left abdomen - took Claritin and used hydro cortisol cream and the rash subsided. Monday 3/22: mid way through work shift, felt extremely dizzy, jittery and light headed. Difficult to stand and walk on my own and rash started to come back. Went to care.
29 2021-03-22 flushing About 30 minutes after my face got flush. It stayed flush, but no temperature on work gun 97.2. Woke... Read more
About 30 minutes after my face got flush. It stayed flush, but no temperature on work gun 97.2. Woke up with fever 100.5, joint pain, headache, and little pain in the right side of my neck.
29 2021-03-22 tingling about 1 hour after the vaccine, I noticed my right ear felt full and dry mouth. after 1hr and 45 mi... Read more
about 1 hour after the vaccine, I noticed my right ear felt full and dry mouth. after 1hr and 45 minute the right side of my mouth felt tight and tingly (kind of like after you get a numbed at the dentist but your not completely numb) my right thumb felt the same way, and as the night went on the tight, tingly, numb feeling grew across the right side of my face from my lips to my ear. the next morning it was still there, and as the day progressed that feeling grew up to my eye. that is when I was seen by a doctor , who confirmed that what I was experiencing was not a muscle reaction, but a nerve reaction. I can still move my lips and eyes, but it just feels very weird and tight, and almost like I have to work hard to make them move.
29 2021-03-23 migraine Early period, migraines. Know three others who got their second period of the month from their vacci... Read more
Early period, migraines. Know three others who got their second period of the month from their vaccines.
29 2021-03-23 numbness ONSET 3/16/2021 FEELING TINGLING ON HER TONGUE; 3/17/021 NOTED RIGHT SIDE FACIAL NUMBNESS WHEN PATIE... Read more
ONSET 3/16/2021 FEELING TINGLING ON HER TONGUE; 3/17/021 NOTED RIGHT SIDE FACIAL NUMBNESS WHEN PATIENT WOKE UP.
29 2021-03-23 feeling hot Patient reported to check-out table approximately 13 minutes after receipt of vaccine complaining of... Read more
Patient reported to check-out table approximately 13 minutes after receipt of vaccine complaining of feeling "hot and dizzy". I was called to patient's side to evaluate. A pulse ox was placed and gave a reading of SPO2 100% and HR 80. Quick history was taken and patient was moved outside due to cooler temperatures. Patient was able to ambulate under her own power and did not appear ill or have any signs of respiratory distress or AMS. She did note a sensation of tingling/numbness in her lips after sitting down outside There were no signs of labial edema or edema of the airway. Patient was given cold water and 25mg po Benadryl with improvement in symptoms 25 minutes later. After her extended observation period patient was released from the vaccine site with strict follow up precautions.
29 2021-03-23 seizure, weakness Vasovagal Response Confusion, Disorientation, Dizziness, Loss of consciousness, Seizure, Weakness N... Read more
Vasovagal Response Confusion, Disorientation, Dizziness, Loss of consciousness, Seizure, Weakness Nausea
29 2021-03-23 weakness Vasovagal response, Lightheadedness, Loss of consciousness, Weakness
29 2021-03-24 numbness Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower ex... Read more
Feeling of weakness in L upper/lower extremity; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; numbness/blunted sensation in L whole upper lower extremity, L face, L tongue; This is a spontaneous report from a contactable physician (patient herself). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left deltoid, on 11Jan2021 09:55, at a single dose, for covid-19 immunization. The patient's medical history was not reported. The patient's father got thyroid storm from influenza vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), intramuscularly on the left deltoid on 20Dec2020 18:00 for covid-19 immunization at the age of 29-years-old and experienced L face; tongue, L upper; lower, extremity numbness. The vaccine was received at the hospital. The patient experienced numbness/blunted sensation in L whole upper lower extremity, L face, L tongue on 11Jan2021. As treatment, the patient received acetaminophen 650mg po on 11Jan2021. The patient then experienced feeling of weakness in L upper/lower extremity on 22Jan2021. All the adverse events resulted in a visit to an emergency room. The patient was admitted to the hospital due to all adverse events for 2 days, from 02Mar2021 to 04Mar2021. The patient underwent lab tests and procedures on 24Jan2021 which included the following: MRI brain w/wo con with results of negative, MRI spine w/wo con with results of negative, CT head wo con with results of negative, and CXR with results of negative. The patient underwent lab tests and procedures on 02Mar2021 which included the following: MRI head with results of negative, CBC with results of negative, MRI neck with results of negative, MRI brain w/wo con. with results of negative, CMP with results of negative, UDS with results of negative, U/A with results of negative, and B12 with results of negative. The patient underwent lab tests and procedures on 03Mar2021 which included the following: CSF with results of negative, TSH with results of negative, and PT/INR with results of negative. The patient underwent MRI spine w/wo con on 04Mar2021 with results of negative. The outcome of the events was unknown.; Sender's Comments: Causality cannot be excluded for the reported serious events and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-03-24 tenderness, tingling In the week following my vaccination, I presented no symptoms. After day 7, I developed soreness/ten... Read more
In the week following my vaccination, I presented no symptoms. After day 7, I developed soreness/tenderness in my left armpit and a series of neurological symptoms that are very concerning including depression, anxiety, insomnia (accompanied with heart racing, sweating, tingling in extremities, obsessive thoughts etc). Although, I have had sleep issues during the course of the pandemic, I do not deal with daily anxiety. I very rarely have to turn to any medication and especially have not had any anxiety symptoms or sleep issues recently. I do not believe the CDC has commented on the connection between vaccine safety and any relationship between vaccine immune response and neuropsychiatric disorders. Or how antibodies produced via vaccine react to other proteins. My daily activities have been significantly impacted over the course of this week. I would appreciate learning if there is possible cross-reactivity and if that has presented in other adults.
29 2021-03-24 migraine fever 99.9/ fever 100.6; chills; sweats; muscle aches; joint aches; fatigue; confusion; migraine; se... Read more
fever 99.9/ fever 100.6; chills; sweats; muscle aches; joint aches; fatigue; confusion; migraine; severe nausea; This is a spontaneous report from a non-contactable consumer (patient). This 29-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration on 15Feb2021 at 13:00 (at the age of 29-years old) as a single dose in the left arm for COVID-19 immunization. Medical history included asthma. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccine. Concomitant medications included birth control; caffeine, paracetamol (EXCEDRIN), and ibuprofen from unknown dates for unknown indications. The patient previously received acetaminophen in doses over 500 mg and experienced allergy. On 16Feb2021 at 02:00, 13 hours after the vaccine, the patient experienced fever of 99.9, chills, and sweats. Sixteen to twenty-eight hours after the vaccine the patient experienced fever of 100.6, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of fevers of 99.9 and 100.6, chills, sweats, muscle aches, joint aches, fatigue, confusion, migraine, and severe nausea were recovered. It was also reported that since the vaccine, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
29 2021-03-25 involuntary muscle movements Chest pains, high heart rate, jerkiness, restless, muscle / body aches
29 2021-03-25 pain in extremity Fever, intense body aches, headache, sweats, extreme arm pain, swollen lymph nodes on neck.
29 2021-03-25 tingling Immediately after receiving her vaccination, she developed lightheadedness, nausea, and felt like sh... Read more
Immediately after receiving her vaccination, she developed lightheadedness, nausea, and felt like she was having a recurrence of a panic attack. She does have a history of aversion to needles. She was taken to a private section and monitored. Her vital signs are within normal limits. She also developed tingling in bilateral hands. She was monitored and her symptoms resolved.
29 2021-03-26 seizure AFTER 15 MINUTE OBSERVATION, PT WAS UNABLE TO WALK MORE THAN 10-15 FT BEFORE NEEDING TO SIT BACK DOW... Read more
AFTER 15 MINUTE OBSERVATION, PT WAS UNABLE TO WALK MORE THAN 10-15 FT BEFORE NEEDING TO SIT BACK DOWN AT WHICH TIME SHE SLOWLY SLID OFF THE CJAIR AND ONTO THE FLOOR (GUIDED BY HER FRIEND WHO ACCOMAPANIED HER). SHE REMAINED LYING ON THE FLOOR UNTIL MEDICAL PERSONNEL ARRIVED. SHE APPREARED TO HAVE PASSED OUT, HAD VERY BRIEF CONVULSIONS/TREMORS BEFORE COMING TO, AT WHICH TIME SHE WAS ABLE TO REPSOND TO QUESTIONS AND ANSWER THEM. HER PULSE RATE SEEMED WITHIN NORMAL WITH SLIGHTLY ELEVATED RESPIRATORY RATE. MEDICAL PERSONNEL ASSISTED HER FROM THE FLOOR TO THE GURNEY. SHE WAS TAKEN TO THE AMBULANCE IN THE PARKING LOT FOR FURTHER EVALUATION. NO UPDATE ON HER STATUS WAS GIVEN TO US.
29 2021-03-26 feeling hot, cold sweat About 3-4 hours after the vaccine (3/25/2021 at 4:20pm) at approximately 8pm, I began to become exh... Read more
About 3-4 hours after the vaccine (3/25/2021 at 4:20pm) at approximately 8pm, I began to become exhausted and had a mild headache of a 1/10 pain. I thought the symptoms could be because I had worked almost a full work day. The next morning of 3/26/2021 at 6:30am, I woke up with injection-site pain (3-4/10 pain) and a worse, but still mild, headache (3-4/10 pain). As the day progressed, I began to feel warm and clammy but had no fever. I took acetaminophen at approximately 7:00pm on 3/26/2021. By the time I woke up on 3/27/2021 at 9am, I felt symptom-free.
29 2021-03-27 tremor Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extre... Read more
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: itching of neck-Mild, Systemic: Shakiness-Mild
29 2021-03-28 pain in extremity, weakness tunnel vision; Nausea; dizziness; feeling weak; headache; metallic taste in mouth; left arm/leg pain... Read more
tunnel vision; Nausea; dizziness; feeling weak; headache; metallic taste in mouth; left arm/leg pain; left arm/leg pain; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 11Mar2021 11:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included premenstrual dysphoric disorder (Pmdd), major depression (mdd), anxiety, high cholesterol and allergies: Penicillin, all from an unknown date and unknown if ongoing. No COVID prior vaccination and not COVID tested post vaccination. The patient is vaccinated at a clinic. No other vaccine in four weeks. Other medications reported was yes, however unspecified. It was reported that the patient experienced Nausea, dizziness, tunnel vision, feeling weak, headache, metallic taste in mouth, left arm/leg pain all on 12Mar2021. The outcome of the events was not recovered. No treatment for the events. Information on the lot/ batch number has been requested.
29 2021-04-01 tenderness ?COVID arm? - goose egg appeared; painful to touch and itchy
29 2021-04-01 pain in extremity Swollen bump, fatigue, sore arm
29 2021-04-01 weakness, tremor, numbness Weakness; shaking; numbness of tongue and face mostly right side; numbness of tongue and face mostly... Read more
Weakness; shaking; numbness of tongue and face mostly right side; numbness of tongue and face mostly right side; This is a spontaneous report from a contactable consumer, the patient. This 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 via an unspecified route of administration in the left arm (at the age of 29 years-old) on 20Mar2021 at 01:30 PM for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 20Mar2021 at 02:00 PM, the patient experienced weakness, shaking and numbness of tongue and face mostly right side and was hospitalized for the events. Treatment was received for weakness, shaking and numbness of tongue and face mostly right side. The clinical outcome of weakness, shaking and numbness of tongue and face mostly right side was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Field Name: NO days hospitalization Field Value: 1 Field Name: Hospital name Field Value: Name Field Name: Hospital city Field Value: Name Field Name: Hospital state Field Value: Name Field Name: if patient recovered Field Value: Recovering Field Name: if treatment ae Field Value: Yes Field Name: Ae treatment Field Value: Tylenol and fluids with Benadryl Field Name: if covid prior vaccination Field Value: No Field Name: If covid tested post vaccination Field Value: No Field Name Known allergies Field Value: No Field Name Other medical history Field Value: No Information about lot and batch number was requested.
29 2021-04-09 hot flush, flushing, night sweats Approximately one week after injection I began to experience intense hot flashes. Hot flashes includ... Read more
Approximately one week after injection I began to experience intense hot flashes. Hot flashes include tachycardia, excessive perspiration, reddening of skin, intense warmth of skin and were followed by chills and my color flushing. Also experiencing night sweats that results in insomnia. This has caused a general interruption to my daily life. The hot flashes continued to get more intense over the past several weeks. I have not had my menstrual cycle since my second injection.
29 2021-04-11 feeling hot syncope and collapse (most likely vasovagal); hypoglycemia; got hot; This is a spontaneous report fr... Read more
syncope and collapse (most likely vasovagal); hypoglycemia; got hot; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 27Mar2021 10:15 (at the age of 29 years) as single dose for covid-19 immunization. The vaccination facility was Pharmacy/drug store. The patient has no medical history and no known allergies. The patient was not pregnant. No vaccines were given 4 weeks prior. No prior issues with vaccines, no health issues, had cereal and juice two hours before vaccine and was not hungry. The patient has no COVID-19 prior to vaccination. The patient was not tested post vaccination. Concomitant medications included ethinylestradiol, norgestimate (SPRINTEC). Historical vaccine includes dose 1 of bnt162b2, on 25Feb2021 (05:15 PM) at the left arm for COVID-19 immunization at the age of 29 years. On 27Mar2021 at 1030 AM, 10 minutes (as reported) after receiving vaccine and during wait period, got hot and passed out. Ambulance was called and transported to hospital. CMP, serum pregnancy test, troponin (ekg), urinalysis with reflex culture, CBC/auto differential, Glucose WH-BLD lab tests performed on 27Mar2021. Monitored pulse and oxygen on 27Mar2021. Diagnosis-syncope and collapse (most likely vasovagal) and hypoglycemia (unspecified). The events resulted in Emergency room/department or urgent care visit and did not receive treatment. The outcome of the events was unknown. Information on about lot/batch number has been requested.
29 2021-04-12 tingling Guillian-Barre Syndrome/Acute inflammatory demyelinating polyradiculoneuropathy - ascending paralysi... Read more
Guillian-Barre Syndrome/Acute inflammatory demyelinating polyradiculoneuropathy - ascending paralysis and paresthesias along with autonomic symptoms. Refractory to IVIG. Patient was sent home after course but then continued to worsen and couldn't ambulate . She was readmitted and started on plasmapheresis and pulsed steroids. Respiratory function has been relatively spared, but she has not clearly yet obtained her nadir.
29 2021-04-13 pain in extremity 4 days after vaccination woke up with severe foot Pain. 7 days later found out this was a superficia... Read more
4 days after vaccination woke up with severe foot Pain. 7 days later found out this was a superficial thrombophlebitis with a gastroc DVT and 4 right subsegmental pulmonary embolisms
29 2021-04-16 feeling cold, muscle spasms, tingling, numbness, burning sensation, muscle twitching, sensory loss, cold extremities, hypersensitivity of all senses, weakness, nerve pain Everything started on January 24th at about 7pm exactly 20 days post first Pfizer vaccine. No other ... Read more
Everything started on January 24th at about 7pm exactly 20 days post first Pfizer vaccine. No other changes or vaccines given since October (flu vaccine) was scheduled for 1/25/21 for second Pfizer dose. It all started when I was working at ER when I started to feel cold like it was in an ice bath and numbness in both feet. I went to discharge my patients when I realized ascending numbness and coldness from the feet was traveling upward. Within 5 hours (around midnight) I went to hospital due to having severe weakness to where I couldn?t walk and loss of bladder control. I was rushed to MRI of brain, cervical, thoracic, and lumbar. I also had blood work done and a lumbar puncture. I was admitted for a couple days to watching the ascending weakness and loss of feeling. My MRIs came back clear from any diseases such as transverse myelitis, MS, etc. My LP showed mild elevated protein at 54 (normal range 15-45), one tube elevated lymphocytes 100% (range 40-80%) and one tube elevated monocytes 50% (range 15-45%). Also CK-MB w/reflex was 352 (range 26-140). I was discharged on 2/26 at 5:30pm with a diagnosis of bilateral leg weakness and numbness. From this point on I was wheelchair bound at home and being cared for 24/7. After discharge some additional random symptoms started such as chills with no fever to where I slept in sweat pants and sweat shirts, leg spasms/ twitches, leg heaviness, severe lower back and hip pain, a loss of sensation while going pee or poo but not incontinent, and things like drop foot with the severe weakness and numbness . On 2/3/22 I started with double vision, blurry vision and pain behind my right eye. I went to ER and had repeat MRIs of brain, cervical, thoracic and lumbar with and without contrast and basic blood work and was sent home to follow up with Dr. on 2/9 and was discharged home. By 2/8 my strength started to get worse to where I couldn?t lift my kids. Finally saw Dr. neurology and MS specialist 2/9, he ran detailed neuro exams from head to toe, looked at both scans from both hospitals, all the blood work and LP results. He reported that I had severe hyper reflexes in both legs and Hoffman?s sign in both hands. My feet were completely numb and cold to where I couldn?t feel them or walk. Literally felt like everyday I was standing in a ice cold bath with no feeling of touch hot or cold sensation or pin pricks. He realized my loss of sensation was from my bra line down and included tingling in my hands and weakness in my arms. I was able to get up for the first time with a walker and take a few steps with assistance at this time. He then sent me to ER to be admitted and see their neuromuscular team to get further treatment. Upon arrival via wheelchair I was brought back to see the ER Doctor and re-did a neuro exam, some blood work and contacted the neurology team to come see me. I was then admitted to the hospital step down ICU under Dr with strict monitoring. On 2/10/21 The neuro team ordered another set of MRI of brain, cervical and thoracic with and without contrast due to a change in condition again since my last visit to hospital. They reviewed and compared studies with no changes. They scheduled me for MRI lumbar on 2/11/21 with and without contrast which came back no changes from previous MRI as well as another LP which everything that was off before was now normal. Everyday I would work with PT, OT and speech. I had no changes in speech and slowly got some strength back, and was able walk using a walker. I was then discharged home on 2/13 mid afternoon and was told I would do home health and follow up with their neurologist and Neuromusclar team once everything was resulted back. On 2/19/21 I saw my primary doctors office (nurse practitioner) where she checked up on the status of me, took me officially off work and on state disability, filled out paperwork for work and a handicapped pass. On 2/25/21 followed up with neurology, and discussed all my imaging and blood work. All CSF fluid came back normal, all labs were fine and wanted me to get an EMG to look for nerve damage. She also wanted a follow up with cardiology as my resting heart rate was 110-120 and would spike to 160s. On 3/1/21 Home health was started for physical therapy for strengthening and working on sensation for both legs. At this point I had almost full strength in my arms, still tingling in my hands and constant numbness and cold feeling in both feet and knees with severe sensitivity to cold, wind or touch on my legs. I had Home health twice a week every week for 2-3 weeks then started outpatient physical therapy which has been twice a week for 1.5 hours. On 3/5 I saw cardiology and was placed on a holt monitor for 48 hour monitoring. On 3/9 I had my EMG with Dr. and had a follow up with Dr. for 35 tubes of blood he had drawn for multiple diseases which both blood work and EMG came back negative. On 3/16 symptoms started to change from numbness to severe hypersensitivity to touch, severe shooting nerve pains, burning sensations, non stop tingling in hands, issues with temperatures either hot or cold, and swelling of both legs. On 3/17 I saw rheumatology that looked into everything said it was not lupus related as none of my inflammatory markers or lupus DNA strands were elevated and no lupus symptoms like rashes, ulcers in the mouth or tongue, hair loss or joint pain. He ordered more blood work and confirmed it was not a lupus flare up. He suggested doing a small nerve fiber biopsies. On 3/19/21 saw spinal orthopedics who reassured it has nothing to do with my spine, prescribed gabapentin for all the nerve pain and told me that neurology is who should be following me. On 3/26 I had an echocardiogram done due to the leg swelling and heart rates which came back negative for any heart problems and was told since the tachycardia is getting better to just continue watching it and was prescribed trazodone 25mg to help with sleep due to severe nerve pains, spasms and severe back and hip pains at night. On 4/1/21 was followed up again with neurology. Ordered small nerve fiber biopsy for may 18th, increased the gabapentin to 300 mg- 3 times a day and had me wean off cymbalta. I am still dealing with tingling, burning hot and cold sensitivities in both legs, still tingling in hands all day but strength is back to full. I am scheduled to hopefully return to work 5/30/2021 after being off since 1/24/2021.
29 2021-04-17 bell's palsy Bells palsy; This is a spontaneous report from a contactable Other Healthcare Professional (patient)... Read more
Bells palsy; This is a spontaneous report from a contactable Other Healthcare Professional (patient) reported for herself. A 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 at single dose for covid-19 immunization. Medical history included allergies to sulfa, covid-19, prior to vaccination, the patient was diagnosed with COVID-19 (test positive). The patient's concomitant medications were none, the patient didn't receive any other medications within 2 weeks of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 on 25Jan2021 15:30 at 28 years old for covid-19 immunization. The patient experienced bells palsy on 13Mar2021. Therapeutic measures were taken as a result of bells palsy included steriods. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered. Follow-up attempts are completed. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's Palsy cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
29 2021-04-17 weakness, seizure, muscle spasms passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; i... Read more
passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; in and out of consciousness/passed out; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; sweating profusely; couldn't support her own body without tipping over.; seizure; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; chills; extreme muscle pain; spasms; This is a spontaneous report from a non-contactable consumer (patient herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 13:15 (Batch/Lot Number: ER8737) as single dose, for COVID-19 immunisation. Medical history was reported as no. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccines within 4 weeks prior to COVID-19 vaccine. Patient's concomitant medication includes omeprazole, ethinylestradiol, levonorgestrel (MARLISSA), venlafaxine and gabapentin from unspecified dates, received within 2 weeks of vaccination, for unspecified indication. Patient historically took first dose of Pfizer BNT162B2 (Lot number: EN6204) on 13Mar2021 at 11:00 AM on the left arm for COVID-19 immunisation. Patient previously took hydrocodone bitartrate, paracetamol (VICODIN) on an unspecified date and indication and had allergy. On 02Apr2021, around 10pm, patient began having chills and extreme muscle pain and spasms, and the lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain. By midnight (03Apr2021 00:00), patient had a fever and was unable to stand unassisted. She was writhing in pain and arching uncontrollably off the bed. She believed in hindsight that this was a seizure as she went in and out of consciousness and her tongue swelled up, making it hard to breathe and impossible to speak. She was sweating profusely, and had to drink water constantly. Her husband had to help her get to the bathroom because she couldn't support her own body without tipping over. The chills and fever alternated all night, and she finally passed out from exhaustion at 03Apr2021 at 7am. The next 2 days, she was in a cycle of fever and chills again, and the fever got so bad that she seized twice more on Saturday (03Apr2021). She had to take the day off work on Monday (05Apr2021) as she was still in so much pain that she could barely leave bed except to use the bathroom. Events were reported as life-threatening, immediate risk of death from the events. Patient was not hospitalized. Treatment for the adverse events were cool baths, naproxen (ALEVE) for fever and pain, and PEDIALYTE. COVID-19 was not tested post vaccination. Vaccination facility type was at a hospital. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
29 2021-04-20 weakness Fever 102.3 F, nausea, chills, sweats, headache, fatigue, joint pain and body weakness
29 2021-04-22 numbness Jaw pain and numbness on left side under ear Body aches Chills
29 2021-04-24 pain in extremity Nausea; Pain in legs, back and arms; Pain in legs, back and arms; Headache; Low blood pressure; preg... Read more
Nausea; Pain in legs, back and arms; Pain in legs, back and arms; Headache; Low blood pressure; pregnant at the time of vaccination; This is a spontaneous report received from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 at 14:30 at single dose for COVID-19 immunization. The relevant medical history was reported as none. Concomitant medications were not reported. The patient experienced nausea, pain in legs, back and arms, headache, low blood pressure on an unspecified date. The patient was pregnant at the time of vaccination. The patient last menstrual period was 15Nov2020. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
29 2021-04-26 tingling This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt... Read more
This is a spontaneous report from a contactable physician. A 29-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history was not reported. The reporter is not related to a study or program. Concomitant medications included unspecified medication (She does take other medications but does not know the significance). On 30Mar2021, the physician stated that, the patient developed immediate right-side neck pressure, skin and jaw tingling, and swollen lymph nodes. She did not have any trouble breathing and did not have any hives. These events were considered as medically significant. The pharmacist gave her 2 Benadryl and she stayed there for an hour. She said she does not think the Benadryl did anything for her. The physician stated that the patient went home and slept off the immediate reaction she experienced and had fatigue for 3 days. The patient had fatigue for 3 days and no other problems. The physician inquired on advisable information for the second dose. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported serious events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
29 2021-04-27 numbness, tingling Extreme numbness in hands that is worsening over time. Causes extreme pins/needles, aching and inabi... Read more
Extreme numbness in hands that is worsening over time. Causes extreme pins/needles, aching and inability to hold basic objects like a cell phone. Attempting to see a doctor for this immediately. Originally had this in December -- presumably with COVID that never got diagnosed. Worsened after 1st shot, worsened dramatically after 2nd shot.
29 2021-05-03 numbness, pain in extremity Hurts to move her arm; Felt like she had the flu; Congestion; Headache; Tiredness; lymph nodes in he... Read more
Hurts to move her arm; Felt like she had the flu; Congestion; Headache; Tiredness; lymph nodes in her underarm area are swollen, really achy; lymph nodes in her underarm area are swollen, really achy; Chest pain; Numbness in her face; Completely lost her vision; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 (Batch/Lot Number: ER8729) as single dose for COVID-19 immunization. There were no medical history or concomitant medications. The patient experienced completely lost her vision on 12Apr2021 with outcome of recovered on 12Apr2021, congestion on 16Apr2021 with outcome of not recovered, chest pain on 12Apr2021 with outcome of recovered on 12Apr2021, numbness in her face on 12Apr2021 with outcome of recovered on 12Apr2021, felt like she had the flu on 17Apr2021 with outcome of recovering, lymph nodes in her underarm area are swollen, really achy on 13Apr2021 with outcome of not recovered, headache on 15Apr2021 with outcome of not recovered, tiredness on 13Apr2021 with outcome of not recovered, hurts to move her arm on an unspecified date with outcome of not recovered. lymph nodes in her underarm area are swollen, really achy was reported as worsened. Clinical course: the patient was asking for advice because she had the first dose of the Covid Vaccine 1 week ago and had a really bad reaction and had to go to the hospital. It has been a week now and the symptoms are continuously getting worse. It sounds like the side effects were all expected. She felt like she had the flu yesterday. She is really achy, her lymph nodes in her underarm area are really swollen, and it hurts to move her arm. She is familiar that these symptoms are expected, but it has been a week. She wants to know if she should see a physician or if there is something she should do. Event details: The flu like feeling was not until 6 days after she got the first shot. It is not as bad but she does have aches and congestion. Her lymph nodes are really swollen and she has a headache and tiredness. She had symptoms before, that was just the start of the flu like feeling. On the day of the shot she went to the hospital because she completely lost her vision and had chest pain. She got the shot on Monday, 12Apr2021. She had numbness in her face, vision loss, and chest pain. From there she went to the hospital and that subsided. It was just like total exhaustion and body aches for the next couple of days. She lost her vision for 5 minutes total. The numbness to her face was right after the shot and is all gone now. The achiness is pretty bad now. It differs per day but her symptoms have probably gotten a little worse as time has gone on. She had slight pain in her lymph nodes and they weren't really swollen. It got progressively worse to now they are very swollen and it hurts to move her arm. It was the same arm where the shot was given. The headache is off and on. It started around Thursday 15Apr2021. It is sporadic when she gets it. It hasn't gone away. The tiredness has been the same since she got the shot. When she went to the hospital she went to the ER. She was not admitted. She spent 4 to 5 hours there. Treatment: In the ER she just had an IV (intravenous). Other than that they did a bunch of lab work. She had no medicine or anything. Investigations: They did a chest X-ray and lab work in the ER. Emergency Room Visit required for events completely lost her vision, chest pain, numbness in her face, felt like she had the flu.
29 2021-05-04 seizure, unresponsive to stimuli Pale/unresponsive approx. 1 min after receiving vaccine. Appeared to have a seizure. After about 5... Read more
Pale/unresponsive approx. 1 min after receiving vaccine. Appeared to have a seizure. After about 5-7 min appeared to improve. Reported after event that she had hx of "vasvagals". Transported to local hospital for further assessment.
29 2021-05-05 weakness, flushing Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild, Additional Details: approx 10 minutes after the vaccine pt felt light headed then fainted. she was unresponsive at first then she woke up. i gave the patient orange juice and used checked her bp. her blood pressure came back 115/75 i asked if the pt has taking any meds and pt said no. when pt fainted she fell on the floor scractching her forehead and upper lip. no other problems
29 2021-05-13 numbness, tingling, migraine 12 hours post vaccination blacked out. Post regaining consciousness both hands and arms became numb;... Read more
12 hours post vaccination blacked out. Post regaining consciousness both hands and arms became numb; Mild migrane; Forehead felt numb for 3 d/Post regaining consciousness both hands and arms became numb; slight tingling in fingers; This is a spontaneous report from a non-contactable other hcp (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Apr2021 19:00 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient felt okay after vaccine. 12 hours post vaccination (24Apr2021 08:00) blacked out. Post regaining consciousness both hands and arms became numb. Felt slight tingling in fingers. Mild migrane. Forehead felt numb for 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no known allergies and other medical history. The outcome of the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported event of Loss of consciousness and BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
30 2020-12-31 numbness, facial paralysis, face paralysis, tingling, cold extremities 12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermitten... Read more
12/28/2020-1230 began feeling numbness/tingling left foot, left hand, left cheek (face), intermittent 1500- chest tightness, palpitations lasting 20-30 minutes 1900- feet b/l ice cold, muscle aches, chills, lasting 8 hrs 12/29/2020- upon awakening-fatigue, SOB 6 hrs, intermittent paresthesia persist left foot, left cheek, new onset teeth pain (lasts less than 1 minute) left sided headache (1-5 min) left sided back pain at SI joint 12/30- tingling sensation persist, fatigue is gone. Chills- 1-3 min duartion, intermittent. left ear pain, left headache, "pings " of left cheek, tingling back pain persists (left) 12/31/2020 noted mild left facial weakness-, left eye brow rise, unilateral wrinkle forehead, smile reduced left sided tingling persists with intermittent headache, ear pain, teeth pain sought care of PCP tx of early onset bells palsy with steroid taper + PPI Began prednisone 40 mg PO 1/1/2021 left sided back pain persists
30 2021-01-01 numbness, tingling Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain... Read more
Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital. Since then, I lost feeling in my hands and feet, numbness and tingling. I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.
30 2021-01-02 pain in extremity Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throug... Read more
Arm became very sore about 10 hours after the vaccine. Around 12 hours later became very sore throughout entire body, had very bad chills, and was unable to sleep. By 9 am I was finally able to sleep one hour and awoke sweating, but chills had subsided. Body aches did not subside until Wednesday morning (vaccine was administered Monday).
30 2021-01-03 tenderness For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after... Read more
For 2 days after the vaccinations, my left deltoid/ upper arm was sore. Approximately 7-8 days after my vaccination, my left armpit started feeling sore. This has continued to today where I have left armpit swelling and what feels to be a swollen, hardened lymph node in my armpit. It feels like a hardened lump that is not fixed and is tender when I palpate it. On visual inspection, I can tell that my left armpit is more swollen than my right armpit (which is normal). It hurts to have my arm at my side and it hurts to lay on my left side at night when I am sleeping.
30 2021-01-03 pain in extremity I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion... Read more
I had a sore arm the first couple of days, on the 22nd I had chills sore throat headache congestion sneezing sniffling and low grade fever 99.6. on the 23rd loose stools nasal drainage, I called the hospital hotline and I had to be off for ten days and went to Urgent care and took a rapid test and the test was positive. I have been quarantined for 14 days . The 25th was probably the worst day the 26th was a little better. the 27th symptoms were more mild and I also had diarrhea The 28th I woke up with a headache and light sniffles and the 27th I had no symptoms
30 2021-01-03 flushing, tremor Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red ... Read more
Patient began to experience symptoms shortly after vaccination. Pt became flushed and developed red splotches over chest and neck. C/o difficulty swallowing and some GI upset. Began to shake uncontrollably. Initial BP was 149/99 and HR 118. O2 sats at 99%. Administered 25mg of benadryl and monitored patient for approximately 1 hour. After about 30-45 minute, her vitals stabilized at 120/80, Pulse 90, O2 at 100% on room air. D/C'd home at 1:32pm. 24 hours later patient c/o of hives and flushing off and on. Also complained of some GI upset and fatigue. Pt was able to return to work on 1/3/2021.
30 2021-01-03 hot flush Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine u... Read more
Pfizer-BioNTech COVID-19 Vaccine: On the day I received the first does of the vaccine, I felt fine until about 6 hours later. At that point, I started to get very dizzy and lightheaded. Every time I opened my eyes, everything was spinning. This lasted four about 3-4 hours. I kept breaking out into sweats. I had a horrible headache for about 4 days straight. I am still continuing to having headaches. I am still having hot flashes and dizziness episodes at times that go away after about a few minutes. Two days ago, I stated to developing swelling in my hands with achy joints which has not gone away.
30 2021-01-04 pain in extremity 12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For t... Read more
12 hours after injection I began to have chills and rigors, the rigors subsided after ~30 min. For the next 11 hours i had chills, severe body aches, a headache and spiked a fever to 101. The following day after ~12 hrs of symptoms I began to improve slightly and all that remained was a severe headache and body aches. Now, I am about 32 hours in to the adverse event and I still have a headache and sore arm/shoulders but other symptoms have resolved.
30 2021-01-04 pain in extremity Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; Th... Read more
Body aches; low grade fever; chills, shivering; headache; nausea; stiff/sore arm; stiff/sore arm; This is a spontaneous report from a contactable Other Health Professional for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685) dose number 1, intramuscularly on 26Dec2020 15:30 at single dose on arm Left for COVID-19 immunization. Medical history included irritable bowel syndrome, chicken allergy and COVID-19. Concomitant medications received within 2 weeks of vaccination included clonazepam, spironolactone and melatonin, all from unknown date for unknown indication. Onset of symptoms began roughly 9hrs post vaccine. Lasted roughly 24 hours (28Dec2020). Body aches, low grade fever, chills, shivering, headache, nausea, stiff/sore arm. Adverse event start date: 27Dec2020 00:00. No treatment was received for the events. The action taken in response to the events for BNT162B2 was not applicable. Outcome of the events was resolved on 28Dec2020.
30 2021-01-04 pain in extremity Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed ch... Read more
Patient received vaccine on 12/17/2020 at approximately 12pm. At 10pm that day, patient developed chills and fatigue. At 6am on 12/18/2020, patient developed fever (temperature 100.2) and a very sore arm. Patient took acetaminophen (Tylenol) at 6:30am for the fever and pain. By 1pm on 12/18/2020, patient reports headache and dizziness. Patient took Rizatriptan (Maxalt) for the headache and dizzy, but it did not help. Patient took ibuprofen at approximately 4pm. Patient felt normal at 5:30pm on 12/18/2020. Took Tylenol at 6:30 for the sore arm. Took Maxalt for the headache/dizziness (sometimes migraines make me dizzy, maxalt didn?t help). Took ibuprofen around 3-4ish? And felt fine by 5:30.
30 2021-01-04 pain in extremity Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site... Read more
Still having pain in right arm a week after injection; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; Warmth/redness and hardness of injection site; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 19Dec2020 19:15 at single dose on right arm for COVID-19 immunization in hospital. Medical history was reported as none and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced still having pain in right arm a week after injection, warmth/redness and hardness of injection site from 19Dec2020 19:15. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. The information on the batch number has been requested.
30 2021-01-05 tingling 1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambul... Read more
1215-Noted pt sitting on the floor fanning herself after receiving her COVID vaccine. 1220-Pt ambulates to stretcher for further evaulation of clinic staff, FNP. Patient reported no previous adverse reaction to vaccines, but did note an anaphylactic nut allergy. Pt reported a milder version of the symptoms she is experiencing today after her initial vaccine Dec 17, 2020. Initial HR 64 SPO2 74% room air(employee wearing dark fingernail polish and reporting tingling in her hands) Pt instructed to breath slowly in through nose, out through mouth. 1225 BP 150/95 HR 85 SPO2 99% Pt given some water and crackers and reports eating NO food today other than a few cookies. Pt reports feeling better, color has now returned to pt. 1235- BP systolic 180s. pt advised to be seen in the ED for further evaluation. 1240 patient taken to ED by this RN; FNP; and second RN for further evaluation. 2L SPO2 put on pt en route based on previous low oxygenation. 1245- Pt arrived in ED, pt began reporting blurred vision; handoff to ED staff. Evaluated by ED staff, medicated with 1L NS bolus, 125mg IV Methylprednisone; 20mg IV Famotidine, 50mg IV Benadryl. 1640-employee reported to ED complete resolution of symptoms . Employee discharged from ED with prescription for an Epi-pen and prednisone.
30 2021-01-05 pain in extremity 15 weeks today, healthy pregnancy, due date is June 30th. I had a lot of arm soreness and fatigue. F... Read more
15 weeks today, healthy pregnancy, due date is June 30th. I had a lot of arm soreness and fatigue. Felt like I could not get up or do anything.
30 2021-01-05 tremor Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until... Read more
Burning sensation in throat, mild color change in neck and chest- beginning around 8am lasting until about 10am. Uncontrollable tremors, feeling like I need to constantly be moving and tachycardia- started around 830a started to diminish once I took a benadryl around 10a. Headache, fatigue and nausea beginning hours after vaccine, still present on 01/05. Sore arm at injection site and swollen axillary lymph node in same arm.
30 2021-01-05 pain in extremity I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itch... Read more
I took the vaccine on Sunday and Monday morning my arm was sore and in the afternoon my arm was itching but not at the injection site, lower. then my eye started itching a little later. I got scared and went to the UC and they told me to take Benadryl. It was just for a day after I took the Benadryl the next day all was back to normal.
30 2021-01-05 migraine Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fat... Read more
Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; Lightheaded ness immediately after vaccine About 24 hours later SEVERE diarrhea/urgency. Nausea. Fatigue. Fever 101. Migraine.; This is a spontaneous report from a contactable Nurse (the patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL0140, expiration date unknown) via an unspecified route of administration on 29Dec2020 at 12:30 PM (at the age of 30-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. The patient's medical history was not reported. No information was reported regarding allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient answered "yes" when asked to list any other medications she had received within two weeks of vaccination but did not list those medications. The patient stated that she experienced lightheadedness on 29Dec2020 "immediately after vaccine." About twenty-four hours later, on 30Dec2020 at 13:00 she experienced "SEVERE" diarrhea/urgency, nausea, fatigue, fever of 101 and migraine. The patient did not receive any treatment for the events. The clinical outcomes of lightheadedness, severe diarrhea/urgency, nausea, fatigue, fever of 101 and migraine were reported as recovering. The patient underwent lab tests and procedures which included body temperature: 101 on 30Dec2020. It was also reported that since the vaccination the patient had not been tested for COVID-19.
30 2021-01-06 pain in extremity Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm... Read more
Fever for 8 hours with max 101.7, Tylenol taken x2 doses Chills and body aches for 30 hours Sore arm for 60 hours
30 2021-01-06 pain in extremity Headache, arm pain, and chill
30 2021-01-06 migraine Left sided Migraine that lasted 3 days. I took BC powder, Excedrin, and my regular prescribed migrai... Read more
Left sided Migraine that lasted 3 days. I took BC powder, Excedrin, and my regular prescribed migraine meds. Nothing helped, it was relentless. I am still having some pain but not as severe. I did not seek treatment as I hate the shots they used to do before my Topamax was prescribed. I had been migraine free for a little over year before this shot.
30 2021-01-07 pain in extremity Fatigue, body aches, chills, very sore site extremity all last about 24 hours, rigid neck, headache
30 2021-01-07 tingling Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from ... Read more
Low grade fever; Tingling face and tongue; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular on left arm on 02Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included fibromyalgia. The patient was not pregnant. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced low grade fever, tingling face and tongue, muscle aches, and fatigue, all on 03Jan2021 06:00. The events were reported as non-serious. Patient was not diagnosed with COVID-19 and has not been tested for COVID-19 prior to vaccination. Outcome of the events was recovering. Information on the Lot/Batch Number has been requested.
30 2021-01-07 numbness, tingling My jaw, cheeks and wrists went numb. It lasted around 30-40 minutes and then went away.
30 2021-01-07 pain in extremity Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next ... Read more
Over night on 01/06 I experienced chills and was very cold. At times I was extremely warm. The next morning I had a fever and my joints, muscles, head and even my skin was hurting. My fever never came down to normal even with advil and I was extremely tired all day. The arm that had the injection is extremely sore with splotches of red (which is expected.) Today, 01/08, I woke up in a pool of sweat. My head is still hurting and I still have a fever. My arm is still sore but my skin and joint pain has improved. I am still very cold. Have been wearing my winter coat in my house even with the heat and the fire place on. I had to take the last two days off work.
30 2021-01-07 pain in extremity Pain from left arm and up to left shoulder Lymph node is enlarged and tender Diarrhea Body Aches
30 2021-01-07 difficulty speaking Patient complained of itching of tongue, mouth, and lips. Given Benadryl 50mg po, Pepcid 40mg, and ... Read more
Patient complained of itching of tongue, mouth, and lips. Given Benadryl 50mg po, Pepcid 40mg, and Xyzal 5mg. Shortly after complained of hoarseness. No respiratory, GI or cardiovascular symptoms. ENT consulted. patient observed for 3 hours.
30 2021-01-07 tremor Pfizer-BioNTech COVID-19 Vaccine EUA Patient received vaccine and shortly after was in a chair and ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient received vaccine and shortly after was in a chair and experienced a syncopal episode. Pt was caught by staff member, and lowered to the floor. Patient reportedly had two syncopal episodes with brief periods of tremoring. Patient reportedly has prior syncopal history. Patient was A&O x4 when med response arrived. Patient was lying on floor with feet up on chair. Patient had unsteady gait and required multiple staff members' assistance. Patient was then transported to emergency department. While in the elevator, patient had her 3rd syncopal episode. Patient syncopal episode lasted for approximately 20 seconds. Patient regained consciousness and was brought into emergency department.
30 2021-01-07 pain in extremity a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a c... Read more
a little fatigue; minor body aches; her arm was a little sore; This is a spontaneous report from a contactable nurse . A 4-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Was notified on 04Jan2021 while the reporter scrolling on Facebook a friend of her who is a nurse who got the Pfizer COVID-19 vaccine and had side effects. Someone on had asked if the patient had any affects, patient stated a little fatigue and minor body aches. The reporter went back to and took a screenshot of the post that was dated from 23Dec2020. Patient was in her late 30's. Patient received vaccine on 23Dec2020 and she worked at Hospital name. This then triggered her to look into her other nurse friends. Apologizes for not having much information to provide on patient, she hasn't spoken to patient in 6 years. Mentioned that post only mentioned her arm was a little sore, but that was with any vaccine. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
30 2021-01-07 tenderness generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surroun... Read more
generalized pruritis, left arm swelling, redness, tenderness. significant redness and warmth surrounding site of injection.
30 2021-01-07 burning sensation palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable phy... Read more
palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable physician. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced palpitations on 04Jan2021 08:00, shortness of breath on 04Jan2021 08:00, ears burning on 04Jan2021 08:00. All events were nonserious. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received. It was unknown if the patient diagnosed with COVID-19 prior to vaccination. the patient has not been tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. The outcome of the events was resolved in Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
30 2021-01-07 weakness shortness of breath/progressed until I went to urgent care; I started to really bad cough and then i... Read more
shortness of breath/progressed until I went to urgent care; I started to really bad cough and then it actually got worse and worse; I was so weak like I am breastfeeding, I couldn't even hold my baby; extreme fatigue; I couldn't stay awake for more than a few hours at a time; Headache; lung problem; This is a spontaneous report from a contactable physician (the patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EH9899, via an unspecified route of administration on 16Dec2020 13:00 at single dose for COVID-19 immunisation. Medical history included history of reaction to mango (like face swelling and just a rash) and then gluten intolerant: if she eat it she doesn't have difficulty breathing. She never had problems with asthma in the past. The patient previously took BENADRYL for shortened like when she had a reaction with mango many years ago. In the past the patient had problems with cold and problems having bad cough that linger but she never needed Albuterol or steroids before. The patient had flu vaccine a month before, administered in deltoid left. The patient's concomitant medications were not reported. The patient experienced extreme fatigue on 19Dec2020 with outcome of recovering, shortness of breath/progressed until she went to urgent care on 21Dec2020 with outcome of recovering, She started to really bad cough and then it actually got worse and worse on 21Dec2020 with outcome of recovering, She was so weak like she was breastfeeding/She couldn't even hold her baby on 19Dec2020 with outcome of recovered on 20Dec2020, She couldn't stay awake for more than a few hours at a time on Dec2020 with outcome of unknown, headache on Dec2020 with outcome of unknown, lung problems on Dec2020 with outcome of unknown. The patient underwent lab tests and procedures which included chest x-ray: normal on unspecified date; SARS-COV-2 test: negative on 23Dec2020. The vaccine was administered at Hospital Facility. The patient was treated with steroids (20mg for 5 days) and an albuterol inhaler (2 puff every 4 hour). The events required visit to Emergency Room. The events were non serious.
30 2021-01-08 pain in extremity Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causi... Read more
Immediately after getting the vaccine my left arm was sore, which became worse in the evening, causing me pain to raise my left arm. Around 5 pm the same day, I started having body aches and had the chills. Then around 8pm I spiked a fever which reached up to 102.0 Fahrenheit, which I treated with Tylenol. In the morning (1/9/2021) the fever returned at 101.2 Fahrenheit, which I treated with Tylenol again.
30 2021-01-08 feeling hot, tingling, pain in extremity Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately afte... Read more
Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately after injection. Benadryl was given and EMT advised going to the hospital for observation. Heart rate and bp returned to normal a few hours later. Still feel dizzy and lightheaded when standing. Was informed that it was a vasovagal reaction. Arm is also very sorry at injection sight. Left arm where injection was placed it still tingling in hand, right hand feels normal.
30 2021-01-10 pain in extremity Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5... Read more
Arm soreness- mild, 2 days Headache - mil, 20-60 minutes Diarrhea - mild, 1 day Fatigue - mild, .5 day
30 2021-01-10 numbness, tingling At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they wer... Read more
At 3 am the next day after my vaccine (sat the 9th)I woke up to all my joints burning, like they were on fire. The next morning I had chills, severe joint pain, fatigue, dizziness, nausea, and rash/ redness on my face (cheeks, nose, forehead). The next day (Sunday, the 10th) I felt much better but still a bit of joint pain and fatigue. Today (Monday the 11th) I felt fatigued, with. A resting heart rate of 90 according to my fitbit. I had some numbness/tingling in my right arm, dizziness, and felt fatigued. Towards the end of today I felt better but still have some pain in lower back and neck.
30 2021-01-10 flushing, numbness Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling fa... Read more
Immediate numbness on top of left hand, tachycardia, flushing, dizziness, dry/numb mouth, feeling faint, lethargy. Was wheeled to ED where they left me in the waiting room for two hours, not seen by a provider, before being told I was "fine" and sent home. On 1/9/2020 I began experiencing widespread bodily itch, no hives or swelling that included in and around my mouth. Took cirtirizine and symptoms were alleviated.
30 2021-01-10 tremor, flushing, cold sweat Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well ... Read more
Within seconds of vaccine administration, I felt flushing of my upper and lower extremities as well as muffling in my right ear. My hands and feet became clammy. A small fan helped subside symptoms momentarily. Within minutes my lower extremities became shaky. I developed chills and felt faint. VS were measured. I was hypertensive (BP 134/100, baseline BP usually runs 110/80s). I developed intermittent tachycardic and heart palpitations, with a max HR of 124. Symptoms lasted approximately 1hour post vaccine administration. I work at a COVID testing site, chances of me being exposed to COVID-19 are high. I was not tested prior to receiving either dose of the vaccine; however, I have remained asymptomatic for the duration of the series.
30 2021-01-10 pain in extremity fever up to 102 body aches arm pain
30 2021-01-10 numbness hives- like breaking out on fore head a lot of swelling in face numbness glands swollen under tongue
30 2021-01-10 numbness, tenderness left hand numbness, then progressed to tenderness under left arm, around deltoid, radiates to back, ... Read more
left hand numbness, then progressed to tenderness under left arm, around deltoid, radiates to back, swelling. Went to Urgent Care. RX Tylenol, cold/hot presses
30 2021-01-11 hypersensitivity of all senses 12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia... Read more
12 hours after vaccination: Uncontrollable Rigors, muscle contractions, fever, chills, hyperesthesia, abdominal pain, nausea, headache, back pain
30 2021-01-11 pain in extremity Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/2... Read more
Fever, body aches, chills, joint pain, headache, felling inwell, fatigued, sore arm all started 12/28/2020 at 2100. Took cold/flu medicine
30 2021-01-11 migraine Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the P... Read more
Nausea; Feeling unwell; 1st dose Pfizer covid vaccine administered on 17Dec2020/second shot of the Pfizer Covid vaccine yesterday (04Jan2021); back pain/back pain was pretty severe and was worse than it would normally be; severe headache that turned into a migraine; severe headache that turned into a migraine; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284, Expiry Date: Apr2021) intramuscular at left deltoid on 04Jan2021 16:00 at single dose for covid-19 immunisation. 1st dose Pfizer covid vaccine was administered on 17Dec2020 (Lot number: EH9899). She was covid positive the day after receiving her first dose of the Pfizer covid vaccine. Her primary care informed her to get the booster despite testing positive for the virus. She was told since she was asymptomatic that she could get the vaccine. Medical history included back pain, covid from 3 weeks ago (Dec2020). There were no concomitant medications. The patient experienced back pain and severe headache that turned into a migraine on 04Jan2021, nausea and feeling unwell on 05Jan2021. She got the second shot of the Pfizer Covid vaccine yesterday (04Jan2021) around 16:00. Overnight she had back pain, severe headache that turned into a migraine. Now she had developed nausea and was generally feeling unwell. She had covid 3 weeks ago and she was instructed to get the vaccine. She has a history of back pain but states it was obviously triggered. Reports that last night her back pain was pretty severe and was worse than it would normally be. Nausea and feeling unwell was reported as worsened. Back pain was slightly improved. Headache that turned into migraine improved with medication. The outcome of events back pain and severe headache that turned into a migraine was recovering; of events nausea and feeling unwell was not recovered.
30 2021-01-11 facial pain On day 12 post vaccine, my bilateral temporal area, bilateral jaw, and bilateral cheeks became painf... Read more
On day 12 post vaccine, my bilateral temporal area, bilateral jaw, and bilateral cheeks became painful, erythematous, edematous, and with palpable nodules where I had Sculptra placed back in April/July 2020. Contacted aesthetic APRN in regards to symptoms. Was advised etiology is likely infection resulting from Covid Vaccine. Was started on PO Clindamycin 300 mg TID x 14 days and Ciprofloxacin (unsure of dosage) x 14 days with follow-up in office at Aesthetic office on 1/16/2021.
30 2021-01-11 pain in extremity Patient received Pfizer COVID-19 vaccine second dose this morning at 8:50am and at 12:15pm started w... Read more
Patient received Pfizer COVID-19 vaccine second dose this morning at 8:50am and at 12:15pm started with burning sensation in the area of where the vaccine was administered. Soon after, within the hour, the area became erythematous and warm. She reported her whole left arm felt "achy". Patient took ibuprofen 600mg at 1pm as well as iced the area. She was evaluated by writer at 2:15pm. The area was noted to be erythematous, warm, and mildly swollen. The redness was outlined with skin marker and noted to be 15cm wide and 13cm in height. She denied any other symptoms.
30 2021-01-11 pain in extremity Pt. states that left arm is hardened, red, and painful. This started on 1/12/2021. Pt. states that s... Read more
Pt. states that left arm is hardened, red, and painful. This started on 1/12/2021. Pt. states that she took Motrin for this and is not sure if this is helping.
30 2021-01-11 pain in extremity, tingling, migraine Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball lik... Read more
Vomiting and inability to eat or retain food, swollen/painful arm lasting 4 days, hard welt/ball like swelling at peak of swelling beginning Thursday evening through Saturday, inability to raise, hold, grasp or use arm for 2 days after injection, consistent fever for 36 hours/intermittent fever through Saturday, tightness in chest (relieved with inhaler every 2 hours) for 36 hours, tingling and phantom pain along left side of body and face, excessive exhaustion, dizziness and unfocused thoughts 48 hours, persistent migraine for 36 hours, intermittent headaches continuing with chills and nausea. Worse symptoms were 24-72 hours after injection, more mild side-effects (intermittent headache, nausea and chills) continuing through today.
30 2021-01-11 pain in extremity, hot flush aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a sp... Read more
aches; Chills; Headache; tight muscles; Hot flashes; Next 2 days: soreness in left arm; This is a spontaneous report from a contactable Other HCP (patient). This 30-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK5730) intramuscular at left arm on 03Jan2021 at 10:30 AM at single dose for COVID-19 immunisation. Medical history was unknown. Concomitant medications included cyclobenzaprine, levothyroxine and drospirenone/ethinylestradiol (NIKKI). The patient experienced aches and chills, headache and tight muscles on 03Jan2021 at 13:00. Then the patient had hot flashes and soreness in left arm from 03Jan2021 next 2 days. No treatment was received. The patient had no allergies to medications, food, or other products. The patient was no pregnant. The patient had no other vaccine in four weeks. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of all events was recovered.
30 2021-01-12 pain in extremity 1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 ar... Read more
1/7/21: Sore arm the night of the vaccine. 1/8/21: Woke-up around 4am with chills. Fever of 101.4 around 7am with generalized malaise and severe fatigue. Spent most of the day in bed. Fevers on and off throughout the day with Tmax of 101.4. Some mild body aches. Sore arm with itching at the injection site. Lump at injection site. Had to call off of work. Loss of appetite. 1/9/21: Afebrile the whole day. Moderate fatigue in the morning. Overall felt better by the afternoon. Sore arm continued with itching and lump remaining at the injection site. 1/10/21: Overall felt better, arm soreness and itching at injection improving. 1/11/21: Mild fatigue. No arm soreness. Itching improved. Lump at injection site improving. Mild body aches in the evening. 1/12/21: Mild fatigue. 1/13/21: No arm soreness, itching and lump at injection site gone.
30 2021-01-12 pain in extremity 1st shot: sore arm 2nd shot: woke up the next morning with a low grade fever, headache, chills and b... Read more
1st shot: sore arm 2nd shot: woke up the next morning with a low grade fever, headache, chills and body aches
30 2021-01-12 hot flush 2 hours after vaccine, felt nausea and aching in neck, like my blood pressure was elevated, hot flas... Read more
2 hours after vaccine, felt nausea and aching in neck, like my blood pressure was elevated, hot flashes. stopped after about an hour, returned again in the evening, again lasting about an hour, and did not come back after.
30 2021-01-12 pain in extremity 2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches,... Read more
2pm fatigue, soreness in arm 11pm nausea, vomiting, chills 12pm insomnia, fever, chills, body aches, joint pain 2am continued fever despite fever reducers 6am (day after) continued fatigue, arm soreness reduced 12pm continued low grade fever -99.6-100, fatigue 6pm continued low grade fever, fatigue 6am (2 days after) improvement in symptoms 12pm return of low grade fever, and fatigue. continued soreness in arm
30 2021-01-12 numbness, weakness, feeling cold I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the f... Read more
I developed mild injection site pain about 5 minutes after the second dose which didn?t happen the first time so quickly. It shortly progressed to a cold/numb sensation from my deltoid down to my finger tips. This persisted but seemed to transition from more numbness to moderate pain from my left scapula, neck and down to my fingers about 7 hours after the vaccine. I also developed intermittent fasiculations of my forearm muscles on the left arm. This morning I woke up with worsening pain, mild numbness but new weakness in the hand and arm. I have a weak grip and can?t fully grab objects. My wrist flexión and extension are also weak as well as shoulder abduction (I am a neurologist by the way so can?t localize it to any nerve distribution). I?m not weak anywhere else and I only have mild arthralgia and diarrhea systemically.
30 2021-01-12 numbness Mild facial numbness around mouth
30 2021-01-12 flushing Patient is afebrile,. Has mild erythema on her upper chest where she was itching in her primary con... Read more
Patient is afebrile,. Has mild erythema on her upper chest where she was itching in her primary concern is feeling flushed at this time. Symptoms resolved and patient remained stable. Discharged to home. Medications diphenhydramine (Benadryl) injection 50 mg prednisone (Deltasone) tablet 40 mg Prescription at discharge - Prednisone 20mg take two tabs by mouth one time a day for 4 days.
30 2021-01-12 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue and arm soreness within a few hours turned into full b... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Fatigue and arm soreness within a few hours turned into full body chills, aches, and a fever about 8hrs after injection. Symptoms were intense and lasted throughout the night with Tylenol only minimally reducing fever. All symptoms lasted for about 24hrs, after which I felt completely normal.
30 2021-01-12 pain in extremity The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6.... Read more
The initial shot wasn't bad. Sore arm within 5 hours. That's all I had, until Thursday evening at 6. Overwhelmed with exhaustion and fatigue. Massive headache coinciding. My arm felt like I had tennis elbow and overall joint pain. Nausea and vomiting through the night. Went to bed about 9:30. Woke up with a fever of 99. Off and on fever and chills through Friday, 72 hours after initial injection. Finally resolved late Friday night.
30 2021-01-12 numbness c/o numbness left hand, states happened after 1st shot but was several hours later, declines Benadry... Read more
c/o numbness left hand, states happened after 1st shot but was several hours later, declines Benadryl, states makes her drowsy, states she will just monitor herself and return if it gets worse.
30 2021-01-13 pain in extremity, weakness Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the v... Read more
Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the vaccine. Symptoms included left arm pain, back pain, aches/chills starting at midnight on 1/6/21 into 1/7/21. Headache lasted all day, slept intermittently all day, low energy and extreme fatigue. Was 13 weeks pregnant at the time of the vaccine.
30 2021-01-13 tremor At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral fo... Read more
At 4:10 I awoke with pruritus and when i looked at my arms and I developed hives on my bilateral forearms and bilateral hip area. I felt itchy all over. When I stood up, I felt palpitations and started to feel as if I was going to pass out. I sat down and I started to tremor and felt like it was hard to catch my breath. I took an antihistamine and took a puff of albuterol. I felt a lot better. At 10 AM in the morning, the hives have improved but i still feel some pruritus.
30 2021-01-13 pain in extremity Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss... Read more
Day of vaccination no symptoms. Day after about 0730 had slight headache, sore arm, fatigue and loss of taste. Day 2 post vaccination only loss of taste, slightly improved.
30 2021-01-13 tingling Dizzy, tingling in left arm, chest tightness and heaviness, tongue feels weird
30 2021-01-13 pain in extremity Fatigue, Nausea, Arm soreness Currently pregnant: EDD 08/20/2021
30 2021-01-13 pain in extremity Fever 100.8, right arm soreness and fatigue. Treatment: Tylenol. Outcome: mild improvement
30 2021-01-13 flushing Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Ra... Read more
Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Rapid Response called and she was brought to ED. At ED, evaluation done, pt stable, felt to be likely anxiety/panic attack as cause of symptoms, and low likelihood of anaphylaxis. Pt was given rx for Epi pen to keep on hand just in case.
30 2021-01-13 pain in extremity Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took... Read more
Less than an hour after the shot, i had a sore arm, headache and slight sensitivity to light. I took 975mg of Tylenol when I got home in the evening. But 12 hrs later after the vaccine shot, i woke up with severe body aches, chills, headache. Then i took another 975mg Tylenol but 3 hours later I started having fever that?s on and off. My fever even went up to 102.5F and the headache is very bad that is not relieved by Tylenol.
30 2021-01-13 migraine Migraine, stiff neck, and body aches
30 2021-01-13 pain in extremity Upper arm soreness and dizziness both started 5.5 hours after receiving vaccine.
30 2021-01-13 flushing within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated wi... Read more
within 15': flushed, nauseated, throat swelling. dizzy., tachycardia Transferred to ED: treated with Benadryl. solumedrol. sx resolved. Observed for 4 hrs. d/cd to home
30 2021-01-14 tenderness 15 weeks pregnant, due date 7/4/21. Fourth pregnancies one two year old, two miscarriage's. My left ... Read more
15 weeks pregnant, due date 7/4/21. Fourth pregnancies one two year old, two miscarriage's. My left arm became super tender, I woke up with significant joint pain in my right knee. I almost couldn't walk, it was chronic pain when I tried to walk. It lasted about 24 hours and went away. I did inform my OB.
30 2021-01-14 feeling hot 20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure... Read more
20 hours after first dose of COVID19 vaccine arm was very sore (normal). Around 2:30am felt pressure and warmth (coming in waves) up towards my chest, lasting 1-2 seconds and occurring about every 5 minutes . Was able to withstand feeling until it became difficult to breath. Lips and face turned white and blue, fainted. Felt extremely nausea when awake. Called 911. Vitals were normal apart from BP was very high 130/100's. EKG was NSR. Blood sugar taken was normal around 113. After 1 hour of event, I took a shower and drank water. I felt the wave one more time before trying to fall asleep. Then stopped. Woke up fine.
30 2021-01-14 numbness Chest pain, predominantly on the right side, numbness in right arm and increased heart rate. Symptom... Read more
Chest pain, predominantly on the right side, numbness in right arm and increased heart rate. Symptoms started about an hour after the vaccine. Each episode lasts 30-40 mins then subsides and symptoms go away completely. I had 3 episodes of these symptoms the first day and so far 3 the second day. My doctor recommended I go to the emergency room. Based off my EKG, vitals, and family history there was no reason to believe that the episodes were causing any heart abnormalities.
30 2021-01-14 feeling cold Cold Symptoms , headaches , fever, chills
30 2021-01-14 feeling of body temperature change Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not fe... Read more
Got 2nd dose vaccine at 7:20 am at 5:30 pm I developed chills, went to bed around 8:30 due to not feeling well. I woke up at 10 pm sweeting and body aches. All through the night I was hot then cold. I developed a temperature of 100.8. Had no appetite in the morning. At 7:30 am I started to feel better. Had head ache through out the day Thursday.
30 2021-01-14 hot flush Hot flashes, extreme nausea with no relief from medication
30 2021-01-14 weakness Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, ... Read more
Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; Itchiness, hives, wilts, abdominal pain; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown unable to locate or read the details) via an unspecified route of administration at Left arm on 23Dec2020 14:15 at single dose covid-19 immunization. Facility type vaccine was Hospital. No known allergies and no other medical history. Concomitant medication included ascorbic acid, calcium pantothenate, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine mononitrate (PRENATAL VITAMINS), colecalciferol (VITAMIN D). No other vaccine in four weeks. The patient experienced itchiness, hives, wilts, abdominal pain on 01Jan2021 23:45. The events resulted in Doctor or other healthcare professional office/clinic visit. No covid prior vaccination and covid was not tested post vaccination. Treatment Benadryl was received for the events. The outcome of the events was recovered in Jan2021. Information about lot/batch number request.
30 2021-01-14 tingling Pins and needles tingling sensation throughout entire body at 10 minutes. At 20 minutes hives coveri... Read more
Pins and needles tingling sensation throughout entire body at 10 minutes. At 20 minutes hives covering face, chest and arms. Given 50mg Benadryl and 40 mg Pepcid. Symptoms resolved a little over an hour post injections
30 2021-01-14 difficulty speaking chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after rece... Read more
chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after receiving the vaccine employee reported mild chest pressure/pain, hoarse voice, SOB, light-headedness, and scratchy throat. (She was given the vaccine in the ED because of a history of anaphylaxis with taking antibiotics). Her physical examination and vital signs were normal. No evidence of swelling to lips, tongue or throat. No treatment was required. Employee was observed for 4 hours and discharged to home. She was diagnosed with a minor allergic reaction.
30 2021-01-15 tenderness Injection site pain initially (11/11/21). Followed by generalized body aches starting approximately ... Read more
Injection site pain initially (11/11/21). Followed by generalized body aches starting approximately 12 hours later. Significant lymphadenopathy in the left axilla (same arm as injection site), with tenderness, generalized aching, and obvious swelling and fullness to palpation of the left axilla. Body aches were treated with Tylenol and resolved in 24 hours. Lymphadenopathy in the left axilla persisted until 11/17/21, with improvements in severity of ache and size of swelling noted on 11/16/21.
30 2021-01-15 tingling Neck stiffness/left jaw pain and stiffness within 1 hour of administion, lasting all day. Around 210... Read more
Neck stiffness/left jaw pain and stiffness within 1 hour of administion, lasting all day. Around 2100 the same night, rapidly progressing paresthesia of complete left face without obvious facial palsy yet (numbness happened over the course of about 30min to the point where I had no perception of touch in the left face). At this point I took 60mg of prednisone and went to bed. When I woke up, the paresthesia/stiffness was less and progressively so since finishing a course of prednisone. Concerned that this could have been a bells palsy reaction to the vaccine.
30 2021-01-16 tremor, weakness 2:30PM Chest pains, weakness, dizziness, feeling shaky. 6:20pm Tachycardia, hypertension, fever, fa... Read more
2:30PM Chest pains, weakness, dizziness, feeling shaky. 6:20pm Tachycardia, hypertension, fever, fainted, whole body went limp and unable to keep head up. 8:30 able to use arms again and feel them 10:30pm able to use legs and walk again
30 2021-01-16 burning sensation Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very... Read more
Immediately after the vaccine, my arm started burning in my neck and opposite arm joints became very sore throughout the day my entire body became extremely sore and I developed an ear ache and a headache and I am very fatigued. Today is the 17th of the month and that your aching headache still has not always go away. I?m not sure if this is a normal reaction or not.
30 2021-01-16 migraine Migraine Body aches Large red painful lump at injection site Exhaustion
30 2021-01-17 migraine Migraine, Sore Throat
30 2021-01-17 feeling cold Started with alternating chills and sweating at 10pm day of vaccine which lasted through the night. ... Read more
Started with alternating chills and sweating at 10pm day of vaccine which lasted through the night. Never had a fever. Woke up the next day with a headache and significant muscle/body aches that lasted the day and into the night. On the 2nd day post vaccine still fatigued and new sore throat.
30 2021-01-17 pain in extremity Starting the night after the vaccination Jan. 7 the patient woke up with a fever of 100.2 and also a... Read more
Starting the night after the vaccination Jan. 7 the patient woke up with a fever of 100.2 and also arm soreness, body aches and headache. Patient temperature spiked to 101.2 at 9pm that evening. Jan 9 patient temperature was 100.5 at 3pm and patient noticed some stuffiness in the nose. Jan 10 temperature 99.5. Jan 11 3am temperature of 101.3, stuffy nose, cough, body aches, headache, nausea. Jan 12 temperature of 102.8 with Rigors. Jan 13 still having headaches, on and off nausea, cough, low grade fever 99.2. Jan 14 Temperature 100.9. Jan 15 Temperature 101.8. Patient continues to have fever every evening.
30 2021-01-17 breast pain, pain in extremity fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site a... Read more
fist dose on 21Dec2020, second dose on 07Jan2021; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back; Started having chills; Severe headache; collapsed on the way back to bathroom and was unable to get up for about 20 minutes; tachycardia; extremely fatigued entire day; This is a spontaneous report from a contactable Pharmacist who reported for herself. A 30-year-old female patient received her second dose of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number Ej1685) at a single dose at 09:45 AM 07Jan2021 at left arm for Covid-19 immunization in a hospital. The patient had her first dose of Pifzer Covid-19 vaccine on 21Dec2020 at 12:00 PM at left arm, and experienced very mild reactions which included mild pain at injection site and runny nose/sneezing day after vaccine. The paitent had a medical hisotry of rash to penicillin as a child. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to her first dose of Pfizer COVID vaccine. In the evening of second vaccine (around 17:00), pain and stiffness radiated from injection site all the way down arm, into breast, and middle of back. She started having chills. Around 10 hours after dose chills became somewhat violent despite being under 4 blankets. Severe headache also started. In the middle of the night to go to bathroom, she collapsed on the way back and was unable to get up for about 20 minutes. She also suffered from tachycardia overnight. her baseline heart rate runs in 60s- 70s, but was in 110s-120s (based on Apple Watch monitoring). Day after vaccine, she was extremely fatigue entire day and spent all but a few hours in bed. Arm pain mostly gone. Headache was very strong and persistent through the day. On second night chills not as bad but still occurred overnight. HR still elevated in 80s overnight. Morning of day 2 still had headache and fatigue. The patient did not receive any treatment for the events. The outcome of collapse and unable to get up for 20minutes, pain and stiffness radiating from injection site all the way down arm,into breast, and middle of back was resolved, chills and tachycardia was resolving, headache, fatigue was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The reporter considered that the events was non-serious.; Sender's Comments: Based on a chronological temporal association and known BNT162B2 vaccine safety profile, causality between events fainting, violent chills and severe headache and BNT162B2 ((Pfizer/ BioNTech Covid-19 vaccine) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-01-17 tremor injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering to... Read more
injection site soreness, Headache, Fever, nausea, muscle soreness, joint pain, shaking/ shivering took 1 Tylenol at 2:15 am. woke up at 3:23 am to bout of SVT 154 and tachycardia for a few hours after.
30 2021-01-18 flushing, tingling 15 minutes after her shot c/o pins and needles to her arms, feet followed by a flushed chest. Devel... Read more
15 minutes after her shot c/o pins and needles to her arms, feet followed by a flushed chest. Developed flushing to her face, arms. Administered 50mg PO Benadryl (employee declined IM Benadryl). VS remained stable during observation period. Hydration provided. Also took 40 mg Pepcid. Reported symptom relief, declined ER observation and obtained transport home.
30 2021-01-18 feeling hot I experienced SOB, feeling of hot ,dizzy, lightheaded and tachycardiac and hypotensive, shivering an... Read more
I experienced SOB, feeling of hot ,dizzy, lightheaded and tachycardiac and hypotensive, shivering and generalized body aches.
30 2021-01-18 migraine, pain in extremity Shortly after the vaccine I started having a migraine and extreme light sensitivity. Today I have gr... Read more
Shortly after the vaccine I started having a migraine and extreme light sensitivity. Today I have gradually become nauseated, have a poor appetite, feel very lethargic, and have a mildly sore arm.
30 2021-01-18 tingling Within 5 mins of injection tingling between shoulder blades and face, came in waves. Within 20 mins... Read more
Within 5 mins of injection tingling between shoulder blades and face, came in waves. Within 20 mins of the injection throat tightness, dysphagia. 50mg Benadryl PO, 20mg Pepcid PO, 2 puffs of Albuterol. Throat tightness resolved within the following 30 mins. The next day body aches, itching of arms, and swelling in the left axilla (same side as injection). 48 hours after injection rash and itching on the upper back, chest, and both arms resolved with 50mg Benadryl.
30 2021-01-18 weakness not feeling good (felt like crap); dizziness (really dizzy); weakness; shortness of breath (short of... Read more
not feeling good (felt like crap); dizziness (really dizzy); weakness; shortness of breath (short of breath); arm feeling weak (arm felt weak); This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0140, expiration date 31Mar2021) via an unspecified route of administration on 08Jan2021 at a single dose in the left arm as Covid-19 vaccine due to being a front line worker. Medical history included ongoing pre-diabetic from 2015. There were no concomitant medications. The patient received the vaccine today on 08Jan2021. Within 15 minutes (also reported as 15 minutes after the vaccine), she experienced not feeling good (felt like crap), dizziness (really dizzy), weakness, shortness of breath (short of breath), and arm feeling weak (arm felt weak) on the side where the injection was received. It's the weirdest thing, she never had issues with vaccines before. She was asking if this was normal. The outcome of the events was unknown. The nurse reported that the events were related to the suspect product.
30 2021-01-19 feeling hot 30yo female with no documented allergies received COVID-19 Pfizer BioNTech vaccination, dose#1. Pat... Read more
30yo female with no documented allergies received COVID-19 Pfizer BioNTech vaccination, dose#1. Patient c/o feeling warm, blotchy across her face and chest. Stated she was really nervous about receiving the vaccine. Monitored for 45 minutes under direct observation of clinic staff. Initial SBP 156 and decreased to 120/80s. Denies nausea, drinking water. Remained on 100% RA. Blotches appear less bright. Asked to go back to work. No dizziness, ambulated to door without problems. Discharged to self and returned to work.
30 2021-01-20 muscle spasms, pain in extremity Arm soreness started evening on 1/20/21. At 1:30AM 1/21/2021 I woke with a fever, chills, muscle pai... Read more
Arm soreness started evening on 1/20/21. At 1:30AM 1/21/2021 I woke with a fever, chills, muscle pain, joint pain, muscle cramps, headache, nausea and fatigue. Highest fever 102.3, fever holding at 100.5 with Tylenol. Drinking fluids.
30 2021-01-20 weakness, numbness, paralysis Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous r... Read more
Cardiac event; Paralysis; Fever; Numbness; Chest Pains; Dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient started to receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 15Jan2021 14:15 at SINGLE DOSE for covid-19 immunisation. The patient was not pregnant. Medical history included tachycardia, Pre-ventricular contractions, allergies to Latex, covid-19 (reported as covid prior vaccination: Yes). Concomitant medication included metoprolol and multivitamin. No other vaccine received in four weeks. On 15Jan2021 14:30, the patient experienced chest pains, dizziness, weakness. On 15Jan2021 18:20, the patient experienced cardiac event, paralysis, fever, numbness, chest pains. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event)]. Treatment received for the events. No covid tested post vaccination. The outcome of the events was recovering. Information on batch/lot number was requested.
30 2021-01-20 flushing Fever of 99.5; Body aches; chills; red face; feeling flushed 5 hours after 1st shot; Headache for ne... Read more
Fever of 99.5; Body aches; chills; red face; feeling flushed 5 hours after 1st shot; Headache for next two days; This is a spontaneous report from a contactable other hcp (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), intramuscular on 15Dec2020 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Covid 19. Patient is not pregnant. Patient had no known allergies. Concomitant medication included pseudoephedrine. Facility type vaccine: Hospital. There was no other vaccine in four weeks. On 15Dec2020 15:00, it was reported that patient had Fever of 99.5, body aches, chills, red face, and feeling flushed (5 hours after 1st shot). Temp increased to 100.6 so I took Aleve and I felt better in 30 min. Headache for next two days. After second shot, fever of 99.6 and body aches with chills after 12 hours. Took Aleve and fever was gone felt fine by noon next day. The patient underwent lab tests and procedures which included Nasal Swab: negative on 18Dec2020. Therapeutic measures were taken as a result of fever of 99.5. The outcome of the events was recovered on an unspecified date. Information about lot/batch number has been requested.
30 2021-01-20 pain in extremity I received the vaccine at 8:00am, and at approximately 7:00pm the same day, I developed a headache. ... Read more
I received the vaccine at 8:00am, and at approximately 7:00pm the same day, I developed a headache. About an hour later, I developed generalized muscle aches and subjective fever/chills. The symptoms did not interfere with my sleep, and when I woke up the next morning, the fever/chills had resolved. The myalgia and headache resolved by approximately 11:00am the day after I received the vaccine. I also had arm soreness from approximately 12 hours to about 72 hours after the vaccine.
30 2021-01-20 discomfort Nausea; Muscle aches; General unwell; Anxiety; Body feels heavy and hard to move; Body feels heavy a... Read more
Nausea; Muscle aches; General unwell; Anxiety; Body feels heavy and hard to move; Body feels heavy and hard to move; Arm where injected is very uncomfortable; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 12Jan2021 at a single dose on left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Zk5730), via an unspecified route of administration on 22Dec2020 at a single dose on left arm for COVID-19 immunization (at 29 years old). The patient experienced nausea, Muscle aches, General unwell, Anxiety, Body feels heavy and hard to move around, Arm where injected is very uncomfortable on 13Jan2021 01:30 AM. The outcome of the events was recovering. The events were assessed as non-serious. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
30 2021-01-20 pain in extremity Rash on her right forearm consisting of clusters of vesicles on an erythematous base; rash is consis... Read more
Rash on her right forearm consisting of clusters of vesicles on an erythematous base; rash is consistent with a diagnosis of herpes zoster or shingles; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Radiating burning pain down the underside or volar side of her right arm to her wrist; first felt like a bruise; Pain then began to feel more like a bad sunburn with her skin being tender in the same distribution; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in right arm, on 04Jan2021 at 18:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was her workplace clinic. On 05Jan2021 at 03:00 PM, the patient developed radiating burning pain down the underside or volar side of her right arm to her wrist (vaccinated arm) that at first felt like a bruise within 24 hours of receiving the vaccine. In Jan2021, the pain then began to feel more like a bad sunburn with her skin being tender in the same distribution. Then on 11Jan2021, the patient developed a rash on her right forearm consisting of clusters of vesicles on an erythematous base. The patient consulted with a dermatologist in her primary care physician who agreed that the rash is consistent with a diagnosis of herpes zoster or shingles. This resulted in doctor or other healthcare professional office or clinic visit. Treatment received for shingles included valacyclovir. Post-vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
30 2021-01-20 pain in extremity Very sore arm, slight headache, fatigue
30 2021-01-21 migraine 1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and ac... Read more
1/13 at 3 am started experiencing severe nausea/vomiting, severe diarrhea, severe body chills and aches, severe migraine and fever of 101.2F. Continued through 1/14 and missed work. Returned to work on 1/15 still having fatigue, nausea and severe headache.
30 2021-01-21 numbness, seizure Fever, intense seizure for 10 min causing blackout, lost feeling in face and three toes, still can't... Read more
Fever, intense seizure for 10 min causing blackout, lost feeling in face and three toes, still can't feel 3 toes, lost consciousness.
30 2021-01-21 pain in extremity Muscle pain on upper extemedies Hip,back , pain on both arms Left had has been swollen for 2 days ... Read more
Muscle pain on upper extemedies Hip,back , pain on both arms Left had has been swollen for 2 days After one week of vaccination
30 2021-01-21 weakness chest pain fever of 102.0, sore throat, headache, dizziness, weakness tiredness
30 2021-01-21 discomfort, migraine, tremor, cold extremities extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( nor... Read more
extremely decreased blood flow (temperature) in extremities. Core far above normal temperature ( normally 96.8, currently 100.8). Sweating. Shaking due to cold extremities. Migraine. Pain in lower back (kidney area), chronic and achey. Joint pain in legs/ hips. Nausea constantly. Feeling of overall pain and discomfort. exhaustion.
30 2021-01-22 weakness 24 hours after taking the second covid dose I felt weak and nauseous and was having chills then diar... Read more
24 hours after taking the second covid dose I felt weak and nauseous and was having chills then diarrhea 48 hours not sure if its the vaccine but I thought it?s good to report it I just took motrin and felt relief
30 2021-01-22 tingling Tachycardia, hypertension, dizzy, tingly
30 2021-01-23 seizure Patient had 4 seizures within 72 hours after receiving the vaccination. This is increased frequency ... Read more
Patient had 4 seizures within 72 hours after receiving the vaccination. This is increased frequency compared to regular amount of seizures.
30 2021-01-23 tingling, numbness Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted over 18 hou... Read more
Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted over 18 hours
30 2021-01-24 tingling 30 mins after injection-tingling upper back, severe headache, profusely sweating. Symptoms lasted ab... Read more
30 mins after injection-tingling upper back, severe headache, profusely sweating. Symptoms lasted about 6 hours
30 2021-01-24 cold sweat ER for restricted airway after 3 hours. Muscle pain, joint pain, extreme dizziness, sore throat, hea... Read more
ER for restricted airway after 3 hours. Muscle pain, joint pain, extreme dizziness, sore throat, headache, cold hot sweats, fatigue, for 5 days. dizziness, sore throat, still after 6 days
30 2021-01-24 pain in extremity Injection was given and burned on insertion. That evening and proceeding into next day I experience... Read more
Injection was given and burned on insertion. That evening and proceeding into next day I experienced loss of Range of motion in Left upper extremity, pain up to neck and down left arm, and back behind shoulder blade.
30 2021-01-24 weakness Lightheaded, weakness
30 2021-01-24 feeling hot, seizure Patient has history of seizures under control with medication. After administration of vaccination, ... Read more
Patient has history of seizures under control with medication. After administration of vaccination, patient had seizure episode within 10 minutes. Patient said while waiting during observation period she got very hot and heat can be a trigger for her seizures. Patient's head and body was secure. Patient claims no injuries from seizure. With ice and water patient cooled down. Checked on patient frequently, Patient felt hot again after 2 hours, however patient was working at this time. Patient again sat and ate some ice and water. Checked patient's blood pressure and heart rate at 2 and half hours after administration. BP was 130s/70s and HR was 64. Patient was recommended to take Tylenol whenever she gets a chance or when she gets warm and was advised to contact her PCP or specialist as soon as possible. Patient felt good enough to continue working according to patient.
30 2021-01-24 flushing Patient immediately on administration became flushed, reported metallic taste in her mouth, thickeni... Read more
Patient immediately on administration became flushed, reported metallic taste in her mouth, thickening of her throat, and light headedness. VS, O2 6l/min via NC and EPI 0.3mg/0.3ml IM injection given and patient transferred to ED.
30 2021-01-24 night sweats headache, chills, body aches, temperature, fatigue, night sweats, 3 days
30 2021-01-25 cold sweat, tremor, tingling ACHES AND TINGLES. @12:45AM WOKE UP FREEZING WITH A FEVER. WEDNESDAY MORNING WOKE UP WITH A COLD SWE... Read more
ACHES AND TINGLES. @12:45AM WOKE UP FREEZING WITH A FEVER. WEDNESDAY MORNING WOKE UP WITH A COLD SWEAT. WEDNESDAY NIGHT- SAME SYMPTOMS BUT 10X WORSE. UNCONTROLLABLE SHAKES, FEVER, FREEZING, ENTIRES BODY ACHES. TOOK TYLENOL, NYQUIL AND ADVIL.
30 2021-01-25 pain in extremity Arm pain, joint pain, treated with naproxen
30 2021-01-25 tingling, nerve pain Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 min... Read more
Extreme muscle stiffness and skin tenderness, burning hot (nerve pain over entire body lasting 5 minutes every 30 minute or so) Tingling in my hands and finger tips.
30 2021-01-25 cold extremities I had a fast heart rate, light headedness and cold extremitits.
30 2021-01-25 migraine Successive severe migraines- not typical of my usual migraines. My usual medications are not working
30 2021-01-26 tingling Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/20... Read more
Chest pain since 12/25/2020 (no treatment, written off as anxiety), flare of bursitis since 12/25/2020 (solumedrol injections from rheumatologist in right knee and both shoulders), tingling in fingers, toes, & lips since 12/25/2020 (no treatment), psoriasis flare of face since 12/25/2020 (never experienced before reaching out to dermatologist) Low grade fever off and on 12/31/2020 until 1/11/2021
30 2021-01-26 pain in extremity Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and bo... Read more
Lymph node in my right armpit was swollen; Diarrhea; Exhausted/Still tired; Headache/ My head and body still hurt; Felt sick; Broke out in hives all over my body; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain in my right arm, upper right side of my back and under my right breast; Extreme pain under my right breast/body still hurt; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not available), via an unspecified route of administration on 12Jan2021 13:00 at single dose in right arm for COVID-19 immunization. Medical history included the patient had known allergies to Erythromycin and pineapple. The patient had Covid-19 prior vaccination on an unspecified date. The patient had other concomitant medications. On 12Jan2021 14:00, 1 hour after vaccine the patient broke out in hives all over her body. The patient went to the ER at around 2-3pm. Later that night the patient had extreme pain in her right arm, upper right side of her back and under her right breast. The patient called ER and they told the patient to monitor it. The next morning on 13Jan2021 the patient was exhausted, had a headache and felt sick. Her right arm was painful to touch or lay on. The hives went down some. On 14Jan2021 the patient woke at 7am and her lymph node in her right armpit was swollen. It's painful to lower her arm due to the swelling. The patient was still tired and now the patient had diarrhea (on 14Jan2021). The patient's hives were less noticeable today. Her head and body still hurt. The patient had been on bed rest. No treatment was received for the events. The outcome of the events was reported as recovered with lasting effects in Jan2021. Information on the lot/batch number has been requested.
30 2021-01-26 numbness Patient experienced a mild reaction with first Covid vaccine and upon second vaccine administration,... Read more
Patient experienced a mild reaction with first Covid vaccine and upon second vaccine administration, patient experienced numbness in ear and jaw, hives, nausea, dizziness, and tachycardic. Patient was seen in the emergency department given diphenhydramine 50 mg, famotidine 20 mg, ondansetron 4 mg, and 1L of sodium chloride. Patient was monitored, EKG normal, and then discharged.
30 2021-01-26 discomfort Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and p... Read more
Symptoms s/p 2nd dose of Pfizer vaccine. Moderate to severe headache, nausea, body/joint aches and pain, and generalized fatigue resulting in inability to work the day after dose given. Fatigue started around 20:00 on 1/5/2021 (same date as 2nd dose administration), with increasing discomfort throughout the night. Symptoms continued until about 1:00 on 1/7/2021. Peak symptoms 1:00am-12:00pm on 1/6/2021.
30 2021-01-27 pain in extremity, tingling Besides the typical fever, chills, headache and arm soreness on day 1 and 2, I developed a rash and ... Read more
Besides the typical fever, chills, headache and arm soreness on day 1 and 2, I developed a rash and a feeling of pins and needles throughout my body (except my face) (on Day 2 post vaccine administration). Urgent care on day 3- prescribed loratidine 2x a day and prednisone 1x a day. Day 7- very mild itching.
30 2021-01-27 pain in extremity I did not feel the shot going in, so much so that I wished I had looked to see if I was actually vac... Read more
I did not feel the shot going in, so much so that I wished I had looked to see if I was actually vaccinated. About 6 hrs after vaccine, I felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine, my arm was so sore I could not lift it. That night I took two Tylenol and had to wrap my arm in a heating pad. I woke up around 3am that following morning with a fever of 104 F. I was so dizzy from the high fever. I felt extremely nauseated. My body ached mostly in my legs and lower back. It hurt to sit on the toilet, to put on clothes. My Fevers happened at night time ranging from 102-104F for 4 days. My injection site soreness lasted for 7 days. Body aches lasted around 2-3 days. Dizziness subsided after my fever broke, but was replaced with a severe headache lasting 2 days.
30 2021-01-27 night sweats Muscle aches, chills, fever and night sweats within approximately 10 hours or second dose. Lasted fo... Read more
Muscle aches, chills, fever and night sweats within approximately 10 hours or second dose. Lasted for ~ 48 hours. Some relief with Tylenol.
30 2021-01-27 night sweats Night sweats x 3 weeks, on-going, negative work up; This is a spontaneous report from a contactable ... Read more
Night sweats x 3 weeks, on-going, negative work up; This is a spontaneous report from a contactable physician (patient). A 30-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ELD140), via an unspecified route of administration in right arm on 22Dec2020 16:00 at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history included depression. No known allergies. No Covid prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), bupropion hydrochloride (WELLBUTRIN). The patient experienced night sweats x 3 weeks, on-going, negative work up (non-serious) on 24Dec2020. AE resulted in ''Doctor or other healthcare professional office/clinic visit''. No treatment received for the event. Patient was not pregnant. Patient not received other vaccine in four weeks. The patient underwent lab tests and procedures which included nasal swab: negative on 07Jan2021. The outcome of the event was reported as recovered/resolved with sequel.
30 2021-01-27 numbness, burning sensation Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: dizziness burning sensation in the right side of her neck and r ear Lot: EL 3247 Time of Administration: 1:10pm in LEFT arm Time Symptoms Began: 1:40pm when she stood up. Felt a rush and then got dizzy She was given a pink card-dizziness and numbness in legs after last vaccine. For the next few days, she had intermittent dizzyness, nausea, extremely tired _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. She was sitting on the couch in the observation room. Initial Assessment @ _1:42om_: Patient is Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. She is talking and making conversation. She was given a Ginger Ale. We made convsersation for the next ~10 minutes. She was in no distress at all. Vitals @: 155pm HR: 79 BP: -- O2: 98 Employee was discharged without treatment. The RN was notified for follow up. Patient wil call us if anything progresses.
30 2021-01-27 flushing WHEN THE 15 MINUTE OBSERVATION PERIOD ENDED, PATIENT NOTED SCATTERED BLOTCHY RED RASH ACROSS HER UPP... Read more
WHEN THE 15 MINUTE OBSERVATION PERIOD ENDED, PATIENT NOTED SCATTERED BLOTCHY RED RASH ACROSS HER UPPER CHEST/FRONT SHOULDER AREA. RASH ALSO NOTED OVER L SCAPULAR AREA. SKIN IS CLEAR ON THE REMAINDER OF BACK, ADBOMEN, EXTREMITES, BLOTCHES ARE NOT RAISED OR PRURITIC. FACE FLUSHED. PATIENT STATES SHE GETS THIS RASH WHEN SHE IS ANXIOUS. NO DIFFICULTY BREATHING, NO TIGHTNESS IN THROAT OR CHEST, NO NUMBNESS,SWELLING OR TINGLING OF LIPS/TONGUE. PATIENT REMOVED JACKET LAYERS OF CLOTHING AND MASK, GIVEN WATER AND CRAKERS (ALSO HAD NOT EATEN FOR SEVERAL HOURS). LUNGS ARE CLEAR TO AUSCAULTATION. BP 130/91, PULSE OX 100%, PULSE 93. RASH BEGAN TO SUBSIDE ABOUT 5-10 MINUTES AFTER PATIENT FIRST NOTED IT, AND WAS COMPLETELY GONE WITHIN 20-30 MINUTES. PATIENT STATED SHE FELT WELL, HAD NO FURTHER COMPLAINTS.
30 2021-01-27 tingling immediate tingling in injected arm which went after 10 minutes photophobia and blurred near vision 3... Read more
immediate tingling in injected arm which went after 10 minutes photophobia and blurred near vision 30 mins after vacc 8 hours after vacc: severe headache, chills, joint pain over whole body, extreme fatigue, sinus congestion. these lasted over 24 hour period.
30 2021-01-27 muscle spasms severe chills during night after injection. body aches for 2 days leading to muscle spasms in neck.
30 2021-01-28 unresponsive to stimuli, seizure Pt has hx of epilepsy but did not inform staff of this. Pt received vaccine. Approximately 12 minute... Read more
Pt has hx of epilepsy but did not inform staff of this. Pt received vaccine. Approximately 12 minutes in to 15 minute observation period, pt expressed she began to feel an aura. RN tended to pt. Pt was safely lowered to the ground where she was placed on her right side. Pt was alert but not responding to RN questions, thus EMS was called as a precautionary. Seizure activity described as full body movements began and lasted approximately 30-40 seconds. EMS arrived post seizure. Post seizure, pt alert and answering questions appropriately. Declined going to hospital via EMS. RN placed call to pt boyfriend who came and picked up pt from the West Allis health department.
30 2021-01-29 burning sensation After receiving the first dose of pfizer covid-19 vaccine, pt had stated she had itchy and burning s... Read more
After receiving the first dose of pfizer covid-19 vaccine, pt had stated she had itchy and burning sensation in right and left jaw, as well as same sensation on the upper lip. Treatment for symptoms included oral intake of Cetirizine 10mg. Pt was observed for 30 minutes without any developing reactions.
30 2021-01-30 pain in extremity Headache, dizziness, nausea, sore arm, vomiting
30 2021-01-31 feeling cold, weakness At 2:30 am I got up to use the restroom. I felt very dizzy and cold as if I were going to pass out.... Read more
At 2:30 am I got up to use the restroom. I felt very dizzy and cold as if I were going to pass out. I got out my blood pressure machine and my BP was 80/60. It is usually 117/70 so this was way out of the ordinary. I felt like I was going to need to call 911 due to the weakness and not being able to stand up without wanting to pass out. Got some salt and water and relaxed until the about 7am when it subsided.
30 2021-01-31 tingling Loss of taste, tingling in face and mouth. Lasted for 2 days.
30 2021-02-01 tenderness I received the Pfizer vaccine on January 11th, 2021. On January 12th,2021 I experienced nausea, seve... Read more
I received the Pfizer vaccine on January 11th, 2021. On January 12th,2021 I experienced nausea, severe body aches, chills, sweating, a severe headache and fatigue. Symptoms lasted about 24 hours. I had some axillary tenderness (I had this with the first vaccine as well) this lasted about a week. I also had some moderate bleeding at injection site after the vaccine was given. it resolved quickly. I took Tylenol and ibuprofen for the headache and body aches.
30 2021-02-01 cold sweat, numbness, flushing, tremor My first reaction after the second dose of Pfizer vaccine was numb right arm immediately after the i... Read more
My first reaction after the second dose of Pfizer vaccine was numb right arm immediately after the injection. This was followed by a feeling of shakiness and cold sweating. After about 20 minutes my heart started racing and hives/rash on neck and chest. After about 30 minutes of observation I was told to go straight to urgent care. I went to Accelerated Urgent Care. I received a shot of I believe Dexamethasone and was prescribed prednisone. Throughout the weekend following the injection on Friday I have felt tired and have had moderate diarrhea and feelings of being flushed.
30 2021-02-01 tingling Received 1st dose Pfizer COVID vaccine at 8:36am. At 9:43 am patient complained of chest tightness ... Read more
Received 1st dose Pfizer COVID vaccine at 8:36am. At 9:43 am patient complained of chest tightness and shortness of breath. Facial redness and tension. Complained of facial tingling and cheeks feeling "tingly". Administered 1 epi-pen to right thigh at9:00am. Continued to complain of chest pain, throat tightness, and facial tingling and numbness. Administered 2nd epi-pen at9:04am and 911 called. Patient transported to ER.
30 2021-02-02 pain in extremity 8am: fatigue, sore arm. 12pm: extreme fatigue, really sore arm, fever. 4pm: extreme fatigue, really ... Read more
8am: fatigue, sore arm. 12pm: extreme fatigue, really sore arm, fever. 4pm: extreme fatigue, really sore arm, fever, nausea. 8pm: extreme fatigue, really sore arm, fever, nausea, headache. 8am 1/21: totally fine.
30 2021-02-02 feeling hot Patient reports she felt hot, dizzy and nauseated. She did have a syncopal episode which she has had... Read more
Patient reports she felt hot, dizzy and nauseated. She did have a syncopal episode which she has had in the past during stressful experiences. She reports some chest tightness. Patient was transferred via EMS to hospital after being given Zofran 4mg IVP for nausea. She was administered Decadron 8mg IVP at the hospital along with K-tab 20mEq for hypokalemia. She was released and stated she felt better.
30 2021-02-02 tingling patient had vaccine and more than 15 minutes later after she left the clinic she came back with c/o ... Read more
patient had vaccine and more than 15 minutes later after she left the clinic she came back with c/o sob, tingling in hands and throat. Had previously felt the throat tingling when she had covid-19 virus. Patient reported anxiety and was tachycardia and hypertensive. sat in clinic for additional thirty minutes and vitals normalized and no further complaints.
30 2021-02-03 tingling Five to ten minutes after the vaccine I got red, head itched/sweaty and face was tingly as well as h... Read more
Five to ten minutes after the vaccine I got red, head itched/sweaty and face was tingly as well as hands. My heart rate went up to 186 I became Tachycardia. I t came in all of a sudden. I ended up going to the E. They gave me IV fluids, Benadryl thru the IV. They also did a CT scan on my brain. After three hours they discharged me . I felt Tachycardia for about two days after. After the 2-3 day I felt better. I had another Tachycardia episode on January 25,2021- I was scheduled to get my second dose but didn't get it done. It just hit me and my heart rate went up, it has not gone away and have been dealing with it for about two weeks. I have a heart monitor on me. I saw a Gastrologist and they want to do an EGD to rule out ulcers. I'm not able to eat without feeling a hot rush and my heart rate going up. I have lost 12lbs since the 20th.
30 2021-02-03 feeling hot, weakness, feeling cold I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off... Read more
I was so faint/nearly passed out; so hot; very chilled for about 15 or 20 minutes; feeling sort "off"; weak; fatigued/very drained/exhausted; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176), via an unspecified route of administration on 19Jan2021 at 08:15 AM at single dose in right arm for COVID-19 immunisation. Patient age at time of vaccination was years 30 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. The patient had no relevant medical history and received no concomitant medications. The patient reported the following: 'About 5 minutes after receiving the vaccine I was so faint I nearly passed out and was so hot I was given an ice pack to try and cool me down. It took about 45 minutes for me to be able walk across one room. I then was very chilled for about 15 or 20 minutes, and very drained. The rest of the day I was back and forth between feeling sort "off" and feeling like I was weak, exhausted, and fatigued'. Adverse events onset date was reported as 19Jan2021 at 08:15 AM. No treatment was received for the events other than ice pack for feeling hot. The patient was recovering from the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
30 2021-02-03 flushing Patient complained of feeling flushed, sweaty, and nauseated. She was given water and laid down. V... Read more
Patient complained of feeling flushed, sweaty, and nauseated. She was given water and laid down. Vital signs: BP 120/77, HR 89, O2 99% on room air. Monitored for additional 20 minutes and patient's symptoms resolved.
30 2021-02-03 pain in extremity Severe arm soreness; This is a spontaneous report from a non-contactable other health professional A... Read more
Severe arm soreness; This is a spontaneous report from a non-contactable other health professional A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. Vaccine location: Left arm, Dose number:1. The patient medical history and concomitant medications were not reported. The patient experienced severe arm soreness on an unspecified date with outcome of unknown. The action taken was not applicable. No follow-up attempts are possible; information about lot/batch number cannot be obtained
30 2021-02-03 tremor anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting fo... Read more
anaphylactic reaction; had a fever of 100.8; This is a spontaneous report from a nurse reporting for herself. A 30-years-old female patient received the first dose of bnt162b2 (BNT162B2; Lot # EL0140) vaccine , via an unspecified route of administration on 13Jan2021 at single dose for Covid-19 prophylaxis . Medical history included ongoing asthma Diagnosed when she was a child , seasonal allergy , food allergy , contrast media allergy (gadolinium). There were no concomitant medications. The patient experienced anaphylactic reaction on 13Jan2021 with outcome of recovered , had a fever of 100.8 on 13Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included allergy test: unknown results on Jan2021 , body temperature: 100.8 on 13Jan2021. The reaction began 28 minutes later. She says she started to get jumpy, her hands swelled and got itchy. She couldn't bend her hands, they were so swollen that she couldn't bend them. Her legs were shaking. Then saline and eventually her mouth started to get numb and they used an Epi pen twice. Her throat never closed, she thinks it did not close because the Epi pen was done twice, She had 2 masks on she cannot say for sure if she had trouble breathing but her mouth began to get dry and tingly and she started to no be able to feel her mouth. She says she would says it was resolved completely the next day. The patient also received Decadron and Benadryl. The reporter would say the event were life threatening because they treat it that way due to anaphylaxis precautions. Follow up information has been requested.
30 2021-02-04 weakness Elevated heart rate that is almost like in her throat; Low grade fever; weakness that comes and goes... Read more
Elevated heart rate that is almost like in her throat; Low grade fever; weakness that comes and goes/Very weak; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899), via an unspecified route of administration on 20Jan2021 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 20Jan2021, the patient experienced weakness that comes and goes/very weak. The patient reported that it started an hour and a half after the COVID-19 Vaccine. Comes in waves. At the time of the report, the patient stated that it was starting to subside, but after a while it will come back again. The patient added that she trying to fight through the weakness, but it was stopping her from doing things. The patient also experienced low grade fever on 20Jan2021 that was fluctuating. In the evening of 21Jan2021, the patient experienced elevated heart rate that was almost like in her throat. Heart rate was normally between 75-80, but it continues to jump over 100. The outcome of the events was not recovered.
30 2021-02-04 burning sensation Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: burning form the inside out some dizziness Lot: EN9581 Time of Administration: 14:37 Time Symptoms Began: _____ Patient alerted observer who took the patient to the medical observation area. I was alerted and responded. Initial Assessment @ _2:44p_: Patient is AAO. The employee is sitting up on the sofa. The employee is pink and does not appear to be in distress. They are talking and making conversation. Vitals @: 2:44pm HR: 98 BP: 163 / 95 - BP is usually 100/70ish O2: 99 Vitals @: 2:46pm HR: 84 BP: O2: 98 Vitals @: 2:49pm HR: 65 BP: 135/96 O2: 99% Patient is feeling much better. She no longer feels hot. Discharged at 2:52pm
30 2021-02-05 migraine Body aches, burning sinus cavity, migraine, loss of appetite
30 2021-02-05 migraine Severe migraine lasting 24 hours that was incapacitating.
30 2021-02-05 feeling hot Shortly after receiving the Covid-19 vaccination, patient reported "feeling hot", "dizzy", "nausea",... Read more
Shortly after receiving the Covid-19 vaccination, patient reported "feeling hot", "dizzy", "nausea", and felt like she was going to "pass out". She was evaluated by medical staff. Initially presented as hypertensive and slightly tachycardic. She declined transfer to an Emergency Room. She was evaluated by medical staff for 30+ minutes. By 30 minutes she verbalized an improvement in her symptoms. Vitals at that time. She was instructed to seek emergency care if her symptoms worsened. BP 148/90 HR 98 O2 100% RR 16 T mildly elevated at 100.1F. She again expressed she wanted to leave. She left with her sister (her sister accompanied her to the appointment and was present throughout the entire evaluation).
30 2021-02-05 weakness, inability to speak Vaccine started at 4. Roughly 5 minutes after, I raised my hand in the waiting for for the male nurs... Read more
Vaccine started at 4. Roughly 5 minutes after, I raised my hand in the waiting for for the male nurse to come over due to symptoms of dizziness, loss of consciousness, ?blacking out?, and confusion. The male nurse came over and started seeing signs of profuse sweating as water began dripping from all over my body. 5 minutes after that I started heaving and gasping for air unaroused next to the nurse as he took my blood pressure. Blood pressure dropped to 85/76. I started breathing heavy, sweating uncontrollably and couldn?t talk or stand. I remained hardly alert and almost passed out due to weakness.
30 2021-02-06 weakness, pain in extremity At around 3 am started intense shivers, temp was over 100, spent night with chills and shivers, and ... Read more
At around 3 am started intense shivers, temp was over 100, spent night with chills and shivers, and couldnt move my injection site arm due to pain. Next morning, had intense headache, joint pain, and my eyes burned. Couldn't get up without assistance because of how weak I was. Fever 102.6 around noon took tylenol. Don't think i have ever felt this sick in my life. Fever all day over 100. Sweating, muscle and joint pain (worse at joint between neck and head, hips and wrists). Nausea throughout, had soup to hydrate at around 5pm. Started to feel better but fatigued still with fever of 100 by midnight. Spent night sweating with headache, woke up 2/7 still with 99.8 temp, much lower temp without tylenol. Throughout the day i have had joint and muscle aches, and fatigue, a mild headache. Finally around 4pm stated to improve, haven't had a fever since noon, still achy but have a little more energy.
30 2021-02-06 pain in extremity Flu symptoms 1 hour after getting home . Fatigue, runny nose, red eyes, tired eyes, body aches, diar... Read more
Flu symptoms 1 hour after getting home . Fatigue, runny nose, red eyes, tired eyes, body aches, diarrhea . Sore arm, swelling, painful to move arm
30 2021-02-07 numbness, tremor "Trembling ,numbness to her upper arm and lower extremities, felt dizzy and near syncopal" vitals 7... Read more
"Trembling ,numbness to her upper arm and lower extremities, felt dizzy and near syncopal" vitals 78/55 pulse 58 O2 sat 100% , " patient was pale ,felt uncomfortable reported nausea, was given oral hydration EMS was dispatched and she agreed to be taken to nearest Emergency room repeat BP 100/59 pulse 62
30 2021-02-07 unresponsive to stimuli DOB 06/15/1990 female received Pfizer vaccine 1st dose at 1045, was observed for 15 minutes, no reac... Read more
DOB 06/15/1990 female received Pfizer vaccine 1st dose at 1045, was observed for 15 minutes, no reaction noted. Post vaccine was rounding on floors when she began to feel ill and dizzy. Was brought back down to her department where she became unresponsive. Rapid Response was call and patient was taken to the ER at approximately 1:20 P.M. At 3:00 P.M. Patient remained in the ER pending discharge. Stated feeling well, dizziness had subsided and no longer feeling ill. States she had not eaten breakfast and had been experiencing stress
30 2021-02-07 inability to speak, flushing, muscle spasms, pain in extremity, sensory loss Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. A... Read more
Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks". Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure. I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities. Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe. Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm). Other non-severe effects included fatigue, slight chills/flush.
30 2021-02-07 tingling, numbness Nausea; Elevated Heart Rate (24+Hours After); Tingling; Numbness of the arm (24+ Hours); Pain in the... Read more
Nausea; Elevated Heart Rate (24+Hours After); Tingling; Numbness of the arm (24+ Hours); Pain in the armpit (started approx 36 hours after the injection; Fever; Pain in hips and entire back; Pain in hips and entire back; Headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received second dose of bnt162b2 (Brand: Pfizer, Lot number: EJ1686), via an unspecified route of administration in left arm on 19Jan2021 15:45 at single dose for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient previous received first dose of bnt162b2 (Brand: Pfizer, Lot number: EK9231), via an unspecified route of administration in left arm on 29Dec2020 07:00 AM for covid-19 immunization. The patient experienced nausea, elevated heart rate (24+hours after), tingling, numbness of the arm (24+ hours), pain in the armpit (started approx 36 hours after the injection), fever, pain in hips and entire back, headache (24+ hours) all on 19Jan2021 19:30. The patient underwent lab tests and procedures which included heart rate: elevated on 19Jan2021. The outcome of events was not resolved. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment received. No other vaccine in four weeks. Other medications in two weeks: Birth control. No COVID prior vaccination. No COVID tested post vaccination. Not known allergies. No follow up attempts are possible. No further information is expected.
30 2021-02-07 flushing Patient at site for 1st dose of COVID Vaccine. Patient approximately 2 minutes after receiving vacc... Read more
Patient at site for 1st dose of COVID Vaccine. Patient approximately 2 minutes after receiving vaccine at 1028 started feeling tongue swelling with throat itching. Patient taken to first aid room where she was assessed by provider and ems on duty. Patients skin was red and flushed and with slight swelling of the tongue noted. Patient still A7 O x4 with respirations even and unlabored. Patient had O2Sat of 96% on RA. Patient states she has an allergy to all Bovine proteins and had a mini-stroke approximately 4-5 years ago. Patient is a healthcare worker and is currently at home with newborn son. Provider ordered Benadryl 25mg PO and pt received 1st dose at 1045. Then provider ordered a second dose of Benadryl 25mg after patient stated her Jaw felt "Wonky" and patient received at 1048. Pt slowly responded to treatment and after 15 minutes from first dose of Benadryl patient had a decrease in redness and tongue swelling. Itching was slowly decreasing. At 1105 patient stated itching had subsided and by 1110 patient had a full return to baseline. Pt discharged at 11:15 home and pt communicated understanding that she was ok to drive and that she should follow up with PCP prior to receiving second dose of vaccine. Also, patient was able to communicate understanding of a rescue plan at home if symptoms should flare up again. Patient stated she did have an epi pen at home as well and note if she needed to she would use epi-pen and seek immediate medical attention after use.
30 2021-02-07 pain in extremity Sore arm; Swollen injection site and halo formation; This is a spontaneous report from a non-contact... Read more
Sore arm; Swollen injection site and halo formation; This is a spontaneous report from a non-contactable consumer reported for herself. A 30-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration on 20Jan2021 11:15 on right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at workplace clinic. Medical history and concomitant medications were not reported. The patient experienced sore arm within 20 minutes from vaccination on 20Jan2021 11:30, swollen injection site and halo formation at 18h on 20Jan2021. Soreness subsided after 72h. No treatment was received for the events. The outcome of the events were resolving. No follow-up attempts are possible. No further information is expected.
30 2021-02-07 tremor high fever of 101.8; body aches; headache; rigors/chills; shaking; increased pain at injection site;... Read more
high fever of 101.8; body aches; headache; rigors/chills; shaking; increased pain at injection site; one instance of vomiting; This is a spontaneous report from a contactable other health professional (patient). A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: El3302, via an unspecified route of administration on 20Jan2021 02:00 at a SINGLE DOSE for covid-19 immunization. Medical history included allergies to penicillin and cephalosporin. Patient received her first dose of BNT162B2 on 30Dec2020 at (12:00) (lot number: ELO140), (in the right arm) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient developed a high fever of 101.8 (unit not provided), chills, body aches, headache, rigors, shaking, increased pain at injection site, and one instance of vomiting starting approximately 6 hours after her second dose (for clarification) of the vaccine (20Jan2021, 20:00). the outcome of event was reported as 'recovering'. the patient did not receive any treatment due to the events. The events were considered as non-serious by the reporter. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
30 2021-02-07 pain in extremity nervous; back started to itch/There was irritation; back felt itchy; back felt itchy and pinkish red... Read more
nervous; back started to itch/There was irritation; back felt itchy; back felt itchy and pinkish red/back was red; Arm soreness; This is a spontaneous report from a contactable consumer (patient) via a Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. Medical history included steel rods in back from 2006 and ongoing. The patient's concomitant medications were not reported. The patient was vaccinated and felt fine. She experienced arm soreness on 20Jan2021 originally. Then today, it was so bizarre, about an hour and a half ago, her back started to itch on 22Jan2021. There was irritation. She checked in the mirror, and her back was red on 22Jan2021. She was wondering if this was a reaction from the vaccine. She was getting nervous. A medical student gave her the vaccine. She didn't have a prescribing doctor. Twenty minutes after getting the vaccine, she noticed the arm soreness. It was worse yesterday, but today she thinks it is the same or maybe a little better. The irritation on her back seems a little better since she first noticed it. The outcome of the events back felt itchy and pinkish red and irritation was recovering. The outcome of the event arm soreness was not recovered. The outcome of the event nervous was unknown.
30 2021-02-08 weakness Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent... Read more
Approximately 12 days after vaccination co began to have fatigue, weakness, Pancytopenia Recent hospitalization which involved initial presentation at hospital on AK 12/29, and then again on 12/30, after eval on 12/30 was then transferred to another hospital, and later transferred where she later recovered and was discharged. She was initially very ill and was thought to have sepsis due to fever/initial presentation/clinical picture, also had lab abnormalities including thrombocytopenia. These things necessitated transfer. While at hospital, hematology was consulted. Decision was made to transfer due to concern for DIC/possibility of leukemia. Also there was concern for C Diff, treatment was given for this. While in hospital, she underwent further testing on blood samples which revealed no evidence for malignancy, also bone marrow biopsy was performed. While there, DIC labs were trended/began to improve. Discharged on 1/5/21. Had f/u with hematology @ hospital on 1/12/21. No reason has been found as of yet as to why she became ill. Per discharge note it's thought it could have been viral in nature, or possibly related to supplement use. Will f/u with heme in early Feb. Of note, she does report getting her first dose of pfizer covid vaccine on 12/17/20, she reports concern that this could have played a part in her illness. She states this was the only new/out of the ordinary thing that she can remember recently, regarding her medical hx, prior to recent acute illness/hospitalization. Requests I reach out to inquire how she can file a report with Pfizer or CDC
30 2021-02-08 numbness I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there fo... Read more
I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there for 15 minutes and nothing happened. I get home and still felt fine. Around 6:30 pm I started to feel neck pain and stiffness as I continued to do house chores the pain just kept going up towards my neck into my left cheek where I feel numbness. My throat and jaw hurt as well. My neck is stiff and I can?t look to the left unless I turn my body. The back my head is also starting to hurt. My arm is sore where the shot was given but what hurts most is my neck, throat and head. I have body chills but no fever. I took Tylenol and called the dr on demand who told me to take Benedryl and if the symptoms got worse to go to the hospital.
30 2021-02-08 paralysis, pain in extremity Pt. describes severe pain in her left arm within 12 hours of administration. She also reports a fee... Read more
Pt. describes severe pain in her left arm within 12 hours of administration. She also reports a feeling of "paralysis" and severe "sluggishness." She has mental foginess. Her symptoms lasted 4-5hrs. This occurred again about 24hrs after administration.
30 2021-02-08 flushing sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report fr... Read more
sudden onset lower lip angioedema- only on the right side of my lip; This is a spontaneous report from a contactable Other HCP. This other HCP reported different events for the same patient during diffferient vaccination dose. This case is referred to the second vaccine dose A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL3247 intramuscular on 13Jan2021 12:30 second dose at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Hospital . Vaccine location: right arm Medical history included asthma, eczema, hypersensitivity, anxiety and depression. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan (RIZATRIPTAN), salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levocetirizine dihydrochloride (XYZAL), betamethasone (BETAMETHASONE). The patient previously took aspirin and experienced rash. The patient experienced flushing, palpitations and hyperhidrosis after the first dose of bnt162b2 vaccine. The patient experienced sudden onset lower lip angioedema- only on the right side of my lip on 16Jan2021 20:30 with outcome of recovered. The action taken was not applicable. Therapeutic measures were taken: benadryl inhaler self treated, consultation w/allergist and allergy testing. The reporter stated "developed sudden onset lower lip angioedema only on the right side of my lip. I took 50mg benadryl and my inhaler and monitored- I never developed itching, additional swelling, difficulty breathing or other symptoms of anaphylaxis. Swelling had resolved by morning. I had no other new exposures that have yet been identified, although I am going through a work up with an allergist."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021073355 Same patient/ drug, different dose/AE.
30 2021-02-08 tingling tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills... Read more
tingling with pins and needles feeling all through arms, legs, face; nausea; dizziness sight; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on the left arm on 21Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included "Celtics disease", allergies to gluten and negative COVID-19 test nasal swab on 10Oct2020. Concomitant medication included birth control and prenatal vitamin. Patient did not have COVID prior to vaccination and was not pregnant. Vaccination was received in the hospital and no other vaccine was received four weeks prior. On 21Jan2021 16:00, the patient reported nausea, dizziness sight and chills were normal then she had tingling with pins and needles feeling all through arms, legs, face. She still had prickling feeling in arms and her left foot was tingling and it had been four days later. The adverse events pins and needles reportedly resulted in disability or permanent damage. Patient has been tested for COVID post-vaccination on an unspecified date with unknown results. Treatment was received for the events. Outcome of the events was not recovered.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of prickling feeling in arms and her left foot tingling cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
30 2021-02-09 tingling, numbness Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted for over 1... Read more
Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted for over 18 hours; Tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted for over 18 hours; This is a spontaneous report from a contactable nurse. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL1284, intramuscular at left arm on 04Jan2021 11:45 at a single dose for COVID-19 immunisation. Medical history included asthma. The patient was not pregnant. Concomitant medications were not reported. On 04Jan2021, the patient experienced tingling and numbness in left forearm and left lower leg extending to all 5 toes, lasted for over 18 hours. The patient tested negative on COVID test by nasal swab on 12Jan2021. The patient did not receive any treatment. The outcome of the events was recovered on an unspecified date.
30 2021-02-09 flushing flushing; palpitations; diaphoresis; This is a spontaneous report from a contactable other HCP repor... Read more
flushing; palpitations; diaphoresis; This is a spontaneous report from a contactable other HCP reported for self. This 30-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via intramuscular on 23Dec2020 at 12:30 at single dose in right arm for COVID-19 immunization. The patient's medical history included asthma, environmental allergies, eczema, anxiety/depression. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 24) 1/20, bupropion hydrochloride (WELLBUTRIN XL), fluoxetine hydrochloride (PROZAC), rizatriptan, salbutamol (ALBUTEROL) inhaler, fluticasone propionate (FLONASE), levocetirizine dihydrochloride (XYZAL), betamethasone topical. The patient had none known allergies although possible rash with acetylsalicylic acid (ASPIRIN) in the past- other NSAIDs are fine. The patient experienced flushing/palpitations/diaphoresis about 5 minutes after she received the vaccine, but this resolved quickly and spontaneously. Information on lot/batch number has been requested.
30 2021-02-10 discomfort, feeling of body temperature change She reports with a few minutes she felt light headed, dizzy and mentally disconnected. Symptoms incl... Read more
She reports with a few minutes she felt light headed, dizzy and mentally disconnected. Symptoms included feeling nonspecific discomfort, hot, cold, palpitations, nausea. She states her chest cavity felt strange and can best describe it as internal burning. She states breathing was strange, and was 'almost' SOB. She felt palpitations. They seated her in a chair for 15 minutes and observed her for 35-45 minutes. Her VS were normal. She denies pruritis, urticaria, flushing, sweating, cough, wheeze, oral/facial/throat/tongue swelling, red/watery eyes. She went home and continued to feel uncomfortable and restless. She had one emesis. She took a Tylenol pm at 19:00 and slept until about midnight. She reports the restlessness and discomfort stopped, but she then felt flulike symptoms (malaise, myalgias) for the next 3 days. She noted onset of edema at the injection site day 1, but no erythema or dermatitis.
30 2021-02-11 discomfort enlarged lymph node in armpit of the side the injection was on; uncomfortable; uneasy to keep her ar... Read more
enlarged lymph node in armpit of the side the injection was on; uncomfortable; uneasy to keep her arm down; This is a spontaneous report from a contactable other healthcare professional (hcp). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number ELI284, expiry date not reported), intramuscular on 29Dec2020 07:30 at a single dose in the left arm for COVID-19 immunization. The patient had no medical history. Patient had no COVID prior vaccination and had no known allergies. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks and no other medications in two weeks. Patient was just reporting symptoms experienced outside of normal symptoms that she was aware of: enlarged lymph node in armpit of the side the injection was on that began swelling about 7-10 days post vaccine and subsided after two days (Jan2021). Swelling of armpit lymph node was very uncomfortable and uneasy to keep her arm down. Again, went away after two consecutive days. No treatments received in response to the events reported. The patient was not tested for COVID post vaccination. The outcome of the event "enlarged lymph node in armpit of the side the injection", uneasy to keep her arm down, and uncomfortable was recovered in Jan2021.
30 2021-02-14 weakness Fatigue; Chills and Sweats; Chills and Sweats; Fever (102); Headache; Muscle aches; Weakness; Cough;... Read more
Fatigue; Chills and Sweats; Chills and Sweats; Fever (102); Headache; Muscle aches; Weakness; Cough; Out of Breath; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient receives the 2nd dose of bnt162b2 (BNT162B2, lot # EL9264) at single dose at left arm on 27Jan2021 14:30 at 30 years for covid-19 immunisation, administered at hospital. Medical history included bladder cancer. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. The patient previously received the 1st dose of bnt162b2 (BNT162B2, lot # E1L9L31) at single dose at left arm on 04Jan2021 for covid-19 immunisation. The patient had not received other vaccines within 4 weeks prior to the COVID vaccine. On 28Jan2021 01:00 the patient experienced fatigue, chills and sweats, fever (102), headache, muscle aches, weakness, cough, out of breath. The patient underwent lab tests and procedures which included body temperature: 102 on 28Jan2021. No treatment received for the adverse events. Since the vaccination, has the patient been not tested for COVID-19. The outcome of events was recovering. Case was reported as non serious. No follow-up attempts are possible. No further information is expected.
30 2021-02-14 pain in extremity When I took this vaccine the next day my body was aching especially my arm. Then on the 5th I have b... Read more
When I took this vaccine the next day my body was aching especially my arm. Then on the 5th I have been experiencing nosebleed n stuffy nose. I am still experiencing this now. Today is the 15 of February. Mine you I took this vaccine on the 3rd of February.
30 2021-02-14 pain in extremity fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and l... Read more
fever of 104 F; dizzy; my arm was so sore I could not lift it/ My body ached mostly in my legs and lower back; felt soreness at the injection site; felt extremely nauseated; My body ached mostly in my legs and lower back; Body aches/extreme tiredness; headache; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 09:45 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EJ1686. Medical history and concomitant medications were unknown. Historical vaccination included flu vaccine for immunization (vaccination site pain). About 6 hrs after vaccine on 07Jan2121, the patient felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine on 07Jan2021, arm was so sore that the patient could not lift it. That night the patient took two Tylenol and had to wrap arm in a heating pad. The patient woke up around at 03:00 on 08Jan2021 with a fever of 104 F; the patient was so dizzy from the high fever. The patient felt extremely nauseated on 07Jan2021. Body ached mostly in my legs and lower back on 07Jan2021. It hurt to sit on the toilet, to put on clothes. On 07Jan2021, the patient experienced body aches/extreme tiredness. On 07Jan2021, the patient experienced headache 8as reported). Fevers happened at night-time ranging from 102-104F for 4 days. Injection site soreness lasted for 7 days. Body aches/extreme tiredness lasted around 2-3 days. Dizziness subsided after fever broke, but it was replaced with a severe headache lasting 2 days (as reported). The patient was not COVID tested post vaccination. The patient recovered from the events. No follow-up attempts are possible. No further information is expected.
30 2021-02-15 numbness, tingling Soreness at injection site starting night of 2/15. Ulnar numbness abs tingling in forearm and hand o... Read more
Soreness at injection site starting night of 2/15. Ulnar numbness abs tingling in forearm and hand of left arm. (Same side as injection)
30 2021-02-18 pain in extremity She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction t... Read more
She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26. She had hives on her neck, arms chest, headache arm pain and mild dizziness. Symptoms resolved with Benadryl She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER. She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80) given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen With ongoing asthma, dizziness, light headed , nausea and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list
30 2021-02-21 inability to speak Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of ... Read more
Fine for hour or so then began to lose voice slowly over the next few hours and cough. Shortness of breath from simply walking around swelling of the glands and consul in the neck and throat
30 2021-02-23 tingling Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previou... Read more
Noted difficulty swallowing 10 minutes post vaccination. Observed, given water, client notes previous rx to radio active iodine. Notes scratchy throat, tingling and puffy lips. Symptoms did not worsen over 60 minutes in observation. No difficulty breathing. Advised to take benedryl and seek medical attention if symptoms worsen. Patient left with her mother. RN called later in the evening, client confirmed sxs improved with Benedryl, feeling better.
30 2021-02-25 flushing Experienced malaise, dizziness, nausea, flushing 15 minutes after receiving dose 2. Patient reported... Read more
Experienced malaise, dizziness, nausea, flushing 15 minutes after receiving dose 2. Patient reported no side effects on dose 1 received 2/5/2021. Additional 30 minutes of monitoring was performed, which the symptoms persisted. Patient instructed to call out from her shift and go home after.
30 2021-02-25 feeling cold Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from... Read more
Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from a contactable consumer reporting for herself. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 10Feb2021 at single dose in Left arm for COVID-19 immunisation. Medical history included coeliac disease from an unknown date. There were no Allergies to medications, food, or other products. The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), on 20Jan2021 at the age of 30-year-old at single dose in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Painful left arm (where vaccinated). She experienced flu like aches the day after vaccination as well as feeling cold on 11Feb2021. Since the vaccination, the patient had not been tested for COVID-19There was no treatment received for the adverse event. The outcome of events was recovered. The events were reported as non-serious.
30 2021-02-27 nerve pain 1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above righ... Read more
1/1/21- Severe right side eye pain 1/3/21 - Appearance of vesicular rash with sever pain above right eyelid 1/3/21 - Diagnosed with Zoster Ophthalmicus of Right Eye at urgent care and initiated on Valacyclovir 1000 mg PO TID x 10 days 1/4/21 - Ganciclovir eye drops added to treatment course 1/10/21- Rash crusted and resolved but with severe neuropathic pain and itch 1/12/21 - Second dose of COVID vaccine received
30 2021-02-27 weakness, pain in extremity intermittent pain on my left hand-arm only: from fingers to elbow The pain came like waves, intensif... Read more
intermittent pain on my left hand-arm only: from fingers to elbow The pain came like waves, intensified within 5-10 minutes, and stayed at that pain level:6 for 2 hours. At that time I couldn't use my left hand at all. The total duration of each episode is around 4-5 hours and it almost turned to normal afterward. I had 6 cycles of intermittent pain. 02/08/2021: one in the afternoon, one in the evening It started on my fingers (left hand). restriction with the movement due to pain and weakness. I could still hold objects but it hurt and I didn't want to use my left hand at all. I took OTC ibuprofen in the afternoon, but it didn't help. 02/09/2021: woke up at 6-7 am due to pain. the pain reached to my elbow. total of 3 pain cycles. 02/11/2021: 1 mild pain cycle and then the pain resolved.
30 2021-02-28 tingling, numbness 2-26-21 8pm bump quarter sized to injection site, numbness and tingling lasting half an hour after t... Read more
2-26-21 8pm bump quarter sized to injection site, numbness and tingling lasting half an hour after taking ibuprofen, today reports itching. reports area of bump is now larger at the size of a golf ball
30 2021-02-28 migraine Nausea, diarrhea, migraine, chills, body aches, dizziness, sinus and chest congestion
30 2021-02-28 hypersensitivity of all senses Pain at injection site, fever, chills, joint aches, overly sensitive to physical stimuli. Began abou... Read more
Pain at injection site, fever, chills, joint aches, overly sensitive to physical stimuli. Began about 6 hours after vaccine was administered and lasted about 24 hours. Standard OTC dose of ibuprofen every 6 hours provided slight relief.
30 2021-02-28 weakness Parsonage Turner Syndrome. Severe debilitating pain in right shoulder beginning 2/2/2021 that beca... Read more
Parsonage Turner Syndrome. Severe debilitating pain in right shoulder beginning 2/2/2021 that became progressively worse throughout the day. Decreased range of motion, unable to lift/move arm by evening. The following day range of motion gradually returned but was clunky and limited. Over the next 4 days profound weakness with intermittent sharp stabbing pain in the joint. Utilized ibuprofen, Tylenol, flexeril, and heat with minimal relief. PCP 2/11/2021 prescribed medrol dose pack, x-ray shoulder, mri shoulder and referral to ortho. 2/11/2021 X-ray normal. 2/24/2021 Mri showed disfuse fluid signal with recommendation to pursue neurogenic approach. Saw Ortho on 2/19/2021. They ordered PT, scheduled to begin 3/17/2021 (first available). Spoke with PCP 3/1/2021, referral to physiatry placed for EMG and possible joint injection. Have been utilizing NMES and doing basic range of motion exercises. Continue to have severe muscle weakness.
30 2021-02-28 burning sensation mild discomfort to my urethra; UTI symptoms; Burning upon urination; pain upon urination; urgency; f... Read more
mild discomfort to my urethra; UTI symptoms; Burning upon urination; pain upon urination; urgency; frequency; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL0140) solution for injection, via an unspecified route of administration in left arm on 28Dec2020 15:45 at a single dose for Covid-19 immunization. Medical history included Hashimoto's Thyroiditis. Patient was not pregnant. The patient's concomitant medications included levothyroxine, unspecified daily multivitamin, and collagen. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and had allergies. The patient experienced UTI symptoms, burning upon urination, pain upon urination, urgency, and frequency on 29Dec2020, and mild discomfort to her urethra on an unspecified date. The patient visited her physician. Patient received antibiotic - Keflex. The patient underwent lab tests which included culture: no bacterial growth on an unknown date, Covid-19 rapid swab: negative on an unknown date, and urine analysis: urine had leukocytes and blood present on an unknown date. Outcome of the event mild discomfort to my urethra was unknown while the rest was recovered. No follow-up attempts are possible. No further information is expected. Information about lot/batch number has been obtained.
30 2021-02-28 pain in extremity whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; ... Read more
whole body felt sore and exhausted; whole body felt sore and exhausted; bad cold/flu; bad cold/flu; little chest pain; minor fever; blood pressure dropped; dizziness; backpain; left arm felt sore; sleepy/light drowsiness; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration on the left arm on 11Feb2021 15:30 at a single dose (at the age of 30-years-old) for COVID-19 immunization. Medical history included >13 years ago: diagnosed TB with no symptom, completed TB treatment 1 year-plan and has issue no since then; >16 years ago: Hepatitis-b positive but received treatment and cleared out on diagnostics afterward. The patient was not pregnant. Concomitant medications were not reported. The patient had no COVID prior to vaccination. The patient has no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 21Jan2021 at 13:15 on the left arm at a single dose (at the age of 30-years-old) for COVID-19 immunization. After about 4.5h post-vaccination (20:00), her left arm felt sore and within the next 3h, she felt sleepy and experienced random light drowsiness. She woke up around 06:30 the next day (12Feb2021) only felt continued sore arm. However, at 08:30 to 09:30, her whole body felt sore and exhausted, especially back pain, as if she having a bad cold/flu. She also felt a little chest pain, had a minor fever and went sleeping from 12:00, woke up around 18:00-19:00. The whole body ache was almost gone but her back was still in pain and her blood pressure dropped with random dizziness when she was walking or standing up. The next morning (13Feb2021), the back pain was gone and she felt it back to normal except for a little random dizziness in movement. She did not take any medication to alleviate the adverse effects during the timeline. The patient was not COVID tested post vaccination. The patient recovered from back pain in 13Feb2021, the patient recovered from the remaining events in Feb2021.
30 2021-03-01 tenderness Fatigue (began noticing 8 hours after injection, slept a lot), body aches (20 hours after), chills (... Read more
Fatigue (began noticing 8 hours after injection, slept a lot), body aches (20 hours after), chills (20-24 hours after), fever (24-28 hours after). Symptoms continued until I took Tylenol following night (33 hours after injection). Pain/soreness at injection site almost immediately + swollen left underarm lymph nodes noticeable 40+ hours after. Tenderness and bruise-like pain there.
30 2021-03-02 numbness, migraine 11hrs after the vaccine I experienced numbness and tingling in my right eye, face, neck and tongue i... Read more
11hrs after the vaccine I experienced numbness and tingling in my right eye, face, neck and tongue in which I took already prescribed antihistimine medication for that. I developed a migrane the following day which lasted about 7 days and I alternated Ubrelvy and Sumatriptan to manage the migrane. I reached out to my allergist who monitored me vitually for a few days and finally all symptoms finally subsided.
30 2021-03-02 breast pain A few hours after the vaccine I started feeling fatigued and having chills. I was so tired and slee... Read more
A few hours after the vaccine I started feeling fatigued and having chills. I was so tired and sleepy I slept almost all day for the first 48 hrs after. Developed fever between 100.5-101 which lasted about 18hrs which did require me to have to call into work the following day. 2/3 I developed swelling and pain in the lymph nodes under my right arm and breast. The swelling subsided within 4days but I still have some tenderness to date. I took tylenol and ibuprophen for the first 48 hours to help with all the symptoms.
30 2021-03-02 cold sweat Fever of 101.5°, chills, cold sweats, headache, body aches, unable to sleep.
30 2021-03-03 pain in extremity Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for... Read more
Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for herself). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration single dose arm left (at the age of 30) on 02Feb2021 for covid-19 immunisation. No other vaccine was received in four weeks. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness on 02Feb2021, minor fatigue on 02Feb2021. No treatment received. The events outcome was recovered.
30 2021-03-03 flushing Patient reported being flushed; slightly short of breath; and a severe headache. EMS was called at t... Read more
Patient reported being flushed; slightly short of breath; and a severe headache. EMS was called at the patient's request and she was examined by them. She later saw her primary care provider that day and they reported she is fine.
30 2021-03-03 pain in extremity Sore arm, headache and fatigue following the first dose.
30 2021-03-03 weakness about 1 min and 30 sec to 2 mins after getting the vaccine, I felt as if I was about to faint (felt ... Read more
about 1 min and 30 sec to 2 mins after getting the vaccine, I felt as if I was about to faint (felt a draining in my body and my arms got very weak) my HR had gone from resting 85bpm to 108bpm (recorded on my watch) this lasted for about 30 seconds and went away
30 2021-03-04 weakness Muscle pain and tightness at injection site. Not being able to lift arm past shoulder height. Pain w... Read more
Muscle pain and tightness at injection site. Not being able to lift arm past shoulder height. Pain with touch or movement of arm. Severe headache, joint pain, generalized body aches, low grade fever, fatigue, chills, nausea and weakness. Called in sick to work. Rest, drinking water, a hot bath, muscle ache cream, alternating Tylenol and Motrin.
30 2021-03-06 feeling hot Bumpy, red rash turned flaky as it healed. Fatigued and feeling warmer than normal but no fever. Ras... Read more
Bumpy, red rash turned flaky as it healed. Fatigued and feeling warmer than normal but no fever. Rash on chest, back, and inner wrists. Benadryl taken twice daily until rashes subsided; about a week later.
30 2021-03-07 inability to speak Patient told nurse that after her 1st shot she had an itchy throat so she pre-medicated with Benadry... Read more
Patient told nurse that after her 1st shot she had an itchy throat so she pre-medicated with Benadryl at 8:20. Pt. was sent for 30 minute observation period. At 0840, pt. started complaining of throat itching, SOA and heart racing. It was hard to get words out. Denied trouble swallowing. Respirations fast and shallow. This lasted less than 2 minutes, denied CP. After 2 minutes, pt. started feeling better. Pt. encouraged to be assisted to ED for monitoring. Pt. stated feeling better and refused to go to ED. At 0900, pt. stated feeling much better and ready to check out. Pt. instructed to go to ED if worsening symptoms or new concerning symptoms. Pt. verbalized understanding.
30 2021-03-07 feeling cold Throat felt tight about 30 min after injection. Got extremely tired and cold. I could breathe but it... Read more
Throat felt tight about 30 min after injection. Got extremely tired and cold. I could breathe but it hurt to swallow. Stomach was burning a bit right under right rib cage. Head started to hurt at about the 1 hour mark. Lost all color in face - white as ghost. Fell asleep for 2 hours and woke up with color and much better. Throat was just scratchy. next morning throat was still scratchy but much better.
30 2021-03-08 pain in extremity, hot flush 20 minutes after injection inner ear pressure, light headedness, dizziness, faintness. Three hours a... Read more
20 minutes after injection inner ear pressure, light headedness, dizziness, faintness. Three hours after injection low grade fever, dizziness, fatigue. 24+ hours after injection headache, fever, arm soreness, inner ear pressure, hot flashes, neck tension, eye "floaters"
30 2021-03-09 feeling hot Vasovagal syncope, onset 1 hour after vaccine administration. Resolved in ~15 minutes, upon lying do... Read more
Vasovagal syncope, onset 1 hour after vaccine administration. Resolved in ~15 minutes, upon lying down. Sudden lightheadedness, seeing stars; tunnel hearing, then tinnitus; leaned forward and lightheadedness continued to worsen, so I laid the car seat back; suddenly felt hot and started sweating profusely; slight nausea; bradycardia (which I never have - I am on a prescription stimulant, and usually run >80 when seated). Called roommate to pick me up and take me back to the vaccine site to check with paramedics there before continuing home.
30 2021-03-10 pain in extremity "I experienced a severe headache, body aches, and fatigue the next morning after the shot for about ... Read more
"I experienced a severe headache, body aches, and fatigue the next morning after the shot for about 24 hours. My arm was sore for 72 hours, not just a little sore but considerably sore."
30 2021-03-10 tingling, numbness Developed left arm numbness and tingling distal to site of injection on the radial and ulnar side an... Read more
Developed left arm numbness and tingling distal to site of injection on the radial and ulnar side and entire hand. Preserved grip strength and sensation. Symptoms began to improve in ~15 minutes but did not resolve. Instructed to go to the ER if developed weakness, worsening signs/symptoms, or any new concerns.
30 2021-03-10 feeling hot Experienced swelling of tongue, difficulty swallowing, feeling hot, feeling of elevated heart rate. ... Read more
Experienced swelling of tongue, difficulty swallowing, feeling hot, feeling of elevated heart rate. Administered 25mg Diphenhydramine with improvement. Patient sent home at 1500 with significant other and instructions to go to the ED if symptoms persist or worsen.
30 2021-03-10 tingling, numbness Numbness on left side of body (face, arm, leg) onset at 12:25pm approximately 3 hours after leaving... Read more
Numbness on left side of body (face, arm, leg) onset at 12:25pm approximately 3 hours after leaving vaccination facility. Dizziness. Heart palpations. Numbness subsides 24 hours later, and had tingling sensations in left hand/ fingers 6 days later.
30 2021-03-11 tremor Client came to the POD for her Pfizer vaccine. Prior to receiving the vaccine, she stated that she i... Read more
Client came to the POD for her Pfizer vaccine. Prior to receiving the vaccine, she stated that she is afraid of needles and feels very anxious about getting the vaccine. After receiving the vaccine, as she walked away from the vaccinator, accompanied by the vaccinator assistant and her fiancée, she started to pass out. She was caught by her fiancée and did not fall. The EMS was called, she was slowly lowered to the floor, protected by a privacy screen and her legs were raised up. She regained consciousness after a few seconds, and immediately starting talking ? stating that she does not have any medical condition, but she has anxiety attacks which cause her to pass out. Client looked pale, sweaty and shaky. Her vital signs were as follows: BP=111/78; Pulse=83. Client stated that she felt better and would wait for 15 minutes and then leave. The EMS arrived, evaluated her but did not transport her to the hospital.
30 2021-03-11 tremor Due to extensive history of allergies and concerns she was pre-medicated 30 minutes prior to vaccina... Read more
Due to extensive history of allergies and concerns she was pre-medicated 30 minutes prior to vaccination with 25 mg of Benadryl. At 1209 she started getting anxious and having tingling on her tongue. She progressed to nausea, throat tightness, shaking and then chest pain. EMS was called to transport to the ED
30 2021-03-11 unresponsive to stimuli Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted immediately after inje... Read more
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted immediately after injection. Immunizer (RN) administered epinephrine and the patient arose from her fainting state with no issues. Patient stated that she always faints from every needle stick (did not inform the immunizer beforehand). Patient was monitored for 30 minutes before leaving.
30 2021-03-12 pain in extremity, migraine 4 days after my last vaccine I started getting really intense calf pain like a bad cramp. After the ... Read more
4 days after my last vaccine I started getting really intense calf pain like a bad cramp. After the pain just kept getting worse I ended up going to the ER on January 15th 2021. They did an ultrasound and found out I had a dvt. I was also experiencing horrible migraines since the 1st shot I also started seeing black spots in my vision. I also was having fevers and chills
30 2021-03-12 numbness, burning sensation, tingling, migraine I had a migraine for three days starting on wed and burning tingling and numbness in my hands feet ... Read more
I had a migraine for three days starting on wed and burning tingling and numbness in my hands feet back of my calf also, my veins in my wrist hurt and felt tight and by Friday night my face was starting to get numb. I also have a bad sore throat. I went to the hospital they ruled out blood clot and stroke. My Covid test was negative.
30 2021-03-13 feeling hot, pain in extremity, weakness Somnolence, pain in left arm, pain of left side of the body, problems with eyesight, feeling warm, a... Read more
Somnolence, pain in left arm, pain of left side of the body, problems with eyesight, feeling warm, annoyance, dizziness, weakness, liver and gallbladder pain.
30 2021-03-13 feeling cold, discomfort Starting around 11pm patient experienced mild fever, aches, chills. Overnight, fever increased, and ... Read more
Starting around 11pm patient experienced mild fever, aches, chills. Overnight, fever increased, and pt had moderate/severe chills, aches, discomfort. Pt took Tylenol and ibuprofen overnight and fever after medication was approx. 101F. The next morning, pt experienced syncope and vomiting. Nausea, dizziness, fatigue, aches, low grade fever (99.4F) and mild chills continued for approx 36-48 hours.
30 2021-03-14 unresponsive to stimuli History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on ... Read more
History, patient received 1st COVID-19 Pfizer vaccine on 1/28/21 and 2nd Pfizer COVID-19 vaccine on 2/17/21 Unsure if any relation but patient was treated in our urgent care on 3/8/2021 18 day post receipt of 2nd COVID-19 vaccine unresponsive. Patient received ACLS support for unknown cause with suspected neurological/respiratory/cardiac complications. Patient was transferred to higher level of care.
30 2021-03-14 tremor I received the second COVID vaccine (Pfizer-BioNTech) on 2/14/21. Within 12 hours of the vaccine, "n... Read more
I received the second COVID vaccine (Pfizer-BioNTech) on 2/14/21. Within 12 hours of the vaccine, "normal" reaction symptoms occurred including fever, chills, sweating and rigors, which was a shaking feeling in the legs, arms, torso and other areas of the body. These symptoms lasted 1.5 days and then seemed to disappear, only to appear again in waves over 10 days following the second vaccine. On day 10, I had a fever of 101.4. By 2 weeks out, most of the symptoms had dissipated aside from an internal shaking feeling which moves from the chest to the torso, legs etc. It's different all the time and but muscles are felt vibrating in the body and nearly 1 month later the vibrating symptoms are still present. The vibrating can be described like having an electric toothbrush inside your body.
30 2021-03-14 numbness Numbing of left leg/Numbing of left side of face; This is a spontaneous report received from a conta... Read more
Numbing of left leg/Numbing of left side of face; This is a spontaneous report received from a contactable pharmacist (patient herself). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number: EL3247 and expiry date: May2021) via an unspecified route of administration to left arm on 17Jan2021 12:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. She was administered vaccine about 12:30 on 17Jan2021 she sat there monitored for about 15 minutes. She reported the Numbing of left leg started while she was walking out, about 13:00 from her left leg down to her foot; her left arm was fine, there was no Numbing there or other areas of body or left side of body other than onset of Numbing of left side of face a little bit after onset of Numbing of left leg. She thought at first maybe it was from the way she had been sitting, but she had been sitting normal. The Numbing of left leg and Numbing of left side of face lasted for a couple of hours on 17Jan2021; resolved and she recovered completely as far as she is aware by 17Jan2021. She reported not serious for both events because it went away. She is due for her second dose on Sunday and is afraid to get second dose. Both events were recovered on 17Jan2021. No follow-up attempts are possible. No further information was provided.
30 2021-03-14 weakness Recieved vaccine dose 1 on 1/5/21, recieved dose 2 on 1/25/21. Was exposed to COVID19 on 3/10/21, de... Read more
Recieved vaccine dose 1 on 1/5/21, recieved dose 2 on 1/25/21. Was exposed to COVID19 on 3/10/21, developed symptoms (chills, body aches, sore throat, runny nose, weakness) on 3/12/21 and tested positive for COVID on 3/13/21 via rapid and PCR. Still recovering from symptoms on 3/15/21 (still body aches, weakness, runny nose, congested feeling). Health Department and lab facility unable to hold specimen for variant testing. Per CDC guidelines, reporting this since I am a healthcare provider and was fully vaccinated since 1/25/21.
30 2021-03-14 feeling hot rash, itching, hot chest and neck, post nasal drippage, left arm feels hot, right arm itchy, itchy t... Read more
rash, itching, hot chest and neck, post nasal drippage, left arm feels hot, right arm itchy, itchy throat
30 2021-03-15 pain in extremity, tremor Fatigue, extended arm pain, dizziness, blurred vision, feeling feverish, nauseous, internal organ pa... Read more
Fatigue, extended arm pain, dizziness, blurred vision, feeling feverish, nauseous, internal organ pain, shaking
30 2021-03-15 feeling hot, flushing Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by:, MD at 3/16/2021 9:55 AM ... Read more
Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by:, MD at 3/16/2021 9:55 AM Expand AllCollapse All VACCINE CLINIXC 3/15/2021 Subjective Pateint is a 30 y.o. male who was seen at Vaccine Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness and nausea, hot, dry mouth. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and vomiting. Past Medical History: Diagnosis Date ? Hernia ? Past Hospitalization Admit on: 20130219; Diagnosis: Aseptic meningitis, dehydration; at: HealthCare; MD; Hx of + covid infection in November 2020. ALLERGY REVIEW OF SYSTEMS: Patient complains of chills and vomiting (scantly, x 3 times) Patient denies fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, rash, hives, itching of skin, abdominal pain, dizziness and headaches + nausea: + lightheaded: Previous Reactions: none with vaccines. Objective Vitals Vitals: 03/15/21 0956 03/15/21 1009 03/15/21 1032 BP: (!) 142/95 127/79 129/83 Pulse: 84 SpO2: 99% Blood Sugar 112 collected at 1045 Physical Exam Vitals reviewed. Constitutional: General: He is not in acute distress. Appearance: He is ill-appearing. He is not diaphoretic. Comments: Slightly flushed HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds and air entry. Abdominal: Tenderness: There is no abdominal tenderness. Skin: General: Skin is warm. Coloration: Skin is pale (improved with rest). Findings: No rash. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Thought Content: Thought content normal. Judgment: Judgment normal. Patient with several brief episodes of dry heaving/burping throughout his observation here. He's managed to have scant amount of emesis. Pepcid 20 mg given, then zofran odt 4mg given, He was feeling better with ice pack and laying down. Upon sitting up he started to feel lightheaded and dizzy again. Restarted to burp with scant periods of nausea with dry heaves. Pepcid 20 mg given again. Pt able to sit up but still feeling nauseated. New ice pack given to neck. Pt asked to call for a ride. Security had to go out to his car to get his phone. Pt called his mom. Mom will come to pick pt up. Pt reports dizziness/lightheaded with position changes with increased nausea upon transfer to wheelchair. Assessment/Plan Treatment included: water, snacks and pecid and zofran. Follow up response to treatment: no change. Patient discharge: Transported to ED . Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Nausea and lightheaded/dizziness primarily. Pt monitored in bay for over an hour. Stable vs. Mom here to pick up patient and will transport to ED at for further evaluation/treatment due to failing PO challenge. Pt wheeled out in wheel chair. ED notified of patient coming. , APRN Electronically Signed 3/15/2021 10:12 AM
30 2021-03-15 pain in extremity Very tired, fatigued, nausea, headache, sore arm
30 2021-03-17 feeling hot Pt read through the list of questions and stated "I am short of breath at baseline, I am chronically... Read more
Pt read through the list of questions and stated "I am short of breath at baseline, I am chronically anemic and tired, and I get sick for like 2 weeks after my flu shot." She denies having a flu shot over the last few years. Discussed at length the risks/benefits of vaccine and potential side effects, expected time frame and duration expected. Pt stated she had Lupus and consented to her first dose. Pt also stated she had an anaphylactic history to PCN, Amoxicillin, and Sulfa. Therefore she was instructed to stay for 30 minutes observation. Approximately 10 minutes post vaccine, pt stated she was "really hot and tired, like she couldn't keep her eyes open." She was given an ice pack and water. She denied any difficulty breathing, throat irritation, dizziness, or vision changes. She initially stated she did not think she could drive home and requested a work note so she did not have to return back to work. Requested pt have someone pick her up and she refused and stated "she was fine to drive." Of note, pt carried on an entire conversation for the one hour she was observed in the lobby here Hospital, laughing and acting appropriately. She denied the need to be seen at Urgent Care by a Provider for her c/o tiredness. Upon re-evaluation prior to d/c patient, she was asked by this RN, "do you feel you are able to drive home safely?" She responded with "I don't know, I still feel very tired and having trouble keeping my eyes open and I have not walked around." Explained to pt that if she was not able to drive home safely she needed to go to Urgent Care here for further monitoring and pt was lead to registration.
30 2021-03-17 facial paralysis, slurring TIA approximately 2 days later. PT had unilateral facial paralysis, dysarthria, and arm/leg paralysi... Read more
TIA approximately 2 days later. PT had unilateral facial paralysis, dysarthria, and arm/leg paralysis. Non-ambulatory, unable to use right arm or right legs. Could not lift. Admitted to hospital. CT scan negative for acute stroke. Pt had complete resolution of all symptoms with 6 hours of admission. Felt to represent TIA.
30 2021-03-18 depressed level of consciousness 1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to n... Read more
1022 - Patient received her 1st Pfizer vaccine by RN. She noted a history of vasovagal syncope to needles in the past (did not seem like it was complete syncope to all needle sticks per RN). RN offered for her to lie down, but she said she felt ok sitting. She did not endorse any history of severe allergies or reactions to injectables in the past; she was asked the necessary questions prior to vaccination. We later learned she has Crohn?s and is on immunosuppressant Imuran for this disorder. 1023ish ? walked to checkout area 1025 - While sitting at the checkout registering for her second shot she started to feel faint and checkout staff called for help 1026 - RNs were getting the BP cuff on her. She appeared obtunded and slouching in her chair- eyes closed. Gentle sternal rub and she was able to open her eyes and tell us what her name was and ask to call her dad. BP 90/58. Cold cloths placed on her neck. Continuous pulse ox monitor placed, showing 99%. 1030 - Still drowsy and diaphoretic. Able to tell us that "she passes out when she gets shots" C/O nausea and vomited. Still in and out of awareness. NP is site coordinator is now present and suggests taking patient by wheelchair to safer and more private area for evaluation in SR Room. Patient able to stand and transfer to wheelchair, which we did slowly and carefully. 1034 ? Now in safer and more private area SR room with NP and RN and Dr. Firemen are here and assessing the scene with medic assessing patient. Ambulance in route, about 5 - 10 minutes out per radio communication. Checking BP every 2 minutes. Now is 68/44. C/O nausea and vomited. Pulse ox won?t pick up. Patient with decreasing LOC, eyes rolling back in head, unable to maintain posture seated, and not able to describe symptoms to us (unknown if she felt itchy but no obvious cutaneous manifestations). Unable to visualize oropharynx. 1037- BP 57/40. NP administered Epi pen 0.3 mg dose to L lateral thigh due to s/s of systemic allergic reaction/anaphylaxis including 3 known body systems: hypotension (cardiovascular), vomiting (GI), and decreased LOC (neuro). No IV fluids immediately available but were preparing to obtain. Staff getting cot for patient to lie down. Provider spoke with her mom on the phone and informed her of event. Mom confirmed that she has often before passed out with vaccines and blood draws. Dad was on his way to center and rerouted to ER. 1038 - BP 68/45 Talking to medics and able to tell them she ate breakfast and that she has a hx of Crohn's and takes a monthly injection. Informed provider that her dad was on his way. EMS team here to transport to ER. We were preparing to put her on a cot so help with her blood pressure/blood flow when she started to stabilize and EMS arrived with stretcher. 1040 - BP 97/53. Patient is now alert and talking to us. Says she has had syncope in the past ?but never anything like this.? 1041 - BP 115/53. Patient still alert and talking. Oriented x 3. 1042 - Transported to ER by EMS ambulance on stretcher. DEBRIEF: Somewhat atypical (no obvious cutaneous manifestations) and rapid, severe reaction. Ddx vasovagal vs anaphylaxis. Response to epi consistent with anaphylaxis reversal. Perhaps immunosuppressant medication contributed to severity and rapidity of reaction.
30 2021-03-18 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA headache first day, immediate itching and redness and lump at i... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA headache first day, immediate itching and redness and lump at injection site, nausea and shortness of breath, tenderness on injection site, arm soreness it is now day 9 since my 1st shot, and everything else has gone away except for the redness, itchiness, and the lump size which has progressively gotten worse not cleared up in 7 to 10 days
30 2021-03-18 flushing, feeling hot injection site pain; chills; flushing; tired; unable to sleep; It felt like I had a fever but my tem... Read more
injection site pain; chills; flushing; tired; unable to sleep; It felt like I had a fever but my temperature did not go above 98.6.; This is a spontaneous report from a contactable Other HCP. A 30-years-old female patient (Other HCP) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration on 26Jan2021 at single dose for Covid-19 immunization. Medical history included panic attack from an unknown date and unknown if ongoing and not known drug allergies (NKDA). The past drug included received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EJ1685) via an unspecified route of administration on 05Jan2021 10:30 AM at single dose for Covid-19 immunization. The patient's concomitant medications included multivitamins (Smartypants) and birth control. As per adverse event description, 14 hours after the injection on 27Jan2021 at 03:00 AM, she began to have injection site pain, chills, flushing, tired/unable to sleep. It felt like she had a fever but the temperature did not go above 98.6. The outcome of events was not recovered. No follow-up attempts are possible. No further information was provided.
30 2021-03-19 muscle spasms I am unsure if this is related but thought I should report it because it was highly unusual, but: My... Read more
I am unsure if this is related but thought I should report it because it was highly unusual, but: My menstrual cycle began at around 12:30am on 03-19-2021. There was some bad cramping as is usual for me in the first 24 hours. I was able to function normally enough until about 9P (on 03-19-2021), at which time I began experiencing debilitating cramps and muscle spasms that made it difficult to walk or move. I felt lightheaded and like I was going to pass out (which has never happened related to my period before). I got in bed and this persisted until moving at all brought me to tears. I have not been in this much pain from cramps and muscle spasms in over a decade. And never this prolonged and intense. I was unable to sleep until about 4:30am, managed to sleep for a few hours, had to see, and now I'm here filling this out before I attempt to go back to sleep. My pain at the moment is high, but similar to what a normal "first day of cycle and it's bad" day would be for me. Before this, though, was 8 hours straight of some of the worst pain I've ever felt in my life. I felt it important for me to make a formal report in the event that adverse effects surrounding menstruation were common for others and in case this does not subside. I am thinking it will like the initial muscle aches after receiving the shot.
30 2021-03-20 flushing, feeling hot Client reports that 5 minutes after her dose she felt lightheaded, palpitations, flushing of her fac... Read more
Client reports that 5 minutes after her dose she felt lightheaded, palpitations, flushing of her face and feeling hot.
30 2021-03-20 tingling, numbness Severe back pain and numbness on left leg/ needle stabbing
30 2021-03-21 pain in extremity I received the 1st vaccine on 1/8/2021 and immediately my arm was very sore but was fine a few day a... Read more
I received the 1st vaccine on 1/8/2021 and immediately my arm was very sore but was fine a few day after. however when i got my second vaccine on 2/4/2021 is when I began to experience more side effects. My arm was extremely sore for more than a week. I could barely fully extend my entire arm and I developed a lump in the pit of my arm pit. Both my tricep and bicep mussels were tender. I also experienced headaches and tinnitus. The soreness of my arm and lump have gone away however I still have headaches and tinnitus to this day.
30 2021-03-21 tingling, pain in extremity Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/19/2021 9:22 AM Expand AllColla... Read more
Notes (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/19/2021 9:22 AM Expand AllCollapse All Clinic 3/18/2021 Patient: Date: 3/18/2021 Subjective Patient is a 30 y.o. female who was seen at COVID Vaccine Clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience paresthesia down R arm. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling, tongue swelling and weakness in arm. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms. PMH insignificant ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches + paresthesia in R arm: Previous Reactions: none Objective Vitals Vitals: 03/18/21 1430 BP: 108/62 Pulse: 72 SpO2: 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No facial asymmetry. Sensory: Sensation is intact. Motor: No weakness. Coordination: Coordination is intact. Gait: Gait normal. Comments: + 5/5 strength against resistance to bilateral upper extremities. Pt able to put on her own sweater without difficulty or assistance. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: ice pack Follow up response to treatment: fair. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Suspect superficial nerve secondary to injection. Discussed ice/warm cloth, movement of R arm. Follow up with pcp as needed. We will check in with her tomorrow via phone. Pt voiced appreciation of evaluation today. Nurse Practitioner Electronically Signed 3/18/2021 8:58 AM
30 2021-03-22 pain in extremity I had the 2nd vaccine on Friday night and had a headache and arm pain. I woke up on Saturday morning... Read more
I had the 2nd vaccine on Friday night and had a headache and arm pain. I woke up on Saturday morning with arm pain again and a red, raised rash where my injection site was. about the size of a half dollar and it was warm to the tough Arm pain went away by Sunday but the rash grew to about the size of a golf ball in diameter and it was egg shaped and became darker red. Monday the rash did not grow anymore but was still warm to the touch and there was pain if I pushed on the rash. It was getting lighter in color. Right now on Tuesday, rash has gotten even more lighter to just a pink/almost skin color, it has not grown in size.
30 2021-03-22 cold sweat, cold extremities Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/15/2021. Patient was... Read more
Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/15/2021. Patient was vaccinated at 1147 and began to walk toward EMT monitoring area at 1153. While the patient was walking, the patient reported feeling faint. RN, followed the patient from behind. RN noticed patient beginning to fall and was able to catch her using her leg as support and guided patient to the floor. Both RN and patient decline sustaining any injuries related to this event. When on the floor, patient appeared pale, had cold and clammy hands, and was diaphoretic. RN assisted the patient by holding her legs in the air while the patient layed on her back. Patient was A&Ox4 at 1155 with a BP of 121/76. At 1159, patient reported feeling "better" and was transferred to zero-gravity chair. The patient's blood pressure was reassessed at 1201, 1221, and 1227 and reported to be 124/81, 122/74, and 125/79, respectively. The patient refused transport via EMS and stated she preferred to drive herself home. Patient able to ambulate without assistance. Patient left to her car at 1230. Upon departure, patient was ambulatory, A&Ox4, with no reports of trouble breathing, dizziness, or lightheadedness. The patient was given education related to when to seek medical care, including shortness of breath, chest tightness, and sensation of throat tightness. The patient was provided with additional guidance on what to do when receiving a second dose, including notifying the nurse that she has had a history of fainting.
30 2021-03-22 tingling, numbness Pt experienced numbness/tingling in left cheek, around mouth, and in left arm. Resolved with 25mg Be... Read more
Pt experienced numbness/tingling in left cheek, around mouth, and in left arm. Resolved with 25mg Benadryl.
30 2021-03-23 flushing Fever a few hours after receiving vaccination. 99.5 after taking ibuprofen. felt flushed and red in ... Read more
Fever a few hours after receiving vaccination. 99.5 after taking ibuprofen. felt flushed and red in the face.
30 2021-03-23 face paralysis, one side paralysis Head and ear pain on left side began on 3/6/2021. I took Tylenol and OTC ear drops but pain continue... Read more
Head and ear pain on left side began on 3/6/2021. I took Tylenol and OTC ear drops but pain continued to get worse. 3/10- pain worsened, ear itched, hyperacusis began. 3/11- 8am Finally made an appointment in clinic due to the worsening ear pain and was prescribed ciprofloxacin/dexmethasone drops and told to contact clinic in 24 hours if symptoms didn?t improve. 3/11- 8pm noticed weakness on left side of face (inability to close eye tightly), went to bed. 3/12-6:30am weakness on left side progressed- eye wouldn?t blink/close, asymmetric smile...called clinic and was asked to come in. My primary saw me and sent me to the ER. They looked in my ear and Diagnosed me with Ramsay Hunt Syndrome (shingles outbreak in ear/ impacting facial nerves causing acute paralysis) on 3/12/2021 after initial symptoms began on 3/6/2021. I was put on 1000mg of valacyclovir 3x day and 60mg prednisone for 1 week each. Moderately-Severe Paralysis remains as of 3/24/2021.
30 2021-03-23 difficulty speaking Patient sent to emergency department from nearby vaccine clinic with tachycardia (HR 138). She recei... Read more
Patient sent to emergency department from nearby vaccine clinic with tachycardia (HR 138). She received her second dose of the Pfizer vaccine approximately 45 minutes prior to arrival to ED. On arrival to ED she also had abnormal sensation in the back of her throat, change in her voice, and a new rash which developed few minutes prior to arrival. At this point, with signs and symptoms c/w anaphylaxis, she was given IM epinephrine, solumedrol, Benadryl, and famotidine. Symptoms improved entirely after 3-hour observation period and she was discharged home on EpiPen, prednisone, Benadryl, and famotidine.
30 2021-03-23 nerve pain Shingles on the same arm that received the injection. Skin rash and water blisters. Burning pain, fo... Read more
Shingles on the same arm that received the injection. Skin rash and water blisters. Burning pain, following nerve pain.
30 2021-03-24 involuntary muscle movements Otherwise in normal state of health when she presented to have her first vaccine today. In observati... Read more
Otherwise in normal state of health when she presented to have her first vaccine today. In observation area she developed jerky movement of right upper extremity and called to be taken to first aid bay. As soon as she was transported to the bay she exhibited myoclonic jerks. She reports this has happened in past and that as long as she does not lose consciousness it is normal for her. Jerky movements lasted for about 15minutes and resolved spontaneously. She was not post ictal and was awake and alert and conversive throughout episode. She reports history of seizures but not on any medication. She likely has pseudoseizures. Her vitals were stable. She reports her full blown myoclonic jerky movements have not happened
30 2021-03-24 tremor Total body shaking, trembling, tachycardia. Of note, patient took 1 week course of Septra. NP though... Read more
Total body shaking, trembling, tachycardia. Of note, patient took 1 week course of Septra. NP thought reaction could have been attributed to the antibiotic. Vitals wnl. Benadryl 50 mg IM given.
30 2021-03-25 migraine Fatigue- started at 7am and slept most of day, continued to experience fatigue into the next day 3/2... Read more
Fatigue- started at 7am and slept most of day, continued to experience fatigue into the next day 3/26/21. Nausea- woke up at 7am on 3/25/21 with nausea that lasted until 7pm on 3/25/21. Migraine- took Tylenol every 4-6 hours from 7am on 3/25/21 until 9pm on 3/25/21.
30 2021-03-25 muscle spasms Night after vaccine severe chills, muscle aches. When waking in morning, had neck pain and muscle sp... Read more
Night after vaccine severe chills, muscle aches. When waking in morning, had neck pain and muscle spasms. Was in severe pain in neck with difficulty swallowing. Went to urgent care and was given muscle relaxers. Pain continued for 3 weeks after, severe still. Began chiropractor visits, no improvement. Had MRI completed, showed golf ball sized lymph node swelling in neck on side of severe pain. Went to ENT for course of steroids with mild improvement. Still having mild to moderate neck pain everyday and it has been 2 months since vaccine. Would never get this type of vaccine again, and I am a medical professional who usually trusts them.
30 2021-03-25 flushing When I first got the vaccine I had a flush reaction (felt like I had an IV and they had just flushed... Read more
When I first got the vaccine I had a flush reaction (felt like I had an IV and they had just flushed the IV). I felt dizzy. It went away quickly. 5 mins later I had diarrhea. I was also feeling post nasal drip, itchy throat, my chest had a burning sensation from the inject arm towards the middle of my chest. Throat was closing and tongue and lips were swelling. Entire body was itchy.
30 2021-03-26 feeling hot AFTER VACCINATION, DURING 15 MINUTE OBSERVATION PERIOD, PT WAS SITTING AND SUDDENLY SLID OUT OF CHAI... Read more
AFTER VACCINATION, DURING 15 MINUTE OBSERVATION PERIOD, PT WAS SITTING AND SUDDENLY SLID OUT OF CHAIR. SHE LOST CONSCIOUSNESS MOMENTARILY. SHE FELT VERY HOT, AND WAS PALE. EMT'S WERE CALLED AND CAME. PT DID NOT FEEL THE NEED TO GO WITH THEM. NO BENADRYL OR EPI PENS WERE ADMINISTERED
30 2021-03-27 pain in extremity Chills, muscles aches, nausea, and headache suddenly set in at 9:30pm on the same day as second dose... Read more
Chills, muscles aches, nausea, and headache suddenly set in at 9:30pm on the same day as second dose, ibuprofen helped and all these symptoms were gone by Saturday 03/27/2021 morning. Sore arm started earlier but was manageable pain and longer lasting.
30 2021-03-27 tension headache Tension headache still lasting at day 11 has not improved and works past pain meds. Also taking musc... Read more
Tension headache still lasting at day 11 has not improved and works past pain meds. Also taking muscle relaxants and my daily escitalopram and emergency meds lexapro
30 2021-03-28 weakness Chills, fever, joint pain, body aches, weakness, fatigue and tiredness
30 2021-03-30 discomfort The arm that I received the vaccine is still swelled/puffy; The arm that I received the vaccine is s... Read more
The arm that I received the vaccine is still swelled/puffy; The arm that I received the vaccine is still swelled/puffy; muscles are sore; lymph node is swelled/puffy; still in pain and discomfort; still in pain and discomfort; This is a spontaneous report from a contactable 30-year-old female consumer reported for herself. A 30-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 30Jan2021 12:30 as single dose for covid-19 immunisation. Medical history included asthma, blood pressure increased, and allergies: penicillin. Concomitant medication included biotin (BIOTIN) and multivitamin. On 01Feb2021 the patient had, the arm that I received the vaccine is still swelled/puffy, muscles are sore, arm pit/lymph node is swelled/puffy, still in pain and discomfort after 5 days. The was no treatment for the events. Facility the most recent COVID-19 vaccine was administered in Hospital. The outcome of the events was not recovred
30 2021-03-30 feeling hot, weakness, cold extremities cardiac arrhythmia; dizziness/lightheadedness; nausea; muscle weakness; extreme fatigue; lost consci... Read more
cardiac arrhythmia; dizziness/lightheadedness; nausea; muscle weakness; extreme fatigue; lost consciousness/She is in and out of consciousness; extreme weakness; extremely low blood pressure; tachycardia when resting/heart rate is high/HR gets up to 135; One foot and leg became very cold and turned blue; One foot and leg became very cold and turned blue; other foot warm and hot; This is a spontaneous report from a contactable consumer (patient's sister). A 30-year-old non-pregnant female patient received the second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN/ EW 6198; expiration date: unknown), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 02Mar2021 as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with covid prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EN6198), at vaccination age of 30-year-old via an unspecified route of administration in the left arm on 09Feb2021 as a single dose for covid-19 immunisation but had weakness, fainted, lost consciousness and concussion. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The reporter mentioned that on the next day after vaccination (03Mar2021), the patient's one foot and leg became very cold and turned blue other foot warm and hot started cardiac arrhythmia, dizziness, lightheadedness, nausea, muscle weakness, extreme fatigue, extremely low blood pressure and tachycardia when resting. The reporter stated that since 02Mar2021, she hasn't been able to get out of bed due to extreme weakness. The reporter also mentioned that her heart rate (HR) gets up to 135 [unit unspecified]. The reporter also stated that the patient was wearing a heart monitor and was waiting for data. They went to the emergency room (ER) on 12Mar2021 due to concerns of blood clot, ruled out blood clot. The doctors can't explain what is happening to her. She was extremely healthy and fit, no previous cardiac or energy issues. No blood pressure issues or family HX. She says she "feels like she's dying". The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The hospitalization was reported as 1 day. It was unknown if the events received treatment. The patient was not tested post vaccination. It was further reported that her sister had the second Covid shot 02Mar2021 and a few hours later she lost consciousness. She has been in the hospital ever since. She was in and out of consciousness, her blood pressure is low, and her heart rate is high. One of her legs is blue and cold, the other is hot. She cannot get out of the bed. The doctors don't know what is wrong. It was mentioned that the patient was healthy and not taking any medication. The outcome of the events was not recovered.
30 2021-03-30 weakness fainted; lost consciousness; weakness; concussion; This is a spontaneous report from a contactable c... Read more
fainted; lost consciousness; weakness; concussion; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6198) on 09Feb2021 in left arm at single dose for COVID-19 immunisation. Medical history was none, unknown if known allergies. No covid prior vaccination. Concomitant medications were none (no other medications in two weeks). No other vaccine in four weeks. The patient was not pregnant, was not pregnant at time of vaccination. No covid tested post vaccination. The patient received first dose on 09Feb2021, on 28Feb2021 05:00 PM, experienced weakness fainted, lost consciousness, diagnosed with concussion. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for one day. Unknown if treatment for the events. Outcome of the event was not recovered.
30 2021-04-12 one side paralysis, sensory loss, tingling, numbness This is a 30-year-old female with no significant past medical history who presents to RMC ED with co... Read more
This is a 30-year-old female with no significant past medical history who presents to RMC ED with complaints of acute onset headache and left-sided weakness shortly after receiving her first Pfizer COVID-19 vaccine today. Patient states that after the injection she immediately had a headache and several minutes later she developed left-sided numbness tingling and subsequent weakness. She was activated as a code stroke. CT head, CTA head and neck were unremarkable. Patient was evaluated neurology was thought that her symptoms are likely related to vaccine reaction as opposed to acute CVA she is not given TPA. Upon my assessment patient states that she continues to have left-sided weakness both her arm and her leg. She has decreased sensation on her left side. She is able to move her left extremities however she states that they feel heavy and weak. Patient was given Benadryl IV as well as famotidine in the ED. She will be given Solu-Medrol as well. Patient denies any history of any vaccine reactions in the past, to penicillin and seasonal allergies otherwise denies any sensitivities. Denies any history of autoimmune diseases. Patient denies any HA, dizziness, vision changes, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, fevers chills, dysuria. This is a 30-year-old female with no significant past medical history who presents to RMC ED with complaints of acute onset headache and left-sided weakness shortly after receiving her first Pfizer COVID-19 vaccine 4/9/21. Patient states that after the injection she immediately had a headache and several minutes later she developed left-sided numbness tingling and subsequent weakness. She was activated as a code stroke. CT head, CTA head and neck were unremarkable. Patient was evaluated neurology was thought that her symptoms are likely related to vaccine reaction as opposed to acute CVA she is not given TPA. Admitting physician felt she has decreased sensation on her left side. She is able to move her left extremities however she states that they feel heavy and weak. Patient was given Benadryl IV as well as famotidine in the ED. She will be given Solu-Medrol as well. Patient denies any history of any vaccine reactions in the past, to penicillin and seasonal allergies otherwise denies any sensitivities. Denies any history of autoimmune diseases. Pt has improved. She is able to move her LUE and LLE now. " Does not feel like moving bricks " Her tingling has decreased and she is able to feel things again with her left hand and leg. Pt had c/o chest pain 4/11/21. Her trop have been neg. EKG neg. D-dimer within normal limits. Will give dose of mobic 7.5 mg. Will try lidoderm patches for pain. Pt will follow up with pcp in 1-2 weeks.
30 2021-04-14 difficulty speaking Hoarse voice, itchy throat, tight chest, trouble breathing, difficulty swallowing, throat closing (h... Read more
Hoarse voice, itchy throat, tight chest, trouble breathing, difficulty swallowing, throat closing (happened sequentially in that order)
30 2021-04-17 pain in extremity I blacked out completely; Felt very dizzy; fallen on the dresser; hit myself on my stomach and leg; ... Read more
I blacked out completely; Felt very dizzy; fallen on the dresser; hit myself on my stomach and leg; hit myself on my stomach and leg; Was completed disoriented; Headache; Sore arm; Body ache; wound on my stomach; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left on 30Mar2021 19:45 as single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. Concomitant medications were unspecified received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After taking the vaccine at 19:45, the patient drove back home and had minor symptoms when she went to bed (headache, sore arm, body ache) on 30Mar2021. She woke up around 3:45 am on 31Mar2021 to use the restroom and felt very dizzy. While walking back to bed, she blacked out completely, fallen on the dresser and hit herself on her stomach and leg. She was feeling extremely dizzy at this point, was completed disoriented and couldn't process what was happening around me. Her husband walked her back to bed and put her to sleep. Treatment was reported as First aid for the wound on her stomach. Since the vaccination, the patient had not been tested for COVID-19. The report was non-serious. The outcome of the events was recovering. Information on the lot/batch number has been requested.
30 2021-04-18 pain in extremity, weakness I had my first dose of Covid 19 Pfizer vaccine on the 5th of April, 2021 at 1pm. I had sore arm and ... Read more
I had my first dose of Covid 19 Pfizer vaccine on the 5th of April, 2021 at 1pm. I had sore arm and was fatigued which was expected. However, the day I had my vaccine was also the day my menstrual cycle started and just to assure myself I informed the pharmacist and asked if that was okay and they said it shouldn?t be a concern. I was doing fine until toward the end of day 3. I was expecting my period to stop as it always does on 3rd day but I started bleeding heavier that day there after. It didn?t worry me much until I started discharging huge blood clots as big as an apple 2 times every after 30 mins from that moment. I rushed to the ER later that night(still bleeding heavily with blood clots every now and then) but I was not admitted since my vitals and the blood counts were normal at that moment. I went back home and hoped the bleeding would stop but again with on pain or fever what so ever I kept bleeding all day. This is my 5th day of bleeding. Then on Sunday morning, I still kept bleeding heavy and I was too weak that I went back to the ER again. This time , (day 6) I got admitted because I have had lost a lot of blood and I needed blood transfusion. My HB dropped from 11.3 to 6.7 and it went further down to 5 something. I got 3 units of blood transfusion in the ER. They did ultrasound, CT scans(with and without contrast) and still couldn?t figure out the cause of the bleeding. My uterus showed no problems but my body was not even responding to Tranexamic acid to stop the bleeding. So the doctor proceeded with an angiogram and did an emergency uterine artery Embolization to stop the blood supply to the uterus. The bleeding stopped there after and I started regaining my vitals. However, the cause of the bleeding still remains unknown.
30 2021-04-22 pain in extremity Fatigue, body aches, soreness in right arm, soreness in armpit, headache,
30 2021-04-22 discomfort Woken from sleep approx 11hrs after shot. Chills, mild fever, uncomfortable, joint pain including wr... Read more
Woken from sleep approx 11hrs after shot. Chills, mild fever, uncomfortable, joint pain including wrists and fingers, lymphnode in left armpit sore. As time went on alternated between chills and sweats. Symptoms continued for approx 36hrs. Lympnode soreness lasted approx 3days
30 2021-04-24 feeling hot passed out/stared to black out; got really hot; had trouble breathing; This is a spontaneous report ... Read more
passed out/stared to black out; got really hot; had trouble breathing; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 30 years). Medical history included anxiety, depression. Concomitant medications included trazodone; phentermine (ADIPEX [PHENTERMINE]); omeprazole; citalopram; alprazolam (XANAX). The patient previously took Imitrex and experienced allergies. On 08Apr2020 (13:00), the patient stated that she felt fine and was texting. Then all of a sudden she got really hot, had trouble breathing, and stared to black out. She was blacking out. She could hear someone asking if she was okay and if she needed help. She dropped all her things and passed out. The patient was not pregnant. The patient did not received any treatment for the events. Outcome of the events was recovered on an unspecified date.
30 2021-04-24 flushing severe dehydration from vomiting; severe dehydration from vomiting; very bad headache; body aches; w... Read more
severe dehydration from vomiting; severe dehydration from vomiting; very bad headache; body aches; was going from shivering to over heating; esophagitis; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the right arm on 29Mar2021 16:00 (Batch/Lot Number: EP6955) as single dose (at the age of 30-years-old) for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. There were no concomitant medications. The patient was negative for the nasal swab on 03Mar2021. The patient received the first dose of BNT162B2 intramuscularly on the right arm on 08Mar2021 16:00 (at the age of 30-years-old) for COVID-19 immunization. The patient had no other medication in two weeks and no other vaccine in four weeks. The patient had no COVID prior to vaccination. After about 4 hours of receiving second dose (29Mar2021, 19:00), the patient had a very bad headache, body aches, and was going for shivering to overheating. She began to vomit non-stop, couldn't keep food or liquids down. She ended up going to urgent care on 30Mar2021 and was sent to the ER. She was admitted to the hospital on that day for severe dehydration from vomiting and was told she had esophagitis. The adverse events resulted in doctor or healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization. The patient was hospitalized for three days. The patient received unspecified IV's, medications and had scans (unknown results). The patient was recovering from the events.; Sender's Comments: The events was considered related to suspect vaccine BNT162B2 based on strong temporal association and known safety profile of the drug. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
30 2021-04-26 pain in extremity Fever; aches; severe arm pain; skipped menstrual cycle completely; chills; This is a spontaneous rep... Read more
Fever; aches; severe arm pain; skipped menstrual cycle completely; chills; This is a spontaneous report from a contactable consumer (Patient). A 30-years-old not pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, in arm right, on 15Feb2021 at 11:30 AM (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Patient past medical history included Asthma, depression, anxiety. Patient concomitant medications were not reported. The patient had experienced fever, chills, aches, severe arm pain, skipped menstrual cycle completely on 16Feb2021, 03:00 AM. Outcome of the events were recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
30 2021-04-26 weakness Patient presented to Immunizations clinic for Covid Vaccine (Pfizer LOT EW0175 EXP 08/2021) Dose 2. ... Read more
Patient presented to Immunizations clinic for Covid Vaccine (Pfizer LOT EW0175 EXP 08/2021) Dose 2. Patient received vaccine and moved to post-vaccination observation area. After 15 minutes, patient went to leave clinic. Shortly after patient returned and informed lobby staff that she was not feeling well. Nurse on staff went to escort patient back to observation area when patient complained of feeling weak. Nurse held patient and patient had syncope episode. NUrse was able to guide patient to floor without impact to floor. Patient was alert and oriented when placed on floor. Patient denies history of syncope and/or vasovagal after injections. Patient returned to baseline and stayed for additional 20 minutes for further observation then released.
30 2021-04-27 muscle twitching, muscle spasms, involuntary muscle movements, pain in extremity, electric shock sensation Three days after receiving my first Pfizer vaccine I began experiencing twitching and muscle spams a... Read more
Three days after receiving my first Pfizer vaccine I began experiencing twitching and muscle spams all over by body. They spasms range from large jerking of my neck, head, spine, and legs, to small consist contractions and fluttering twitches all throughout my body. I am also experiencing rapid heart beats and massive amounts of anxiety as well as painful electric like shocks going through my feet and legs.
30 2021-04-27 weakness, seizure lost consciousness for a brief period; doing something that looked like a small seizure; got tunnel ... Read more
lost consciousness for a brief period; doing something that looked like a small seizure; got tunnel vision; vasovagal response; feel faint, dizzy, and lightheaded; feel very weak; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EP7524. Medical history included periodontal surgery. Concomitant medications included spironolactone, adapalene, benzoyl peroxide (Epiduo Forte), azelaic acid (FINACEA), aciclovir, hydrocortisone (Xerese). The patient believed she experienced some kind of vasovagal response. On 13Apr2021 at 08:00, the patient got up from sleeping and went to the restroom, where she started to feel faint, dizzy, and lightheaded. The patient sat down and got tunnel vision and she started to feel very weak but regained her vision after sitting. The patient was helped back to bedroom but had to stop and sit in the floor where patient lost consciousness for a brief period, less than 10 seconds. Her partner said patient was doing something that looked like a small seizure. The patient had had this response before many times when giving blood and even after her periodontal surgery. The patient was recovering from the events.
30 2021-04-29 pain in extremity Adverse event was body aches and intense headaches for two days after the adverse symptoms started. ... Read more
Adverse event was body aches and intense headaches for two days after the adverse symptoms started. This is only after the second vaccine. There was no reaction other than arm soreness after the first vaccine. At the time of the second vaccine, I was 13 weeks pregnant due to deliver on October 31, 2021.
30 2021-04-30 tremor, weakness pneumonia; kidney infection; severely dehydrated; extreme joint pain; fever; chills; uncontrollable ... Read more
pneumonia; kidney infection; severely dehydrated; extreme joint pain; fever; chills; uncontrollable shaking; Severe headache; nausea; vomiting; When Coughing, feel pain in uterus; When Coughing, feel pain in uterus; Very sick; weak; This is a spontaneous report from a contactable consumer, the patient. This 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533), via an unspecified route of administration in the left arm on 03Apr2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. There is no medical history reported. Concomitant medication included celecoxib (CELEXA). The patient did not have any allergies to medications, food, or other products. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E46955), via an unspecified route of administration in the left arm on 11Mar2021 10:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Two hours after the vaccination on 03Apr2021 at 12:00, the patient experienced extreme joint pain, fever, chills, uncontrollable shaking; severe headache, nausea and vomiting. No change after 3 days, she went to Emergency Room ended up with pneumonia, a kidney infection and severely dehydrated. She was hospitalized for one day (in Apr2021). When coughing, she feels pain in her uterus. She was very sick for 11 days after the vaccination and was still weak, and her joints continue to hurt. Therapeutic measures were taken included fluids, antibiotics, blood tests and nausea medications. Since the vaccination, the patient had been tested negative for COVID-19 virus via a nasal swab test on 06Apr2021. The patient had recovered with lasting effects from the extreme joint pain, fever, chills, uncontrollable shaking, severe headache, nausea, vomiting, pneumonia, a kidney infection, severely dehydrated, when coughing, feels pain in uterus, and very sick.
30 2021-05-04 weakness exhausted / Fatigue; she could hardly sleep; Mild sore throat; Headache; No energy; Myalgia; Arthral... Read more
exhausted / Fatigue; she could hardly sleep; Mild sore throat; Headache; No energy; Myalgia; Arthralgia; This is a spontaneous report from a contactable physician. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 16Apr2021 at 18:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing asthma, attention deficit disorder, and depression. Concomitant medications included ongoing methylphenidate hydrochloride (CONCERTA) for attention deficit hyperactivity disorder and ongoing bupropion for depression. Family history included brother had Covid. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 16Apr2021, the patient developed headache (important medical event - IME), no energy (disability), myalgia (disability), arthralgia (IME), and mild sore throat. On 18Apr2021, she could hardly sleep and exhausted/fatigue (disability). The patient had no shortness of breath, even though she has asthma and it was not an anaphylactic reaction. The patient took TYLENOL for the events which helped somewhat but didn't relieve it fully. It resolved as time passed. The outcome of the events headache, no energy, myalgia, arthralgia, mild sore throat was recovered on 18Apr2021. The outcome of the events could hardly sleep and exhausted/fatigue was recovered in Apr2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine and known product safety profile, causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
30 2021-05-05 numbness Numbness in arms, hands and feet
30 2021-05-07 bell's palsy Bells palsy; miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-y... Read more
Bells palsy; miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 17:00 (Lot Number: ER8729) (at the age of 30-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at time of vaccination, last menstrual date was 20Feb2021, due date was 27Nov2021, the patient was 6 weeks pregnant at the onset of the events. The patient did not test positive to COVID-19, pre or post vaccination. Medical history was none. No known allergies. There were no concomitant medications. On 15Apr2021 at 07:00, the patient experienced Bell's palsy and miscarriage. the events required emergency room visit and physician office visit, the patient was hospitalized for one day due to the events. Therapeutic measures were taken as a result of the events and included ultrasound. The patient outcome of the events not recovered.
30 2021-05-10 flushing Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth s... Read more
Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); Allergic reaction- characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling); This is the spontaneous report received from a contactable other health professional. This other HCP (patient) reported for herself that a 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) at the age of 30-years, via an unspecified route of administration in left arm on 19Mar2021 13:00 at single dose for COVID-19 immunization, in hospital. Medical history included PTSD, anorexia, chronic migraines, bradycardia. Patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included propranolol, atorvastatin (LIPITOR), prazosin, alprazolam (XANAX). On 19Mar2021 13:15, the patient experienced allergic reaction-characterized by hives and flushing and anaphylactic reaction (throat and mouth swelling). After medical treatment, hives continued for 3-4 days. The events result in doctor or other healthcare professional office/clinic visit. The patient received high dose diphenhydramine hydrochloride (BENADRYL) and epinephrine (EPIPEN). Outcome of the events was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Allergic reaction, Anaphylactic reaction. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
30 2021-05-12 inability to speak, pain in extremity hard to hear at times; horrible pain from head to toe; couldn't see anything; couldn't breathe at al... Read more
hard to hear at times; horrible pain from head to toe; couldn't see anything; couldn't breathe at all; face turned green; fever; aching in her legs; extreme exhaustion; blacking out; diarrhea; sweating; unable to talk; This is a spontaneous report from a contactable consumer. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 12:00 (Batch/Lot Number: EW0150) as 1st dose, single, at the age of 30-years-old for COVID-19 immunization. The patient had no medical/family history and concomitant medications. The patient went to go get her second shot of Pfizer covid vaccine but they wouldn't give it to her based on her reactions to the first dose. They said there was a chance of anaphylaxis reaction to the second shot. The patient reported blacking out, diarrhea, sweating and unable to talk. She consulted with her healthcare professional regarding whether to get the second shot and they didn't know. She asked if her reactions were normal. She doesn't know what to do whether to get a second shot given her reaction. It was mentioned that the patient was hard to hear at times. She got the vaccine on 06Apr2021 around noon and she was fine until around 3:30 am. She woke up in horrible pain from head to toe, she thought maybe she just needed to pee, she didn't know what was going on. She stood up and she blacked out like she was about to faint. She couldn't see anything, like it was completely black. She got to bathroom and she couldn't breathe at all, she couldn't talk. She thought she needs to go to the hospital, but she couldn't talk. Her face turned green, she had diarrhea, she was like dripping wet. At this point, she could sort of breathe. She felt like she was being held under water, still dripping sweat. She has recovered completely from these symptoms. The severity of symptoms was so severe she doesn't know if she had a fever at the same time, it was hard to tell. With the breathing part, she was so freaked out by that, so it's hard to know for sure, maybe yes. She may have had a low fever. She had a fever that night to the point where she was dripping on the floor. She has aching in her legs. She went to the doctor thinking she had Lyme disease, which she doesn't. Since that vaccine, she's had very, somewhat severe leg aches and extreme exhaustion like all the time. she can hardly go to work sometimes. Everybody has days they are tired, but this was different. She had to come home at 2pm and lay down for like five hours. She stated it was persisting. She had a blood test recently and everything came back perfect on 26Apr2021. She thought she had Lyme disease because of all the symptoms she was having, and it all came back negative. She didn't exactly get turned away. They said they didn't feel comfortable giving her the second dose of vaccine. The patient stated if a nurse tells her they don't feel comfortable, she wouldn't feel comfortable until she speaks to Pfizer. The nurse told her she had to go to an allergist and rheumatologist. The nurse said the same thing, the nurse told her that she should have gone to the hospital, but she wasn't thinking at that moment. She was just at a loss of what to do. That day at the hospital, they were scared with the second vaccine that she could go into anaphylaxis and she's not sure what to do. The patient had no other vaccines administered on the same date of Pfizer suspect and no other vaccinations within 4 weeks. The event hard to hear at times started on an unknown date while other events started on 07Apr2021 and ended the same day. The outcome of the events aching in her legs and exhaustion was not recovered, hard to hear at times was unknown while for other events was recovered. The events "she blacked out, like she was about to faint" was assessed as serious medically significant. No follow-up attempts are needed. No further information expected.
31 2021-01-01 tingling, pain in extremity A few hours after receiving the vaccine I noticed typical arm soreness associated with vaccines. Ho... Read more
A few hours after receiving the vaccine I noticed typical arm soreness associated with vaccines. However, this time I also noticed there was a cold tingling feeling in my arm, leg, and toes on the left side of my body (injection side). It happened on and off and lasted for a few minutes at a time. It was not bothersome and resolved within 24 hours. Soreness the next day was worse than with any vaccine received prior (including tetanus shot) and limited range of motion but did not interfere with activities of daily living.
31 2021-01-02 burning sensation, numbness, tingling, pain in extremity Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely... Read more
Developed mild redness, hives, and itching at site of injection on days 2 and 3. Symptoms completely resolved independently on days 4 and 5. On day 6, developed significant welt-like hives, intense burning and itching, and numbness/tingling of entire extremity. Also developed a non-pruritic, flat, diffuse, pinpoint rash to the trunk. Rash and itching resolved with Benadryl. Right upper extremity burning, pain, and numbness persist.
31 2021-01-03 muscle spasms, depressed level of consciousness Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body... Read more
Immediately I got nauseas and headache. Next day my whole lower back was spasm and had horrible body pain/back pain. I almost passed out putting pants on. A friend took me to an Urgent care they gave me Shot of tramadol and given Tylenol 3. They also did a test on my kidney. About 50 hours after the shot I was feeling better.
31 2021-01-03 flushing Patient experienced feeling flushed and nauseated after receiving covid vaccine injection. Declines ... Read more
Patient experienced feeling flushed and nauseated after receiving covid vaccine injection. Declines ED evaluation. No further symptoms reported on 12/19 follow-up
31 2021-01-03 pain in extremity Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours ... Read more
Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours - tylenol and heat/ice (no change) chills without fever overnight the night of - no treatment soreness in arm 1 hr post to up to its worst at 24 hours later when I could not abduct >90 degrees for 24 more hours
31 2021-01-03 numbness, hot flush Started with hot flashes , light headed, partial facial numbness on the ride side. Light heart pro... Read more
Started with hot flashes , light headed, partial facial numbness on the ride side. Light heart problems
31 2021-01-03 numbness patient stated felt numbness in her left middle finger and thumb. Started feeling lightheaded and th... Read more
patient stated felt numbness in her left middle finger and thumb. Started feeling lightheaded and though she was going to pass out. Patient states she has needle phobia and has had this happen in the past.
31 2021-01-04 pain in extremity Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck... Read more
Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing)/ Left and right neck pain; Chest, back and left neck pain (chest and back pain worse with breathing); Chest, back and left neck pain (chest and back pain worse with breathing); Arm Pain at injection site; Arm Pain at injection site; This is a spontaneous report from a non-contactable physician (patient). A 31-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/ Lot number: EK5730), intramuscularly on 22Dec2020 09:45 at single dose on left arm for COVID-19 immunization in hospital. Medical history included gastrooesophageal reflux disease (reported as GERD). No true allergies; unable to take NSAIDs or eat bananas or avocados 2/2 GERD. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain at injection site on Day 1 (22Dec2020); chest, back and left neck pain (chest and back pain worse with breathing) on Day 2 (23Dec2020); left and right neck pain on Day 3, resolved on Day 4. No treatment received for the adverse events. The events outcome was resolved on 25Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious. No follow-up attempts are possible. No further information is expected.
31 2021-01-04 pain in extremity Extreme pain in arm for 72 hrs. Continued pain for 2 more days.
31 2021-01-04 tingling I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have ... Read more
I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; I have got tingling in both of my arms; like a lightness, it's like my arms felt very light; Hypertensive; Tachycardiac; This is a spontaneous report from a contactable physician (patient). This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose in the left arm on 22Dec2020 for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID) at 112 ug on 22Dec2020 for hypothyroidism. Physician stated, "I was about 2 minutes after the administration of vaccination on 22Dec2020, I have got tingling in both of my arms as well as hard to describe but like a lightness, it's like my arms felt very light. And they observed me and took my vitals and I was definitely hypertensive and tachycardiac". The outcome of the events was unknown. The vaccine was administered at Hospital Facility.
31 2021-01-04 pain in extremity Solitary enlarged lymph node in left posterior cervical chain, approximately 2 cm in diameter, nonte... Read more
Solitary enlarged lymph node in left posterior cervical chain, approximately 2 cm in diameter, nontender. Enlargement initially felt the morning after receiving the vaccine. The lymph node continued to enlarge for several days and has remained 2 cm (visible bulge) at 7 days post-vaccination. No other cervical or axillary lymphadenopathy. Left arm sore for 24 hours post vaccination. No other swelling, redness, systemic or local reactions.
31 2021-01-04 pain in extremity The next day I was feeling fatigue. My arm was sore & I had headaches. I did talk to a clinic virtua... Read more
The next day I was feeling fatigue. My arm was sore & I had headaches. I did talk to a clinic virtually for my headaches.
31 2021-01-04 throat numbness numbness of the throat and back of the tongue
31 2021-01-04 pain in extremity sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day afte... Read more
sore arm (unable to lift without aching/hurting) for 2-3 days (improved each day, worst the day after vaccination) chills, low grade temp of 100.4F (went down with Tylenol), malaise, myalgia for one day starting the day after vaccination (Sunday evening and resolved by Monday morning)
31 2021-01-04 numbness whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened al... Read more
whole left arm was numb/numbness and itching happened also to the soles of feet; itching happened also to the soles of feet/hands also became red and itchy; hands also became red; hives; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient (non-pregnant) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 20Dec2020 11:45 at single dose at left arm for immunization. Medical history included known allergies: sulfa. Concomitant medication in two weeks included bupropion hydrochloride (WELLBUTRIN). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Immediately following vaccination, patient whole left arm was numb, the numbness slightly improved, but then only palms of hands were numb. Later that night, the numbness and itching happened also to the soles of feet, hands also became red and itchy, and then patient got hives that lasted 48 hours, but nightly hives after that, the hives would resolve after taking PO (per oral) diphenhydramine hydrochloride (BENADRYL), and then would come back again that night. Patient was still having them. The adverse events resulted in emergency room/department or urgent care. Outcome of events was reported as recovered/resolved with sequel. The report is considered as non-serious. Information on the lot/batch number has been requested.
31 2021-01-05 pain in extremity 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful.... Read more
8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscular in the right arm on 21Dec2020 15:00 at a single dose for COVID-19 immunization at the age of 31 years old at the workplace clinic. Medical history included asthma and seasonal allergies. Concomitant medications included fluticasone nasal spray, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), salbutamol sulfate (ALBUTEROL), zinc and unspecified multivitamin. On 29Dec2020 16:00, 8 days after the vaccine, the patient had swelling at the injection site on her right arm, it is hot and painful. Also, the patient had pain in right fingers and lymph pain in axillary region. Outcome of the events was unknown. No treatment was given for the events. The events were assessed as non-serious.
31 2021-01-05 pain in extremity, tremor Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable... Read more
Arm soreness; headache; shakiness; nausea; diarrhea; This is a spontaneous report from a contactable other health professional reported for herself. A 31-year-old female patient (not pregnant at time of the report) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), intramuscularly on left arm on 30Dec2020 14:30 at single dose for COVID-19 immunization. Facility type Vaccine was reported as Doctor's office/urgent care. Medical history included SVT, neurocardiogenicy syncope, PVCS, known allergies: PCN. Concomitant medications were not reported. The patient experienced arm soreness, headache, shakiness, nausea, diarrhea on 31Dec2020. No treatment was received for the events. The outcome of the events were not resolved.
31 2021-01-05 weakness, feeling of body temperature change At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate hea... Read more
At 10 pm I started having severe body aches, fatigue, alternately feeling hot and cold, moderate headache, weakness, sweats
31 2021-01-05 throat numbness, difficulty speaking At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and ha... Read more
At about 10 to 12 minutes after she received the vaccine she felt that her throat "felt numb" and had trouble swallowing her own saliva. Approximately 30 minutes after the vaccine she noticed significant tongue and oral itching and then hoarseness. Vitals were normal. Did not notice any flushing, rash under skin or swelling. The symptoms all resolved after she received a dose of Benadryl (which she was able to swallow) followed by a dose of Zyrtec.   3 days after she received her injection she developed sore throat and body aches.
31 2021-01-05 burning sensation Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is b... Read more
Dizzy; Nausea; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; felt bad/did not feel right all day; she broke out with what felt like a million bugs on her head and face, states it is burning and itching/burning and itching on face and head during hair appointment; there is a lot of paranoia; This is a spontaneous report received from a contactable consumer (who is also the patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK9231), via an unspecified route of administration, on 28Dec2020, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated she got the first dose of the Pfizer Covid vaccine on Monday, 28Dec2020. She mentioned that she read the list of side effects and all the print outs and stated her events were not on there. She wanted to make sure and stated maybe it was not even from the vaccine. She reported she just came from the hair dresser, had hair colored before many times, but today (30Dec2020), when she put the dye on her hair, she broke out with what felt like a million bugs on her head and face, stated it is burning and itching, maybe it is her imagination. She knows there is a lot of paranoia. She reported that she has had hair colored before and this has never happened, it occurred during hair coloring treatment. She also mentioned that on 30Dec2020 (also reported as "yesterday", pending clarification), she felt dizzy and nauseous; on 29Dec2020 (reported as "yesterday"), she felt bad and did not feel right all day, but says she knows those were listed symptoms. The outcome of the events dizziness, nausea, burning sensation and pruritus was recovering; the outcome of events paranoia and feeling abnormal was unknown.
31 2021-01-05 weakness Fever, nausea, muscle pain, weakness
31 2021-01-05 pain in extremity Worsening arm pain after injection that eventually resulted in my being diagnosed with a blood clot ... Read more
Worsening arm pain after injection that eventually resulted in my being diagnosed with a blood clot in the arm that I recevied the injection on
31 2021-01-05 pain in extremity, tingling headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling ac... Read more
headache; body aches; fatigue; still was feeling achiness in the arm and wrist; still was feeling achiness in the arm and wrist; some tingling feeling in the fingertips or feet; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date was unknown, via an unspecified route of administration on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if tingling in feet or fingertips a common adverse effect of the vaccine. The patient experienced headache, body aches, fatigue after receiving the shot. Yesterday at 6PM, she still was feeling achiness in the arm and wrist. She took Ibuprofen and started feeling some tingling feeling in the fingertips or feet. The outcome of the events was unknown. The following information on the lot/batch number has been requested.
31 2021-01-06 pain in extremity Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache... Read more
Day 1: nausea, severe stomach cramps, pain in the injection site Day 2: fatigue, tiredness, headache, chills Day 3: fatigue, raised area, itching in the arm, pain in arm Day 4: nausea, diarrhea, itching in arm, raised bump at injection site, itchy throat, cough, runny nose
31 2021-01-06 pain in extremity Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills N... Read more
Dizziness, Headache, Myalgia, RespDepression, Palpitations, arm soreness and discoloration, chills Narrative
31 2021-01-06 flushing Facial flushing with extension to anterior neck approximately 10 minutes status post vaccination. Mi... Read more
Facial flushing with extension to anterior neck approximately 10 minutes status post vaccination. Mild pruritis forehead reported. Denies SOB and other symptoms. Epinephrine x 1 administered 15 minutes after vaccination left thigh. After epinephrine felt better and transported to ER via ambulance without incidence.
31 2021-01-06 pain in extremity Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lo... Read more
Significant arm pain at site of injection starting at 5pm. Then developed vague aching throughout lower back, shoulder, and hips. Progressed to shooting pains (mild) into both legs and down both arms into fingers and toes. muscle aches and pains persisted until 4pm on 1/7. Also developed inflamed lymph node under left arm pit.
31 2021-01-07 pain in extremity Arm pain began on 1/2 at approximately 4 pm and gradually worsened. Was significantly improved by th... Read more
Arm pain began on 1/2 at approximately 4 pm and gradually worsened. Was significantly improved by the next morning; however, lower back pain began around 4 pm on 1/3 and gradually worsened, peaking on 1/4 and 1/5. This is still slowly improving. Appears to be some sort of sacroiliac joint inflammation.
31 2021-01-07 tremor, migraine First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 1... Read more
First dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 Fatigue, malaise, soreness at injection site. 12/31-1/4 Migraines, increased fatigue and malaise, increased lightheadedness, body aches, intermittent dry cough. 1/5-1/8 decreased body aches, decreased fatigue, sustained lightheadedness.
31 2021-01-07 pain in extremity Got the shot on 1/5/2021 around noon. In about 2 hours, started feeling soreness around the injectio... Read more
Got the shot on 1/5/2021 around noon. In about 2 hours, started feeling soreness around the injection area. After 14 hours of the shot, started feeling chill, whole body joint and muscle pain, headache, fatigue, 99.5 fever. on 1/6, took Tylenol every 6 hours, three times in total, 1950 mg total dose. helped. felt a lot better on 1/7, the second day after the shot but still took 2 tablets of Tylenol before went to bed. on 1/8, felt totally fine.
31 2021-01-07 weakness Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday ... Read more
Heart palpitations, tachycardia, PVCs and shortness of breath, fatigue, weakness started on Monday (1/4), worsened over next 2 days. Saw primary doctor on 1/7 who called paramedics to take me to the ER due to EKG results and increased work of breathing. ER doctor suspects mild guillain-barre reaction, I will be following up with cardiology and pulmonology as soon as possible as they were unable to determine exact cause or fix the issues.
31 2021-01-07 migraine, tremor I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness an... Read more
I received my first dose of the Pfizer vaccine on 12/23. Day of experienced mild light headedness and shakiness. 12/24-30 fatigue, malaise. 12/31-1/4 Increased fatigue and malaise, migraines, body aches, intermittent dry cough, lightheadedness, photophoibia. 1/5-1/8 Intermittent lightheadedness, slowly improving body aches.
31 2021-01-07 tingling, burning sensation, pain in extremity On day 6, developed large, urticarial hives at injection site associated with significant burning, a... Read more
On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity; Developed diffuse, pinpoint, non-pruritic, flat rash to trunk.; redness, and itching at injection site; redness, and itching at injection site; Developed mild hives at injection site/large, urticarial hives at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscular from 28Dec2020 08:00 at single dose in the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took cephalosporin and experienced allergies. The patient developed mild hives, redness, and itching at injection site on days 2 and 3. Symptoms resolved entirely on days 4 and 5. On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity. On 30Dec2020, she developed diffuse, pinpoint, non-pruritic, flat rash to trunk. Rash resolved with Benadryl. Extremity pain and burning persists despite Benadryl. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within 2 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did receive treatment for the events which included Benadryl and Pepcid. The events resulted in emergency room/department or urgent care. The outcome of the events "Developed mild hives at injection site/large, urticarial hives at injection site", "On day 6, developed large, urticarial hives at injection site associated with significant burning, aching, and tingling of entire right extremity" was unknown; for events "Paraesthesia" and "pain in extremity" was not recovered; and for the other events was recovered on an unspecified date.
31 2021-01-07 feeling hot, tremor Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on... Read more
Patient alerted pharmacist to feeling light headed at 12:10pm. Patient was instructed to sit down on the floor. She stated she felt hot and hadn't eaten all day. She was given a few bites of apple sauce and some Dr. Pepper to drink in case of low blood sugar. She was also given 25mg of diphenhydramine in case of an allergic reaction after the vaccine adminstration at 12:15pm. A few minutes later, she began shaking and stated she thought she was having an anxiety attack. At this time, the patient requested we call 911 because that would make her feel better and so we did.
31 2021-01-07 pain in extremity STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT AR... Read more
STARTED AT 1AM 1/8/2021 WITH CHILLS, STRONG HEADACHE, MODERATE GENERALIZED MUSCLE PAIN, PAIN LEFT ARM WITH ABDUCTION. LOWER BACK PAIN, MALAISE AND FATIGUE
31 2021-01-07 pain in extremity, feeling cold Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, h... Read more
Sore arm, fatigue, feeling cold, sinus pressure and nasal congestion. Taking Tylenol and Benadryl, helping minimally .
31 2021-01-07 nerve pain hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/p... Read more
hyperthermia, tachycardia, chills, malaise, anxiety, sensitive skin/nerves, muscle and joint aches/pains.
31 2021-01-07 muscle spasms, pain in extremity raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my ... Read more
raised/bruised baseball marking at injection site; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 2: headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; baseball size red warm to touch welt; baseball size red warm to touch welt; temp; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; day 1: baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand, chills; This is a spontaneous report from a contactable nurse, , the patient. A 31 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot_number: unknown), via an unspecified route of administration on 29Dec2020 at 11:30 AM, (at the age of 31 years-old) for COVID-19 vaccination. Medical history included Crohn's. The patient was allergic to adalimumab (HUMIRA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Dec2020 at 08:00 PM, the patient had a baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills. On 30Dec2020 (reported as day 2), the patient experienced headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The patient was not treated for baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site. The clinical outcome of baseball size red warm to touch welt, temp, muscle aches (couldn't use arm for 24 hours without serious pain), hand cramping in that hand and chills, headache no medicine could get rid of, my underarm (glad) hurt when lifting my arm past a point day 4: still with a raised/bruised baseball marking at injection site was recovering. It was also reported that since the vaccination, the patient was been tested for COVID-19 (nasal swab) on 02Jan2021. No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
31 2021-01-07 flushing, feeling hot, tingling within 5 minutes after the vaccination I got hot an flushed all over. I was nauseated and my BP wen... Read more
within 5 minutes after the vaccination I got hot an flushed all over. I was nauseated and my BP went to 166/80 HR 160s. My body began to feel tingly all over even my tongue but it never swelled. I was given 25mg of benedryl and monitored for 30 minutes and finally my body began to normalize and my BP went down to 130/70. I went back to work but when I got home I took more benedryl because my body still had the same tingly feeling. After about 24 hours all symptoms had subsided.
31 2021-01-07 tingling, feeling hot, flushing within about 5 minutes after the injection I got warm and flushed feeling all over my body, my body ... Read more
within about 5 minutes after the injection I got warm and flushed feeling all over my body, my body started feeling tingly all over even my tongue, but it never swole. My HR went up to the 160s, my BP was elevated to like 166/80. I was given 25mg benedryl, which calmed the flushed feeling and I was monitored for about 30 minutes and finally my BP and went back down to around 130/70 and my body normalized out besides the tingling which lasted the remainder of the day. I had a little nausea. I went back to work and finished out the day. I took more benedryl when I got home to help with the tingling feeling which finally deminished after about 24 hrs.
31 2021-01-09 pain in extremity Body aches, chills, joint pain and arm pain. Lasted for 10 hours roughly
31 2021-01-09 migraine Chills, fever of 103, migraine
31 2021-01-09 weakness Extreme fatigue/weakness, headache, chills, dyspnea, chest pain, body aches
31 2021-01-09 flushing, pain in extremity First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed... Read more
First dose resulted in shoulder injury. Severe arm pain began evening after the first dose, followed by pain in the shoulder joint when raising arms above head which has persisted for 23 days. Second dose resulted in fever, chills, nausea, swelling of hands and flushing sensation in hands/feet, with maximum fever of 100.2 F documented 24 hours after the second dose. Fever and chills resolved about 36 hours after the injection.
31 2021-01-09 flushing, feeling hot, burning sensation Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feel... Read more
Noticed burning in left forearm immediately after vaccine, within 1 min. Symptoms progressed to feeling hot, flushed, and tachycardia briefly around 5 min. 10 min developed a pressure in my chest, and dizziness. Within 20 min, developed itching, flushing and hives specifically on left arm, hand, and across chest. Within 45 min, both ears and forehead covered with hives. Hospital staff made me go to ED. Within ED hives continued to progress across the chest and bilateral arms and wrists. Received 50mg of Benadryl, and 40mg of prednisone. Symptoms improved but did not resolved. 3 hrs following vaccine, bilateral lip swelling. Took 40mg of percribed pred and 25mg of Benadryl again around 4pm. Within 12 hrs, significant diarrhea. Hives resurfaced on face, bilateral wrists, arms, and ears around 645 on the 12/29. Fever 100.3 noted on 12/29-12/30. Intermitted hives, and lip swelling remained until 1/1. Nausea diarrhea and body aches until 1/2.
31 2021-01-09 tingling One week after the shot (Left Arm), from my left deltoid to my left hand fingertips have a tingling... Read more
One week after the shot (Left Arm), from my left deltoid to my left hand fingertips have a tingling sensation similar to a limb falling asleep. The frequency ranges from every two hours to every 5 minutes with the sensation lasting for about 5 seconds.
31 2021-01-09 tremor Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart ... Read more
Right after the second dose less than 2 minutes my heart rate began to spike. I could feel my heart pumping fast. I couldn?t sit due to this so I began pacing the room. I didn?t know this was a side affect so I thought I was over thinking the second dose. I attributed this to all the worry and doubt the media and people around me try pumping in your head. I thought I was having a panic attack. I didn?t alert any of the medical team there because again, I thought I was over thinking it. A few hours later my heart rate had gone down. My Apple Watch helped me monitor this. The next day I felt pain at the injection site, not my normal self, groggy. Slightly feverish and chilled. I work in a cold environment so I couldn?t quite tell if the chilled feeling was a side effect, or the room. Later that evening around 9pm things took a turn. I began running a low grade fever and was shaking from being so cold. About another hour late my fever was up to 101 and I was still shaking from being so cold. I took about 600mg of ibuprofen. I couldn?t sleep, tossed and turned. Probably another hour later my temperature was 102, still shaking uncontrollably. Covered in about 5 blankets I kept waiting it out. And I?d say around 2-3am I could feel my fever breaking. By late morning my temp was back to normal but I felt achy still. Tired, sore. Definitely sore at my injection site. And I don?t know if this is worth mentioning or not but just haven?t been able to shake that panic attack feeling. Like a worry or a dread over me. I just don?t feel as clear-headed as I did before. This is my biggest concern. Just don?t feel myself yet.
31 2021-01-09 flushing nausea, feeling flushed, dizzy evaluated by EMTs - VSS and wnl employee continued to feel unwell
31 2021-01-09 tremor vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), ho... Read more
vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), horrible aches and pains, significant fatigue, and persistent headache from about 3am the morning after (on 1/8) and lasting until bedtime that day. The next morning (1/9), most symptoms had resolved except for fatigue. I also experienced a new sx: severe pain and tightness in my chest/torso; was hard to breath normally and could not take a deep breath without experiencing significant pain. This lasted until about 3pm. Fatigue persisted the rest of the day. All symptoms had resolved by the next morning (1/10).
31 2021-01-10 weakness, discomfort 0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before ... Read more
0830 1/7/21 experienced rapid onset lightheadedness that lasted for a duration of 15 minutes before resolving. From 0900 to 1600 experienced fatigue and heaviness that prevented me from working that day. From 1600 to 2000 I felt "normal". At 2100 I went to bed with chills and overall malaise, awoke at 0000 1/8/21 with a fever of 101 F. Throughout the night I experienced severe body aches and a headache that made my teeth and jaw ache 7/10 on the pain scale. Tylenol 500mg taken at 0500 1/8 with relief. Fatigue/weakness experienced until 1700 on 1/8/21 after which I felt like myself again. In total, 2 days of work missed as a result of symptoms.
31 2021-01-10 tenderness After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my ... Read more
After 24 hours of receiving vaccine my lower back started to ache, I experienced body chills and my skin was sensitive to touch. This lasted for about 6 hours. I was also light headed and woozy for about 3 hours. The next morning all of these symptoms were gone.
31 2021-01-10 feeling cold, hot flush Hot flashes Cold chills Headache Body aches Fatigue Dizziness
31 2021-01-10 migraine, tremor, flushing I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By ... Read more
I felt flushed and light headed after receiving the vaccine but as the day went on I felt worse. By 2030 I had severe full body chills and could not stop shaking. I had a severe headache/migraine. Every muscle in my body hurt. This continued on for the entire night. Got tested for COVID the next morning with the rapid results and the symptoms continued with the muscle aches and severe headache. Vision became blurry and I became very dizzy. Slept for 8 hours during the day on 1/7/2021 and then slept another 12 hours that night. The body aches and headaches continued until 1/8/2021 at which the symptoms finally subsided
31 2021-01-10 tingling, numbness, pain in extremity Mild to moderate left arm pain on first couple of days after vaccine, which was not bothersome, foll... Read more
Mild to moderate left arm pain on first couple of days after vaccine, which was not bothersome, followed by constant, numbness and tingling in left hand, started yesterday, has not gone away, and nothing seems to make it better or worse. Does not affect daily functioning currently, has remained the same/not worsened or spread, but is moderately bothersome and uncomfortable. I have never had any symptoms like this before.
31 2021-01-10 pain in extremity Started with aches and chills, progressed to being very hot and having a 99.5 fever, then had linger... Read more
Started with aches and chills, progressed to being very hot and having a 99.5 fever, then had lingering headache. Arm was very very sore and painful. All symptoms disappeared next day.
31 2021-01-10 numbness, weakness The patient developed numbness in her left leg then shortly later numbness in her right arm affectin... Read more
The patient developed numbness in her left leg then shortly later numbness in her right arm affecting her balance and ability to walk accompanied by generalized weakness.
31 2021-01-10 nerve pain Three and a half days after the vaccine experienced nerve pain in my legs. Went into the ER was admi... Read more
Three and a half days after the vaccine experienced nerve pain in my legs. Went into the ER was admitted for observation. Is getting better day to day.
31 2021-01-10 weakness Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of t... Read more
Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of the day. Friday (3 days after) felt tired and weak.
31 2021-01-10 pain in extremity day 1 fatigue, sore arm day 2 more fatigue, extra sore arm, head ache
31 2021-01-10 weakness, pain in extremity, facial pain, numbness, tingling it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts ... Read more
it was debilitating for her at work; It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad.; pain in right leg and bottom sole of right foot; hurts to speak; numbness right upper side of lip; pins and needle feeling right upper quadrant of face; pain and dull aching right upper side of face; right hand numbness, wasn't able to feel anything; generalized headache; generalized muscle weakness and pain; generalized muscle weakness and pain; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Jan2021 at single dose in deltoid right for covid-19 immunization. There were no medical history or concomitant medications. The patient received the vaccine on 03Jan2021 and within 15 minutes had a generalized headache. Later that night she had generalized muscle weakness and pain, but really didn't think too much about it. The next day at work (04Jan2021), she had numbness on the right upper side of her lip and a pins and needle feeling in the right upper quadrant of the face. Had a lot of pain in the area as well on the right upper side of the face as well as a dull aching pain that lasted for hours. Later that day when using the computer and she was trying to reach for her mouse she noticed her right hand wasn't able to feel anything and that lasted about 20-25 minutes. Kept slapping the mouse with her hand, but could not feel anything, her hand went numb. Yesterday (05Jan2021), she had the same pins and needle feeling in the same area of the face and that dull achy feeling and it occurred for hours and it was very kind of debilitating for her at work. Later that night she had pain in her right leg and felt the same way, that very severe achiness, which was the pins and needles feeling up and down the leg and underneath the right foot. All these symptoms tend to be on her right side and it definitely lasted for hours. It started about 1 and didn't end until 6-7pm. It even hurts to move the right eye in one direction and hurts to speak, the pain was so bad. This morning (06Jan2021) she had to call out of work because at 3am the generalized headache, pain was unbearable. She was still experiencing the pain in right leg and bottom sole of right foot. She did not receive any vaccines the same day or 4 weeks prior. No problems with vaccines in past. She had made an appointment with a neurologist and will have a MRI done on Friday, 08Jan2021. No further details provided. All events required a visit to physician office. All events were reported as serious per medically significant. The outcome of all events was not resolved. The reporter considered all events were related to the vaccine. Information about Lot/Batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, causality between reported events and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-11 night sweats, numbness, pain in extremity On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thou... Read more
On 12/25 I was driving home and my left arm got numb, tingly and weak to the the point where I thought I was suffering from a stroke. I rushed to my moms and had her to drive me to the hospital where they did a neuro check to include a CT scan which ruled out the stroke but the symptoms lasted about 4 days which came and went with the pain and intensity varying each time which ended around 12/29. I suffered from body aches and night chills one night. Around the 12/29 I began to have pressure around the back of my head which felt as if I was laying on bricks when I laid down. It got to the point to where I couldnt sleep which caused me to go back to the ER on 1/1 where I was given toradol, decadron and sudafed which allowed me to sleep. I was released from the ER with Motrin 800 and contined to take that and Tylenol until the headaches ceased which was about 3 or 4 days later. The headache went away but the pressure still remained. My lymph glands were swollen so I was also given a prescription for amoloxicillin.
31 2021-01-11 numbness, tingling She received the second dose of the COVID-19 vaccine yesterday. Shortly after that she started to f... Read more
She received the second dose of the COVID-19 vaccine yesterday. Shortly after that she started to feel some strange sensation in her arm. States her arm felt "heavy". She went home and then felt like she had potentially some numbness and tingling up the right side of her face. She did receive the shot in the right deltoid. Patient states she has no weakness in her arms or legs. But they do feel "heavy". Patient states this morning she felt like the tingling sensation on the right side of her face had improved but it felt more swollen than it did yesterday. She states her family members came over this morning and they also felt that she had some swelling to the right side of her face. Patient was administered Dexamethasone 10mg IM x1 dose and prescribed Prednisone 20mg daily x 5 days then follow-up with PCP
31 2021-01-11 tingling, numbness Shortly after receiving 2nd dose she reported feeling strange sensation in her right arm. States he... Read more
Shortly after receiving 2nd dose she reported feeling strange sensation in her right arm. States her arm felt heavy and experienced some numbness and tingling up the right side of her face. On 1/12/21 she woke up and felt tingling on the right side of her face and swelling. She was evaluated in the Emergency Department and treated with Dexamethasone 10mg IM x1 dose and prescribed Prednisone 20mg daily x 5 days.
31 2021-01-11 pain in extremity Sore arm for first day after injection. Resolved about 36 hours after injection.
31 2021-01-12 tingling Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 clie... Read more
Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx 1525. At apx 1545 client verbalized complaint of tingling sensation to lips and face. Client denied any difficulty breathing. Client administered 50mg of Diphenhydramine via IM to right arm at apx 1546. 1547 BP= 117/70; HR = 98bpm; RR = 18; temp = 97.2. Client verbalized tingling sensation lessening at apx 1550. 1552 BP = 113/69; HR = 92; RR = 15; temp = 97.2 At 16:00 client verbalized tingling sensation had completely subsided. Client denied any difficulty breathing. Client declined transport to ED and instead called friend to pick her up as she was too drowsy to drive per Dr.
31 2021-01-12 burning sensation I developed a raised red rash that started under my chin and has spread up my face, all down my neck... Read more
I developed a raised red rash that started under my chin and has spread up my face, all down my neck, around my ears, down my chest, and in my groin. The rash burns and itches.
31 2021-01-12 pain in extremity Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild ... Read more
Pain at injection site, Arm soreness starting at time of injection , elevated temp 99F with mild chills, fatigue and malaise starting the following morning lasting about 8 hours.
31 2021-01-12 flushing Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis,... Read more
Patient had sudden onset of flushing/erythema of skin (no pruritus, but warm to touch), diaphoresis, and itchy throat. She denies shortness of breath or any respiratory problems. Symptoms started 20 min prior to arrival at the Emergency Department. When the patient arrived at the ED, all of her signs and symptoms had started to subside.
31 2021-01-12 throat numbness Pt developed post COVID vaccine side effects at 1000. Pt received COVID vaccine at 0932 by LVN. ... Read more
Pt developed post COVID vaccine side effects at 1000. Pt received COVID vaccine at 0932 by LVN. Pt complained of a numb throat, and said, "I cant seem to swallow my saliva well." This writer did an immediate assessment of patient's throat with flashlight, and no swelling, abnormal discharge, or discoloration noted. Pulse-ox that was available on hand was used on pt, and sats were 96% and HR 78. MA on site was asked to grab a complete VS machine for somewhere stat, for there was none on site. This writer reassured pt was going to be okay and to breathe normally, for assessed pt was breathing fast. This writer called every doctor listed on the "Contact List for COVID Vaccine Clinic," but there was no response. This writer then called Urgent Care and Minor Injury Clinic, but the doctors were busy with patients. Asked MAs from those areas to have a doctor call immediately for a patient here was symptomatic. Once VS got here, VS were taken, and pt was assessed again. Pt said there was no more numbness in her throat, but tongue was feeling itchy, and her body temp went from hot to cold. Intitial VS: Temp: 98.3 BP: 122/80 HR: 77 O2: 99% RR: 18 Dr from Urgent Care finally called. Background story given, and she ordered Diphenhydramine Cap 25mg (Benadryl) which this writer had on hand in the emergency kit. Order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Benadryl given at 1025. Dr also suggested that ID doctor be called. At 1030, I got a hold of Dr., gave her a background story, and she advised that the pt stay for another 30 mins to be observed and she would come see the pt. Dr. arrived at 1100, assessed the patient, and ordered Cetrizine Tab 10mg (Zyrtec) to give to pt, which Dr. had to get from another department. There was no Zyrtec available in emergency kit. Again, order was on computer, but could not acknowledge or scan, so order detail was printed, and pt and I signed form together. Zyrtec given at 1128. An additional Zrytec Tab 10mg was given at same time at 1128 "for home use" per Dr and per her order. VS set #2 taken at 1133 Temp: 98.1 BP: 133/94 HR: 63 O2: 100% RR: 16 Dr suggested that she schedule an appt to see an allergist and to get an allergy test done prior to the next dose of the COVID vaccine. Patient was feeling a lot better and more at ease. Pt left comfortably with no symptoms at 1200.
31 2021-01-12 pain in extremity Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm p... Read more
Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm pain. Ibuprofen helped to relieve symptoms. Still feels chills, arm pain, and now fatigue.
31 2021-01-12 muscle twitching So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fe... Read more
So on the night of the 25th, my lymph nodes were so swollen, my left eye was twitching, low grade fever that was constant from Friday through Sunday. My left leg was twitching and also my left bicep. I had left sided twitching that was off and on. I had fatigue and some aching in my knees.
31 2021-01-12 pain in extremity, feeling cold Sore arm, fever, body aches and chills, sore lymph nodes in armpit of shot arm
31 2021-01-12 burning sensation vaccine recipient had diffuse itching and burning feeling after her vaccine. reported she has had t... Read more
vaccine recipient had diffuse itching and burning feeling after her vaccine. reported she has had this with another medicine, penicillin. continued to itch all over so administered 25 mg of Bendaryl and 20 mg of Pepcid to treat symptoms.
31 2021-01-13 weakness, night sweats, tremor, feeling cold, feeling hot 01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Ex... Read more
01/08/21 received the vaccination, am of 01/09/21 woke up with headache, body aches, chills, took Excedrin and ibuprofen, worked all day and by the end of the shift started feeling worse. Symptoms to include : shaky, felt like she was freezing to death but no fever at this point, skin felt like it was on fire, Around 8:00pm temp of 100PO at this time took 1000mg Tylenol and when she had got the shower skin was very sensitive to the water and felt like it was hot, but the water was not, by 10:00 pm temp of 103, felt shaky, achy all over, dizziness/nausea, muscle weakness, fatigue. Went to bed that night, had night sweats during the night. 01/10/21 got up around 4:30am to get ready for work, continued with severe muscle weakness, shaky, headache, got in shower and fell from being so weak and tired. Gradually through the day got better, had went back to bed that morning and slept almost all day and by 3:00pm -4:00pm was feeling much better.
31 2021-01-13 cold sweat 1104 a.m. felt shaky, lightheaded, funny feeling in her chest; moved to 30 min observation status; ... Read more
1104 a.m. felt shaky, lightheaded, funny feeling in her chest; moved to 30 min observation status; 1105 a.m. BP 142/92, P 128, Resp 18, SpO2 99%; A&O x 3; skin cool and clammy; resp/lungs clear and unlabored; EMS called; Moved to gurney; juice given. Pt has hx of Hashimoto's 1110 a.m. BP 136/100, P 100, R 18, SpO2 91%; A&O x 3; skin cool and dry; remains shaky; resps unlabored; EMS arrived; Care handed off to emergency crew and taken to hospital.
31 2021-01-13 speech disorder Extreme lockjaw unable to barely talk or chew
31 2021-01-14 cold extremities, pain in extremity, feeling cold, hot flush 1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting... Read more
1/12 0715: Received Pfizer covid-19 vaccine dose 2 at end of shift. Went home to sleep after waiting 15 min. 1630: Woke up. Felt more tired than usual. 1900: Arrived at work. Felt fatigue and sore arm. 2000: Felt sore arm, fatigue, and mild HA. Drank coffee and this helped with fatigue and HA. 2100: Mild nausea starts. Still have sore arm. Less fatigue, no HA. Still able to eat with the nausea. 2200: Developed chills. I was putting up curtains in an isolation room and had to pause halfway through due to being short of breath as if I'd done something strenuous. I then was short of breath again walking specimens to lab, which is unusual for me. Walking samples to lab involves walking 400 ft and going up and down 1 flight of stairs. 2300: Coworkers keep asking me why I'm always out of breath. They are concerned. Chills are worse now and I go from feeling normal to feeling cold. My hands are like ice and I am gripping my arms to keep warm. I walk 2 samples to lab and each time I am dizzy on the way back. By the 2nd time I have to hold the wall to keep balance. I can no longer hide the side effects and a coworker offers me 650mg Tylenol. I gladly accept. I measure my spO2 and it is 97%. 1/13 0530: I am almost back to normal other than feeling fatigued. 0815: I get home and go to bed. My feet are ice cold so I have to wear socks, but my hands feel normal temperature. I feel like my blanket isn't warm enough. 1330: I wake up and feel absolutely miserable. I am going between having chills to having a hot flash. I can't seem to will myself to leave bed. I'm pretty sure I have a fever, which I haven't had in over 10 years. My mouth is completely dry. 1400: I manage to roll out of bed and take my temperature, which is 101.3F. I feel an overall malaise and keep getting periodic hot flashes, but manage to make it downstairs and I mix 1 liquid IV electrolyte packet w/ 24fl oz. water. I drank the whole thing. I also cooked myself some dumplings and 1 waffle w/ maple syrup due to feeling much hungrier than usual. 1430: I take 1000mg Extra Strength Tylenol after eating. 1830: I feel almost normal except for significant fatigue and go to bed. 1/14 0430: I wake up and feel completely normal. No fatigue. Go about my day as normal. 1545: Suddenly I feel lightheadedness and mild HA. Have trouble with inattention (ex. not following w/ conversation or forgetting what people just said, or listening but not registering, or can't find the words to respond or answers to a question.). I take my Vitals: 117/95, spO2 85%, HR 63. I then try taking a couple deep breaths and spO2 increases to 98% and lightheadedness and HA go away. Then a few minutes later lightheadedness and HA begin again and spO2 is 80-90%. Then I take 2 deep breaths and spO2 is 98% and HA and dizziness improves. This repeats several times and I grow concerned. My hands are cold and the pulse oximeter is $30 from Amazon. However, I used the pulse ox on my mother and she was 97% consistently every time without fail. I also used pulse ox on myself when perfectly healthy and same thing it was 98%+ every time. This is why I was now worried. 1630: I take Tylenol since this seems to have helped with any and every symptom I've had so far and book an Urgent Care appointment. 1700: I get up to take a shower and feel extremely dizzy to the point where I'm worried I might fall. I stumble into the bathroom holding the wall. I take spO2 and it is 87%. 1800: I show up to Urgent Care and after the shower I feel my hands are warm now. At Urgent Care they are using pulse oximeters and I am spO2 99% and HR 64. So they chalk it up to my crappy Amazon pulse ox and they tell me to hang in there. Perhaps if I had not taken a shower before going there it may have been a different story? Hard to say now. Also the Tylenol may have started to work by then. 2200: I am still inattentive, spacey, lightheaded, and fatigued. I then fell asleep on the couch without realizing. 1/15 0230: I wake up and feel fatigued with brain fog, but no more lightheadedness. 0630: I go back to bed because I'm too sleepy.
31 2021-01-14 tremor Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration o... Read more
Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration (left arm) second dose on 07Jan2021 09:30 at single dose for covid-19 immunisation. The patient's medical history included known allergies: Sulfa drugs and known allergies: latex sensitivity. The patient's concomitant medication included spironolactone, bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), and multi vitamin. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), for covid-19 immunisation first dose on 17Dec2020, Vaccine location Left arm, lot number EH9899. On 07Jan2021 10:00 PM, the patient experienced Chills, shaking, body aches, fever up to 101.4, vomiting Began about 12 hours after administration of shot. Lasted approximately 10 hours. The patient did not received treatment for the events. The outcome of the events was recovered in Jan2021. Facility where the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not tested positive for covid post vaccination.
31 2021-01-14 nerve pain Developed a golf ball sized painful lymph node in my left axilla after getting the 2nd Pfizer vaccin... Read more
Developed a golf ball sized painful lymph node in my left axilla after getting the 2nd Pfizer vaccine in my left arm. Associated with shooting sharp nerve pain radiating down the left arm in the medial nerve distribution, likely from nerve impingement. I am self treating with advil since I am a physician and giving it time to resolve
31 2021-01-14 muscle spasms Diarrhea/severe cramps overnight the next day (6-7 loose stools), treated with one dose of Imodium w... Read more
Diarrhea/severe cramps overnight the next day (6-7 loose stools), treated with one dose of Imodium with some improvement. Resolved after 12hours. Severe fatigue and chills lasting 24hrs and resolved without any treatment.
31 2021-01-14 tingling, pain in extremity, numbness Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout en... Read more
Extreme pain in arm where injection was placed; Numbness in hands; Tingling sharp pain throughout entire arm and under arm; Tingling sharp pain throughout entire arm and under arm; Weakness in arm that injection was placed.; This is a spontaneous report from a contactable Other HCP (patient). This 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via intramuscular route of administration, on 07Jan2021 at 11:00 AM as a single dose in the right arm for COVID-19 immunization at hospital facility. Relevant medical history was none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL). The patient previously received the first dose of BNT162B2 (lot number/expiration date: unknown) on unknown date via unknown route of administration for COVID-19 immunization. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 08:00 PM, after the second dose, the patient experienced extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. No treatment was received for the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed. The outcome of the events extreme pain in arm where injection was placed, numbness in hands, tingling sharp pain throughout entire arm and under arm and weakness in arm that injection was placed was unknown. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2 dose 1, was not provided and will be requested during follow up.
31 2021-01-14 migraine Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contact... Read more
Fatigue; Body aches; Migraine; Vomiting; Chills; Sweats; This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 07Jan2021 09:15 at a single dose on Left arm for COVID-19 immunization. Medical history included Chronic back pain, and latex allergy. Concomitant medication included gabapentin, acetaminophen, tramadol, sulindac, methocarbamol. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 17Dec2020 09:30 at a single dose on right arm for COVID-19 immunization. The patient experienced fatigue, body aches, migraine, vomiting, chills, sweats on 07Jan2021 12:30. No treatment received for adverse event. The outcome of the event was recovered on an unspecified date in Jan2021. The events were assessed as non-serious. The patient was not pregnant at time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
31 2021-01-14 pain in extremity, tingling Head felt heavy/full/tingly starting about 6 pm on day of vaccination, fell asleep around 9:30 pm an... Read more
Head felt heavy/full/tingly starting about 6 pm on day of vaccination, fell asleep around 9:30 pm and woke up about 11 pm with left arm pain, very fatigued. Went back to sleep and woke up around 4 am with fever up to 100.6F, headache, muscle aches, joint pain, and extreme fatigue. My left axilla was swollen with arm pain to mid left chest and back, and my axillary lymph node was painful and swollen to about the size of a large grape. I took 440 mg of Aleve around 8:30 when the fever did not subside. The fever broke and did not return. I slept most of the day and was unable to work. My left axillary lymph node is still palpable as of today, 1/15.
31 2021-01-14 flushing Patient did not report an adverse reaction following dose #1. Within minutes of receiving vaccine d... Read more
Patient did not report an adverse reaction following dose #1. Within minutes of receiving vaccine dose #2, patient c/o flushing. VS 131/88, 100% RA, Hr 102, temp 97.5, RR 20, no SOB nor difficulty breathing. About 10 minutes post dose, patient reported feeling anxious, BP 130/87, HR 107, RR 20. Some swelling of lip on inner side. About 20 minutes post dose, patient started coughing and c/o itchy throat. Transported to ED where patient received epinephrine, Benadryl, solu-medrol, famotidine, NS 500mL bolus. Symptoms resolved and after 3.5 hours observation was discharged. After the patient was transported to the ED, a jar of nuts was found in the vicinity of where the patient was sitting post-vaccination.
31 2021-01-14 tingling, feeling hot, numbness Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizzin... Read more
Sensation of heat and numbness tingling in Chest up into throat mouth and lips, palpitations, dizziness, elevated heart rate, chills, tingling in extremeties, burning in throat ; started aprroximately two minutes after administration, took benedryl and water, waited another 15 minutes where signs and symptoms started to subside a little bit and thought I was okay but then came back at about 25 minutes post vaccine where it was decided to go to emergency department.
31 2021-01-15 weakness 1/14 Around 5pm general malaise, headache, chills 1/15 Around 4am worsening headache, body aches, f... Read more
1/14 Around 5pm general malaise, headache, chills 1/15 Around 4am worsening headache, body aches, fever 101.7 Spent all day in bed no energy to get up or do anything 1/16 no fever, general malaise, headache. Got covid test pending results
31 2021-01-15 numbness loss of feeling in left hand, tip of fingers, shooting pain in thumb (comes and goes). immediately a... Read more
loss of feeling in left hand, tip of fingers, shooting pain in thumb (comes and goes). immediately as vaccine was given area where vaccine was given swell up like a hard marble was under skin. about 3 mins after vaccine left hand got cold and all feeling was loss. Arm burned for about 12/16 hrs. feeling has not yet come back in hand
31 2021-01-16 pain in extremity Itchy skin Nausea Bad Headache Severe L arm pain
31 2021-01-17 tremor 6-7 hours after inoculation, I developed fatigue and mild body aches. 15 hours after inoculation, I... Read more
6-7 hours after inoculation, I developed fatigue and mild body aches. 15 hours after inoculation, I developed shaking chills then sweats (felt too unwell to go get thermometer to see if febrile). 24 hours after inoculation, still having body aches, chills (no more rigors/shaking chills), mild nausea, mild headache, mild back and neck pain, and fatigue.
31 2021-01-17 numbness Face went numb on my left side, can not stay awake after 2 days, body hurt so bad couldnt move, and ... Read more
Face went numb on my left side, can not stay awake after 2 days, body hurt so bad couldnt move, and froze. Benadryl, decatron steroid, fluids but still having effects
31 2021-01-17 pain in extremity Soreness in left arm persisting for 3 days, fever
31 2021-01-17 feeling hot felt a little bit warm and itchy in her chest area; felt a little bit warm and itchy in her chest ar... Read more
felt a little bit warm and itchy in her chest area; felt a little bit warm and itchy in her chest area; Rash/ rashes in her neck and chest area; swollen lymph node in armpit area; soreness/pain at injection site; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: Mar2021), intramuscular in the left arm on 07Jan2021 at 0.3 mL, single dose for COVID-19 immunization. Medical history included testing positive for COVID in Apr2020. There were no concomitant medications. The patient previously took flu shot and experienced soreness. The patient did not receive any vaccination within 4 weeks prior to the COVID vaccine. The patient called in regards to Pfizer COVID Vaccine. She received her first vaccine last Thursday, 07Jan2021. She was not sure if she can report this as a side effect, but she had some rashes appear just today (11Jan2021), at midnight, in her neck and chest area. The rashes were going away, but she still has some itching. She also stated that she took some over-the-counter diphenhydramine (BENADRYL, UPC: 1254717031, lot number: PJF044, expiration date: Jun2021) tablets to relieve the symptoms. She explained that she started to experience soreness/ pain at the injection site a few hours after receiving the COVID-19 vaccine. The pain in her arm has already went away. She noticed a swollen lymph in her armpit area on Friday morning, 08Jan2021 and it's still a little bit swollen. She didn't expect on getting a rash since she read symptoms only appear around 2-3 days only. Therefore, she is not sure if she can report this as a side effect because its been like 3 days already. She noticed the rash just today, at midnight. She stated that she is still itchy. She stated that there is just a little bit of itchiness in her neck. She felt a little bit warm and itchy in her chest area, at midnight (unspecified date), and she kept scratching. She knows she shouldn't have done that but it was itchy. The patient would consider these events to be non-serious. She did have some soreness with a flu shot before so it's not too serious. She explained she is a healthcare worker. She works in a nursing home facility and they asked if she wanted to receive the Covid-19 vaccine and she filled out the form. She also explained that she doesn't have any allergies to any medications. So, with the rashes that came, she is not really sure what is the cause of it. The events did not require a visit to the emergency room or physician office. She stated she wanted to report this information but she also needs advice on whether she needs to continue taking Benadryl. Her rash is improving, but she is still a little bit itchy. She doesn't have any shortness of breath or anything. It's not a major reaction, just a little bit of a rash/itchiness in her chest and neck area. The outcome of the event vaccination site pain was recovered on 10Jan2021, for lymphadenopathy and rash was recovering, for pruritus was not recovered and for feeling hot was unknown.
31 2021-01-17 flushing following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covi... Read more
following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-01-18 tingling Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine howev... Read more
Anaphylaxis less than two hours after vaccination. I had no symptoms immediately after vaccine however did develop symptoms within one minute of completing a run. Developed b/l hand swelling and tingling, diffuse hives and itching, tachycardia, elevated blood pressure, lips tingling and swelling which required emergency room visit and EpiPen, IV fluids, Benadryl and IV steroids. This is similar to previous reactions I have had to running previously. Symptoms resolved within one hour after treatment in ED.
31 2021-01-18 tremor Approximately 15-20 minutes post-injection I started to feel lightheaded, dizzy, shaky and increased... Read more
Approximately 15-20 minutes post-injection I started to feel lightheaded, dizzy, shaky and increased heart rate. This was swiftly followed by a feeling of tightness in my throat, shortness of breath, and coughing. In addition I had a moderate to severe headache. The hospitals rapid response team was called and I was brought to the emergency department on-site. I was given a racemic epinephrine and albuterol neb treatment which resolved upper airway stridor and cough. I received PO Benadryl, Pepcid, and Prednisone. A EKG was completed. I was observed in the emergency department for about 2 hours until discharge. I was discharged with prescriptions for an Epi-Pen, Prednisone, and Pepcid. The diagnosis on my after visit summary was: Allergic Reaction. I was unable to finish my scheduled shift as an RN.
31 2021-01-18 weakness Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6. Fever pos... Read more
Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6. Fever post Tylenol 100.8.; Racing heart rate recorded at 120 bpm; Severe chills; body ache; muscle and bone pain; muscle and bone pain; Shooting pains in various joints; Brief stomach pain; Sore axillary lymph node on side of injection arm; Sore arm at injection; dizziness; weakness; This is a spontaneous report from a non-contactable other HCP. A 31-year-old female patient received BNT162b2 (lot: EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history included covid (Previous covid was diagnosed with serology antibody test in doctors office. Not diagnosed with a covid test). The patient's concomitant medications were not reported. Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6 (Jan2021). Fever post Tylenol 100.8 (Jan2021). Racing heart rate recorded at 120 bpm (08Jan2021). Severe chills and body ache, including muscle and bone pain. Shooting pains in various joints. Brief stomach pain. Sore axillary lymph node on side of injection arm. Sore arm at injection site began 3/4 hours post injection (08Jan2021). All other symptoms began 11 hours post injection (08Jan2021). Continued dizziness and weakness 56 hours post injection (Jan2021). The patient was not pregnant at the time of vaccination. The outcome of the events was Resolved with Sequel in Jan2021. No follow-up attempts are possible. No further information is expected.
31 2021-01-18 pain in extremity, nerve pain Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of va... Read more
Pregnant at the time of vaccination; Pregnant at the time of vaccination; Pregnant at the time of vaccination; bilateral nerve like pain; small headache; temp 100.3; enlarged axillary lymph nodes; pain in both shoulder joints; chest soreness; feel exhausted/feel tired; Braxton Hicks contractions; slight chills; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; injection site soreness/arm pain radiates around seems like nerve like pain with chest tightness; arm pain radiates around seems like nerve like pain; This is a spontaneous report from a contactable other HCP. A 31-year-old female other HCP reported for herself that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EKS730) into the left arm at single dose on 22Dec2020 at 05:30 PM and received the second dose of BNT162B2 (Lot number EKS730) into the left arm on 08Jan2021 at 08:00 AM at single dose for COVID-19 immunization. The patient is pregnant, last menstrual date 29Apr2020, gestational period 35 and estimated delivery date 07Feb2021. Concomitant drug included Prenatal vitamin. The patient reported that on 08Jan2021 she experienced injection site soreness at 20:00, the arm pain radiates around seems like nerve like pain with chest tightness. Temperature 97.7, she took Tylenol 1000 mg. On 09Jan2021 at 00:15 she had slight chills, at 01:20/01:30 chills, arm pain, chest more tight, Braxton Hicks contractions for about 1 hour, temperature 99.9, she took Tylenol 1000mg and went to sleep. At 08:00 she had no chills temperature 98.8, pain in both shoulder joints, chest soreness- feel exhausted. At 09:00 1000mg Tylenol, at 14:15 temperature 98.0, at 17:45 temperature 99.8, she took 750mg Tylenol. At 18:20 temperature 100.3, she took 250mg Tylenol, at 18:50 temperature 99.0 after shower, at 19:08 temp 98.8 and at 22:00 feeling slightly better, she had bilateral nerve like pain, chest pain, small headache. On 10Jan2021 at 02:45 temp 98.2 she took 1000mg Tylenol, at 09:00 temp 97.9, bilateral nerve like pain and enlarged axillary lymph nodes, chest sore, slight headache. At 17:00 temp 96.6 bilateral nerve/lymph node pain and felt tired. The patient did not have Covid prior vaccination and she was not Covid tested post vaccination. At the time of reporting the patient was recovering.
31 2021-01-19 flushing, feeling hot Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become ... Read more
Approximately 10 to 15 minutes post injection she started feeling hot, then patient began to become flushed . I gave her oral benadryl 50 mg and 40 mg of famotidine oral. The difficulty in breathing did not lessen. She began to use her accessory muscles. Her O2 sats were 99% via finger pulse oximeter. Breathing became increasingly labored. An Epi pen 0.3 mg was administered. An ambulance was called. Her breathing became less labored, she was transported to the hospital via ambulance to be checked out.
31 2021-01-19 feeling cold BODY ACHES, HEADACHE, COLD. PRESSURE ON LEFT ARM AND PRESSURE ON LEFT CHEST. UTILIZED HEATING PADS F... Read more
BODY ACHES, HEADACHE, COLD. PRESSURE ON LEFT ARM AND PRESSURE ON LEFT CHEST. UTILIZED HEATING PADS FOR ARM AND CHEST.
31 2021-01-19 pain in extremity Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she develope... Read more
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours after her vaccine she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 (Friday, January 15, 2021) she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a deep vein thrombosis of the proximal vein. She also came to the ETC and was ruled out for a PE. The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
31 2021-01-19 pain in extremity Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever wit... Read more
Employee received her 2nd Pfizer vaccine on 1/12/2021. Twelve hours later she developed a fever with a T-max of 102 degrees. The fever lasted 18 hours. She also complained of severe malaise and fatigue lasting 36 hours. On day 3 she developed left lower extremity pain that persisted over the weekend. She was seen in Urgent Care today where she was diagnosed with a thrombosis. She also came to the ETC and was ruled out for a PE The employee does have a family history of antiphospholipid in her mother. She has a follow up with her PCP and will also receive a work up in hematology as she had never been tested for any genetic coagulation conditions after her mom's diagnosis.
31 2021-01-19 migraine, pain in extremity Estimated due date: 07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started... Read more
Estimated due date: 07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started having all body aches and chills, never had a fever. Very fatigued. At night I threw up and about 2AM I woke up drenched in sweat and I did not take my temperature. I woke up around 7AM and I had a migraine for about 2/3 hours - pounding headache. I took Tylenol, My body was really achy and my arm was like it was dead. General malaise, fatigue, it felt like I had a hangover, from my pounding headache. I threw up once again in the afternoon. Not sure if pregnancy related or the vaccine. Sunday morning I started feeling a little better. Saturday I felt horrible.
31 2021-01-19 pain in extremity Fever (max 102 degrees Fahrenheit) after 12 hours of the vaccine, lasting for approximately 18 hours... Read more
Fever (max 102 degrees Fahrenheit) after 12 hours of the vaccine, lasting for approximately 18 hours total. Accompanied by chills, malaise, myalgias. Continues with mild tiredness and shortness of breath on exertion over the next few days. COVID-19 test done on 1/13/2021 due to severity of symptoms, was negative. 3 days later (1/15/2021) left calf pain with mild edema, subsequently diagnosed (1/20/2021) as a left posterior tibialis complete vein occlusion (DVT). Chest CT done to rule out pulmonary emboli. Anticoagulation prescribed (xarelto).
31 2021-01-19 tremor, migraine High fever 101.9 began the evening when I got my shot and as of an hour ago just came under the 100 ... Read more
High fever 101.9 began the evening when I got my shot and as of an hour ago just came under the 100 mark. I?ve been taking Tylenol every 4-6 hours to combat high fever but it wasn?t going down. I had chills with the fever, so bad that my body was shaking. Fever stayed in the 101 range from Monday evening until Wednesday morning. Extreme shoulder pain radiating from left to right on Monday evening - lasted into the early morning on Tuesday. Chest tightness with R shoulder pain Tuesday afternoon from roughly 130p-315p. It subsided and so I did not seek medical attention. I?ve also had a severe migraine the entire time since getting my shot, but haven?t taken my Ubrelvy as I wasn?t sure how my body would react.
31 2021-01-19 weakness Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00... Read more
Jan 4, 2021 received shot at work in morning around 11:00 am- felt fine at work all day. Around 7:00 that night began to have back pain, fever reached up to 102 around 2:00 am and took Tylenol. Felt very weak, headache, difficulty walking and decreased balance. On Jan 5, 2021 still had back ache and headache. On Jan 6, 2021 I felt better and began to have abdominal pain after eating dinner. I assumed it may be because of eating more then I had in past few days and did not attribute to much but the pain gradually increased to a strange burning/pressure across my upper abdomen that night. Very nauseous and ran low grade fever (99.45). Next morning I had less diffuse pain and could localize it to right lower quadrant.
31 2021-01-19 flushing Patient received her second Pfizer dose and began to complain of stomach cramps, feeling flushed and... Read more
Patient received her second Pfizer dose and began to complain of stomach cramps, feeling flushed and itchiness in her hands. Patient received 50mg of Benadryl IM and was transported to the hospital via ambulance.
31 2021-01-19 tingling Tingling fingers on side of injection. No pain at site elsewhere in arm. Felt fine on injection.
31 2021-01-20 feeling cold 5 mins after receiving shot pt started to experience dizziness and coldness in her hands. pt was tol... Read more
5 mins after receiving shot pt started to experience dizziness and coldness in her hands. pt was told to lay down, brought jacket to cover up with and observed for worsening of symptoms. at 11:40 pt stated she felt better so she sat up but then felt dizzy again so asked pt to stay put and gave her some water to drink. at around 12 pt said she felt better so I had pt stand up slowly and walk back and forth down the hall to see if she had recovered fully. she then started to clear her throat constantly and stated she felt she had something in her throat that she couldn't clear, after about 20 mins she said it felt like it was getting worse so she was given 25 mg of Benadryl and laid back down. at 12:30 pt said she started to feel a pain in her chest but went away after about a min. and for for the next hour pt experienced dizziness and coldness off and on. at about 2: 30 pt was picked up by husband and taken home, since symptoms were not getting worse.
31 2021-01-20 pain in extremity Had arm soreness on the day of the vaccine. The following day continues to have soreness of the arm ... Read more
Had arm soreness on the day of the vaccine. The following day continues to have soreness of the arm but noticed a firm hard small lump in her left neck. Left neck lump persists. Non painful
31 2021-01-20 flushing, pain in extremity Had to wait longer immediately post vaccine due to nausea and flushing. About 7 pm that even slight ... Read more
Had to wait longer immediately post vaccine due to nausea and flushing. About 7 pm that even slight soreness in arm. Woke next morning with swollen lips, face, eyes, and extremities. This seemed to go away on its own around 1pm on Friday but the. Developed severe headache and vertigo and extreme fatigue. This lasted for the next 40 hours. By Sunday mid day I felt great.
31 2021-01-20 numbness L arm became immediately numb, immediate dizziness, and light-headed feeling. Increased HR. EMT mo... Read more
L arm became immediately numb, immediate dizziness, and light-headed feeling. Increased HR. EMT monitoring at vaccination site, went to work, monitored by NP who sent me to ER. Monitored at ER, given anti-vert and released.
31 2021-01-20 pain in extremity Sore arm, but with this dose I had a red bump at injection site that started the size of a pea and a... Read more
Sore arm, but with this dose I had a red bump at injection site that started the size of a pea and as of the evening of 1/21/21 it is the size of a quarter, red hot and hard lump, it?s been itchy on and off since last night. I did not have anything other than a sore are with the first dose.
31 2021-01-20 tingling Within minutes and almost instantaneously, as the shot was being injected, my arm tingled. Then it ... Read more
Within minutes and almost instantaneously, as the shot was being injected, my arm tingled. Then it moved to my mouth and tongue. The roof of my mouth, and tongue became numb. I needed to think really hard how to swallow. It was like I could not figure out how to work that muscle. I took benadryl, to ease symptoms. It helped but did not take it away. Next day, mouth and tongue still numb, and my ears, eyes, nose and throat were itchy. My external skin was also itchy. My doctor put me on a steroid pack. 4 days later, I am doing much better still not 100% percent myself, but very close to being back to normal. Still have slight sensation in tongue.
31 2021-01-21 weakness, numbness Systemic: numbness in arms, legs, weakness -Severe
31 2021-01-22 feeling hot About an hour after getting the shot, I did get extremely light headed and pulled my car over to get... Read more
About an hour after getting the shot, I did get extremely light headed and pulled my car over to get gas. I then noticed a rash all down the arm I got the vaccine and all over my chest and up my neck. I felt extremely hot. I got back in my car and sat at the gas station waiting for the lightheadedness to pass. I did call my GP at that time to make sure everything was OK. The nurse said that it sounds like a reaction but as long as I do not feel like I can not breathe or that my throat was swelling I should be ok. They advised me to eat something and also take benadryl once I got home. Rash stayed for a total of 2 days and today (3rd day) I only have a rash at the injection site. Its very red and hot to touch. Other symptoms I have/still have was very bad headache, fever (highest was 102.8 and today 3 days later is still over 101). Body aches, chills and the first 24 hours I felt like my internal organs were hot (sounds really weird!)
31 2021-01-22 numbness After I had the 2nd dose of the Pfizer, my left arm was numb and couldn?t drive but I was able to li... Read more
After I had the 2nd dose of the Pfizer, my left arm was numb and couldn?t drive but I was able to live with it until the 4th day, during working period I suddenly felt dizzy and nauseous, went to throw up, dizziness was intense then I fell off my chair and was rushed to the Emergency for treatment, was treated for vertigo and given Meclizine to reduce the dizziness and nausea. Till date the dizziness wouldn?t go away.
31 2021-01-24 feeling of body temperature change About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortne... Read more
About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortness of breath, body aches (extreme), joint pain especially in hips and knees, extreme fatigue, headaches, ears constantly rang. Rash on my arm where I received it went down to my elbow and up to my shoulder and on to my upper back, about 3 hours for it show up. It red, raised and bumpy and it felt hot. This lasted for 4 days. I was very pale and my eyes were sunken in. I literally felt like I was ran over by a vehicle. I was sleeping for about 15 hours a day. I kept getting chills then I profusely sweats then it switch to freezing cold and back and forth between the two. I took Tylenol and Benadryl to control symptoms but still felt miserable. The symptoms all stayed with me to the end. I still do not feel 100%, I am still having ringing of the ears, moderate body aches and headaches. Someone else said they still see the rash but I cannot really tell. I was also having trouble focusing for a few days after receiving the vaccine, I felt highly medicated not the fun high the bad high
31 2021-01-24 feeling of body temperature change About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortne... Read more
About 15 minutes after receiving vaccine symptoms started. Nauseous, dizziness, chest pain, shortness of breath, body aches (extreme), joint pain especially in hips and knees, extreme fatigue, headaches, ears constantly rang. Rash on my arm where I received it went down to my elbow and up to my shoulder and on to my upper back, about 3 hours for it show up. It red, raised and bumpy and it felt hot. This lasted for 4 days. I was very pale and my eyes were sunken in. I literally felt like I was ran over by a vehicle. I was sleeping for about 15 hours a day. I kept getting chills then I profusely sweats then it switch to freezing cold and back and forth between the two. I took Tylenol and Benadryl to control symptoms but still felt miserable. The symptoms all stayed with me to the end. I still do not feel 100%, I am still having ringing of the ears, moderate body aches and headaches. Someone else said they still see the rash but I cannot really tell. I was also having trouble focusing for a few days after receiving the vaccine, I felt highly medicated not the fun high the bad high.
31 2021-01-24 tingling ED notes as follows: 31 y.o. female who arrived to the emergency department for Vaccine reaction. ... Read more
ED notes as follows: 31 y.o. female who arrived to the emergency department for Vaccine reaction. The patient presented to the ED after getting her second COVID vaccination. She reports feeling confused, nauseous, and having a racing heart. She has never had a reaction like this before. She reports having a tickling sensation in the back of her throat and both hands feel like they are tingling. The patient denies any other known allergies. The patient has a past medical history of anxiety, depression, PTSD, prior conversion disorder. Patient denies any shortness of breath or chest pain but does report a headache. The patient denies any drug use, alcohol use, tobacco use. Patient has no other complaints at this time. The patient was given Benadryl, Epi, solumedrol, for anaphylactic-like presentation. Patient also began on fluids and Zofran for possible vaccine reaction. Patient symptoms began to improve over the course few hours. At the 3-1/2-hour mark after initial arrival to emergency department the patient began to have similar symptoms to her initial presentation with tachycardia, dry heaving, and finger tingling. The patient was also hyperventilating. The patient was given 1 mg Ativan which relieved her tachycardia had resolved her hyperventilation signifying possible anxiety component to symptoms. Patient was allowed to relax for 20 to 30 minutes at which time she was comfortable and felt like she was okay to discharge home. Patient was instructed to follow-up with her primary care doctor that she could next week. Patient was informed to return to emergency department if new symptoms arise or current symptoms worsen. Dispo: Discharge home with PCP follow up on Monday Initial Vital Signs [01/22/21 1424] Blood Pressure 161/99 Heart Rate 112 Respiratory Rate 24 Temp 36.4 °C (97.6 °F) Temp src Oral SpO2 99 %
31 2021-01-24 tingling, feeling cold, numbness PATIENT SAID COLD, TINGLING, NUMBNESS LIKE FEELING IN ARM THAT INJECTION WAS GIVEN IN, NO ANGIOEDEMA... Read more
PATIENT SAID COLD, TINGLING, NUMBNESS LIKE FEELING IN ARM THAT INJECTION WAS GIVEN IN, NO ANGIOEDEMA PRESENT, NO REASH, HIVES OR REDNESS AT THE INJECTION SITE. VITALS WERE MONITORED. PATIENT ADVISED TO CONTACT PCP OR GO TO ER IF GOT WORSE. SHE WENT BACK TO WORK ON 6SOUTH AFTER 30 MIN WAIT TIME. 11:12 AM 134/91 HR 71 98% IN LEFT ARM, RIGHT ARM 124/88 HR 70 OXYGEN 99% 11:27AM 137/82 LEFT ARM, HR 72, OXYGEN 99%, RIGHT ARM 128/95 HR 65 OXYGEN 99%
31 2021-01-24 tingling Paresthesia of upper and lower extremities, observe for now
31 2021-01-24 feeling hot Right after vaccination patient felt warm, rash started to appear and had intense itching about 10 m... Read more
Right after vaccination patient felt warm, rash started to appear and had intense itching about 10 minutes in to the event. She had premedicated with Benadryl 12.5mg along with Zyrtec. After itching started she was given an additional 12.5 mg of Benadryl. She was monitored for >30 minutes with improvement of symptoms. Rash still present but she said no longer has itching and that she knew her body well and that she was fine to leave. She stated that her mother was in the car waiting for her since she knew that she might have this type of reaction. We had a long discussion about going to the ER but she said she has Benadryl on her if needed and knew when she needed to get to an ER in terms of symptomatology. We also discussed option of having next dose with an allergist. She would like to call her allergist to discuss options but feels comfortable getting 2nd dose knowing how she reacted this time.
31 2021-01-25 muscle spasms, pain in extremity, speech disorder, burning sensation Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 ... Read more
Injection site immediately felt severe itchy following injection but diminished after approx. 30-45 minutes. I then felt fine until exactly 3:00 pm (approx. 3 hours following injection). I stood up and immediately felt like passing out. I had excruciating cramping throughout my legs and horrible joint pain in my knees. By 3:30 I had hives covering my right hand- my hand was also very red and swollen and had severe itching/burning. By now I also had horrific joint and muscle pains all over my entire body and the leg cramping was even worse. the hives responded well two doses of Benadryl and the muscle aches somewhat improved with rotation of ibuprofen and Tylenol. By 5:00 am the following day, the joint and muscle pains were worse. My entire body felt like it was on fire and I had excruciating pain in my throat. It was difficult to speak or swallow and I could feel my throat swollen on the inside. My neck was also slightly swollen and the lymph nodes on the left side of my neck were in horrific pain but not swollen. I continued doses of Benadryl, ibuprofen and Tylenol all day and night and slept most of the time. By Sunday Morning, my throat felt even worse and I had 100 degree fever and continued body aches and joint pain. I was seen at a local urgent care who ran various tests (see below) that were negative and advised me to treat as if it were an allergic reaction and go to ER if I got any worse. Fever and pain improved by Monday and by Tuesday I was able to return to work but with significant fatigue and continued pain in my legs. I continued to improve throughout the week. Now the following week I overall feel back to normal other than I have continued leg pain, esp. in my knees by the end of the day.
31 2021-01-25 migraine No symptoms at time of dose, was observed for 15 mins for safety. Reactions began 2 hrs afterward, a... Read more
No symptoms at time of dose, was observed for 15 mins for safety. Reactions began 2 hrs afterward, at home. Migraine, extreme fatigue, fever of 100.1 lasted from Friday 1/22 to Monday 1/25 between doses of Advil. Saturday 1/23, redness, swelling, pain, hot at injection site growing from golf ball size to softball size by Sunday morning. Began spreading inflammation around shoulder and inside arm. Slight hives visible Monday 1/25. Itching present.
31 2021-01-25 facial pain, pain in extremity On 01/14/21 I started developing neck and shoulder pain. I reported symptoms to ER. On 01/20/21 I a... Read more
On 01/14/21 I started developing neck and shoulder pain. I reported symptoms to ER. On 01/20/21 I also started developing stiffness and pain on may arms, hands and feet on both sides. I reported symptoms to Urgent Care. Since then the pain has increased and is now worse on my right hand side-arms, feet; leg-up the glutes and face. I was seen on Urgent Care on 01/22/21 and was told to take OTC ibuprofen. Since symptoms worsened I went to ED on 01/24/21 and was told to keep taking ibuprofen and follow-up with my PCP. I saw my PCP on 01/25/21 and was told to continue monitoring symptoms, continue ibuprofen and f/u in week. I was also prescribed an Hydroxyzine to help with anxiety.
31 2021-01-25 pain in extremity Swollen lymph node in left armpit for ten (10) hours. Painful to the touch and with arm movement, fe... Read more
Swollen lymph node in left armpit for ten (10) hours. Painful to the touch and with arm movement, felt like a Charlie horse. About the size of a chicken egg. No treatment given. Swelling subsided in late morning. Arm soreness persisted for two more days (through 16 JAN).
31 2021-01-25 hot flush increased appetite; Hot flashes; itching; This is a spontaneous report from a contactable consumer (... Read more
increased appetite; Hot flashes; itching; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient (non-pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: El3302), via an unspecified route of administration on 11Jan2021 18:45 at single dose on left arm for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced increased appetite, hot flashes and itching, all on 11Jan2021 20:00 with outcome of not recovered. No treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. No COVID tested post vaccination.
31 2021-01-26 tingling, pain in extremity, numbness 8 days after my first vaccine shot, on Jan 19th night, I suddenly started having pain in the chest... Read more
8 days after my first vaccine shot, on Jan 19th night, I suddenly started having pain in the chest. The pain was located in the left side of the lower end of the sternum, in the epigastric region. Pain lasted for 3-4 hours. Initially it was severe, pulsating, acute pain as if nerve pressing against chest. Unbearable pain. I was unable to lie down, turn on sides. Pain would aggravate on movements and if I would touch the specific spot in my chest. . Deep breaths reduced the pain to some extent. Pain severity decreased after 4 hours after which I started getting pain in my left arm, radiating to my pinky finger. The pain also radiates to left upper back on movements and exerting left arm for long time, especially typing computer keyboard, doing daily chores cooking, washing dirty dishes, sleeping on the side. ,I am unable to sleep on the left side, if I sleep on left side, I start getting tingling and numbness in my left arm. I did not take any pain medications until Jan 26th as the pain did not disappear. Once at night the pain also radiated to my left leg , I felt numbness when I tried to sleep on my left side. Occasionally, I feel pain in my right arm and right back. The pain near the sternum area reduced significantly when I took two doses of Ibuprofen 600 on Jan 26th in the afternoon and night. The pain in left arm radiating towards left pinky still persists, with numbness and tingling if I do daily task for longer duration. Ibuprofen helps to relieve pain temporarily. Mild pain in right arm, neck and upper arm. I will continue to closely monitor my symptoms.
31 2021-01-26 flushing EE develop tachycardia, hypertension, and face flushing within 40 mins of receiving dose. Symptoms ... Read more
EE develop tachycardia, hypertension, and face flushing within 40 mins of receiving dose. Symptoms resolved without treatment.
31 2021-01-26 discomfort I am reporting my symptoms through this avenue because the VAERS wouldn't let me complete my daily r... Read more
I am reporting my symptoms through this avenue because the VAERS wouldn't let me complete my daily report on that day (no submit button found). I had malaise a few hours after the shot. 12 hours after the shot, this turned into a fever that would peak at 103 within the next 12 hours. Fever was accompanied by severe chills, moderate headache, moderate muscle aches, mild joint aches, and mild nausea. I also had a swollen lymph node under my armpit ipsilateral to the injection, the diameter of a baseball. Discomfort from the lymph node was mild. The fever and chills were so bad that I couldn't do any daily activities and stayed in bed all day. I called a nurses line to ask them if I could take something for the discomfort and they advised Tylenol, so I took 1000 mg. Tylenol did bring down the fever to 101 and the fever rose back to 103, 9 hours after Tylenol. All the aforementioned symptoms lasted for 3 days, and the severe symptoms decreased in severity to "moderate" after about 36 hours.
31 2021-01-26 pain in extremity Upset stomach resulting in three consecutive trips to the bathroom (diarrhea) over about a 15 minute... Read more
Upset stomach resulting in three consecutive trips to the bathroom (diarrhea) over about a 15 minute time frame. Upper left arm muscle pain - similar to right arm injection site. Felt like there was a lump in my throat for awhile making it very slightly difficult to breathe.
31 2021-01-26 difficulty speaking Within thirty minutes of administration I started feeling itchy around injection site then all over ... Read more
Within thirty minutes of administration I started feeling itchy around injection site then all over my entire body. I stated to have some facial swelling then my throat started to swell/tighten. I was brought to the ED and an IV was started. They administered IV fluids, Benadryl, Prednisone, and Pepcid. The throat swelling started to interfere with my speaking and vocals. They monitored me for 7 hours then I was discharged home. All symptoms returned within a few hours and persisted for a week following. My PCP took over care and prescribed me the following in replace of the medications the ER prescribed: Albuterol HFA, Dexamethasome, Pepcid, Benadryl, Z-Pak, Vitamin D 100,000iu, and Fish Oil. I missed a week of week then was released to work again on 1/25/21.
31 2021-01-27 tenderness 5 weeks pregnant swollen lymph node, golf-ball sized on collar bone, same side as injection. Warm to... Read more
5 weeks pregnant swollen lymph node, golf-ball sized on collar bone, same side as injection. Warm to the touch and moveable, agitated by pressure and palpation.
31 2021-01-27 unresponsive to stimuli After vaccination, patient complaining of chest pain / pressure, and sense of impending doom.Medicat... Read more
After vaccination, patient complaining of chest pain / pressure, and sense of impending doom.Medication administered per EMS EPI given x2 at 0956 and 1015 ASA 325 chewable given at 1004 for c/o crushing chest pain. Emergency response provider arrived present. Pt started with c/o epigastric and then crushing CP. Pt appeared to be unresponsive at 1020 but the several minutes later she is arousable and anxious, breathing labored and she is stating she is "going to die". Transported to ED where delirium was noted and due to elevated ammonia level current presumptive diagnosis is hepatic encephalopathy.
31 2021-01-27 burning sensation, muscle spasms Roughly 4-5 days after each dose of my COVID-19 vaccine, I began to feel pelvic cramps and burning, ... Read more
Roughly 4-5 days after each dose of my COVID-19 vaccine, I began to feel pelvic cramps and burning, as though I had a UTI. It stopped after my first dose, but returned more strongly after my second dose. It has been more than two weeks since the second occurrence, and the pain has now spread to my upper abdomen and back, with the pelvic pain and burning continuing.
31 2021-01-27 numbness, face paralysis, pain in extremity, tingling, burning sensation Some fatigue and arm pain the day after the vaccine. Starting 1/17/21 she had intermittent burning i... Read more
Some fatigue and arm pain the day after the vaccine. Starting 1/17/21 she had intermittent burning in her scalp. The following day she also started having a weird taste in her mouth. These symptoms continued and a few days after she also started having intermittent numbness and tingling in her face. The face parasthesias stopped on 1/23 or 1/24. The weird taste in her mouth is still intermittent but less frequent. The scalp irritation has mostly resolved.
31 2021-01-27 pain in extremity, migraine Sore arm, stinging pain in left arm on day following injecting. Lasted 24 hrs. Migraine started day... Read more
Sore arm, stinging pain in left arm on day following injecting. Lasted 24 hrs. Migraine started day after injection, lasted 7 days with mild to moderate relief through use of Advil, Tylenol, fioricet (prescribed by neurologist for migraine). Required Rx of decadrone from neurologist to break migraine cycle
31 2021-01-28 night sweats 103-104 fever, night sweats, severe headache/dizziness upon rising, mild shortness of breath/chest t... Read more
103-104 fever, night sweats, severe headache/dizziness upon rising, mild shortness of breath/chest tightness.
31 2021-01-28 tingling, numbness 15 hours after 2nd dose vomiting, intense pain over 3 days, swelling, redness, itching, lump at site... Read more
15 hours after 2nd dose vomiting, intense pain over 3 days, swelling, redness, itching, lump at site, numbness and tingling, low body temp, profusely sweating
31 2021-01-28 tremor 4pm- tiredness 7pm-tiredness,nausea and chills 11pm- stomach cramping, tiredness, nausea, chills 1/... Read more
4pm- tiredness 7pm-tiredness,nausea and chills 11pm- stomach cramping, tiredness, nausea, chills 1/29 @1am- nausea, vomiting, severe chills, shaking, body aches, tiredness. 1/29- bodyaches continue through day.
31 2021-01-28 weakness A few after hours after second dose, I have experienced vomiting, diarrhea, chills, sweating, feelin... Read more
A few after hours after second dose, I have experienced vomiting, diarrhea, chills, sweating, feeling faint/weak. Still 2 days later still having same side effects
31 2021-01-28 facial pain HEADACHE, NECK PAIN, RIGHT SIDED FACE PAIN, BODY ACHES, FEVER
31 2021-01-28 flushing Patient received Pfizer COVID-19 vaccine (second in series) at 12:34pm by RN in left Deltoid, came t... Read more
Patient received Pfizer COVID-19 vaccine (second in series) at 12:34pm by RN in left Deltoid, came to sit in observation area. At about 12:50pm she began to feel flushed and dizzy. Vital signs taken, 136/78 bp, HR 106 regular, normal SpO2. Noted to be mildly diaphoretic with left arm injection site warm to touch, no visible skin changes. No report or evidence on evaluation of respiratory distress. Normal mental status and orientation throughout. Benadryl 25 mg oral tab administered. She also drank apple juice and ate part of a sandwich. After about 15 minutes, bp normalized to the patient's baseline systolic ~110 and slower heart rate, dizziness and flushing resolved.
31 2021-01-28 feeling hot This is a spontaneous report from a contactable other health professional (patient). A 31-year-old f... Read more
This is a spontaneous report from a contactable other health professional (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 14:30, at left arm, at single dose for covid-19 immunization. Medical history included migraines from an unknown date, Allergies to medications, food, or other products: penicillin, sulfa. Concomitant medication included propranolol. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Eh9899) via an unspecified route of administration on 23Dec2020 15:00 at left arm, at single dose for covid-19 immunization. The patient experienced Severe rash, red skin and hives across my abdomen and legs. Hot to the touch, all on 16Jan2021 16:00. Treatment was reported unknown. The outcome of the event was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
31 2021-01-28 pain in extremity, migraine migraine, soreness in arm, unable to lift arm or turn head, whole body aches, extreme chills, slight... Read more
migraine, soreness in arm, unable to lift arm or turn head, whole body aches, extreme chills, slight nausea
31 2021-01-28 numbness, tingling numbness to my left leg (from my ankle to my hip/waist)/ right side also became slightly numb/numbne... Read more
numbness to my left leg (from my ankle to my hip/waist)/ right side also became slightly numb/numbness to her left arm; My left knee was buckling, making walking very difficult; My left knee was buckling, making walking very difficult; my right side also became slightly numb, and was also tingling; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO140, expiration date unknown), via an unspecified route of administration in the left arm on 10Jan2021 at 11:45 AM at a single dose for COVID-19 immunization. Medical history included neuropathy and migraine. The patient did not have COVID prior to vaccination. Patient is not pregnant. Concomitant medications included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), colecalciferol (VITAMIN D [COLECALCIFEROL]) and acacia senegal, ascorbic acid, betacarotene, calcium carbonate, calcium pantothenate, calcium silicate, cellulose microcrystalline, colecalciferol, croscarmellose sodium, cyanocobalamin, dextrin, dl-alpha tocopheryl acetate, ferrous fumarate, folic acid, gelatin, glucose, hypromellose, lecithin, macrogol, magnesium oxide, magnesium stearate, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, starch, thiamine mononitrate, titanium dioxide, zinc oxide (ONE-A-DAY WOMEN'S) on unspecified dates for unspecified indications. The patient has not had other vaccines in four weeks. On 10Jan2021, three hours after being vaccinated (at approximately 3:00 PM), the patient experienced complete numbness to her left leg (from her ankle to her hip/waist). Hours later, the patient noted numbness to her left arm. Her left knee was buckling, making walking very difficult. The patient reported to the ER, and after several hours of waiting to be seen by a doctor, her right side also became slightly numb, and was also tingling. 18 hours after symptom onset (at approximately 9:30am, the day following injection), the numbness on her right side resolved. It was also reported that the numbness on her left side did not completely resolve for more than 24 hours. The patient underwent lab tests and procedures which included nasal swab test which was negative on 13Jan2021 . Therapeutic measures were taken as a result of the events which included anti-anxiety medication for calming. The outcome of the events left knee was buckling, making walking very difficult and tingling was recovered on unspecified date, while the rest of the events was recovering at the time of report.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported complete numbness to her left leg (from her ankle to her hip/waist)/numbness to her left arm, left knee was buckling, walking very difficult, right side also became slightly numb and tingling, and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
31 2021-01-29 tingling . She received the second covid pfizer vaccine 1/29/21. Within minutes post vaccine she had bilate... Read more
. She received the second covid pfizer vaccine 1/29/21. Within minutes post vaccine she had bilateral hand arm tingling. She stayed longer for observation and the provider did a brief exam which was normal. The paresthesias have persisted but now only in bilateral 4th to 5th digits. Severe, 8-10 HA began 7-8 hours later and has persisted in severity of 8/10 at worst and 6/10 this morning as she slept better through the night. It is located in the left orbit, left frontal area, throbbing, persistent, causing nausea and vomited 4 times since onset. Her vision is intermittently, "fuzzy" like she as if she does not have her glasses on only in the left eye. This comes and goes and seems to be present as the HA worsens. She has a hx of menstrual triggered headaches that resolve with meneses and just with OTC treatment. No photophobia. She has taken IBU 400mg q 8 hours, APAP 1g last night, melatonin 10 mg last night to sleep. Did not work her night shift last night due to the vision and HA she did not think she would be able to perform functions of her job. She also has flu Like symptoms of body aches, tired, no fever. Admits her anxiety is making the symptoms worse.
31 2021-01-31 feeling hot, weakness Headache, nausea, chills at start; chills transitioned to fever/hot sweat in middle of night then im... Read more
Headache, nausea, chills at start; chills transitioned to fever/hot sweat in middle of night then improved. Next day very weak and lethargic with headache, loose stool (not classified as diarrhea but looser and more frequent than normal), lots of indigestion (burping, gas). Day after than felt tired and weak with minimal stomach indigestion, and the day after that fully back to normal, with some fatigue
31 2021-01-31 pain in extremity, cold extremities, hot flush Struggle to balance; lightheaded/ Lightheadedness/ dizzy; cold hands; Wake up w/ T 101.3F; hot flash... Read more
Struggle to balance; lightheaded/ Lightheadedness/ dizzy; cold hands; Wake up w/ T 101.3F; hot flashes; Dizziness with too much exertion; Chills; SOB with normal work activities/ out of breath; Mild nausea; mild HA; sore arm; Felt more tired than usual/Fatigue/fatigued; This is Spontaneous report from a contactable Other Health Professional (HCP) (patient). A 31-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EK9231), via Intramuscular on left arm on 12Jan2021 at 7:15 AM at single dose for COVID-19 immunization. The relevant medical history included anterior uveitis (HLA-B27), known allergies: Kiwi, kiwiberry, Meloxicam, pineapples, certain lactose products (milk, cream). Concomitant medications included colecalciferol, menaquinone (D3 +K2), borago officinalis oil, fish oil, hippophae rhamnoides oil, linum usitatissimum oil (OMEGA 3,6,7,9), ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S), ascorbic acid, fish oil, selenium, tocopheryl acetate, xantofyl, zeaxanthin, zinc (EYE CARE), vitamin d3 and Nature's Bounty Hair, Skin, and Nails Gummies. The patient previously received first dose of BNT162B2 at the age of 31 years old on 22Dec2020 (lot number=EK5730, at 04:30 PM, via Intramuscular on left arm) for COVID-19 immunization. On 12Jan2021 at 16:30: the patient woke up, felt more tired than usual. 19:00: Arrived at work, fatigue, sore arm. 20:00: Sore arm, fatigue, mild HA (headache). Drank coffee and fatigue and HA improved. 21:00: Mild nausea started. Still able to eat. 22:00: Chills. SOB with normal work activities. 23:00: Coworkers kept asking her why she was always out of breath. Chills worsen. Dizziness with too much exertion. I take 650mg Tylenol. On 13Jan2021 at 05:30 Almost normal. 13:30: Wake up w/ T 101.3F, chills, hot flashes. 14:30: Take 1000mg Tylenol after eating. 18:30: T 98.3F. Fatigued and sleep. On 14Jan2021 at 04:30 feel completely normal. 15:45: Lightheadedness, cold hands, and HA. spO2 85%. spO2 improves with deep breaths. Pattern repeats several times. 16:30: Take 1000mg Tylenol. Struggle to balance. 18:00: At Urgent Care spO2 is 99%, HR 64. Her hands are no longer cold. 22:00: Still dizzy. Sleep. On 15Jan2021 at 02:30: Still lightheaded & fatigued, but no balance issues. 06:30: Sleep. 15:00: Mild fatigue. Events resulted in Emergency room/department or urgent care. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered on an unspecified date in Jan2021.
31 2021-01-31 tingling Tingling; felt itchy; swelling of the lips; This is a spontaneous report from a contactable healthca... Read more
Tingling; felt itchy; swelling of the lips; This is a spontaneous report from a contactable healthcare professional. A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 09Jan2021 09:30 at single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination), penicllin allergy, and shrimp allergy. Concomitant medications included cetirizine, fexofenadine and triamcinolone. On 09Jan2021 11:00. the patient experienced tingling, felt itchy and experienced swelling of the lips. Therapeutic measures were taken as a result of the events that include Benadryl and famotidine. Clinical outcome of the events was recovered on an unspecified date.
31 2021-02-01 feeling hot, cold sweat, inability to speak, feeling cold, weakness, tremor, feeling of body temperature change Approximately 2am of 01/29/2021 I became very over heated for about one hour. Around 3am I then beca... Read more
Approximately 2am of 01/29/2021 I became very over heated for about one hour. Around 3am I then became incredibly cold and shaking. Around 4am I got out of bed and stood for a few moments, then walked slowly around my room making my way to our bathroom. I noticed my vision was not right, almost like a fisheye affect and I felt dizzy. I made it to our master bathroom and sat down on a chair for a few moments before I completely passed out. I fell forward, face first on to the bathroom floor hitting the left side of my head. When I regained my conscious I was weak and shaking and was unable to call out to my husband. I slowly pulled myself up to the toilet trying to make some noise and my husband then came to my aide. As he talked I noticed his voice sounded much farther away than it really was. I also had a difficult time cognitively answering his questions about how I felt. I was pale, clammy, still shaking. This episode from the time I left my bed from the time my husband walked me back to the bed was about 45 minutes. My husband took my temp and I did not have a fever. The next five hours I alternated between feeling very cold and very hot. I spent the next 24 hours feeling completely depleted. I rested as much as I could and had a greater than normal appetite.
31 2021-02-01 pain in extremity My arm was pretty sore the first day and a few hours after the vaccine I got a headache. The headach... Read more
My arm was pretty sore the first day and a few hours after the vaccine I got a headache. The headache lasted 48 hours but was worse on the second day. The pain in my arm turned into a big red welt and a hard lump. I took ibuprofen for two days to help with the swelling and headache. The lump at the injection sight was probably 2 inches in diameter and raised a bit.
31 2021-02-01 pain in extremity, weakness, muscle spasms Sore left arm with tenderness both series for 2 days . Two weeks after first vaccine, right-sided ea... Read more
Sore left arm with tenderness both series for 2 days . Two weeks after first vaccine, right-sided eachaches with mild headaches on right began. Prescribed ofloxacin 0.3% otic solution for a week. However, after this and my 2nd vaccine it progressively worsened with pain radiating to right jaw, more persistent and sharp right-sided headaches, blockage of hearing out of my right ear, hearing a pulsatile artery near my right ear mainly at night, and worsening earaches. Self-removed ear wax with an Asian ear pick, and the sharp headaches became intermittent mild headaches and earaches more mild. I was able to hear better but after a few hours my hearing was blocked again. I removed more wax again, but hearing was blocked again after a few hours, but this time, jaw pain went away. Went to see an ENT MD. He removed more right earwax and prescribed me "Neomycin and Polymyxin B Sulfates and Hydrocortisone 1% Otic suspension" for 10 days and sulfameth/trimethoprim 800/160MG TB (10 tablets) over 5 days. After a few days, I was completely relieved of all my symptoms. He then prescribed me another ear solution for the yeast in my ears, which I haven't started yet. Additionally, after my second vaccine, I had a cramp in my upper mid back for a day and weakness/fatigue for 2 days.
31 2021-02-01 weakness diarrhea; weakness; fatigue; malaise; This is a spontaneous report from a contactable nurse reported... Read more
diarrhea; weakness; fatigue; malaise; This is a spontaneous report from a contactable nurse reported for herself. A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 24Dec2020 08:00 AM at SINGLE DOSE for covid-19 immunisation. Medical history included childhood asthma, pancreatitis acute, allergies: sulfa and peanuts, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took ceclor and experienced drug allergy. On 24Dec2020 03:00 PM, the patient experienced diarrhea, weakness, fatigue and malaise for 2 days, all with outcome recovered. No treatment for these events. The patient has no covid prior vaccination. The patient has no covid tested post vaccination. The patient is not pregnant. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
31 2021-02-01 numbness, paralysis, weakness numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no ... Read more
numbness has moved up her neck; she touches her neck, it hurts a little; maintains numbness and "no control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up;it's numb; can barely move her right arm; paralyzed at the shoulder from the elbow up; flu like symptoms; Threw up a couple times; mild pain at the injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 31-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EL3247, Expiry date 31May2021, via an unspecified route of administration in right arm on 16Jan2021 at 07:30 at single dose for COVID-19 immunization as frontline worker. The patient had no relevant medical history. There were no concomitant medications. The patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine in Hospital. The patient reported that she was fine all day Saturday (16Jan2021), she just had some very mild pain at the injection site started a couple hours after getting injection. She developed flu like symptoms on the following day (17Jan2021) at 18:00PM and threw up a couple times. On 18Jan2021 at noon she noticed that she could barely move her arm: anything above her elbow on her right arm was not moving; it was paralyzed at the shoulder from the elbow up. If someone were to pick it up and let go, she couldn't control it at all. She also stated that she had no pain at all in that arm; she couldn't feel anything at all; it was numb. When she woke up on 19Jan2021 the numbness had moved up her neck, instead of being localized to her arm. She stated that when she touched her neck, it hurt a little, but it was not super significant. She stated that it was debilitating at that point as she was maintaining numbness and "no control of her arm". The nurse reported that this event had not required yet a visit to physician, but she has a feeling it will. She will probably have to go somewhere due to her paralyzed arm, but she had not yet. At the time of the report the event "No control of her arm"/can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" had not resolved yet; the event "mild pain at the injection site" resolved on 17Jan2021, the events "Flu like symptoms" and "Threw up a couple times" were recovering and outcome of the events "Numbness has moved up her neck" and "She touches her neck, it hurts a little" was unknown. The reporter assessed the events "Pain injection site" and "Flu like symptoms" as non-serious and assessed the event "Can barely move her right arm; paralyzed at the shoulder from the elbow up; it's numb" as disabling. She assessed all the reported events as related to BNT162B2 Pfizer-BioNTech COVID-19 Vaccine (method of assessment: Global Introspection).; Sender's Comments: Based on the temporal relationship, the association between the events numbness of upper extremity and arm paralysis with BNT162b2 use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
31 2021-02-03 flushing, feeling hot Patient reporting feeling hot and had flushing to the face, neck, and arms. Patient denied shortness... Read more
Patient reporting feeling hot and had flushing to the face, neck, and arms. Patient denied shortness of breath and chest pain. Patient was evaluated, vitals obtained, and IM Benadryl administered. Ambulance was called for further evaluation and transported to the hospital.
31 2021-02-04 tingling, numbness Pfizer-BioNTech COVID-19 Vaccine EUA Employee was found in the staff lounge by crisis RN. Patient s... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Employee was found in the staff lounge by crisis RN. Patient stated she was lightheaded (almost passing out), denies falls, and having palpitations. She tested negative for covid on Tue 1/12/2021 and had her first dose of vaccine on Friday 1/15/21. Today, she c/o intermittent numbness/tingling in left arm and foot. Neurology consulted for L sided paresthesia. Pt absolutely refused an MRI due to past experience. CT brain w/o contrast was normal. Patient discharged from emergency department.
31 2021-02-05 hot flush, migraine Extreme fatigue, whole body muscle aches, hot and cold flashes, migraine, fever, extreme pain at inj... Read more
Extreme fatigue, whole body muscle aches, hot and cold flashes, migraine, fever, extreme pain at injection site, dizziness and light headed
31 2021-02-06 feeling cold Nausea, Light headed, burning and cold sensation in sternum.
31 2021-02-06 pain in extremity Severe muscle ache in left arm between shoulder and elbow, whole body chills, mild disorientation wh... Read more
Severe muscle ache in left arm between shoulder and elbow, whole body chills, mild disorientation when standing?all occurring at 2am
31 2021-02-06 numbness Sore throat, numbness on the left side fingers
31 2021-02-06 pain in extremity Swollen red itchy painful toes on left foot less than 1 week after receiving dose. Intense pruritus... Read more
Swollen red itchy painful toes on left foot less than 1 week after receiving dose. Intense pruritus. Heard of ?Covid toes? so thought I should report here just Incase. Taking Benadryl to help with itching.
31 2021-02-07 muscle spasms Beginning Wednesday, Feb 3, 2021 I had two bouts of diarrhea during the day. Thursday I had 4. Frida... Read more
Beginning Wednesday, Feb 3, 2021 I had two bouts of diarrhea during the day. Thursday I had 4. Friday 4. Saturday 7, Sunday 6. Any time I eat something within 30 minutes to 1.5 hours I have cramping and diarrhea. Starting Saturday I modified my diet to bland foods and have drank plenty of fluids for hydration. As I share the same diet with my husband and he has no symptoms, I do not believe this is food borne. I have had no other lifestyle or dietary changes within the last week.
31 2021-02-07 weakness Itchy mouth, headache for 48 hours, low energy/generally felt unwell.
31 2021-02-08 numbness, tingling 2 hours after vaccine administration, patient reported acute chest pain and facial numbness/tingling... Read more
2 hours after vaccine administration, patient reported acute chest pain and facial numbness/tingling. Patient went immediately to the Emergency Room where she had a normal EKG, CBC, and CTPA. Patient had an elevated D-Dimer but normal ESR and CRP. Patient was diagnosed with a hypersensitivity reaction to the vaccine.
31 2021-02-08 tingling, numbness My lips, face, and neck went tingly and semi-numb. It's a feeling similar to when your foot falls as... Read more
My lips, face, and neck went tingly and semi-numb. It's a feeling similar to when your foot falls asleep.
31 2021-02-08 pain in extremity, tremor Received around 11am, some dizziness and tunnel vision about 10 minutes after while sitting, resolve... Read more
Received around 11am, some dizziness and tunnel vision about 10 minutes after while sitting, resolved within minutes. That evening: fatigue, mild arm sore Overnight: shaking, chills, fever, more severe arm soreness Following day: fatigue, fever, chills Beginning that evening: fever/chills resolved, started having palpitations and dizziness with some shortness of breath. Had these for about 3 more days primarily at rest. Self resolved Vaccine #2 3 weeks later: medicated with Tylenol and Motrin q4 hours, some breakthrough chills and joint pain overnight, mild arm soreness. Self resolved the following day. Have continued bruising at injection site 3 weeks later Continue to have some intermittent palpitations and dyspnea. Not present prior to vaccine 1.
31 2021-02-08 one side paralysis approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minu... Read more
approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minutes later started c/o headache and neck stiffening, left side weakness. NP said her left pupil was not responding the same as the right one. Benadryl 50mg Im given, EMSA called and client was transported to hospital.
31 2021-02-08 slurring, speech disorder, migraine, tremor black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nause... Read more
black outs; Severe migraine; full body shakes; soured; delayed jumbled speech; loss of memory; nausea; motor control issues; This is a spontaneous report from a contactable consumer reported for herself. A 31-year-old female patient (not pregnant at the time of vaccination and event onset) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration on 25Jan2021 10:00AM at single dose in right arm for covid-19 immunization, immunized in hospital. Medical history included obesity, anxiety, post-traumatic stress disorder (PTSD), insomnia, allergy to walnuts pecans. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonidine, fish oil and multi vitamin. The patient previously received the first dose of bnt162b2 lot number: EL1284, on 04Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously also received morphine and codeine, experienced allergy. The patient experienced sever migraine, black outs, full body shakes, soured, delayed jumbled speech, loss of memory, nausea and motor control issues, from 26Jan2021 11:30 PM. The events resulted in emergency room/department or urgent care. It was unknown if treatment was received. The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19. The case was reported as non-serious.
31 2021-02-09 numbness, pain in extremity, tingling "pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/in... Read more
"pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched; Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; soreness to touch or movement of the entire upper arm inclusive of the shoulder; The soreness aside from the injection site did not abate; This is a spontaneous report received from a contactable consumer (the patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the upper left arm on 21Jan2021 14:10 (at the age of 31-years-old) as a single dose for COVID-19 immunization. The patient's medical history included allergies to corn (zein). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ibuprofen on 16Jan2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the vaccine around 14:10 (scheduled for 14:00 but there was a line). Upon standing (21Jan2021 14:15), there was a "pins-and-needles" sensation down to the elbow, and by the time seated for the 15 minute wait, the sensation was present in the whole arm. The sensation was identical to a limb that was "asleep", including the painful jolts whenever touched all the way to the tips of the fingers. This lasted until mid-morning 23Jan2021 (about 44 hours). Random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm (21Jan2021 14:15). These have shrunk but some are still present at the time of reporting. There was additional soreness to touch or movement of the entire upper arm inclusive of the shoulder (21Jan2021 14:15). The soreness aside from the injection site (21Jan2021 14:15) did not abate until late evening on 24Jan2021. The only noted adverse effects were related to physical sensation in the left arm. The patient did not receive any treatment for the events. The clinical outcome of "pins-and-needles" sensation down to the elbow/sensation was identical to a limb that is "asleep"/including the painful jolts whenever touched was recovered on 23Jan2021. The clinical outcome of random several-inch-long patches of the arm were completely numb to physical sensation, mostly on the forearm; soreness to touch or movement of the entire upper arm inclusive of the shoulder; and soreness aside from the injection site, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
31 2021-02-09 pain in extremity Increased heart rate; slight lightheaded; headache; sore arm and neck; sore arm and neck; extreme le... Read more
Increased heart rate; slight lightheaded; headache; sore arm and neck; sore arm and neck; extreme lethargy; This is a spontaneous report from a contactable other-healthcare professional (patient). A 31-year-old female patient (not pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL9263), via an unspecified route of administration at site of left arm at 15:00 on 22Jan2021 at single dose for covid-19 immunization. Medical history included bursitis, chronic migraines, high blood pressure and fibromyalgia. Concomitant medication included methocarbamol, colecalciferol (VITAMIN D), loratadine and omeprazole, all received in two weeks of vaccination. The patient experienced increased heart rate, slight lightheaded, headache, sore arm and neck, extreme lethargy at 15:30 on 22Jan2021. No other vaccine received in four weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No Covid prior vaccination. No Covid tested post vaccination. Not known allergies. The outcome of events was recovering.
31 2021-02-09 migraine Migraine - lasted 48 hours, medication (naproxen - 440mg every 6-8 hours) did not help. Sore Throat-... Read more
Migraine - lasted 48 hours, medication (naproxen - 440mg every 6-8 hours) did not help. Sore Throat-hard to swallow, sharp throat pain, still hurts 48 hours after vaccination. Tongue Pain-started on both sides towards back of tongue, 48 hours later, still hurts, can't eat/talk without being in pain. Right side feels better, left side in a lot of pain. Can't see any type of sore on tongue.
31 2021-02-10 tremor About 2 hours after my first dose, I lost feeling in both my lower arms and hands. I was barely able... Read more
About 2 hours after my first dose, I lost feeling in both my lower arms and hands. I was barely able to move my fingers or wrists. This lasted about 30 minutes. With my second dose, taken 2/1/2021, also the Pfizer vaccine, I was very ill in the middle night (vaccine taken at 11:15am). I had temperature of 102.5F, severe chills, trembling, and moving took too much effort. I was bedridden for about 8 hours. The symptoms improved quickly there after.
31 2021-02-10 pain in extremity About 8hrs prior to the injection I began to have a pain in my arm, nauseous, and a headache. I al... Read more
About 8hrs prior to the injection I began to have a pain in my arm, nauseous, and a headache. I also had slight diarrhea. As of now (2/11/2021 @ 2:54p) i am still experiencing a headache
31 2021-02-10 discomfort Approximately 5 minutes following administration of my second dose of the Pfizer COVID 19 vaccine I ... Read more
Approximately 5 minutes following administration of my second dose of the Pfizer COVID 19 vaccine I began to have signs of lip numbness and lip swelling at the same time. No issues were noted with tongue or throat swelling associated with anaphylaxis. Additionally I noted an odd taste in my mouth, potentially metallic. I also experienced some abdominal pain at that time that passed in approximately 10 minutes. Discomfort and swelling feeling of the lips has persisted for the past 2 hours. Still no difficulty breathing, raving heart or other signed of anaphylaxis. Lips are only slightly swollen on outside appearance if at all but the feeling of swelling is noticeable
31 2021-02-10 pain in extremity Fever, fatigue, nausea, diarrhea, arm pain, joint pain
31 2021-02-10 pain in extremity Left arm is sore and feels weak, similar to the first 24 hours after I got the shot. But that went a... Read more
Left arm is sore and feels weak, similar to the first 24 hours after I got the shot. But that went away until today. The joint where my arm connects to shoulder hurts and the pain increases when pressure is applied or movement of the arm happens.
31 2021-02-11 weakness Fast heart beat, chest tightness and pain, dizziness and weakness 2hours after got shot Chills, mus... Read more
Fast heart beat, chest tightness and pain, dizziness and weakness 2hours after got shot Chills, muscle and join pain, headache the second day
31 2021-02-14 pain in extremity About two hours after receiving the vaccination, I had severe dull pain in my entire leftarm which ... Read more
About two hours after receiving the vaccination, I had severe dull pain in my entire leftarm which received the vaccination. About 7 hours after the vaccination, I had extreme fatigue and slept for about 2 hours. I then got up to go to my neighbor's house (please note, it was about 4 degrees, -6 wind chill, outside at the time). When I got to the house, I stayed outside and smoked a cigarette for about 5 minutes. Upon going inside, I got extremely light headed, fatigued, my hearing went to "white noise" and a high pitched ringing, and my vision got blurry. I then left the house with assistance to head back home. While outside, despite the intense cold, I was dripping sweat in a matter of seconds. I continued sweating and experiencing effects akin to what is felt prior to passing out, for about 7-10 minutes. I then laid down and went to sleep. Third day, still some soreness in the arm, but only at the injection site. No more adverse experiences since.
31 2021-02-14 cold sweat Body chills, cold sweats, fatigue, body aches and pain. Took Acetaminophen Q6hrs for about 2 days. ... Read more
Body chills, cold sweats, fatigue, body aches and pain. Took Acetaminophen Q6hrs for about 2 days. Symptoms went away after about 2.5 days
31 2021-02-14 nerve pain, muscle spasms, pain in extremity, numbness Extreme muscle pain/nerve pain in lower back started on 02/08/2021. Took 220 mg naproxen up until ER... Read more
Extreme muscle pain/nerve pain in lower back started on 02/08/2021. Took 220 mg naproxen up until ER visit for worsening spasms pain / numbness in left foot, thigh, leg, and right side while sitting Prescribed 1,000 mg, 2 tab, oral twice/day for 7 days
31 2021-02-14 tremor Information provided by patient. After second COVID vaccine dose on 2/1 at 10:20am, I woke up aroun... Read more
Information provided by patient. After second COVID vaccine dose on 2/1 at 10:20am, I woke up around 3am on 2/2 with chills and shaking. These chills alternated with sweats - waking up frequently either with chills or sweats. These symptoms ended around 1900 on 2/2. Also on 2/2, I began getting left flank pain. I thought this was muscular. Throughout 2/2 and 2/3, the flank pain became worse and worse and I realized it may be a kidney stone (I have had a kidney stone before). I left my work shift early on 2/3 to go to the ER at 2100. There, it was a little complicated because I am pregnant and could not receive a CT scan to check for stones. Based on the information gained from ultrasounds and the UA, they decided to treat for pyelonephritis. I left the ER around 0130 on 2/4 and picked up pain medications and 14 days of cefdinir. I do know this may not be related to the vaccine, but I think we need to report everything in case there are trends. ER Provider notes as follows: 31 y.o. female who arrived by Home presented to the emergency department for left flank pain that radiates to her left groin. The pain has been present since yesterday and it is sharp in nature. She took tylenol at 7pm this evening, but it did not help with the pain. She is also 12 weeks pregnant. Patient reports that she passed a kidney stone 3.5 years ago. At the time, she was told that she had an additional stone in the left kidney and has been following with urology. She also reports nausea that has improved with Zofran. Denies fever or chills, urinary urgency or frequency, or blood in her urine. Patient had an ultrasound at Hospital two or three weeks ago that showed a viable IUP. This is her third pregnancy. She denies complications with previous pregnancies and reports two prior cesarean sections. Patient is sitting up in bed, in no acute distress. Vital signs are normal. Patient presents for left flank pain for the past day that radiates into her groin with associated nausea, and she is 12 weeks pregnant. She has a history of a kidney stone three and a half years ago with an additional stone present in the left kidney at the time of diagnosis. Will obtain CBC, CMP, UA, urine culture, POC kidney ultrasound. Given 1L IV NS bolus, IV zofran and IV morphine. DDx: Nephrolithiasis versus UTI versus pyelonephritis versus ovarian cyst versus musculoskeletal etiology On reassessment, UA negative for nitrites and leukocyte esterase but positive for 50-250 bacteria perr hpf. POC kidney ultrasound negative for hydronephrosis and UA negative for blood. POC US showed IUP with FHR in 170s with good fetal movement. POC renal US repeated after 1L IVF without evidence of hydronephrosis. Will treat for asymptomatic bacteriuria in pregnancy with cefdenir for 14 days given concern for early pyelonephritis. Nephrolithiasis is still possible but unlikely cause of symptoms as there is no sign of obstructive uropathy on bedside US. Through shared decision making, will not undergo CT limited high for stone evaluation at this time given risk of radiation to fetus. Will discharge home with plan to follow-up with OB and PCP in 1-2 days - also provided Rx for roxicodone and miralax. Strict return precautions discussed. Patient voices understanding and agreement with plan. Denies further questions at this time.
31 2021-02-15 weakness body weakness, fever, chills, vomiting, diarrhea, headache, tiredness, sharp pains in lower back, lo... Read more
body weakness, fever, chills, vomiting, diarrhea, headache, tiredness, sharp pains in lower back, loss of apatite, a lot of gas
31 2021-02-18 numbness, pain in extremity, tingling Next day started with arm soreness when woke up. A couple hours started having headache, chills, arm... Read more
Next day started with arm soreness when woke up. A couple hours started having headache, chills, arm soreness, numbness and tingling in hands for a couple minutes, skin sensitivity, stomach upset, temperature in the evening up to 102.6, full body aches, and fatigue.
31 2021-02-18 feeling hot Patient reports feeling warm and redness on arms, provided Benadryl, patient felt okay after 15 minu... Read more
Patient reports feeling warm and redness on arms, provided Benadryl, patient felt okay after 15 minutes, stayed for observation for 30 minutes. Temperature was 98.2.
31 2021-02-21 numbness Jaw became numb x 5 days. Denies pain of any kind.
31 2021-02-21 hot flush The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The ne... Read more
The night of the second dose of my Pfizer Covid vaccine, my face began to feel hot and tight. The next day, I began with the expected flu like symptoms of the vaccine, accompanied by a red, fine bumpy rash with some swelling on my face where it had felt hot and tight the evening prior. The flu like symptoms lasted about 24 hours. The facial rash persisted and I began oral antihistamines - diphenhydramine and famotidine. The rash continued for one full week, only improving after beginning to use topical hydrocortisone on my face at the suggestion of a friend who is a nurse practitioner. After improvement in the rash I stopped hydrocortisone and antihistamines. The rash reappeared about 5 days later, and continues to randomly reappear about once a week to every 10 days. Flares only last about 24-36 hours now and will go away without medication but it does clear faster with hydrocortisone and antihistamines. The rash only flares at night, and no triggers like heat, alcohol or certain foods seem to bring it out. I have been consistently taking famotidine and cetirizine daily since the last flare of the rash, and have not experienced a flare again yet.
31 2021-02-21 weakness, pain in extremity blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable ... Read more
blurry vision (now resolved), dizzy/weak, sore arm. Side effects so bad that the patient was unable to drive home from work.
31 2021-02-21 facial paralysis nausea, vomiting, fatigue, HA, dizziness, Bel's Palsy
31 2021-02-22 unresponsive to stimuli Near syncope, dizziness, unresponsive to sternal rub. RRT called and transported to ER where she reg... Read more
Near syncope, dizziness, unresponsive to sternal rub. RRT called and transported to ER where she regained adequate mentation without intervention.
31 2021-02-24 pain in extremity Ache body, Nocuous, Right arm sore, slight head ache
31 2021-02-24 feeling hot Rapid heart beat 45 mins after injection - feeling hot but no fever - headache. Took a Benadryl and ... Read more
Rapid heart beat 45 mins after injection - feeling hot but no fever - headache. Took a Benadryl and Tylenol.
31 2021-02-24 burning sensation Upper body burning only at night without fever. Onset the night after vaccination date. Lasted for t... Read more
Upper body burning only at night without fever. Onset the night after vaccination date. Lasted for two nights. Extreme fatigue. started a day after vaccination and lasted for 3 days.
31 2021-02-26 pain in extremity Extremely sore arm
31 2021-02-26 tremor, seizure Injection into left deltoid. 1min later felt "aura" (muscle weakening, light headed). Took two pumps... Read more
Injection into left deltoid. 1min later felt "aura" (muscle weakening, light headed). Took two pumps of rescue inhaler and took out Epi Pen. 2 Mins later: called for help, nurse gave patient provided EpiPen (I was shaking too much to inject myself), additional Epi from crash cart, non rebreather O2. Symptoms included: convulsions; dizziness; bronchospasms; throat closure; difficulty breathing; dry heaving.
31 2021-02-26 numbness On the 3rd night after the vaccine, I was sleeping and started feeling numbness in one arm. It slowl... Read more
On the 3rd night after the vaccine, I was sleeping and started feeling numbness in one arm. It slowly moved to both arms and legs. 4 weeks after, I am having numbness in my toes. It comes and goes. I am not sure if it is related or not.
31 2021-02-26 tingling Received first diose Pfizer at 6:20pm . Symptom onset 6:25 pm with left arm tingling and weakness. ... Read more
Received first diose Pfizer at 6:20pm . Symptom onset 6:25 pm with left arm tingling and weakness. Left sided chest pain developed, radiating to the back. Staff alerted of reaction at approximately 6:33pm. VS 139/65 HR 61, SpOx 100% RR 22 sharp chest pain with deep inspiration. Neuro checks-significant left arm weakness Patient is accompanied by her mother and they agree that they wiil seek a higher level of care. Patient is refusing EMS and feels stable to be transported by her mother.
31 2021-02-27 migraine Frequent migraines , 2-3 per week, severe neck pain and debilitating head pain. Sudden onset?s no au... Read more
Frequent migraines , 2-3 per week, severe neck pain and debilitating head pain. Sudden onset?s no aura.
31 2021-02-27 muscle twitching, burning sensation Symptoms started about 11 hours after administration of vaccine. Resting heart rate averaging 120 bp... Read more
Symptoms started about 11 hours after administration of vaccine. Resting heart rate averaging 120 bpm. Up to 160 bpm on exertion, involuntary movement of my whole body like restless leg syndrome, chills, fever of 101.8, vomiting, profuse sweating, hypersensitive skin causing burning pain when anything touched my skin, headache, dizziness. Benadryl, acetaminophen, and ibuprofen given around the clock at appropriate intervals with not much relief for the first 48 hours.
31 2021-02-28 pain in extremity Fatigue, arm pain that went down my arm, some achy ness
31 2021-02-28 weakness, muscle spasms fast heartbeat, dizziness and weakness; patient presented to the ED on 2/26 with pelvic pain and cra... Read more
fast heartbeat, dizziness and weakness; patient presented to the ED on 2/26 with pelvic pain and cramping for possible miscarriage or ectopic pregnancy. Pt was at approximately 5 weeks gestation
31 2021-02-28 night sweats headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29... Read more
headache; night sweats; achy; chills; last menstrual date 19Dec2020 and first administration date=29Dec2020; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EH9899, via an unspecified route of administration on 29Dec2020 at 13:00 (at the age of 31 years old) as a single dose in the left arm for COVID-19 immunisation. Medical history included seasonal allergies from an unknown date, acid reflux disease from an unknown date, headaches from an unknown date, and irritable bowel syndrome from an unknown date. Concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), prenatal vitamins, cetirizine hydrochloride (ZYRTEC), and unspecified allergy shot. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headache on an unspecified date, night sweats on an unspecified date, achy on an unspecified date, chills on an unspecified date, and last menstrual date 19Dec2020 and first administration date of 29Dec2020. The mother was due to deliver on 25Sep2021. The patient did not receive treatment for the events. The outcome of the events headache, night sweats, achy and chills, and exposure during pregnancy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
31 2021-03-01 weakness Itching/Redness at injection site that spread no more than 6 inches from site (I took 25mg Benadryl ... Read more
Itching/Redness at injection site that spread no more than 6 inches from site (I took 25mg Benadryl OTC and reaction subsided). 02/24/2021 approximately 12:30pm low grade fever 99.5F with aches/chills/head ache/decreased appetite/dizziness/weakness (I took 1000mg Tylenol, however symptoms persisted through 02/25/2021 before subsiding) Called out sick for work on 02/25/2021. 02/26/2021 Vertigo that subsided 02/27/2021.
31 2021-03-01 facial paralysis, numbness, bell's palsy Jaw pain started on 2/19/21. Over 24 hours, it progressed to numbness and paralysis of the right sid... Read more
Jaw pain started on 2/19/21. Over 24 hours, it progressed to numbness and paralysis of the right side of the face. Patient was diagnosed with Bells Palsy on the evening of 2/20/21. As of today's date, patient is still experiencing periodic right sided facial paralysis, jaw pain, taste disturbances, and distorted hearing.
31 2021-03-02 discomfort 2 days after 2nd dose, developed headache feeling pressure behind eyes and vision out of focus at ra... Read more
2 days after 2nd dose, developed headache feeling pressure behind eyes and vision out of focus at random. Headache is current and has lasted longer than 8 days
31 2021-03-02 feeling cold, weakness At 10:35 I started feeling weird in my body like when I get either an asthma attack or flu type. It ... Read more
At 10:35 I started feeling weird in my body like when I get either an asthma attack or flu type. It was an hour later when I first began to feel lightheaded, dizzy, chills, and then really cold. I started then coughing hard like my throat was closing up and hard to breathe. My chest got tight and had sharp pains right under my chest by my stomach side. My heart rate was fast to the point my watch alerted me at over 135. I took my rescue ProAir inhaler to help but it didn?t. I tried to settle down and not panic to make things worse on my asthma attack. I then had to lay down feel weak. Within the next 15-20 min I used my nebulizer at home to help me breathe. After one treatment it helped me tremendously but still felt tired, nauseous, fatigue, pounding headache, but no fever since I barely checked at 98.5.
31 2021-03-02 weakness Background on first covid-19 vaccine dose: Patient received her 1st dose of Pfizer covid-19 vaccine ... Read more
Background on first covid-19 vaccine dose: Patient received her 1st dose of Pfizer covid-19 vaccine at vaccine clinic on 1/12/21 (this clinic is outside of the Health- system). Pfizer vaccine lot# EN3249 left deltoid. She was sent to an emergency department due to dizziness, nausea (ondansetron given in route). Given diphenhydramine in ED. Work up in the ED suggested anxiety reaction/stress response surrounding vaccine rather than an allergic reaction to the vaccine itself. Reported incident related to 2nd dose: Patient received 2nd dose of Pfizer coivd-19 vaccine lot #EN6206 on 2/25/21 at Vaccine Clinic (seen there instead of Center) to allow for closer monitoring. She pre-medicated with 50mg of diphenhydramine on 2/25/21 at 1200 per her PCP's recommendation. She was monitored in the covid vaccine clinic waiting area where at 1310, she felt shaky, pressure headache, and body feeling tight. BP 155/110, HR 90, RR 24, SpO2 100%. had patient lie down. 1325: BP 155/103 HR 90, RR 24, O2 99%. same symptoms as listed above. 1340: BP 150/101. patient reports shorter quicker breathing. O2 WNL and RR 24. 1400: BP 143/98. Patient reports body feeling very exhausted which is what happened with the first shot. No other change in symptoms. 1430: patient up the bathroom using wheelchair, able to stand on own two feet to void, but reports feeling weak. 1445: BP 135/91. Pt not feeling better, but states she feels ok to go home. encouraged patient to continue to rest and find a ride home. Pt is in agreement. 1515: BP 135/99. Patient rested until 1615 and a friend came to pick her up. Wheeled out in wheelchair and able to get into car on own two feet. Seen in PCP clinic on 2/26/21 for BP monitoring/follow up. Pt?s BP 130/80. Pt reports feeling fine. Denied shortness of breath/chest pain/pressure/palpitations. Pt has never had this type of reaction to other vaccines. BPs in clinic over the past year have mostly been 120-130s/70-80s.
31 2021-03-02 muscle spasms Became pregnant end of December. Received first dose January 6 and second dose January 27. Had very ... Read more
Became pregnant end of December. Received first dose January 6 and second dose January 27. Had very bad side effects. Felt pregnancy symptoms up until February 10th. Symptoms started to linger off. Had ultrasound that showed fetus February 10. Cramping started feeling days later. Had ultrasound again February 18 showed fetus had grown. Had another ultrasound February 21 after going to ED for bad cramping and pain. fetus had no heart beat. Miscarried February 26. Contents did not pass completely, had D&C February 27.
31 2021-03-02 pain in extremity The day of - soreness in left arm Day after - severe headache, soreness in left arm 2nd day after - ... Read more
The day of - soreness in left arm Day after - severe headache, soreness in left arm 2nd day after - severe headache, extreme tiredness, loss of appetite, felt unwell 3rd day after - extreme tiredness
31 2021-03-02 tremor Uncontrollable shaking for 15 minutes starting at 12:30 am Trouble standing, Dizziness at 7:00am on ... Read more
Uncontrollable shaking for 15 minutes starting at 12:30 am Trouble standing, Dizziness at 7:00am on March 1 Sore muscles throughout body
31 2021-03-03 weakness, pain in extremity Chills at 12:30 PM lasted all night and into Tuesday until evening. My period came at 12:30 PM afte... Read more
Chills at 12:30 PM lasted all night and into Tuesday until evening. My period came at 12:30 PM after vaccination - still present at 3/4/2021 My arm was very sore I took 1 ibuprofen tablet at 10:00 PM on 3/1 At 12:30 PM I began to feel very confused. This continued on and off and on 3/2 in the morning my head was very foggy all day long. On 3/2/2021 at 1:45 am I woke up to all of my bones feeling like they were going to shatter and I could not move without being in tears. This lasted all night and the pain is still present on 3/4/2021 I slept all day on 3/2/2021 A fever of 99.9 happened on 3/2/2021 at 9:00 PM. The fever was gone by morning of 3/3/2021 with the help of 2 Tylenol tablets. My body felt extremely weak and still is on 3/4/2021
31 2021-03-03 tremor Chills, urticaria, dizziness, tachycardia Pt complained of palpitations immediately after vaccinatio... Read more
Chills, urticaria, dizziness, tachycardia Pt complained of palpitations immediately after vaccination. Dizziness, hives, chills and tremor associated. Hx of Mast-Cell d/o and anaphylaxis to NSAIDs. No reaction to first dose. Initial BP 136/93, HR 147, O2 100% RA. Pt appeared pale, tremor Patient sent to ED.
31 2021-03-03 tingling, pain in extremity, numbness Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pa... Read more
Significant and ongoing left arm paresthesias including numbness, tingling, pain. Also with chest pain that is left-sided rib-type pain. Chest pain improves/resolves with ibuprofen but continues with residual left arm paresthesias
31 2021-03-04 flushing, tingling, numbness, cold sweat Patient received the vaccine in left deltoid and after about 5 minutes reported to me feeling numbne... Read more
Patient received the vaccine in left deltoid and after about 5 minutes reported to me feeling numbness and tingling in that same arm. She did not report any other symptoms that would be concerning in regards to an allergic reaction. She also verbalized feeling "clammy" and sweaty, also feeling a little flush.
31 2021-03-04 tingling Six days after the second COVID vaccine, I experienced significant pain in my left arm (injection si... Read more
Six days after the second COVID vaccine, I experienced significant pain in my left arm (injection site), tingling, numbness, etc. Rash and hives covering large parts of my chest, abdomen, back, buttocks, legs, and feet was prominent. Can attach pictures.
31 2021-03-04 hot flush, weakness, numbness, tingling Ten minutes after the shot, I felt faint and weak. I had a sudden hot flash. After about five minute... Read more
Ten minutes after the shot, I felt faint and weak. I had a sudden hot flash. After about five minutes of sitting down, I felt better, stood up, walked a few paces, and felt faint again. I sat down for another five or more minutes and felt better. I continued to feel a bit dizzy throughout the day. Later that day I developed a headache that continued into the next day but was less severe. The following evening, my left arm felt slightly tingly and my pinky on that hand felt a bit numb, as if my arm had a blood pressure cuff on it. That feeling decreased after about two hours.
31 2021-03-05 tingling 2 days later after the first dose of Pfizer I started feeling tingling in my head. The tingling woul... Read more
2 days later after the first dose of Pfizer I started feeling tingling in my head. The tingling would move around and not stay in one spot. Sometimes it is severe, it would sometimes be accompanied with a headache. I have been taking Tylenol every 6 hours and resting.
31 2021-03-05 weakness Pt began experiencing nausea, weakness, fatigue, and myalgias 4 days after the vaccination.
31 2021-03-05 unresponsive to stimuli RECEIVED VACCINE AT 359PM AND AT 415PM BECAME DIAPHORETIC, PALE, EPISODE OF URINE INCONTIENCE,MOMENT... Read more
RECEIVED VACCINE AT 359PM AND AT 415PM BECAME DIAPHORETIC, PALE, EPISODE OF URINE INCONTIENCE,MOMENT OF "RIGIDNESS AND EYES ROLLED BACK" AND "HAD A BRIEF EPISODE OF NON REPONISIVENESS AND CAME THRU" (PER EMS). PROVIDER ASKED TO EVALUATE PATIENT AFTER EPISODE, IN TENT. PER PROVIDER SEND PATIENT TO HOSPITAL OF CHOICE FOR HIGHER LEVEL OF CARE. NO PO MEDS PROVIDED TRANSFERRED AT 1641PM IN STABLE CONDITION( TO HOSPITAL) , IN STABLE CONDITION.
31 2021-03-06 feeling of body temperature change, pain in extremity Exhaustion, hot and cold sweats - both started roughly 2 hours after injection, lasted approx. 8-10 ... Read more
Exhaustion, hot and cold sweats - both started roughly 2 hours after injection, lasted approx. 8-10 hours. Arm soreness - lasted for about 1 week
31 2021-03-06 pain in extremity NO ADVERSE EVENT OCCURRED WITH THIS VACCINE ADMINISTRATION. The vaccine was not reconstituted prope... Read more
NO ADVERSE EVENT OCCURRED WITH THIS VACCINE ADMINISTRATION. The vaccine was not reconstituted properly and therefore we are unsure of the concentration the patient received. We called the patient and she had no adverse event from the vaccine delivery. She stated her arm was sore, but just like when she has received a Tetanus vaccine.
31 2021-03-07 discomfort Right when she got the vaccine she felt acute pretty severe discomfort. She did not really look but ... Read more
Right when she got the vaccine she felt acute pretty severe discomfort. She did not really look but noted later where they put the Band-Aid that the vaccine was given way too high. Since that time she is had moderate to severe discomfort in the acromial area and subacromial area as well as radiation of pain to the clavicle and really limited range of motion with her arm. Patient went to urgent care on 1/30/21 with possible bursitis-like reaction to vaccine that was injected close to the acromium subacromial area. Treated with anti-inflamatory therapy (Toradol)
31 2021-03-08 seizure Body aches 7pm-10 am chills 7pm-10am body convulsions 9pm-8am vomiting 9pm-3pm headache 9 pm-presen... Read more
Body aches 7pm-10 am chills 7pm-10am body convulsions 9pm-8am vomiting 9pm-3pm headache 9 pm-present (currently 10 pm next day) Treatment-Tylenol, Motrin, fluids, ice pack for head
31 2021-03-08 hot flush SWELLING ON EYES ,HOT FLASHES AND INCHING. WENT TO EMERGENCY ROOM SOLOMEDROL 125MGS IV,BENADRYL 50 M... Read more
SWELLING ON EYES ,HOT FLASHES AND INCHING. WENT TO EMERGENCY ROOM SOLOMEDROL 125MGS IV,BENADRYL 50 MGS IV AND PEPCID 20 IV. NEXT DAY WITH LESS SINTOMES.
31 2021-03-08 pain in extremity Very tender arm and headache for first 24 hours, 36 hours post injection, pain and headache were acc... Read more
Very tender arm and headache for first 24 hours, 36 hours post injection, pain and headache were accompanied by nausea, chills and extreme tiredness
31 2021-03-09 numbness 13 min to 60 mins after the injection she develop mild left lower facial numbness. Gradually decrea... Read more
13 min to 60 mins after the injection she develop mild left lower facial numbness. Gradually decreasing until today 3/10/21 when she told Propranolol and symptoms worsen. No motor weakness.
31 2021-03-09 flushing Dizziness and flushing with chest pain and back pain began on day 5. Then progressively got worse. C... Read more
Dizziness and flushing with chest pain and back pain began on day 5. Then progressively got worse. Cardiologist believe my condition is POTS or IST. Heart rate increases 30-60 bpm with minimal activity.
31 2021-03-09 pain in extremity, feeling cold Felt cold at 4pm 3/8 Sore arm Had a fever of 100.3 F at 4pm 3/9 Felt fine 3/10
31 2021-03-09 pain in extremity, weakness, migraine, inability to speak Post vaccine: 6 hours- very sore arm, migraine headache 12 hours- extreme fatigue, drowsiness, muscl... Read more
Post vaccine: 6 hours- very sore arm, migraine headache 12 hours- extreme fatigue, drowsiness, muscle aches, headache, blurry vision 12-72 hours- unable to function due to extreme drowsiness, fatigue (unable to care for child and operate a vehicle) 3 days to 10 days- continue to experience weakness, difficultly lifting things I would otherwise be able to, foggy brain, unable to recall certain words, difficulty staying awake and doing my job
31 2021-03-10 numbness, pain in extremity Numbness in both arms and both legs ( started 3/1/2021 and still have it) Pain in left arm (started ... Read more
Numbness in both arms and both legs ( started 3/1/2021 and still have it) Pain in left arm (started 3/1/2021 and still have it ) pain in Right side of chest ( started 3/6/2021 and has subsided) dropping things that are in my hands ( started 3/6/2021 and still happening every so often). Went to hospital on 3/6/2021 and had a follow up with PCP on 3/10/2021. Neurologist appointment scheduled 3/24/2021.
31 2021-03-10 tingling Patient felt dizzy, fainted, nauseous and tingling sensation all over her body. Allowed to rest wit... Read more
Patient felt dizzy, fainted, nauseous and tingling sensation all over her body. Allowed to rest with feet higher than her head, 911 called, water given. Refused to go to the hospital. Her friend took her home with no symptoms.
31 2021-03-10 involuntary muscle movements Reported feeling tired, making a chewing like motion with mouth. Stated mouth really dry.
31 2021-03-10 pain in extremity Tired/ sore arm around 8pm. Fever started around 10pm and went up 1 degree in an hours time until 4a... Read more
Tired/ sore arm around 8pm. Fever started around 10pm and went up 1 degree in an hours time until 4am reaching 102.4. Most concerning was a resting heart-rate of 120bpm just sitting doing nothing. Heart-rate would fluctuate as if it skipped a beat and become racing/rapid with little to no movement.
31 2021-03-11 facial pain, migraine 13 hrs after shot: woke up with fever 101, migraine, sore face, sore throat, upper extremety myalgia... Read more
13 hrs after shot: woke up with fever 101, migraine, sore face, sore throat, upper extremety myalgias. Sx lasted 20hrs, treated with nyquil severe (acetaminophen) every 6 hrs + ice pack Residual sore throat, temps in 99F following day
31 2021-03-11 tenderness A week after receiving my first injection I started to notice a tender and itchy raised rash on my b... Read more
A week after receiving my first injection I started to notice a tender and itchy raised rash on my back (left side). I saw the dermatologist who diagnosed me with shingles and placed me on a course of Valtrex.
31 2021-03-11 difficulty speaking Throat tightening, trouble breathing, hoarse voice, hypotension. She administered her epi pen hersel... Read more
Throat tightening, trouble breathing, hoarse voice, hypotension. She administered her epi pen herself and by the time she got to the ER, symptoms resolved and she was monitored here for several hours after solumedrol, benadryl, pepcid.
31 2021-03-11 tingling Tingling in head like firing. Headache when I didn?t have tingling Pressure Dizzy/lightheaded
31 2021-03-13 migraine 2 hours after receiving the vaccine on Sunday, I had significant fatigue and sensitivity to light wi... Read more
2 hours after receiving the vaccine on Sunday, I had significant fatigue and sensitivity to light with watery eyes and a headache and was in bed all day. The next morning on Monday I woke with a pressure headache that was kept at bay with Advil. The headache stayed the same on Tuesday and Wednesday. By Thursday the headache was so uncomfortable I was having trouble working. It stopped responding to Advil and the pressure continued to increase on both sides of my head with sharp, shooting pains throughout that would come and go with the constant pressure. By Friday, I couldn?t co to use work and ended up calling into my PCP and advising them that I had a migraine that was very different from my normal migraines that I get (pain on left side behind eye, very nauseous, sensitive to light, always responds to OTC meds) and it wouldn?t respond to Advil and asked them to call in something. They called in generic version of Imitrex that evening; but since this migraine was so different than my normal pattern, I went to the ER on Saturday. They did a CT scan to make sure there were no brain bleeds and gave me IV magnesium and steroids. I declined the torodol and Benadryl. The headache was still there, but bearable finally when I left. It got worse again that evening and I ended up taking the imitrex at 3am and falling asleep, only to wake up at 7am with a skull splitting feeling. That feeling stayed for the next 4 days, slowly getting less intense. I was unable to workout any of these days (I workout for about an hour daily for the past 3 years) because it was extremely exacerbated by activity. I was not hungry. Finally on Thursday I felt more like my normal self but the headache remained slightly and now on Sunday all that is left is the sharp, shooting pains that come every so often and light sensitivity.
31 2021-03-13 bell's palsy Pfizer vaccine, dose 1 12/17/20, dose 2 1/7/21. Developed mild bells palsy 3/7/21. Unclear if relat... Read more
Pfizer vaccine, dose 1 12/17/20, dose 2 1/7/21. Developed mild bells palsy 3/7/21. Unclear if related to vaccine but given no prior history of bells pallsy or other neurologic disease, reporting for safety monitoring. Saw primary care physician 3/16/21 who diagnosed bells palsy and started steroids.
31 2021-03-14 numbness 12/20 vaccination 45 Minutes later, I looked at my hand and it had a rash; little red marks like hiv... Read more
12/20 vaccination 45 Minutes later, I looked at my hand and it had a rash; little red marks like hives; R arm. My left arm was numb it felt better with time; sore. Took some Tylenol. Rash didn't last long 30-60 minutes.
31 2021-03-14 tingling, weakness, numbness Heaviness on chest (still on going--breathless after speaking/difficulty breathing); began 4 days af... Read more
Heaviness on chest (still on going--breathless after speaking/difficulty breathing); began 4 days after vaccine was given. 1st it was just fatigue and breathlessness, then I got a tingling feeling on left side of chest and tightness. After ER visit I was advised to take Zyrtec and Benadryl. I've paired it with Mucinex to get rid of phlegm build-up and the doctor prescribed Prednisone which I'm going to start today (03/15/2021). So far I have less tightness/less tingling in heart area (still occurs randomly but not as opten) but still get fatigued and breathless real quick. I've also had sporadic headaches brain fog, body chills/aches/weakness/difficulty concentrating. Also had face numbness for 4 days.
31 2021-03-16 cold sweat, tremor 1401- cold, clammy, diaphoretic, hypoxic (vital signs: b/p 90/70, 87% on Room Air, 20 respirations, ... Read more
1401- cold, clammy, diaphoretic, hypoxic (vital signs: b/p 90/70, 87% on Room Air, 20 respirations, 68 HR) 1404- RRT called 1404- 2-3 seconds of shaking, no medical history, per pt 10 weeks pregnant 1409- 101/69 99% 02 2L n/c, 69 HR, 20 RR 1420- 113/70 99% 02 2l n/c, 68 HR, 20 RR (pt transferred to ER)
31 2021-03-16 weakness About 45 minutes after the vaccine, I got home and started having bad chills all over my body, heada... Read more
About 45 minutes after the vaccine, I got home and started having bad chills all over my body, headache and feeling really tired. I was very sleep without any strength. The next morning I woke up with my body hurting I couldn't get out of bed and I had a fever, my body was not functioning like it normally does. All I did the next day was sleep, take Tylenol and drink some Gatorade. I went to an Urgent Care, they told me that the side effects were normal, but just back to them If I couldn't walk or symptom worsen. They were looking for if I didn't have any strength in my legs to walk. The lasted about 5 days and I have recovered.
31 2021-03-16 feeling hot, pain in extremity At the moment of the infection I felt nothing. When I stood up and unfolded mi arm I felt a shooting... Read more
At the moment of the infection I felt nothing. When I stood up and unfolded mi arm I felt a shooting pain along mi arm all the way to my fingers( don't remember exactly which fingers) and I started to feel my arm get hot from the site of injection towards my fingers. It lasted for about 1 to 2 minutes. And I had a residual shooting pain for about 5 minutes, coming and going. Then at 9 pm I had my fingers completely swollen, I couldn't take my rings off. I still have my hand swollen. My arm has the normal pain that the injections is supposed to give, I can't raise my arm quite well without having pain on it.
31 2021-03-16 tingling, numbness I had facial tingly, numbness ad swelling. I went to ER, they did lab work and honestly that was al... Read more
I had facial tingly, numbness ad swelling. I went to ER, they did lab work and honestly that was all and thought it was a side effect. This lasted about a month or so .
31 2021-03-16 throat numbness Patient experienced itchy throat and took a diphenhydramine tablet quick melt. several minutes later... Read more
Patient experienced itchy throat and took a diphenhydramine tablet quick melt. several minutes later patient's throat felt numb. Epipen was administered to right leg and 911 called. Patient did not feel relief in 5-10 minutes of administration. A second one was given in left leg. At this time EMTs arrived.
31 2021-03-17 tingling, burning sensation Within 24 hours of first dose, swelling of lips have occurred and are continuing to swell. Tingling ... Read more
Within 24 hours of first dose, swelling of lips have occurred and are continuing to swell. Tingling and burning sensation present accompanied with itching around lips and face. Benadryl, Claritin and Pepcid are currently being taken to reduce swelling.
31 2021-03-19 pain in extremity 6 days after the COVID 19 vaccine I started having soreness in my left armpit lymph nodes. 8 days af... Read more
6 days after the COVID 19 vaccine I started having soreness in my left armpit lymph nodes. 8 days after, my right arm became sore, hot, achy, inflamed and had a rash around the injection sight. This lasted about 2 days.
31 2021-03-20 weakness Joint and body aches, chills, extreme fatigue and weakness lasting until 48 hours after onset. Exper... Read more
Joint and body aches, chills, extreme fatigue and weakness lasting until 48 hours after onset. Experienced muscle pain, swelling, and itchiness at injection site.
31 2021-03-21 weakness Racing Heartbeat/Weakness -- half hour after injection; resolved on it's own Rash on ride side of to... Read more
Racing Heartbeat/Weakness -- half hour after injection; resolved on it's own Rash on ride side of torso -- rash was not noticed until several hours later (it was warm to the touch, was not raised not raised but more like sunburn and turned white upon pressing) and then resolved; rash reappeared on March 18 and resolved *photos available upon request
31 2021-03-22 numbness, facial pain, burning sensation, weakness Face: numbess, burning, throbbing pain. Difficulty swallowing. Face symptoms started on left side bu... Read more
Face: numbess, burning, throbbing pain. Difficulty swallowing. Face symptoms started on left side but appear on both sides. Left arm is numb. dizziness, weakness, fatigue. Full body itching.
31 2021-03-22 hot flush Patient reported dizziness, dry mouth, and feeling flushed. Nurse observed the patients cheeks were... Read more
Patient reported dizziness, dry mouth, and feeling flushed. Nurse observed the patients cheeks were flushed.Oral mucosa moist. Captain obtained vital signs. Vitals within normal ranges. Patient asked to remain in the observation area for an additional 20 minutes. Patient offered transport to the hospital via ambulance. Patient refused. Patient advised to follow up with her provider if symptoms continue.
31 2021-03-22 tremor, tingling, cold extremities Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue;... Read more
Rash broke out over body; Chills; Pins and needles sensation; shaking; Hand is cold; fever; fatigue; headache; pinched nerve; Achy; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; pain/tingling and numbness in left arm (injection site).; This is a spontaneous report from a contactable other health professional (other HCP) (patient) reported for herself. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203) via an unspecified route of administration at left arm on 26Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunisation. Medical history included congenital sucrase-isomaltase deficiency (CSID). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264) via an unspecified route of administration at right arm on 03Feb2021 (at 31-year-old at vaccination) at 01:00 PM for COVID-19 immunization. No known allergies. No other vaccine in four weeks. Other medications in two weeks included topirmirate, levonorgestrel (MIRENA, intrauterine device (IUD)) and low-dose naltrexone (LDN). The patient was not pregnant. Facility type vaccine was at hospital. The patient experienced adverse events included: 12 hours: chills, fever, shaking; 24 hours: achy, fatigue, headache wouldn't go away 6 days: Rash broke out over body (have pictures), pain/tingling and numbness in left arm (injection site). Rash responded to diphenhydramine hydrochloride (BENADRYL) and cetirizine hydrochloride (ZYRTEC), left arm was still tingling and painful on day 7. Almost felt like pinched nerve. Hand was cold. Pins and needles sensation. The adverse event start date was reported as on 04Mar2021 at 06:30 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of events was not resolved. Treatment received for adverse event included OTC treatment with antihistamines; epinephrine (EPIPEN). No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A contributory role of vaccine BNT162B2 to the reported events rash and chills cannot be excluded based on the plausible temporal relationship and product safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ehics Committees, and Investigators, as appropriate.
31 2021-03-23 flushing Immediate dizziness, then nausea, flushed, "Feeling weird"
31 2021-03-23 feeling of body temperature change, pain in extremity Initially I just had arm pain. Around 4:30pm, I started feeling tired. At 8:00PM I had extreme arm p... Read more
Initially I just had arm pain. Around 4:30pm, I started feeling tired. At 8:00PM I had extreme arm pain, so much it hurt to lift items and take off my sweatshirt. Around 11pm, I started feeling like I had a fever. I was going from hot to cold throughout the night. At 2:30am I woke up with chills that lasted for 20-30 minutes. I continued to have a fever throughout the night. When I woke up around 8am, I felt extremely sore, my body, head and stomach hurt. My symptoms have been improving throughout the day but I still feel tired. I?ve also had diarrhea throughout the entire day.
31 2021-03-23 tingling Vertigo- like symptoms about 24-48 hours post 1st shot. Also paraesthesia throughout body. lasted ... Read more
Vertigo- like symptoms about 24-48 hours post 1st shot. Also paraesthesia throughout body. lasted about 1 week. Similar symptoms post 2nd vaccine that have continued intermittently to this day.; paresthesias throughout body; This is a spontaneous report from a contactable nurse (patient). This 31-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EK5730) intramuscularly on 18Dec2020 (at the age of 31-years-old) as a single dose in the left arm for COVID-19 immunization and dose 2 of BNT162B2 (lot number EL1283) via an unspecified route of administration on 08Jan2021 (at the age of 31-years-old) as a single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccines. The patient was not diagnosed with COVID-19 prior to the vaccines. Concomitant medications included levothyroxine sodium (SYNTHROID) and escitalopram oxalate (LEXAPRO) from unknown dates for unknown indications. The patient did not have any known allergies. About 24-48 hours after dose 1 of BNT162B2 in Dec2020 (also reported as 18Dec2020), the patient experienced vertigo-like symptoms and paresthesia throughout the body that lasted about 1 week. The patient experienced similar symptoms after dose 2 of BNT162B2 that have continued intermittently. The patient visited a doctor or other healthcare professional office/clinic and emergency room/department of urgent care. The patient underwent lab tests and procedures which included a COVID-19 nasal swab test on 11Feb2021 with a result of negative. The patient did not receive any treatment for the events. The outcome of vertigo-like symptoms and paresthesia throughout the body was not recovered. No follow-up attempts are needed. No further information is expected.
31 2021-03-24 tingling, pain in extremity, nerve pain, feeling of body temperature change Patient received their first COVID vaccine shot on 3/11 and on 3/12 had a sore arm. On 3/16, patient... Read more
Patient received their first COVID vaccine shot on 3/11 and on 3/12 had a sore arm. On 3/16, patient woke up with a dull headache that lasted through the day and she felt very lethargic. The patient did not experience fever or body aches/chills. On Friday, 3/19, The patient woke up with nerve pain in their right shoulder radiating down into the right index finger. Over the course of that day and the following day, the patient reports the nerve pain spread to her other arm and down into her legs, feet, and toes. At this point she also experienced feeling colder and hotter, she did not have a fever at any point. The nerve pain symptoms were mostly resolved by 3/22. Patient reports she is still experiencing some on and off tingling sensations in her extremities.
31 2021-03-24 facial paralysis, electric shock sensation, numbness and pain in extremities, tingling Since the vaccine, I have experienced extreme paraesthesia throughout my left head and face. It is... Read more
Since the vaccine, I have experienced extreme paraesthesia throughout my left head and face. It is chronic and lasts from the moment I wake up to the moment I go to bed. I am also experiencing a watering, itchy left eye and tingling behind the eyeball. Extreme neuropathy in brain, it feels like electric shocks coursing through my head and crabs pinching at the brain tissue. I have also deal with temporarily facial paralysis on the left side of my face, though those symptoms have since abated. I am on Lyrica, prednisone, indomethacin, and xanax in an attempt to get some relief but there are very few doctors who seem to understand what is causing this debilitating adverse reaction.
31 2021-03-24 tingling, cold sweat Within 20 mins of injection: Headache Tingling in face Pressure in top of head A lot of gas in ches... Read more
Within 20 mins of injection: Headache Tingling in face Pressure in top of head A lot of gas in chest Lightheadedness Swollen neck/lymph nodes Face itching Sinus pressure Shortness of breathe Cold sweats Rashes Still currently: Rashes Gas Headache Slight lightheadedness
31 2021-03-24 weakness Woke up feeling nauseous/diarrhea at 1 am on Wednesday (approx. 60 hours after injection). Side note... Read more
Woke up feeling nauseous/diarrhea at 1 am on Wednesday (approx. 60 hours after injection). Side note- on Tuesday (day after injection), I donated blood. Not sure if this is relevant. After waking up nauseous, I experience extreme shortness of breath and full body chills for roughly 30 seconds to 1 minute. I walked about 10 steps to wake up my partner and fainted instead. I woke up to him calling my name, and almost immediately threw up. Afterwards, I felt okay, only tired and a little weak. I was able to go back to sleep and woke the next day with no lingering side effects. I would say the entire episode lasted roughly 5 minutes.
31 2021-03-24 discomfort, weakness, tenderness blackout episode (temporary loss of vision) while attempting to rise Extreme pain and feeling of pr... Read more
blackout episode (temporary loss of vision) while attempting to rise Extreme pain and feeling of pressure/bursting all over body; extreme sensitivity when any area of the body was touched (including scalp, legs, etc) Fatigue, weakness and inability to get out of bed or sit without aid for roughly 24 hours O2 dropped to 92 per pulse oximeter at home Swollen, painful lymph node under armpit 2 days after vaccine Gasping for breath (although no coughing or sneezing) Nausea Drinking a lot, extreme thirst but very little urination
31 2021-03-25 numbness, flushing, tingling Client initially reported tingling/numbness in right ear. This progressed over next ten minutes to ... Read more
Client initially reported tingling/numbness in right ear. This progressed over next ten minutes to tingling/numbness across her face and the roof of her mouth, she also reported difficulty swallowing. Client observed to be flushing across face and upper arms. EMS called and transported client to local ER for evaluation.
31 2021-03-25 cold sweat Dizziness Tunnel visioning Hearing muffled Clammy
31 2021-03-25 migraine I had a mild headache for about 6 days. On day 7, I had a temporary vision cut for 43 min and then i... Read more
I had a mild headache for about 6 days. On day 7, I had a temporary vision cut for 43 min and then it returned in full, but I had a severe migraine and nausea. They did CT imaging and labs. Everything was clear. I was medicated with IV pain meds and anti-nausea meds. I continued to have a mild headache for a few days, but it eventually resolved.
31 2021-03-26 migraine Migraine immediately following first dose. Migraine, extreme fatigue, severe chills, sweats, full pa... Read more
Migraine immediately following first dose. Migraine, extreme fatigue, severe chills, sweats, full painful body aches, swollen underarm lymph nodes, and dizziness following second dose. Symptoms lasted approximately 36 hours, however I?m still experiencing swollen lymph nodes and a headache.
31 2021-03-26 seizure On Friday, March 26, 2021 client 31 years old female received her second dose of Pfizer COVID vacc... Read more
On Friday, March 26, 2021 client 31 years old female received her second dose of Pfizer COVID vaccine (LOT # ER 8732, EXP 7/2021) at approximately 2:38pm by vaccinator. After vaccine was administered, client complaint of dizziness and brief seizure seating at the vaccination chair in an upright position. Vaccinator lead registered nurse clinician lead, came to assist vaccinator with client's care. (EMT) assumed care of client. Per EMT prior to onset of syncope and brief seizure, patient was alert and oriented to person, time, place, and situation with Glasgow Coma Scale score of 15 (responsive) with all airway, breathing and circulation intact. Client told EMTshe has no prior medical history or reported allergies and had no issues with first Pfizer vaccination on 3.3.21 with Lot #:EN6199.. EMT placed patient on the ground into a recovery position and assessed vitals first time at 2:43 PM: BP 86/60, P 70, R 18. Patient's vitals assessed the second time at 2:48 PM until paramedics arrived: BP 80/66, P 71, R 18. Client remained stable and paramedics arrived at 2:49 PM and they placed client in a supine position on a gurney before transported client to the hospital. No further interventions indicated.
31 2021-03-26 pain in extremity Sore arm about 2 hours after shot..
31 2021-03-26 pain in extremity, muscle spasms With in 10 mins: sharp pain & muscle cramping/spasms in right arm, then shooting pain head head on l... Read more
With in 10 mins: sharp pain & muscle cramping/spasms in right arm, then shooting pain head head on left side head... these two thing rotated off & on for hours. Around 2 am(26th): extreme nausea, dizziness, full body aches, headache, fever Continued until 6am (March 27th), dizziness still there, fever, dizziness, and slight nausea. When eating: hard to digest solid food. Pain in stomach about 15 mins after eating.
31 2021-03-27 discomfort, hot flush, pain in extremity Extreme fatigue for days, severe insomnia, severe arm pain, mild congestion and post nasal drip, ex... Read more
Extreme fatigue for days, severe insomnia, severe arm pain, mild congestion and post nasal drip, extreme brain fog, severe discomfort in own skin, stomach issues, generally feeling sick, coughing, hot flashes, chills, fever, increased appetite
31 2021-03-27 flushing PATIENT REPORTED SHORTNESS OF BREATH, COUGHING AND FLUSHNESS APPROXIMATLEY 30 MINUTES AFTER RECEIVIN... Read more
PATIENT REPORTED SHORTNESS OF BREATH, COUGHING AND FLUSHNESS APPROXIMATLEY 30 MINUTES AFTER RECEIVING VACCINE
31 2021-03-27 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: p... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: post administration, patient felt light headed, became ghost white and had mild flushing. patient was brought to floor in sitting position and given water. patient fully recovered 10 minutes later with no further issues.
31 2021-03-28 tremor Approx 5 minutes after receiving shot my heart started racing, I began to shake, hives spread across... Read more
Approx 5 minutes after receiving shot my heart started racing, I began to shake, hives spread across my chest, neck and back. I was given a shot of epinephrine via an Epi-pen by a medical provider at the vaccine site and was then transferred to ER.
31 2021-03-28 flushing, unresponsive to stimuli Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
31 2021-03-28 tingling Tingling all over throat, face, arms legs, swollen throat, redness all over neck and chest
31 2021-03-29 pain in extremity, night sweats Super painful arm; night sweats; headache/intermittent headaches; super achy; chills; pregnant; fati... Read more
Super painful arm; night sweats; headache/intermittent headaches; super achy; chills; pregnant; fatigue; This is a spontaneous report from a contactable female nurse. A 31-year-old female pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration, administered in left arm on 19Jan2021 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation. The patient medical history included seasonal allergies, acid reflux, headaches, IBS. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), minerals nos, vitamins nos (PRENATAL VITAMINS), cetirizine hydrochloride (ZYRTEC) and allergy shot. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899) via an unspecified route of administration, administered in arm left on 29Dec2020 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation and experienced headache, night sweats, achy, exposure during pregnancy and chills. It was reported that patient experienced 12 hours post injection that was on 20Jan2021 at 13:00, super painful arm, night sweats, headache, super achy and chills and the 2nd night post that was on an unknown date in Jan2021, continued with night sweats and fatigue and intermittent headaches with achiness. The patient last menstrual period was on 19Dec2020. The patient was 4 Weeks pregnant at the onset of the event. The patient was due to deliver on 25Sep2021. The patient did not receive any treatment for the events super painful arm, night sweats, headache, super achy, fatigue and chills. The events were reported as non-serious. The outcome of the events painful arm, night sweats, headache, super achy, fatigue and chills were recovered on an unknown date Jan2021 while for other event pregnant was unknown.
31 2021-03-30 pain in extremity, muscle spasms, night sweats Could not stay awake fully; Arm pain persistent; Growing lower back pain; Fever; Night sweats; Chill... Read more
Could not stay awake fully; Arm pain persistent; Growing lower back pain; Fever; Night sweats; Chills; General body aches (especially at shoulder joints in both arms); General body aches (especially at shoulder joints in both arms); Brain fog; Very specific muscle spasm in left upper thigh on backside/persistent muscle spasm; This is a spontaneous report from a contactable 31-year-old female other health professional reported that: A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9262) as single dose and on unspecified date, route of administration patient received bnt162b2for covid-19 immunisation. Medical history included autoimmune thyroiditis. Concomitant medications received from unspecified date frequency and unspecified indication were levothyroxine (LEVOTHYROXINE) dose was at 88mcg, ethinylestradiol, norgestimate (TRI-LO-SPRINTEC). The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered in hospital. The patient was not pregnant at the time of vaccination. The patient was not allergic to medications, food, or other products. On 26Jan2021, the patient experienced fever, night sweats, chills, general body aches, brain fog, very specific muscle spasm in left upper thigh on backside/persistent muscle spasm, could not stay. On 27Jan2021, awake fully, arm pain persistent, growing lower back pain, growing back pain. Reported event was reported post 2nd vaccination: 1st night experienced fever, night sweats, chills, general body aches (especially at shoulder joints in both arms), brain fog, and very specific muscle spasm in left upper thigh on backside; 1st day post could not stay awake fully with arm pain persistent and growing lower back pain; 2nd night post continued to experience night sweats and w/ persistent muscle spasm that was previously mentioned in left back thigh and growing back pain. The patient was not received treatment. Outcome of the events were recovering.
31 2021-04-08 seizure convulsions; bronchospasms; throat closure; difficulty breathing; Felt an "aura"; joints loosening; ... Read more
convulsions; bronchospasms; throat closure; difficulty breathing; Felt an "aura"; joints loosening; dizziness; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-year-old, via an unspecified route of administration, administered in left deltoid on 26Feb2021 15:15 (Lot Number: EN6202) as single dose for COVID-19 immunisation. Medical history included known allergies to opioids, Toradol, Valium, and a lot of foods; mast cell activation disorder, eosinophilic oesophagitis (EoE), asthma, celiac disease, Hashimoto, and hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medications included montelukast sodium (SINGULAIR), levocetirizine dihydrochloride (XYZAL), meloxicam (MOBIC), paracetamol (TYLENOL), and levothyroxine sodium (SYNTHROID); all taken for an unspecified indication, start and stop date were not reported. It was reported that one min later after the vaccination (26Feb2021 15:16), the patient felt an "aura" (joints loosening, dizziness), gave herself two puffs of albuterol and pulled out her epi pen and called for help. Two mins later (26Feb2021 15:17), the patient experienced convulsions, bronchospasms, throat closure, dizziness, difficulty breathing. Two rounds of epi, non-rebreather O2, rescue efforts. The patient was then transferred to emergency department (ED) to continue rescue efforts. The patient was treated with O2, Ativan, Steroids, Epinephrine, and Benadryl. The patient underwent lab tests and procedures which included Covid nasal swab PCR test: negative on 26Feb2021 (post vaccination). The patient was recovering from the events.; Sender's Comments: Considering temporal relationship, a possible contribution role of vaccination with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of the reported events, cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
31 2021-04-11 tremor Approximately 30 minutes after vaccination client complained of nausea, dizziness, and shakiness. Cl... Read more
Approximately 30 minutes after vaccination client complained of nausea, dizziness, and shakiness. Client stated later in the evening she began to experience visual hallucinations. Client stated symptoms subsided after about two days. Client stated she visited ith her health provider as a result of her reaction to the vaccine.
31 2021-04-11 tremor Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Alle... Read more
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe
31 2021-04-12 numbness Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient reported throat itching. Parame... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient reported throat itching. Paramedic administered oral diphenhydramine twice at vaccination site. Patient then reported chest pain, shortness of breath, urticaria, and increased throat scratching. Paramedics administered epinephrine twice and methylprednisolone and transported to emergency department (ED). On arrival to the ED patient still reported chest tightness, numbness, and was tachycardic (pulse 122 beats per minute), tachypneic (26 breaths per minute), and hypertensive (blood pressure 139/85). In the ED patient experienced more difficultly breathing and epinephrine continuous infusion was started. Laryngoscopy did not document evidence of airway compromise. Patient diagnosed with possible anaphylaxis and admitted (currently still hospitalized).
31 2021-04-12 feeling hot fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to... Read more
fainted; having an odd taste in my mouth; shortness of breath/breathing took 40 minutes to return to normal; vasovagal syncope response; the expected sore injection site; headache; felt overheated; could quite literally only see stars; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 04Apr2021 10:45 (Lot Number: ER8732) as single dose for covid-19 immunisation. Medical history included hypoglycaemia (she ate before the injection) and fainting. Concomitant medication(s) included Birth control and prednisolone acetate ophthalmic sus. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. 5 minutes after the injection, the patient began having an odd taste in mouth, shortness of breath, and she fainted. She had a history of fainting, but it took longer for her to recover than usual (50 minutes instead of 15). When she regained consciousness a few minutes after, she had a headache, felt overheated, and could quite literally only see stars. Her breathing took 40 minutes to return to normal, and her body temperature took 2 hours to feel normal. She assumed this was mostly a vasovagal syncope response, but she wasn't anxious or in pain beforehand. After 6 hours, she still have the odd taste, a headache, and the expected sore injection site. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included Paramedic took vitals and monitored for an hour. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
31 2021-04-13 facial paralysis, bell's palsy I received the first Pfizer vaccine on 3/16/21 in the afternoon. I am a young, healthy woman with no... Read more
I received the first Pfizer vaccine on 3/16/21 in the afternoon. I am a young, healthy woman with no pre-existing health conditions: I don't smoke, am under 120 lbs., no allergies, etc. Two days after the vaccine, I started to experience an eye twitch, which progressed into Bells Palsy by the following week: by 3/23/2021. I went to an urgent care clinic and was diagnosed as such, and they contributed to the vaccine and told me not to get the second shot. They also advised I get a CT scan to rule out a stroke, which I did, on 3/24/21. I expect that they also reported this. I have facial paralysis on the left side of my face, and developed an ear infection a week after this...I don't have allergy issues, and have not had an ear infection since I was a small child. This has been traumatic, uncomfortable and very scary because I thought I was having a stroke.
31 2021-04-19 weakness 31 year old female who presented to the ED on 4/17/21 complaining of generalized weakness. She repor... Read more
31 year old female who presented to the ED on 4/17/21 complaining of generalized weakness. She reports that since receiving the Pfizer Covid vaccine approximately one month ago she's been feeling unwell. She received Covid vaccine on 2/19 & 3/12. Over the next week she developed began having episodes of nausea vomiting and diarrhea. She was considering issues such as pregnancy and had at least 10 pregnancy test over the last 2 weeks her symptoms worsened and she began having weakness and general malaise. She reports the weakness originally started with the lower extremities and then she was unable to walk and required 2 people to help her stand. She denies any chest pain or shortness of breath, she does have some dizziness and lightheadedness. She does report that she had palpitations over the last week that were gradually worsening increasing in both frequency and duration. Also reports a rash that started on 4/17/21. She has notable lower extremity edema. Clinical course worsened requiring hemodialysis, intubation and a transferred. Hospital on 4/20/21. Assessment indicates patients primary issue is the cardiomyopathy, as there is no evidence of thrombocytopenia, questionable viral cardiomyopathy with subsequent multiorgan dysfunction syndrome . Pt was vaccinated at hospital.
31 2021-04-20 pain in extremity metallic taste in the mouth, arm soreness, redness around the injection site, swelling
31 2021-04-21 numbness Numbness in both feet with onset 12 days after vaccination.; This is a spontaneous report from a con... Read more
Numbness in both feet with onset 12 days after vaccination.; This is a spontaneous report from a contactable other HCP (herself). A 31-year-old female (Non pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9265, Expiry date: unknown), via an unspecified route of administration in left arm on 05Feb2021, at 09:30 AM, as single dose for COVID-19 immunisation. The patient medical history included Hashimoto thyroiditis. Patient concomitant medication included Synthroid (LEVOTHYROXINE SODIUM). The patient experienced numbness in both feet with onset 12 days after vaccination on 10Feb2021. Patient visited at physician's office. Patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
31 2021-04-22 tingling Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mil... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient reported feeling numbness spread over the left side of her face and the back of the head. After waiting 45 minutes, patient reported feeling tingling in the left side of the face.
31 2021-04-23 pain in extremity left arm started aching; pain in left shoulder; This is a spontaneous case is received from a contac... Read more
left arm started aching; pain in left shoulder; This is a spontaneous case is received from a contactable consumer (Patient). A 31-years-old not pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in arm left on 03Feb2021 17:00 as single dose for covid-19 immunization. Medical history included Possible Autoimmune (only diagnosed with vitiligo but monitored for other diseases), known allergies: Seasonal allergies. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), probiotics (PROBIOTICS), vitamin b complex (VITAMIN B), colecalciferol (VITAMIN D [COLECALCIFEROL]) for an unspecified indication. The patient experienced left arm started aching, pain in left shoulder on 11Feb2021 17:00. 8 days after second injection (11Feb2021), left arm started aching and was quickly followed by sharp pain in left shoulder (near injection site) with any movement of the shoulder. Pain made it difficult to move or put any weight on the shoulder. Pain was relieved with ice and heat increased mobility for a short time. Frequent sharp pain events lasted about 48 hours. Alternated ice and heat and took ibuprofen to relieve pain. After 48 hours, most sharp pains subsided. However, the aches in the arm continued with any use of the arm for the next week. The outcome of the events was unknown.
31 2021-04-27 tingling Immediate rash on hands, spread to arms and metallic taste in tongue and tingling.
31 2021-04-28 weakness, feeling hot I feel as if I've been hit by a truck. My whole body hurts. It's like a fibro flare but so so so muc... Read more
I feel as if I've been hit by a truck. My whole body hurts. It's like a fibro flare but so so so much worse. My wrists, elbows, neck, and back hurt very very bad. I used all of my energy to get up and slide a window open and it hurt my wrist so bad it literally brought me to tears. I'm dehydrated and hot, but no temperature. I'm tired and in pain. I've taken Ibuprofen and acetaminophen today. I'm going to bed and hope it's better tomorrow.
31 2021-05-05 muscle twitching While getting the shot my arm was twitching like crazy. The next day on the arm where I got the shot... Read more
While getting the shot my arm was twitching like crazy. The next day on the arm where I got the shot a bump appeared. No pain. The next day the left side of my face was feeling funny. Very twitchy. The following day was the right side and face felt very stiff. And Today 5/6 I have a big bump on my right side of my neck and clavicle bone. Very swollen and sensitive.
31 2021-05-05 tremor, cold sweat Woke up in middle of night vomiting. Had cold sweats/shaking. Vomited 4 times with dry heaving over ... Read more
Woke up in middle of night vomiting. Had cold sweats/shaking. Vomited 4 times with dry heaving over about 2 hours. Was fine next day. I have a very regular menstrual cycle. Was scheduled to start cycle on 5/3/21 and I am now 3 days late and have no symptoms of starting as I normally do.
31 2021-05-05 cold extremities after 15 min - fatigue, nausea. P.S. I walked ~9km to home. Thought it will help. At home - 3 hours... Read more
after 15 min - fatigue, nausea. P.S. I walked ~9km to home. Thought it will help. At home - 3 hours after - temperature 37.5, strong nausea, strong chills (cold feet, cold hands). 5 hours after - insomnia, fatigue, chills. 10 hours after - vomiting. Sleep 2-3 hours. 15 hours after - chills, fatigue. Sleep more 6 hours. 24 hours - fatigue. (no chills, no temperature) Headache. 30 hours - headache, slight insomnia, fatigue 40 hours - no headache, fatigue.
31 2021-05-11 tingling, one side paralysis Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild ... Read more
Hypotension; weakness right side of the body, arm and leg; Paresthesia; Probably post vaccinal mild Brachial Neuritis; probably with autonomic neuropathy component, producing orthostatic hypotension; probably with autonomic neuropathy component, producing orthostatic hypotension; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in Arm Left on 06Apr2021 10:30 (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hypotension, weakness right side of the body, arm and leg; paresthesia, probably post vaccinal mild brachial neuritis, probably with autonomic neuropathy component, producing orthostatic hypotension on 13Apr2021 16:00. The patient was hospitalized for a day on unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Apr2021. The outcome of the event was recovering. Information about lot/batch number has been requested.
32 2021-01-01 pain in extremity Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was... Read more
Middle of the night woke up shivering, chills, fever, bones ached, could not even lift my arm it was so sore and under armpit. Symptoms lasted all day. Next night woke up out of sleep symptoms even worse. Next day same symptoms but now a hard ball that hurts formed near clavicle on side of vaccinated arm. Arm, armpit, clavicle area on right side now all hurt.
32 2021-01-01 pain in extremity Reported at 6:29 sat on toilet with right arm pain of 7-8 out of 10. Reached for her cell phone on s... Read more
Reported at 6:29 sat on toilet with right arm pain of 7-8 out of 10. Reached for her cell phone on sink and had a syncopal episode 1 day post vaccine. reports history of vasovagal and hyperglycemia. A provider she works with was called and she was given juice, crackers, and two Advil. Pain resolved, no other symptoms reported. Is being followed up by her PCP for workup. No other syncopal episodes reported therafeter.
32 2021-01-02 pain in extremity, nerve pain Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as f... Read more
Day 4 after receiving vaccine dose developed nerve pain in the groin and R glute/thigh, as well as fatigue. Sx worsened on day 5, so I had a virtual visit with a medical provider who prescribed me Valtrex x7d to treat suspected Herpes Zoster, which I previously had in my early 20s.
32 2021-01-03 flushing * TESTED POSTIVE FOR COVID ANTIBODIES 06/2020 - 'STILL HAVE RESIDUAL COUGH' 12/21/2020 - VACCINATION... Read more
* TESTED POSTIVE FOR COVID ANTIBODIES 06/2020 - 'STILL HAVE RESIDUAL COUGH' 12/21/2020 - VACCINATION 12/22/2020 9:30 WERE AT WORK; FELT SUPER FLUSHED, SOB, COULDN'T FOCUS, FELT FEVERISH, FELT NAUSEOUS. OCCUPATIONAL HEALTH REFERRED TO URGENT CARE; DR STATED 'NOT TYPICAL RESPONSE'; COVID TEST; NEGATIVE
32 2021-01-03 discomfort, feeling hot C/O heaviness and warmth to neck, shoulder, and back. C/O heart racing- HR 112. BP 143/99. ER diagno... Read more
C/O heaviness and warmth to neck, shoulder, and back. C/O heart racing- HR 112. BP 143/99. ER diagnosed with allergic reaction- minor. Continue to report warmth and heaviness to mid-upper back.
32 2021-01-03 pain in extremity I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine ... Read more
I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine or my Chronic condition. I have called my doctor to follow up. Currently taking Prednisone.
32 2021-01-03 tremor shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in t... Read more
shaking uncontrollably/she was full of shakes to the point the bed was shaking; chills; Woke up in the middle of the night; body aches; as painful as a strep infection; sore throat that was as painful as a strep infection/throat feels sore to the point of Strep/Throat soreness: Felt like sharp razor blades; Feels like she is having an extreme immune response; Feels congestion; severe serum sickness/weird serum sickness; high fever/Had a fever over 101; This is a spontaneous report from a contactable nurse(patient). A 32-year-old female patient received BNT162B2(lot number EH9899) via an unspecified route of administration at Arm Left on 21Dec2020 (from 16:30 to 17:00) at the age of 32 years old at single dose for doesn't want to bring COVID home to her family. The medical history included Migraine headaches. The concomitant medications were not reported. The patient had so many immunizations for international travel, had Yellow Fever vaccine, all of the Guardasil vaccines, had MMR vaccine four times because she never developed immunity to it until the fourth round, got a flu shot yearly,got TDap vaccine every five years because she was an HCP, did Emgality shots( not done it this month. Emgality had a protein inhibitor, was supposed to get Emgality shot on 21Dec2020). On 22Dec2020 the patient experienced severe serum sickness, high fever, body aches to the point that she was shaking uncontrollably, sore throat that was as painful as a strep infection; Caller mentioned she was taking tylenl and benadryl for her symptoms. The patient was a Nurse Midwife. She got the vaccine on Monday evening at 4:30PM. Feeling like she was having a weird serum sickness. Woke up in the middle of the night and she was full of shakes to the point the bed was shaking. She had a fever over 101. Felt like she was having an extreme immune response. She was taking Tylenol and Benadryl around the clock. Woke up this morning and her throat feels sore to the point of Strep. Wondering if she need to distance and get some kind of test. Has been wearing a mask all of the time and doesn't know of anyone people who have COVID that she has been in contact with. Feels congestion and sore throat. Shakes and chills: Began at 02:30. Hard core chills and shakes. High fever over 101: same time as chills and shakes. Woke up from a dead sleep. Didn't have a working thermometer but knows her temperature must have been over 101 by the way she felt. She didn't feel that crappy unless her fever is over 101. She can gauge her own temperature. She experienced throat soreness: Felt like sharp razor blades. The patient was taking numbing throat lozenges. Seriousness: Would say serious. Didn't require hospitalization. She self-treated. Had she not had to work, she would probably have stayed in bed. Has been taking round the clock medicine. The outcome of the events was unknown. The information on the batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported serious events including severe serum sickness, high fever, body aches, shaking uncontrollably, sore throat that was as painful as a strep infection, feels like having an extreme immune response, congestion, chills, woke up from a dead sleep and the administration of the COVID 19 immunization with BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to those, as appropriate.
32 2021-01-04 pain in extremity 12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lighthe... Read more
12/28 8am- Pfizer vaccine (lot#EL0140) received in L arm at Hospital 12:45pm- out on a walk. Lightheaded, fatigue, chills, mild nausea, stomach cramping, and muscle weakness all hit pretty hard at once. Notice slight arm soreness as well. Went back inside and essentially collapsed on the couch 5:30pm- Arm soreness is worse. Chills and lightheadedness only mild now. Fatigue has gone down to where I can resume daily activity 12/29 Wake up with moderate sore throat Stabbing arm soreness at injection site Moderate fatigue and nausea persist. Mild chills. Tried to go for a walk outside and found a 30 minute very slow walk extremely tough 12/30-1/2 Moderate sore throat continues. Other symptoms gone 1/1-2 Arm/ injection site soreness slowly fades 1/2: exercise for the day= 70 min yoga and 7.5 miles of walking. Had a couple glasses of wine at dinner (possibly relevant if issues with vaccine are related to high histamine food issues) 1/3 Moderate headache, fatigue, and muscle aches. Skin feels hot. Sore throat worse than the previous days. Mild runny nose. Severe nausea. Go to Urgent care for COVID test and Zofran Rx. COVID rapid test and PCR test both negative. No fever, higher than usual blood pressure 1/4-5 (current) Nausea lower but still moderate, requiring Zofran. Sore throat persists. Mild fatigue and muscle aches. Skin still feels warm. Mild vertigo during exercise
32 2021-01-04 tingling Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable ... Read more
Also c/o tingling in hands and feet; dizziness; This is a spontaneous report from a non-contactable other HCP. This other HCP reported for a 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) Intramuscular on 18Dec2020 at single dose in Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minutes waiting period after the injection, the patient began to experience dizziness. Also c/o tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Treatment included water, granola bar, and rest. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
32 2021-01-04 pain in extremity Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous repor... Read more
Tachycardia (over 100 bpm for 48hr); Nausea; Headache; Chills; arm pain; This is a spontaneous report from a contactable Nurse reporting for herself. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular in left arm on 18Dec2020 13:00 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Reynald's, Irritable bowel syndrome (IBS), spontaneous pneumothorax. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergy to medication of Vicodin. The patient experienced tachycardia (over 100 bpm for 48hr), nausea, headache, chills, arm pain, started on 18Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Tachycardia was recovered on 20Dec2020 13:00, the outcome of the other event was recovered on an unknown date in Dec2020.
32 2021-01-04 pain in extremity is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from... Read more
is nursing twins; is nursing twins; slight headache; arm soreness; This is a spontaneous report from a contactable other health professional (patient). This other health professional reported information for both mother and babies. This is the maternal report. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 16Dec2020 11:00 AM at left arm, at single dose for protect as a healthcare provider. Medical history was none. There were no concomitant medications. The patient experienced like arm soreness and slight headache on 16Dec2020, that was pretty much it. Arm soreness started that afternoon on 16Dec2020, she received the vaccine in the morning, at 11am, and maybe like shortly after she noticed, it was there for 1-2 days and went away, and she had since recovered completely. Slight headache started that afternoon on 16Dec2020, and that resolved by the evening, she took Tylenol and it went away. And she was nursing twins, they are about 14 months now. She was aware of the risks of getting it, and the only reason she reported it, is it may be beneficial from a research standpoint, she doubts many lactating mothers, especially twins, are involved. She is personally not concerned, she is probably expecting similar for her second dose, and there is not much research. Her next is dose 06Jan2021. The outcome of the events slight headache was recovered on 16Dec2020, the outcome of the event arm soreness was recovered in Dec2020.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518603 Same reporter/drug, different patient/event. baby case;US-PFIZER INC-2020518630 Same reporter/drug, different patient/event. bady case
32 2021-01-05 flushing Lightheaded, dizzy, nausea, flushed, dry mouth began about 10 min after vaccination
32 2021-01-05 hot flush Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021. Went home and started to have light head... Read more
Received Pfizer Lot EL1284 1-6-2021 in right arm 1-6-2021. Went home and started to have light headedness, sweaty palm, hot flashes. She has been drinking water and ate before and after receiving the shot. No reactions to other vaccinations. Has history of anxiety and depression.
32 2021-01-05 feeling cold, pain in extremity, tingling Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reactio... Read more
Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reaction to vaccine except for mild soreness and heat around injection site and intense fatigue for three days after. Symptoms went away after the 4th day. Two weeks later on Jan 5th 2021, i began to notice an intense itching, burning, and swelling at the injection site. Pain and soreness in arm made it difficult to do my job and seem to just get worse. Upon the next morning of Jan 6th 2021, pain remained but itching had gone down, but intense burning, soreness and massive redness around injection site remained and seemed to be getting worse. Pain remains and redness has not gone down, arm is very tender near site and lifting and moving arm is very stiff and sore. Feeling of lump or stiffness on injection site comes and goes and feeling of heavy and sore muscles move from upper left arm down to elbow and extend to hand; making movement and function slowed or slightly numb. Stiffness in arm and intense heat at injection site makes it uncomfortable to move or use arm. Cold tingling sensation on occasion and stiffness in elbow joint. Slight dizziness and fatigue follow with pain in arm. Was informed to see a physician on Jan 6th, 2021 who said to fill out vaccination adverse event report and to keep an eye on arm. If pain or symptoms become worse to return.
32 2021-01-05 tremor, pain in extremity Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to ... Read more
Slight arm soreness about 12 hours after injection, with severe rigors shortly thereafter. Fever to 101.8 and uncontrollable shaking/chills, and moderate to severe headache. Rigors lasted about 6 hours, headache persists.
32 2021-01-05 muscle twitching, muscle spasms The following day I had uncontrollable muscle spasms on my face. Twitching. Etc
32 2021-01-05 tingling, numbness left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty an... Read more
left side tingling and numbness, decrease BP and pulse, nausea, dizziness/lightheaded, difficulty answering questions, itchy-allergic to benadryl so sent to ER for further evaluation
32 2021-01-06 pain in extremity "My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Oth... Read more
"My arm was sore for the first 24 hours, but the next morning I noticed that my hands were red. Otherwise I just felt tired, and my skin felt hypersensitive"
32 2021-01-06 numbness, tremor About 5 min after the administration of the second dose of the vaccine I began to experience tachyca... Read more
About 5 min after the administration of the second dose of the vaccine I began to experience tachycardia, difficulty to breath, sweating, numbness in arms and legs and trembling of limbs. I have not history of allergies.
32 2021-01-06 tenderness, hot flush As soon as I received my shot it was like an electric shot from the injection shot, up the back of m... Read more
As soon as I received my shot it was like an electric shot from the injection shot, up the back of my neck, into my brain. I was instantly woozy and disoriented. They moved me to observation. My hemiplegic migraine started within 10 minutes of the vaccine. I take a preventative every day, and to be honest after the vaccine it was like I had never, ever taken my preventatives. The migraine I got that day is the worst one I have experienced since the first one I ever got. Now on top of the migraines, the vaccine gave me waves of new symptoms. I was having spells of intense heat flashes, with wooziness, and nausea. So the new symptoms were paired with the hemiplegic migraines that, if you aren?t familiar with, mimic strokes because my whole left side tends to go limp, and I struggle with speech, and cognitive issues. So it really wasn?t all too long before the nurse kindly suggested that I didn?t look great and we should head to the ED. They treated the migraine, gave me a CT, everything came back fine. They reached out to my neurologist, gave me some fluids, really they wanted to keep me a little longer, but I know the migraine drill and just wanted to go home and sleep and eat. I promised to follow up with my neurologist and fill out my CDC form. Over the next week the migraine and extra symptoms seemed to slowly but surely let up. The only note worthy thing was really that my left side would get extra tender at times. Not just my injection site, but it was almost like all my nerve endings all over my left side were on fire at times and a pinch on the thigh may as well have been a stab, or a pat on the back a punch. It was pretty intense at times. And just when I thought it was all over my menses started, you see my hormones trigger my migraines. And once again it was like I wasn?t on a preventative. I had an intense Migraine start. I was able to take my bail out medication (sumatriptan) though and get to work. I moved forward with my day, and just when I thought all was normal, I got one of those brutal heat flashes, the room started moving, and I was nauseous. Unfortunately I was in full PPE, I almost passed out, I had to get a coworker to help, they had to get my supervisor. It was a big, unnecessary-necessary, pride-wounding scene. Now I am not a scientist or a doctor, but I might speculate that people with neurological deficits, like myself, are going to have a harder time with this inactive Covid strand. I would much rather be immune to Covid then catch it though, so whatever I can do to help, and protect myself and family and friends and neighbors, I will absolutely do... But I imagine there is probably an adjustment to be made here for the neurologically impaired. Thanks for your time, and let me know if you have any questions.
32 2021-01-06 pain in extremity I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chill... Read more
I started having swelling from the shoulder down, I had site soreness nausea vomiting headache chills fever body aches general malaise lack of appetite, worse than the flu symptoms. I still have some mile symptoms and chills on occasion. The worst of the symptoms is over. I took theraflu and hydrated I only went to the Dr for a note for work
32 2021-01-06 pain in extremity Lightheadedness Fatigue Dizziness Sore arm Nausea Malaise
32 2021-01-06 migraine Persist nausea, headaches, migraines, malaise
32 2021-01-06 feeling hot Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert ... Read more
Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert and oriented Narrative: Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. 126/77, P 81, R 18 O2 sat at 96.1% at 1420; @ 1435 106/67, P. 65, R 16, O2 sat 99%; @ 1444 BP 115/63, P 67, R 17, O2 sat 100%.Symptoms resolved ay 1435 and denied any c/o. D/c'd in stable vs.
32 2021-01-06 pain in extremity Sore arm and loose stool 24 hours
32 2021-01-07 tenderness Left Underarm soreness and tenderness lasting for 16 days.
32 2021-01-07 numbness Numb face, bilateral arm numbness, difficulty breathing
32 2021-01-07 numbness Numbness to face around nose area.; This is a spontaneous report from a non-contactable nurse (the p... Read more
Numbness to face around nose area.; This is a spontaneous report from a non-contactable nurse (the patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 30Dec2020 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On an unspecified date, the patient experienced numbness to face around nose area. The clinical outcome of numbness to face around nose area was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
32 2021-01-07 tingling Patient experienced tingling in hands and anxiety after first dose of COVID 19 Vaccine (Pfizer). Pat... Read more
Patient experienced tingling in hands and anxiety after first dose of COVID 19 Vaccine (Pfizer). Patient was monitored for 30 minutes and did not require medical treatment.
32 2021-01-07 numbness, tingling Patient had her COVID injection on 12/29 and she developed numbness/tingling later that night in her... Read more
Patient had her COVID injection on 12/29 and she developed numbness/tingling later that night in her arms, around 9pm (had vaccine at 2pm). She saw provider on 12/31/20 and was given gabapentin to try. She has been taking it twice daily and it helps a little. She said that the numbness seems to be getting less. She said it was all the way from the shoulder to the hands/fingers, now it's just in her hands and fingers. (Both sides, not just injection site). Circulation is good.
32 2021-01-07 migraine Pfizer-BioNTechCovid-19 vaccine EUA. Headache and migraine lasting approximately 36 hours.
32 2021-01-07 pain in extremity Sore arm, headache, fever, chills, body aches, fatigue
32 2021-01-08 feeling hot, tingling 0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - plac... Read more
0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - placed in supine position, offered oral fluid 0840 continued elevated BP, elevated HR - continued to monitor 0915 continued elevated BP, elevated HR - continued to monitor 0930 reported feeling hot, tingly, sweaty with position change from supine to sitting, BP reduced, HR WNL 0935 transported to ED for continue symptoms > 1 hour post administration
32 2021-01-08 tingling 1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T ... Read more
1352 - Pt reports upper lip swelling, unable to see on visual assessment, BP-141/92, 100% on RA, T - 98.1, HR - 91, RR - 16. Given 25 mg of oral benadryl per this RN per vaccination clinic standing order. 1403 - Pt reports feeling no change from initial report but does note "some finger tingling". 92% on RA, HR - 88. 1410 - Discussed taking a 2nd 25mg dose with patient. Will hold at this time, she states "my hands normally feel puffy when this gets worse but they feel normal now". Pt reports upper lip swelling feels "puffy" but unchanged from initial report. 1418 - Pt reports upper lip swelling increased, BP - 140/85, HR - 80, RR 16, 100% on RA, 25mg of oral benadryl given. 1423 - Pt reports upper lip "puffiness" with slight improvement, new c/o upper back itchiness, no rash or hives visualized on assessment 1428 - Pt reports improvement to feeling of "puffiness", back itchiness remains the same, and pt "feels sleepy" 1438 - Pt reports resolution of upper lip swelling and says "It feels like when I came in", slight back itchiness still present 1448 - Pt reassessed 30 min post 2nd dose of benadryl, pt reports complete resolution of all symptoms, BP - 135/79, T - 98.2, RR - 14, HR - 78, 100% on RA Discussed transportation with patient prior to providing 2nd dose of Benadryl, Pt home via private vehicle with mother (driver) and partner. Educated patient to call nurse on call number with any further concerns or if symptoms resume.
32 2021-01-08 throat numbness After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have di... Read more
After 10 minutes, throat began to become numb/tingly/itchy. Then at 20 minutes, I started to have difficulty swallowing. I told the medical provider who was there in the observation room. My vitals were stable. They sent me to the ER to be watched and observed for 6 hours. my throat's numb/itchiness/tingling went away, but remained difficult to swallow until the next morning. My vitals stayed stable.
32 2021-01-08 tingling As soon as it was administered, I felt my heart start racing and felt a tingling sensation through m... Read more
As soon as it was administered, I felt my heart start racing and felt a tingling sensation through my entire body especially in my hands and feet. I let the nurse know under observation and she took my vitals and my BP was high for me as well 146/85. I waited for an hour and then had my husband pick me up. The tingling continued for a week and a half and made it impossible to sleep. It?s slowly gotten better, but I still feel almost a palpitation/flutter feeling.
32 2021-01-08 pain in extremity Chills, body aches, lethargy, headache, entire left arm pain
32 2021-01-08 weakness Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into r... Read more
Shortly after vaccine admin, patient reported feeling dizzy. Patient appeared pale. Assist x2 into recliner chair and was physically weak. Reclined and provided water and snacks. Patient progressively felt better with 35 min observation, felt "normal" at discharge from clinic.
32 2021-01-08 tingling, muscle spasms, numbness extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near ... Read more
extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near syncope, body spasms, and left sided chest pain (worse with palpation)
32 2021-01-09 tingling, feeling hot, tremor, flushing About 5 minutes after receiving my second dose I became flush, and hot from the outside in over my w... Read more
About 5 minutes after receiving my second dose I became flush, and hot from the outside in over my whole body. I was tingly all over. I felt shaky and like I was going to pass out. Very nauseous. My blood pressure was 169/93 @ 0830. The staff had me lay down. About 5 min later I started to feel better. Another 5 min later it happened again in a wave. The symptoms just came over me. My blood pressure @ 0840 was169/104. The staff had me drink water and rest. @0900 the wave came over me again. My BP was 178/111. I drank more water and rested. BP recheck @ 0925 162/112. @940 BP was slowly coming down at 145/109. At that time they transferred me to the Emergency room. My BP came back into normal ranges, and the waves stopped happening around 12pm. I was then released home with plans to follow up with Primary care on 1/11/2021
32 2021-01-09 pain in extremity G2, P1. 21 weeks 2 days at time of vaccination, due 5/19/20. Est fetal weight approx. 15.7ounces as ... Read more
G2, P1. 21 weeks 2 days at time of vaccination, due 5/19/20. Est fetal weight approx. 15.7ounces as of 1/6/20. Mild arm soreness, onset approximately 5 hours after vaccine. Subsided within 36 hours.
32 2021-01-09 burning sensation Left arm injected, and I have been experiencing burning of the left side of my face. The burning is ... Read more
Left arm injected, and I have been experiencing burning of the left side of my face. The burning is not present on the right side of my face.
32 2021-01-09 pain in extremity chills, entire right arm sore, swollen/painful lymph nodes in right axillary, fatigue, stuffy nose
32 2021-01-10 hypersensitivity of all senses 1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off a... Read more
1/11 "less than 24 hrs, work Sunday night, hands were red, right one swollen. Continued on and off at work when benadryl and chlortabs started wearing off. As night continued y face is a little swollen, headache, hypersensitive skin, sore tired"
32 2021-01-10 pain in extremity Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she h... Read more
Patient received her covid vaccine on 12/28/2020 in her left arm. Three days after vaccination she had pain and swelling in her right arm. She was seen by a health care provider on 12/31/2020 and an ultrasound showed extensive deep venous thrombosis in the left arm. She was started on a blood thinner (eliquis). She had blood tests done on 1/1/20 and this showed leukocytosis. She was found to have acute myeloid leukemia and admitted to our service for treatment. We do not have blood tests prior to 1/1/20 so it is unclear when her leukemia started. Her deep venous thrombosis could be related to her acute leukemia but I decided to report it due to the proximity to the time of her vaccine. Her arm pain and swelling improved after administration of the blood thinner. She is currently being treated for her leukemia.
32 2021-01-10 pain in extremity Soreness to Left arm lasted for 48 hrs Fatigue started 12 hrs after and lasted for 36 hrs
32 2021-01-10 weakness fever, chills, headache, and extreme weakness. Some nausea.
32 2021-01-11 tenderness Fever, pain, chills for two days. Then an enlarged lymph node over my clavicle, pressure and pain in... Read more
Fever, pain, chills for two days. Then an enlarged lymph node over my clavicle, pressure and pain in my neck and above clavicle, lymph node is still swollen and tender 4 post injection.
32 2021-01-11 muscle spasms Severe lower and mid-back pain; tightness; Muscle spasms; This is a spontaneous report from a contac... Read more
Severe lower and mid-back pain; tightness; Muscle spasms; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number 9231), intramuscular in left arm on 28Dec2020 13:30 at a single dose for COVID-19 immunization. Medical history included Migraines, hyperthyroidism, ankylosing spondylitis, and hypertension. Concomitant medication included lisinopril, methimazole, rizatriptan, topiramate, galcanezumab (EMGALITY, alprazolam, ethinylestradiol, norgestimate (MONO LINYAH), diphenhydramine hydrochloride (BENADRYL), ubrogepant (UBRELVY) nd birth control. The vaccine was administered in a hospital. The patient was not diagnosed COVID-19 prior to vaccinations. The patient previously took macrobid [clarithromycin] and experienced rash. On 29Dec2020 04:30, the patient experienced severe lower and mid-back pain, tightness, and muscle spasms. Back pain persisted until early morning 30Dec2020. Rotated Tylenol and Ibuprofen, and used heat with minimal relief. The outcome of the event severe lower and mid-back pain was recovered on 30Dec2020 while the remaining events recovered on an unknown date. The patient was did not have covid-19 test post vaccination. The event was assessed as non-serious.
32 2021-01-11 pain in extremity Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 32-ye... Read more
Sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Jan2021 (13:15) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included abnormal Factor V; and kiwi allergy. Concomitant medication included ibuprofen (ADVIL). The patient previously took Ambroxol, and had drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested since the vaccination. On 06Jan2021 (16:00), the patient had sore arm. The patient did not receive any treatment for the event. The outcome of the event, sore arm, was unknown. Information on batch/lot number was requested.
32 2021-01-11 weakness, speech disorder Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusi... Read more
Started to feel lightheaded, weak, faint like I was going to pass out, heart rate increased, confusion, trouble speaking, brought to the ED, throat started to swell and started having thick spit and clearing my throat excessively. Diagnosed as anaphylaxis.
32 2021-01-11 muscle spasms Starting two nights after receiving the vaccine writer started to get leg cramps, and burning pain. ... Read more
Starting two nights after receiving the vaccine writer started to get leg cramps, and burning pain. The pain is not similar to flu-like body aches. This continues into the next week and is traveling to abdomen. Writer is unable to obtain medical advice on how to proceed.
32 2021-01-11 hot flush Throat and tongue tingling, hot flash
32 2021-01-11 pain in extremity sore arm, could barely move her arm, fatigue, fever 100.5, vomiting diarrhea
32 2021-01-12 feeling cold, muscle spasms 1/11- starting spotting off cycle 1/12 Woke up at 12:30am due to fully body aches, chills and fever... Read more
1/11- starting spotting off cycle 1/12 Woke up at 12:30am due to fully body aches, chills and fever. 7:45am had fever of 102.2 body aches and leg cramps, 2:00pm had fever of 102 and body aches. 10:00pm still had body aches and fever. 10:00am took Tylenol, fever broke to 100.5 still body aches and leg cramps came back.
32 2021-01-12 tingling 30 minutes after vaccine administration patient experienced transient tingling in her left hand. Oth... Read more
30 minutes after vaccine administration patient experienced transient tingling in her left hand. Otherwise patient was stable so patient declined offer of oral diphenhydramine. After checking in with patient an hour after we offered diphenhydramine tingling seemed to have gone away/patient did not report any symptoms.
32 2021-01-12 tingling About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began comp... Read more
About 15 minutes after receiving the second dose of the Pfizer vaccine at Clinic, patient began complaining that she was dizzy and nauseated. Patient was seated on the exam table at this time, and was helped to lay down on the exam table. Vitals were obtained by RN. Patient began complaining of tingling of her lips while vitals were being obtained at 1110. PA was notified and brought to the room to evaluate patient. Patient denied having any difficulty breathing or swallowing, was not experiencing any itching of the mouth, tongue or throat, and did not notice anything else unusual, patient was still dizzy and nauseated. Patient stated that she had a similar reaction to the first dose of the Pfizer COVID vaccine, where the symptoms resolved within about an hour. Nursing staff and PA stayed with patient during the duration of her observation. Patients vitals ranged betwen pulse ox = 98-99%, pulse = 97-106 bpm, B/P = 114-121/80-89 mm hg. Patient also complained of some tingling around the lower jaw at 1147. Patient was observed for 1 hour and 26 minutes after vaccination was received. Symptoms gradually resolved, upon discharge patients lightheadedness had resolved, and the tingling around the lips and jaw were mostly gone. Patient still was not having any shortness of breath, chest pain, trouble breathing, rash or hives, swelling/tingling/numbess of the tongue, mouth, or throat. Discharge instructions were provided by PA, including when to seek further care at the ER or to call 911. Patient felt comfortable driving herself home and left at 1214. About two hours later, pt presented to ED. Pt endorsed throat tingling, lightheaded, nausea. She also stated that while the reaction post Dose 1 and Dose 2 were similar, the reaction after Dose 2 was much more severe. Assessed for transient Bell's Palsy presentation but determined unlikely as no facial asymmetry or deficits were appreciated. RR 24, other vitals WNL. Pt observed for about 1.5 hours before discharging home with instructions to call ED should condition worsen.
32 2021-01-12 feeling cold Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course ... Read more
Beginning on 1/5 at 8 am Fever 101, body aches chills. (expected reaction), however over the course of the next 3 days, short of breath with minimal exertion, increased heart rate to 150 with minimal movement. Resolved symptoms on 1/10.
32 2021-01-12 feeling cold Fatigue, body aches, fever, chills
32 2021-01-12 migraine Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient)... Read more
Fever 101; fatigue; nausea; migraine; This is a spontaneous report from a contactable Nurse(patient). A 32-years-old female patient received BNT162B2(Lot number: EK9231) , intramuscular on 06Jan2021 08:15 at 32 years old at Arm Right at single dose for COVID-19 immunization. Medical history included migraine, Allergies to Latex. Concomitant medications included asa, ascorbic acid (VIT C), cetirizine hydrochloride (ZYRTEC) and ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (Multi Vit). The patient experienced fever 101, fatigue, nausea, migraine on 06Jan2021 19:00. There was no treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 06Jan2021. The outcome of events was recovering.
32 2021-01-12 flushing I waited for a total of 15 mins at clinic as requested for side effects. After the 15 mins past, I w... Read more
I waited for a total of 15 mins at clinic as requested for side effects. After the 15 mins past, I went to my car. By the time I got to my car (about 5 mins later at the most), my face felt flush and I had shortness of breath and began coughing. I then used my emergency inhaler for asthma and was able to breathe better. I went back inside clinic to be monitored by a doctor. The coughing continued and resided after about15 -30 minutes. My blood pressure was normal per the doctor and my breathing returned to normal per the doctor.
32 2021-01-12 feeling cold, weakness I work as an occupational therapist in acute care. On 12/28, I was helping a patient transfer from s... Read more
I work as an occupational therapist in acute care. On 12/28, I was helping a patient transfer from supine to sit. She required maximal assistance, and I was briefly in an awkward position with my trunk flexed and rotated towards the right during this transfer. I felt a pull in my left lower back. After this, I iced the area and took 400 mg ibuprofen and this relieved the mild pain I had. The following two days, I made an effort to follow back precautions (avoid bending, lifting, twisting), avoided heavy lifting at work. On 12/29 in the morning, I felt only a mild soreness in my left lower back and was able to go on my workday without issue (avoiding heavy lifting) On 12/29 around 3 pm I received the first dose of the Pfizer COVID vaccine. On 12/30 (day off work) from the time I woke up until around early afternoon I felt a mild weakness and heaviness in both of my legs. It was most notable when I was standing to cook for about 20-30 minutes that my legs felt shaky and I felt the need to sit. I was able to finish cooking without sitting, however, this sensation was abnormal for me as I normally am on my feet for most of the day with an active job without feeling shaky or weak. Around 22:00 on 12/30 I had severe nausea for about an hour or so. I can't fully remember, but several days after 12/28 or 12/29 I started to feel a mild cold sensation in my lower back. I attributed this potentially to my mild back injury, but it was unclear. The sensory change was intermittent and mild, and ongoing until recently. On 1/9 while at work, I started to feel a mild cold sensation below my belly button, in addition to the intermittent lumbar back cold sensation area. On 1/11 at work, the sensory changes to my lower abdomen and back were more apparent after assisting in a maximal assist transfer with a patient. At this time, it was a combination of cold and burning sensations.
32 2021-01-12 pain in extremity Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later... Read more
Low grade fever, body aches, lightheadedness and sore arm. Developed a localized rash that was later diagnosed as shingles on 01/11/2021 by her PCP. A 01/04/202 COVID test was negative.
32 2021-01-12 tingling, speech disorder, numbness Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with ... Read more
Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with blurred vision, hearing sounded like underwater, felt like I had trouble talking. Notified nurse that gave me vaccine, several other nurses came over and helped me into recliner and laid me back and took vitals. Vitals are stable. I quickly began to feel better (within 5 minutes of being reclined). Still had the numbness and tingling. I laid in recliner for 30 minutes, then sat up for 10 minutes before leaving. I drank water and ate 2 rice krispies while in recliner. Numbness and tingling improved, but lingered throughout the day and was gone next morning.
32 2021-01-12 weakness covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vas... Read more
covid injection #1 on 12/23/20. 5 days later on 12/28/2021 woke up with nausea and diarrhea. Had vasovagal symptoms of lightheaded, blurred vision, hearing changes, and weakness of legs while standing. was in healthcare setting working at the time. Initial vitals 87/60, drank apple juice and rested, BP came up 15 min later to 100/75. At approx. 7pm on 12/28/2020 developed chills which turned into sweats with myalgia's and arthralgia's, took 1g Tylenol, at 9pm fever still 101.7*F. Fever lasted approx 8 hours. Nausea resolved. Diarrhea lasted about 36 hours.
32 2021-01-12 weakness, migraine, tremor tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to ri... Read more
tachycardia (140 bpm); Fever above 101; myalgia; joint pain right arm, joint pain and swelling to right wrist; joint pain and swelling to right wrist; swollen lymph node on right side of body; weakness; skin redness and burning sensation; skin redness and burning sensation; tremors; gum pain; fatigue; migraine; sweating; back pain; first dose of bnt162b2 on 18Dec2020 at 16:00, second dose on 04Jan2021 at 08:00 AM; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELU140), via an unspecified route of administration on 04Jan2021 at 08:00 AM on Right arm at single dose for COVID-19 immunization. The patient medical history included had known allergies with Penicillin, bees and wasp. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol, retinol (VITAMIN A); colecalciferol (VITAMIN D); calcium phosphate dibasic, phytomenadione (VITAMIN K); cyanocobalamin (VITAMIN B12); levothyroxine, liothyronine (NP THYROID). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELO140), via an unspecified route of administration on 18Dec2020 at 16:00 on Right arm at single dose for COVID-19 immunization. The patient experienced fever above 101, tachycardia (140 bpm), myalgia, joint pain right arm, joint pain and swelling to right wrist, swollen lymph node on right side of body, weakness, skin redness and burning sensation, tremors, gum pain, migraine, fatigue, sweating and back pain, all on 04Jan2021 at 20:00, events were resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. It was unknown if any treatment was received for events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
32 2021-01-13 flushing, night sweats, migraine 01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flus... Read more
01/09/21 woke up with Mirgraine, nausea, dizziness with standing and reports inability to eat, flush feeling, night sweats, body aches, tired, fatigue, lymph node tenderness under both arms and arm at injection site was red and swollen about the size of a baseball. Slept most of the day and still did not feel well when woke up later in the day and called into work evening of 01/09/21. Reports when she woke up the morning of 01/10/21 felt great.
32 2021-01-13 numbness, pain in extremity Chest pain, numbness in face, arm pain, numbness in arm
32 2021-01-13 cold sweat Date of symptom onset - ?1/13/21 midday Symptoms - ?EE reports she felt pretty tired of the day aft... Read more
Date of symptom onset - ?1/13/21 midday Symptoms - ?EE reports she felt pretty tired of the day after receiving her 2nd dose of the vaccine. EE reports when she woke up this am she started feeling generalized body aches, chills, ?clammy? and HA. EE reports + congestion and runny nose. EE denies fever but has been taking Tylenol round the clock since yesterday per EE. Last dose of Tylenol taken at 18:30 (1/13) 1000 mg. At time of call temperature 99.6. EE reports her husband called while at work this am and 7- month old son with cough and fever at home. Last day of work and shift - ?currently at work Home remedies? - see ?symptoms? Any improvement? - mild Recommendation? After completing algorithm with EE, EE meets criteria to be taken off of work and to be scheduled for testing. EE educated to notify manager of need to leave work at this time and to contact EH command center for assistance with testing. EE provided with phone number of EH command center. EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE verbalized back understanding and denied further questions at this time.
32 2021-01-13 flushing Facial flushing and heart palpitations after first dose of vaccination lasting approximately 2 weeks... Read more
Facial flushing and heart palpitations after first dose of vaccination lasting approximately 2 weeks. Palpitations onset approx 5 minutes after receiving second dose of medication.
32 2021-01-13 weakness I started feeling weakness, headache and muscle aches on 1/12 the day of 2nd dose of covid vaccine. ... Read more
I started feeling weakness, headache and muscle aches on 1/12 the day of 2nd dose of covid vaccine. On 1/13 I started feeling dizziness, headache and nausea that lasted until now (1/14).
32 2021-01-13 feeling hot, tingling Immediately complained of feeling hot, tingly, anxious, shaky. Noted to have elevated blood pressur... Read more
Immediately complained of feeling hot, tingly, anxious, shaky. Noted to have elevated blood pressure and pulse. Symptoms continued for one hour. Patient was seen in the Emergency Department for monitoring and discharged to home.
32 2021-01-13 tingling Mild tingling on the right side of her mouth and face that started shortly after receiving the vacci... Read more
Mild tingling on the right side of her mouth and face that started shortly after receiving the vaccination. Symptoms were less intense and lasted for a shorter period of time than after the first injection.
32 2021-01-13 weakness On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy a... Read more
On 1/12 I started feeling weak, tired, sore on the injection site. On 1/13 I started feeling dizzy and I?m having headache and nausea and I still feel those symptoms now.
32 2021-01-13 pain in extremity Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated ... Read more
Soreness at injection site; Soreness radiated down to elbow and thumb/Joint pain; Soreness radiated down to elbow and thumb; Intense body aches; chills; This is a spontaneous report from a contactable other nurse (patient). A 32-year-old female patient received the first dose of BNT162b2 (Lot number: EK9231), via an unspecified route of administration at right arm on 04Jan2021 13:30 at single dose for covid-19 immunization. Medical history included birth control. Concomitant medication included probiotics, ethinylestradiol, norethisterone acetate (JUNEL) for birth control. The patient experienced soreness at injection site on 04Jan2021 18:00; soreness radiated down to elbow and thumb, Intense body aches, joint pain, chills on 04Jan2021. The patient received the treatment Acetaminophen 1000mg every 6 hours and Ibuprofen 400mg for events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.
32 2021-01-13 pain in extremity body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal... Read more
body aches headaches fever of 101.2 fatigue tiredness tachycardia reached 152 leg pain light vaginal spotting (not near my expected period dates)
32 2021-01-13 migraine ~36 hours post-shot woke up in middle of night with migraine, chills and nausea. Took Excedrin, napr... Read more
~36 hours post-shot woke up in middle of night with migraine, chills and nausea. Took Excedrin, naproxen and Zofran and was able to fall back asleep in about 2 hours.
32 2021-01-14 tingling, flushing, sensory loss At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and... Read more
At approximately 5 minutes into the 15-minute monitoring window, I became severely dizzy, flush, and light-headed while simultaneously experiencing right-sided tingling, the altered sensation from my forehead to collarbone (right side only). At approximately four hours post-vaccination my right eye had mild blurriness to my vision. The vision resolved within a few hours but the altered right-sided sensations continued for 6 days, gradually improving. The lightheadedness and dizziness that required cool clothes and elevated feet resolved enough to stand after 30 minutes.
32 2021-01-14 hot flush Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating a... Read more
Continued dizziness, dry mouth, sore throat, nausea, headache, vertigo, with intermittent sweating and hot flashes over 48 hrs after vaccination. Improvement with Tylenol 1000mg.
32 2021-01-14 hot flush Fatigue and headache started about 12 hours after vaccine was given, lasted throughout the day on an... Read more
Fatigue and headache started about 12 hours after vaccine was given, lasted throughout the day on and off, fatigue and malaise progressed throughout the day. Nausea started about 24 hours after vaccination. Then overnight about 30 hours later developed chills and hot flashes alternating through the night, difficulty sleeping, headache and fatigue continued.
32 2021-01-14 pain in extremity Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable ... Read more
Hot injection site; sore arm; swollen lip; nausea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 08Jan2021 07:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history reported as none. The patient's concomitant medications were not reported. The patient's historic vaccine included Other Pfizer vaccine on 18Dec2020. The patient experienced hot injection site, sore arm, swollen lip, nausea on 09Jan2021 15:00. Therapeutic measures were taken as a result of events included Benadryl. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. Information on Lot/ Batch number has been requested.
32 2021-01-14 discomfort Neck and shoulder pain; neck and shoulder pain; Not horrible, just uncomfortable; Swollen lymph node... Read more
Neck and shoulder pain; neck and shoulder pain; Not horrible, just uncomfortable; Swollen lymph node at left collar bone; This is a spontaneous report from a contactable consumer reporting on behalf of a patient. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899, expiration date unknown) via an unspecified route of administration on 07Jan2021 (at the age of 32-years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 17Dec2020 (at the age of 32 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced neck and shoulder pain on 08Jan2021 which was described as, not horrible, just uncomfortable. The patient also experienced a swollen lymph node at the left collar bone on 08Jan2021. The patient did not receive any treatment for the events. The clinical outcomes of neck and shoulder pain, discomfort and swollen lymph nodes was reported as recovering It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
32 2021-01-14 weakness, flushing Shortness of breath, extreme itching, full body flushing, chest pain, weakness.
32 2021-01-14 feeling cold patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teet... Read more
patient c/o feels like heart racing, denies shortness of breath, HR regular, skin warm and dry, teeth chattering, patient states they feel cold, monitored for 45 minutes, patient left at 1147 states she is ready to go, states I am ok.
32 2021-01-15 migraine Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain ext... Read more
Severe soreness in left upper arm at location of the shot about 5 hours after the shot, the pain extended into the armpit/lymph area of my left arm and the pain remained steadily severe until Friday 1/15- 3 days after the initial injection. At 1pm on day of shot (1/12/21) had feelings of chills, sweaty and whole body aches. This lasted until Thursday morning 1/14 around 7am. During that time, took Tylenol for the aches and feverish feelings. Arm soreness finally subsided Friday. migraines started Thursday evening into Saturday morning. With little relief from Imitrex (prescription medication for chronic migraines). Went to the emergency room Saturday for a shot of Torodal for the migraine to subside.
32 2021-01-16 night sweats, tenderness 12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills,... Read more
12 hours following injection, I developed fever in mid 101 F along with flu-like symptoms of chills, body aches, headache. 24 hours after injection, I developed swollen and tender lymph node under my left underarm (the same arm that received the shot). 48 hours after injection, I had horrible night sweats needing to change out of drenched pajamas every 1.5 hours.
32 2021-01-16 pain in extremity, burning sensation, flushing Burning and itchiness after Injection which went away within an hour. Several hours later I became v... Read more
Burning and itchiness after Injection which went away within an hour. Several hours later I became very disoriented, dizzy, flush, sevwr headache, diahhrea, nauseous (dry heaving), extremely achy in arm , neck and shoulder. Some symptoms are still present 36/hours later.
32 2021-01-16 night sweats Left cervical painful lymphadenopathy, myalgias, arthralgias, chills, subjective fever, night sweats... Read more
Left cervical painful lymphadenopathy, myalgias, arthralgias, chills, subjective fever, night sweats, headache from afternoon day of vaccine lasting for 18 hours.
32 2021-01-17 numbness Left side facial numbness, intermittent eye and cheek pain, at times entire left side numbness, craw... Read more
Left side facial numbness, intermittent eye and cheek pain, at times entire left side numbness, crawling feeling to left side intermittently
32 2021-01-17 pain in extremity Received first COVID vaccine on 1/11/21. Pain in arm started three days post vaccine leading to arm ... Read more
Received first COVID vaccine on 1/11/21. Pain in arm started three days post vaccine leading to arm swelling and now one week post vaccine armpit swelling in same are as vaccine given.
32 2021-01-17 burning sensation, flushing tachycardia, arm pain, erythema, swelling; facial flushing/burning; fatigue, rash On 1-14-21 she tes... Read more
tachycardia, arm pain, erythema, swelling; facial flushing/burning; fatigue, rash On 1-14-21 she tested +for Covid
32 2021-01-18 pain in extremity Around 9 pm, my arm became more sore and started radiating into my shoulder and I had chills. I had... Read more
Around 9 pm, my arm became more sore and started radiating into my shoulder and I had chills. I had a low-grade fever and I had slight SOB. Not sure if it was due to vaccine or the fact that I'm big and pregnant. The next more I was extremely sore all over. I also experienced major fatigue and a headache. I just rested and felt better afterwards and it went away.
32 2021-01-18 cold sweat CG started having a headache, clammy and chest pain. Pain 6/10 BP 119/78, HR 82, O2 100%,. CG refus... Read more
CG started having a headache, clammy and chest pain. Pain 6/10 BP 119/78, HR 82, O2 100%,. CG refused to lay down, juice offered. 1348 BP 126/76, HR 89, O2 98%, chest pain reduced to 4.5/10 and had no change when ambulating. Due to consistent chest pain, CG was transported via wheelchair to the ER for evaluation.
32 2021-01-18 numbness Had sore arm and felt unwell shortly after receiving the shot. The following morning my arm was stil... Read more
Had sore arm and felt unwell shortly after receiving the shot. The following morning my arm was still sore and I developed a blister behind my left ear and swollen lymph-nodes. The soreness in my arm went away however the blister became worse and started erupting with puss and the lymph-node became larger, tender, and developed sharp . shooting pain. I went to urgent care on 1/3/2020 and was given oral antibiotics and an antibiotic cream for the blisters. A swab culture was taken for possible shingles. On 1/4/20 I went to clinic as the pain had worsen and resulted in a numbing sensation on my left cheek. The doctor prescribed me antivirals for Shingles and I was given an antibiotic shot in the butt. I was off work for two weeks. The pain went away around 1/15/20. The blisters are healed.
32 2021-01-18 feeling cold Low grade fever started 1/18 around 1400: 100.4 F, accompanied by body aches, chills, fatigue and he... Read more
Low grade fever started 1/18 around 1400: 100.4 F, accompanied by body aches, chills, fatigue and headache. Fever spiked 1/19 around 1445: 103.2
32 2021-01-18 tingling, facial paralysis, numbness Quick onset of Left sided numbness/tingling turning into facial paralysis, unable to close eye, head... Read more
Quick onset of Left sided numbness/tingling turning into facial paralysis, unable to close eye, headache, ear ringing, etc.
32 2021-01-18 pain in extremity, tingling Tingling in wrist and hand on injection site arm. Pain/heaviness in hand.
32 2021-01-18 tingling Tingling/heaviness in hand on adjacent arm to administration site.
32 2021-01-18 migraine, weakness migraine; weakness; itchiness, redness and swelling around the injection site; itchiness, redness an... Read more
migraine; weakness; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; itchiness, redness and swelling around the injection site; This is a spontaneous report from a contactable nurse. A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 30Dec2020 at SINGLE DOSE at left arm for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. On 30Dec2020, the patient reported migraine and became more severe on 31Dec2020, weakness, itchiness, redness and swelling around the injection site post vaccination. Caller wants to know if she can receive the second dose of the vaccine despite the redness and swelling around the injection site. The outcome of the event Itchiness, red and swollen injection site was recovered on 31Dec2020, the event migraine, weakness was recovered on 01Jan2021 Information about Lot/Batch number has been requested.
32 2021-01-18 flushing on 1/17/21 I was at home watching a movie around 6:00pm started itching and eyes started swelling wh... Read more
on 1/17/21 I was at home watching a movie around 6:00pm started itching and eyes started swelling when to the bathroom to look and I had hives all over my upper body. I have not changed in anything in my house or tried any new food. I took some Pepcid and a cold shower. in about an hour the itching stopped but I was still red. went to bed then when I woke up the next morning my hands was so swollen I couldn't move my fingers and they was numb, itching and hurting all at the same time. so i went to the clinic. they gave me a steroid shot, Benadryl, Pepcid and Claritin. my hands started to go down some before i left the clinic. not i have to take all the meds the next 3 days. still on 1/19/21 @ 6:00am my face started to flush before i took my meds.
32 2021-01-19 pain in extremity 0710 January 19th I received the second does of the Covid -19 vaccine. The site was very sore all da... Read more
0710 January 19th I received the second does of the Covid -19 vaccine. The site was very sore all day. Around 2230 that night, I started having intermitted sharp pain in my leg arm pit. 0430 January 20th I woke up with sharp pains still in my left arm pit. By 1030 the pain was now constant and extreme. I called my doctor and he told me to come into the office to see him. NP saw me and explained that the lymph nodes in my left arm were swollen. Very tender to touch also. He prescribed me Prednisone twice a day for three days, Ibuprofen, and use hot compresses. So far the pain has gotten better.
32 2021-01-19 tremor Patient awoke in the middle of the night shaking (chills), but was not running a fever. After taking... Read more
Patient awoke in the middle of the night shaking (chills), but was not running a fever. After taking 1000 mg of acetaminophen the shaking resolved in 30 minutes. That same day around 10 AM patient had muscle soreness in neck and shoulders and a mild headache.
32 2021-01-19 burning sensation, numbness Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on ... Read more
Vaccine given on Friday 1/8 at 10am. Started having significant fevers, chills, myalgias, rigors on 1/9 around 1pm. Symptoms lasted for about 8hrs. On 1/10 developed left upper arm, axillary, chest wall, and clavicular soft tissue swelling with significant lymphadenopathy. Lymphadenopathy was tender, multiple nodes ~2cm. Started experiencing severe sharp shooting pain and burning in similar region. On 1/11 started developing weakness in L arm and hand, with numbness in left hand. Went to urgent care on 1/11. Exam demonstrated 4/5 strength of left arm and hand. Started prednisone 40mg on 1/11. Swelling, pain, and weakness persisted. Seen in ER 1/15, exam with persistent weakness and lymphadenopathy. MRI brachial plexus performed which showed multiple enlarged nodes adjacent to brachial plexus. No overt inflammation or compression of brachial plexus. Received IV dexamethasone, and PO prednisone course. Finished 10d of prednisone 40mg with improvement in soft tissue edema, but still with residual weakness and pain. EMG pending. Diagnosed with brachial plexopathy secondary to compressive adenopathy from COVID 19 vaccine.
32 2021-01-20 pain in extremity Ache, chills, fatigue, arm pain, fuzzy head
32 2021-01-20 cold sweat Foggy headed, stuffy nose, chills, fever, cold sweats, body aches, severe headache, extreme fatigue... Read more
Foggy headed, stuffy nose, chills, fever, cold sweats, body aches, severe headache, extreme fatigue all lasting two days so far
32 2021-01-20 pain in extremity Lymph node swelling unilaterally in the armpit on the side of the injection; Sore arm; some fatigue;... Read more
Lymph node swelling unilaterally in the armpit on the side of the injection; Sore arm; some fatigue; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL3246) via an unspecified route of administration at left arm on 06Jan2021, at 04:30 PM (dose number: 2) for COVID-19 immunization. Medical history included depression and anxiety. No known allergies. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, Lot number: EH9899) via an unspecified route of administration at left arm on 17Dec2020 at 04:45 PM at a single dose (dose number: 1) for COVID-19 immunization. No other vaccine in four weeks. Other medications in two weeks included fluoxetine, ibuprofen, acetaminophen, cefixime (FLEXERIL). Facility type vaccine was at hospital. The patient was not pregnant. The patient experienced adverse events included lymph node swelling unilaterally in the armpit on the side of the injection, sore arm and some fatigue. The adverse event start date was reported as 08Jan2021 at 04:45 AM. No treatment received for events. The outcome of events was resolving. No COVID prior vaccination. No COVID tested post vaccination.
32 2021-01-20 hot flush, weakness Monday 4pm was vaccinated. Left arm. Tuesday morning felt ?icky? but went to work. My left arm was s... Read more
Monday 4pm was vaccinated. Left arm. Tuesday morning felt ?icky? but went to work. My left arm was sore at the injection site but no rash. Wednesday morning I woke up with slight shortness of breathe, and felt some wheezing, horrible headache right behind my eyes, hot flashes, I felt like the inside of my body was on fire. No temperature. My body all around ached. My stomach was extremely upset. I had loose stools multiple times through out the day. When I tried to drink anything my stomach felt like it was also ?on fire? it was just not happy with anything being in there. Thursday same way. Headache, muscle aches, I am so tired. I feel drained of energy. My stomach is extremely upset. I have not ate anything since Tuesday afternoon. I have drank a lot of water. My body still ?aches? I have had loose stools.
32 2021-01-20 tenderness Pfizer-BioNTech COVID-19 Vaccine: I had painful axillary lymphadenopathy, chills, fever over 102.5, ... Read more
Pfizer-BioNTech COVID-19 Vaccine: I had painful axillary lymphadenopathy, chills, fever over 102.5, piercing headache, dizziness and vertigo with change in position, severe fatigue, sore throat, generalized muscle aches the following day (1/20) after I received the vaccine. It took hours just to get out of bed this morning, I felt so unwell. I took 1000 mg of tylenol before bed on the day I received the vaccine (1/19), but I still woke up with fever. I continued to take 1000 mg throughout the day every 6 hours, which did help. Most symptoms resolved by 1/21 but I continue with fatigue and painful left axillary lymphadenopathy. The node is still really swollen and tender.
32 2021-01-21 pain in extremity 4 hours after receiving vaccine, I was replacing a door handle, and thought I had moved my arm in su... Read more
4 hours after receiving vaccine, I was replacing a door handle, and thought I had moved my arm in such a way that it had subluxed at the GH joint. The acute, immediate pain in the joint and inability to move my shoulder were surprising. It took me a few minutes to realize this was likely a reaction to the shot. The joint pain migrated to my elbow, wrist, hand, and left side of my neck, and those joints were all cracking for about 2 days. My left shoulder is still experiencing discomfort and cracking frequently when I move that arm.
32 2021-01-21 flushing Flushing and shortness of breath immediately after receiving vaccine Lasted approx 5 minutes
32 2021-01-21 numbness, tingling Immediately following vaccine, I have tingling in my left hand. 20 minutes after vaccine, I started ... Read more
Immediately following vaccine, I have tingling in my left hand. 20 minutes after vaccine, I started to experience tingling in my neck on the left side which then progressed to tingling of the left side of my mouth. 25 minutes after vaccine, the left side of my mouth and my left nare became numb. My left hand still tingled but I lost feeling in my ring and pinky finger on the same hand. All symptoms resolved on their own by 3 hours post vaccine without the need for medical intervention.
32 2021-01-21 tenderness Muscle soreness, severe headache the morning after vaccine about 11 hours after. Joint/muscle aches ... Read more
Muscle soreness, severe headache the morning after vaccine about 11 hours after. Joint/muscle aches began about 5 hours later. Started noticing left a Dillard pain not long after that. Very enlarged left ancillary lymph node noticed around 6pm. Painful with and without touch. Visibly enlarged. Feels about baseball size. Slight enlargement in right axilla but no associated pain or discomfort. Still present next day
32 2021-01-21 flushing PRE-DOSED WITH 10ML ORAL DIPHENHYDRAMINE LIQUID DUE TO REPORTED REACTION TO 1ST COVID VACCINE DOSE. ... Read more
PRE-DOSED WITH 10ML ORAL DIPHENHYDRAMINE LIQUID DUE TO REPORTED REACTION TO 1ST COVID VACCINE DOSE. APPEARED FLUSHED IN THE FACE AND NECK WITHIN 5 MINUTES OF VACCINATION AND REPORTED FEELING ITCHY. NO HIVES NOTED AND NO DIFFICULTY BREATHING REPORTED UPON QUESTIONING.
32 2021-01-21 pain in extremity Started with a headache which ended up lasting for >48 hrs. Treated w/alternating tylenol and ibupro... Read more
Started with a headache which ended up lasting for >48 hrs. Treated w/alternating tylenol and ibuprofen. Then came intense fatigue and malaise w/body and muscle aches. Lastly, swollen lymph nodes in armpit on arm of injection site and arm pain.
32 2021-01-21 burning sensation Symptoms: Patient complaining of rash to face, neck and hand for the last 10-15 minutes. States th... Read more
Symptoms: Patient complaining of rash to face, neck and hand for the last 10-15 minutes. States that they look like hives and have a burning sensation. Had 2nd COVID vaccine about 3 hours ago. Denies any breathing difficulty. Is a 32 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the following clinic/location: Butterworth on the date of: 1/18 and approximate time of 7pm Vaccine was administered to patient's: Left Deltoid Vaccine manufacture was: Pfizer No Previous Reactions to other immunizations Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: Rash: Location other than injection site face neck and hands - burning sesation Modifying Factors or additional details:Around 3 1/2 hrs post vaccine she started to break out in a rash on hands and face. She denies any other changes to her environment. Took benadryl and this seemed to help. ROS
32 2021-01-21 tingling, tremor Was given vaccine at a clinic with EMS present. Approximately 5 minutes after the injection she sai... Read more
Was given vaccine at a clinic with EMS present. Approximately 5 minutes after the injection she said she felt lightheaded/dizzy first, some dizziness, with slight tingling of the tongue. Said her legs felt tingling, hot and hands shook. She said throat felt slightly tight. EMS was on sight and they administered her Solumedrol and Benadryl IM. She was never given an epi injection. They monitored her HR and O2 Sats. After she felt symptoms were resolved she did leave the clinic on her own accord. She returned to her work even though she was advised to go home and rest per medical personal.
32 2021-01-22 tremor Around 8pm my throat felt tight I was shaking an felt wheezy my husband gave me Benadryl an an took ... Read more
Around 8pm my throat felt tight I was shaking an felt wheezy my husband gave me Benadryl an an took me too ER on 12-31-20
32 2021-01-22 seizure I passed out/minor seizure? Was transported to the ER and given fluids. All test results came back ... Read more
I passed out/minor seizure? Was transported to the ER and given fluids. All test results came back OK and I was released. Nothing like this has ever happened in my life.
32 2021-01-22 tingling brief period of feeling extreme heaviness in shoulders and arms, tingling hands/feet. Followed by mu... Read more
brief period of feeling extreme heaviness in shoulders and arms, tingling hands/feet. Followed by muscle aches, general body tension, chills, mild headache. Also ear/jaw pain (possibly related to prior sinus infection)
32 2021-01-23 pain in extremity, breast pain I woke up the next morning after receiving the vaccination with very severe pain to my right arm. It... Read more
I woke up the next morning after receiving the vaccination with very severe pain to my right arm. It was deep in my arm pit (axillary region). Painful lymph nodes in that area. General fatigue and aches progressed throughout the day as well. But the arm pit/ breast pain was very severe!
32 2021-01-23 tingling Immediately experienced tingling in my arm up to my neck. When I left, I noticed my mouth and tongue... Read more
Immediately experienced tingling in my arm up to my neck. When I left, I noticed my mouth and tongue were numb. My throat was tighter than usual. I took Benadryl when I got home and my symptoms were improved. I had a sore throat later that evening.
32 2021-01-23 breast pain Right sided axillary and right breast pain that lasted roughly 12 hours and resolved.
32 2021-01-24 numbness 10:00am Patient returned from walking to car post-vaccination, stating that her mouth began to feel ... Read more
10:00am Patient returned from walking to car post-vaccination, stating that her mouth began to feel numb and she felt a bit lightheaded. Patient brought to back area to semi-reclining chair, BP 128/77, 72HRT. States she ate breakfast, felt a bit anxious. Allergic to amoxicillin which causes rash and vomiting. Takes only prenatal vits; denies any medical condition. Numb lips, mouth, tongue, breathing fine according to patient. 10:17am Numbness spread to hands, nose, upper face, dull headache; states her breathing is fine, feels lump in back of throat however. Given 25mg liquid Benadryl oral, tolerated well. BP 116/69, HRT 67, 10:35am symptoms improving, denies feeling lightheaded, stood for 1 minute, stated she felt fine, patient discharged to self, ambulatory, husband aware and at home.
32 2021-01-24 weakness Chills, headache, Fever upto 102.2 degree F, generalized weakness and body ache.
32 2021-01-24 migraine Terrible migraine about an hour after my first injection lasting through the night. After 24 hours, ... Read more
Terrible migraine about an hour after my first injection lasting through the night. After 24 hours, no headache.
32 2021-01-25 tremor Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe... Read more
Arm swelling with itchiness; Arm swelling with itchiness; warm to touch at site of injection; severe chills with shaking; severe chills with shaking; 103 fever/ approx 20hrs after injection, fever of 100 or greater for 24hrs with minimal relief with Tylenol; body aches; pains in left flank; the first dose on 20Dec2020/second dose on 12Jan2021; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 32-year-old female patient (not pregnant) received the second dose of bnt162b2 via an unspecified route of administration on 12Jan2021 10:30 AM at single dose in Left arm for COVID-19 immunisation. Medical history included cardiogenic syncope, no COVID prior vaccination. Concomitant medications included birth control drugs, no other vaccine in four weeks. The patient previously received the first dose of bnt162b2 on 20Dec2020 03:00PM on Left arm for COVID-19 immunization, topiramate (TOPAMAX) and experienced drug allergy, morphine and experienced drug allergy (hives). The patient experienced arm swelling with itchiness and warm to touch at site of injection, severe chills with shaking, 103 fever, approx. 20 hours after injection, fever of 100 or greater for 24 hours with minimal relief with Tylenol, body aches and pains in left flank. The adverse events started from 12Jan2021, 06:00 PM. Therapeutic measures taken for fever included Tylenol, no treatment was received for other events. The outcome of the events was recovering. The patient didn't test COVID post vaccination. Information on the lot/batch number has been requested.
32 2021-01-25 numbness Pt received vaccine. She was sitting in the observation area after vaccine. About 10 minutes after v... Read more
Pt received vaccine. She was sitting in the observation area after vaccine. About 10 minutes after vaccine, Pt reported feeling numbness in hands and feet, chest tightness and slight difficulty breathing. Pt was offered and ingested diphenhydramine 25mg at 1230 and another 25mg at 1238. Pt continued with same symptoms (not better and not worse). 911 ambulance was called. Pt remained conversing with full sentences with one breath during observation. Radial pulse was strong and regular. No rash. No apparent swelling. Respirations were quiet (no stridor). Ambulance arrived and took over care and eventually transported pt to the ETC.
32 2021-01-25 numbness my face became numb from the nose down; This is a spontaneous report from a contactable consumer (pa... Read more
my face became numb from the nose down; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EL3246, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 12:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had allergies: any sulfa medication. The patient was not pregnant. The patient did not have covid prior vaccination. There were no other vaccine/s in four weeks. Other medications in two weeks include: ethinylestradiol, ferrous fumarate, norethisterone acetate (Blisovi 24 FE), citalopram and lamotrigine. On 11Jan2021 12:45, also reported as 'after 20 minutes of receiving the vaccine,' the patient's face became numb from the nose down. Within three hours, the right side of her face had feeling again. Then, another three hours later she began to have feeling in her nose. She went to bed, and the next morning she had complete feeling in the face. No treatment was received for the event. On 01Jun2020, nasal swab: negative. The patient recovered from the event on 12Jan2021.
32 2021-01-26 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
32 2021-01-26 night sweats Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a con... Read more
Fever; Chills; Body aches; Fatigue; Headaches; Night sweats; This is a spontaneous report from a contactable nurse(patient). A 32-years-old female patient received second dose BNT162B2( lot number Eh9899), Intramuscular at Arm Left on 12Jan2021 11:00 at 32 years old at single dose for COVID-19 immunization. The medical history included Penicillin allergy. The concomitant medication was propranolol. The patient previously took Clindamycin and experienced drug allergy. The Historical Vaccine was first doe BNT162B2 on 23Dec2020 09:00 at 32 years old for COVID-19 immunization. On 12Jan2021 21:30 the patient experienced Fever, chills, body aches, fatigue, headaches, night sweats. All the events resulted in Physician Office Visit. There was no treatment received for all the events. There was no other vaccine in four weeks. There was no COVID prior vaccination. There was no COVID tested post vaccination. The outcome of the events was recovering.
32 2021-01-26 flushing Within a few hours, I became flushed but no fever. Then later in the evening, symptoms include heada... Read more
Within a few hours, I became flushed but no fever. Then later in the evening, symptoms include headache, body ache, fever of 101, aches in my bones and fatigue.
32 2021-01-27 pain in extremity Arm soreness; fatigue; body aches; headache; This is a spontaneous report from a contactable other h... Read more
Arm soreness; fatigue; body aches; headache; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL0142), intramuscular (left arm), on 12Jan2021 16:30, at single dose, for covid-19 immunization. Medical history included GERD, seasonal allergies (dust, mold), and degenerative disc disease (DDD). The patient had received unspecified concomitant medications in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899) intramuscular (left arm) on 21Dec2020 for covid-19 immunization. The patient experienced on 12Jan2021 16:45 arm soreness immediately after up to 48 hours later, significant fatigue, body aches at 20 hours through 36 hours, and headache 8 hours after. The patient had no Covid prior vaccination, had no other vaccine in four weeks and, had not been Covid-tested post vaccination. The patient received Tylenol and naproxen pan as treatment for the events. The patient recovered from the events on Jan2021.
32 2021-01-27 pain in extremity, tingling, numbness Face numbing; chart pain; pain left arm; tingling in left arm; This is a spontaneous report from a c... Read more
Face numbing; chart pain; pain left arm; tingling in left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ELO140, expiration date unspecified), via an unspecified route of administration on 14Jan2021 14:00 at single dose (left arm) for COVID-19 immunization. Medical history included asthma, allergies to bees, pollen dust, and mold. The patient was not pregnant. Concomitant medication included salbutamol sulfate (PROAIR), ibuprofen, paracetamol (TYLENOL), and budesonide, formoterol fumarate (SYMBICORT). The patient previously took tramadol and morphine and experienced allergies to both drugs. On 14Jan2021 at 14:00, the patient experienced face numbing, chart pain (as reported), pain left arm and tingling in left arm. There was no treatment for the events. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had no other vaccine in 4 weeks; no Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.
32 2021-01-27 cold extremities, pain in extremity I had a sore arm and woke up Sweaty. On Sunday around 4 pm my right calve had a cold sensation, this... Read more
I had a sore arm and woke up Sweaty. On Sunday around 4 pm my right calve had a cold sensation, this then progressed to both calves and up to thighs and lower back. It feels as if I put icy hot on them. It has not improved since Sunday.
32 2021-01-27 numbness Numbness of pinky and ring finger; This is a spontaneous report from a contactable other healthcare ... Read more
Numbness of pinky and ring finger; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number not reported, via an unspecified route of administration from 15Jan2021 06:30 to 15Jan2021 06:30 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced numbness of pinky and ring finger on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of numbness of pinky and ring finger which includes prednisone. The patient is not pregnant. The patient was not tested with COVID prior and post vaccination. Information on the Batch/Lot number has been requested.
32 2021-01-27 burning sensation, feeling cold, numbness, tingling, pain in extremity Numbness, paresthesias, burning pain of bilateral legs, left is worse than right. Numbness, paresthe... Read more
Numbness, paresthesias, burning pain of bilateral legs, left is worse than right. Numbness, paresthesias, burning pain, Deep aching pain of left upper extremity, cold sensation of left arm and left leg. Numbness of the face, paresthesias of the lips, objectively decreased light touch everywhere, but worse in all the areas mentioned.
32 2021-01-27 flushing PATIENT RECIEVED SECOND COVID 19 VACCINE. PATIENT TOLERATED VACCINE WELL, STAYED IN CLINIC FOR 30 MI... Read more
PATIENT RECIEVED SECOND COVID 19 VACCINE. PATIENT TOLERATED VACCINE WELL, STAYED IN CLINIC FOR 30 MINUTES AT WHICH TIME PATIENT LEFT FACILITY. PATIENT RETURNED STATING AS SOON AS REACHED CAR DEVELOPED FLUSHING/REDNESS IN CHEEKS. 50MG PO BENADRYL WAS ADMINISTERED AND PATIENT WAS MONITORED FRO 1 HOUR. SYMPTOMS DID NOT WORSEN OR NEW SYMPTOMS OCCUR. PATIENT WAS DISCHARGED AT THAT POINT.
32 2021-01-27 hypersensitivity of all senses, pain in extremity, tremor Painful left axillary lymphadenopathy roughly 6 hours after shot. Headache, fever, soreness, increas... Read more
Painful left axillary lymphadenopathy roughly 6 hours after shot. Headache, fever, soreness, increased skin sensitivity and pain overnight. Shaking chills for several hours the next morning. Persistent low back pain 10/10 radiating to anterior thighs bilaterally from 6PM the day of and has not resolved as of the following afternoon.
32 2021-01-27 feeling cold, weakness, night sweats Pt had injection site tenderness for ~24 hours and night sweats the first night. ~48 hours after inj... Read more
Pt had injection site tenderness for ~24 hours and night sweats the first night. ~48 hours after injection, she developed a "cold" feeling in her calves that over several days had spread to anterior thighs, plus subjective weakness. When I saw her in clinic on 1/27 (day 3 of symptoms), she had no other symptoms. On exam, she had full 5/5 strength and 2+ DTRs (Babinski could not be elicited). She was referred to Neurology who saw her via telemed on 1/28 and agreed on observation unless and until she develops objective weakness.
32 2021-01-27 pain in extremity Severe headache medicine couldn?t get rid of Pain in the same arm shot was given Fever Chills Aches ... Read more
Severe headache medicine couldn?t get rid of Pain in the same arm shot was given Fever Chills Aches and pains Could barely lift my arm cause it was so sore
32 2021-01-27 night sweats fatigue, multiple joint pain, headache, nightsweats for two wks after the shot.
32 2021-01-27 feeling of body temperature change hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spont... Read more
hot and cold chills; body aches; tired; nausea; did not sleep the rest of the night; This is a spontaneous report from a contactable consumer. A 32-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0142, via an unspecified route of administration in the left arm on 12Jan2021 10:30 at a SINGLE DOSE for covid-19 immunization. Medical history included Gluten and dairy allergy. Prior vaccination, patient has had covid-19 from an unknown date to 30Dec2020. Patient was not pregnant during vaccination. Concomitant medications included curcumin, acetylcysteine, ascorbic acid, quercetin, vitamin b complex, vitamin c and colecalciferol. The patient previously took minocycline and zithromax and experienced allergy to both. The patient received the vaccine on 12Jan2021 at 10:30 and started feeling symptoms hot and cold chills, body aches on 13Jan2021 around 1:00 AM. She did not sleep the rest of the night and throughout the day was tired, chills, body aches, nausea. Patient also stated that she started her period the day she received the vaccine which she was not sure if did help her immune system. The outcome of events was recovering. Patient did not received any treatment due to the events. Since the vaccination, the patient hasn't been tested for COVID-19. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
32 2021-01-28 cold sweat, migraine 24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest o... Read more
24 weeks pregnant at time of 2nd shot. Shot given at 1430 on 1/27 in left deltoid. Felt great rest of day. @0500 on 1/28 woke up shivering uncontrollably. Mild fever of 100.5(highest recorded during this whole episode). Body aches, chills, sweats, headache rest of day. 1000 mg Tylenol helped with fever/chills but headache progressed to migraine w/nausea. Took 50 mg sumatriptan and 25 mg doxylamine in evening and this seemed to help with headache and allow me to get to sleep 1/28. Woke up at 0300 1/29 with chills/cold sweats. Took 1000 mg Tylenol again (didn't check temp) and went back to sleep. Woke up at 0530 for work - checked temp since I'm a healthcare worker and it was 100.4 (with tylenol). Waited until clinic opened up and called them at 0700 for recommendations on going to work or not (temp by then was 99.8, with tylenol). Was advised to stay home and if febrile tomorrow to get COVID tested on 1/30. As of right now (1300 on 1/29) headache has returned but mild. Body aches still. Temp 99.4 w/tylenol redosed at 1000.
32 2021-01-28 pain in extremity, feeling hot Arm very sore ~12 hours after injection. Chills, hot sweats, body aches, and headache through the ni... Read more
Arm very sore ~12 hours after injection. Chills, hot sweats, body aches, and headache through the night unable to sleep due to side effects. Day after vaccine achy and tired. 2 days after vaccine feel back to normal.
32 2021-01-28 pain in extremity Fatigue, sore left arm, and 2 episodes of diarrhea occurred about 24 hours after vaccination. All si... Read more
Fatigue, sore left arm, and 2 episodes of diarrhea occurred about 24 hours after vaccination. All side effects resolved 18 hours after first symptom onset.
32 2021-01-28 seizure Multiple Seizures 24 hrs after event unable to breathe lasted for over one week.
32 2021-01-28 breast pain Muscle or lymph nodes in right arm pit is swollen; Muscle or lymph nodes in right arm pit is swollen... Read more
Muscle or lymph nodes in right arm pit is swollen; Muscle or lymph nodes in right arm pit is swollen; painful from elbow to breast a week out; painful from elbow to breast a week out; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), intramuscular in the right arm on 07Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included epilepsy. The patient's concomitant medications were not reported. The patient did not have vaccine in four weeks. The patient had no COVID prior vaccination. The patient is not pregnant. The patient experienced muscle or lymph nodes in right arm pit is swollen and painful from elbow to breast a week out on 08Jan2021 06:00. No treatment received for the reported events. The patient underwent lab tests and procedures which included nasal swab (COVID) on an unspecified date: negative. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
32 2021-01-28 migraine Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks... Read more
Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included spinal stenosis and allergies to cephalosporin. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included gabapentin. On 30Dec2020 19:00, the patient experienced severe headache/migraine which lasted for over 2 weeks, required prescription medication to make them bearable but even then, they didn't go away and were very bad. The patient spent the good part of two weeks in bed or at least not doing her regular level of activity. She went to Urgent Care twice and to the Emergency Room once. The patient was given prescription medication and IV pain medication as treatment for the events. The patient underwent lab tests and procedures which included nasal swab test (COVID-19 virus test) on 11Jan2021: negative result; and the same test on 14Jan2021 with negative result. The patient was recovering from the events. Information on the lot/batch number has been requested.
32 2021-01-28 pain in extremity bad headache; have a lot of soreness in my arm; This is a spontaneous report from a contactable othe... Read more
bad headache; have a lot of soreness in my arm; This is a spontaneous report from a contactable other HCP (patient). A 32-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at 14:30 at single dose for covid-19 immunization. Medical history included joint pain, thyroidic of the bladder, allergies: penicillin. There were no concomitant medications. The patient previously took codeine and experienced allergies: codeine. The patient experienced bad headache, and had a lot of soreness in her arm on 14Jan2021 at 17:30. Event details: 3 hours after getting the vaccine have a lot of soreness in her arm and bad headache that wouldn't leave even after 24 hours and taking paracetamol (TYLENOL) for treatment. The patient did not receive treatment for soreness in her arm. The outcome of the events was resolving. Information on the Lot/Batch number has been requested.
32 2021-01-29 numbness, flushing, tingling Flushed face and feeling around 30 minutes after injection, 45 minutes wide spread rash over arms, l... Read more
Flushed face and feeling around 30 minutes after injection, 45 minutes wide spread rash over arms, legs and face; tightness in jaw, tongue and face swelling with numbness and tingling.
32 2021-01-29 tingling Pt developed tingling around mouth and cheeks as well as itching in on the right Shin. Treatment: C... Read more
Pt developed tingling around mouth and cheeks as well as itching in on the right Shin. Treatment: Cetirizine 10 mg PO and an addition 30 minute observation. The pt felt better after the additional wait time, vitals signs stable She was released home.
32 2021-01-30 pain in extremity After first dose, arm soreness lasting 3 days, headache lasting an hour. After around 5 days, I thou... Read more
After first dose, arm soreness lasting 3 days, headache lasting an hour. After around 5 days, I thought it was stress related, but I started to have itchiness on the roof of my mouth at the back. There is a kind of rashy area in the back of my mouth, mostly on the roof. It itches a lot and it makes my throat hurt when I attempt to scratch it. I have had to use chloraseptic spray and numbing cough drops to ease the itch and pain. Also, I have been experiencing shortness of breath. I attributed it to Chronic Bronchitis, but it feels different and is not constant. I didn't make the connection of mild allergic reaction until I received my second dose. I received my second dose on 01/29/2021. I was experiencing flu-like symptoms on 1/30, and am not experiencing the same symptoms as of 1/31. I am, however, still experiencing the mouth rash and itching, and mild shortness of breath.
32 2021-01-30 tingling, speech disorder From moments after injection, dizziness and nausea, lack of focus, tingling sensation throughout bod... Read more
From moments after injection, dizziness and nausea, lack of focus, tingling sensation throughout body, injection site pain and body aches, vivid dreams, elevated heart rate during sleep (150bpm), difficulty pronouncing some words, unaware of date and time, fatigue. Nausea, lack of focus, dizziness and tingling sensation improving, but still happening at the time of this report.
32 2021-01-30 flushing I had my vaccine at 10:55am on Saturday. I felt completely fine the rest of the day. Early Sunday ... Read more
I had my vaccine at 10:55am on Saturday. I felt completely fine the rest of the day. Early Sunday morning, around 4am, I woke up sweating and with a fever. My normal temp is around 97.5. My temp was 100.5. For the next 30 hours, I had a fever that ultimately peaked around 101.5 on Sunday evening. I felt very bad, like I had the flu. It is probably the worst I have felt in several years. I had significant muscle pain and even laying on the couch was too uncomfortable. I laid in bed and slept off and on. Monday, when I first woke for work at 5:35am I was still feverish and achy, although I could tell I was better than I had been at my worst Sunday evening. After going back to sleep, I woke up at 10am feeling significantly better. Aside from being rather flushed and sweaty, I felt fine the rest of the day. My injection site was mottled red, swollen, and painful for about three more days, with improvement every day. I am not concerned about my reaction. I am only reporting it to provide data.
32 2021-01-30 tingling, pain in extremity My left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after I... Read more
My left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after I received the Pfizer-BioNTech vaccine for COVID-19 in my left arm. My left hand turned blue like it was cold, but I was not cold anywhere on my body. My left hand's veins were also mostly purple in the fingertips. This side effect was not painful and lasted about 30 minutes. Other symptoms I've experienced because of the Pfizer-BioNTech vaccine for COVID-19 in my left arm: - soreness across entire arm, especially at injection site - occurred upon injection and is slowly getting better. I took two 200mg of ibuprofen two days after the injection because the pain randomly got worse without any outward cause - swollen injection site - occurred upon injection and is the same at this time - tingling across entire arm - occurred upon injection and stopped seven hours later at 11pm
32 2021-01-31 hot flush 12 hours after the vaccine she started having chills and hot flashes. Overnight and the next day she... Read more
12 hours after the vaccine she started having chills and hot flashes. Overnight and the next day she had a fever up to 100.8, chills, hot flashes, nasal congestion, muscle aches, joint pain and headache. She took Tylenol for the symptoms.
32 2021-01-31 tingling Tingling and tightness to tongue and R side of face
32 2021-01-31 feeling hot pruritic, textured rash with redness and warmth on the face bilaterally; textured rash with redness ... Read more
pruritic, textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally/cheeks/chin, forehead, ears, nose. Neck and chest spared/unilateral rash (left side)/Rash was red, splotchy in appearance, and flat; textured rash with redness and warmth on the face bilaterally; textured rash with redness and warmth on the face bilaterally; deeper, maroon discoloration; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route at right arm on 16Dec2020 08:15 AM at single dose for COVID-19 immunization. Medical history included depression, ADHD and known allergies: wasp venom (local swelling and redness). Concomitant drugs included methylphenidate hydrochloride (CONCERTA XL), bupropion hydrochloride (WELLBUTRIN XL), escitalopram oxalate (LEXAPRO), and unspecified multivitamin. No other vaccine in four weeks. Historical vaccine included measles vaccine; mumps vaccine; rubella vaccine (MMR VACCIN) for immunization (allergies: local swelling and redness). Patient was not pregnant. No Covid prior vaccination. On 19Dec2020, patient experienced pruritic, textured rash with redness and warmth on the face bilaterally. Most noticeable on cheeks which at times have had deeper, maroon discoloration. Rash also presented on chin, forehead, ears, and nose. Neck and chest spared. Rash recurred daily. It worsened after a warm shower. Additionally, a unilateral rash (left side) was observed for a few minutes on torso and leg after a warm shower 3 days after vaccine. Rash was red, splotchy in appearance, and flat, resolved within minutes (as reported). Right torso and leg were unaffected. No known changes in skin care routine, regular medication or supplements, exposures, chemicals, or contact. No prior history of rashes described. The local injection site was red, warm, and raised for four days following vaccine receipt, followed by bruising. It was reported events resulted in doctor or other healthcare professional office/clinic visit. Treatments Pepcid, ibuprofen (steroid script was not filled) were received for events. Patient had nasal swab/ nasopharyngeal PCR of covid test on 17Dec2020: negative and on 21Dec2020: negative. Outcome of events was not recovered. Information on the lot/batch number has been requested.
32 2021-02-01 tingling Date of vaccine - foot, legs, arm, hand tingling. Intermittently since then including today nearly 3... Read more
Date of vaccine - foot, legs, arm, hand tingling. Intermittently since then including today nearly 3 weeks out, most prominent in left arm and hand. Has caused significant anxiety.
32 2021-02-01 feeling hot Nausea, warm with symptoms worsening with time Pt went to urgent care.
32 2021-02-01 feeling hot, tingling Patient reports chest warmth, light headed, dizziness, tingling in ears. Transferred to ED for evalu... Read more
Patient reports chest warmth, light headed, dizziness, tingling in ears. Transferred to ED for evaluation. PMHX: Allergy to IV dye, shell fish Pre-medicated: 25mg Benadryl PO x 1
32 2021-02-01 night sweats Same day of vaccine in the night I started to get chills & low grade fever I took Tylenol. Then late... Read more
Same day of vaccine in the night I started to get chills & low grade fever I took Tylenol. Then later on that night I woke up & i was sweating & I had body aches. I also lost a little apatite. This lasted about 36hrs.
32 2021-02-01 pain in extremity Saturday, January 23rd I received my second COVID vaccination around noon. Later that day I develope... Read more
Saturday, January 23rd I received my second COVID vaccination around noon. Later that day I developed the typical extremely sore arm. Sunday January 24th: I started to feel just a general malaise and had some headaches, like I was coming down with something, but other than that felt fine. Monday January 25th: I was at work and started developing a sore throat, chest tightness with some shortness of breath, myalgias, fatigue, nausea, and minor chills, although I never had a fever. Tuesday: symptoms were slightly worse Wednesday January 27th: I went to work thinking all these symptoms were still just from the vaccine as I hadn't felt any sickness symptoms before getting the vaccine and hadn't had an exposure I was aware of. While at work, I asked other coworkers if they had any similar symptoms to the vaccine and was told I should call employee health since I was still having such bad symptoms and really didn't feel too great. I called the employee health line and told them all my current symptoms which were all the same still. They told me that the sore throat and chest tightness with shortness of breath were definitely not from the vaccine and to leave work and get tested. I did this and my test came back negative. Because I was still having bothersome chest tightness, the employee health line also told me to go to the ER, thinking it could be something else significant. I went to the ER the night of January 27th to get my symptoms all checked out as told to. Everything came back ok and the ER doctor wanted me tested for COVID again Friday around the 48 hour mark to verify it wasn't the virus. She also told me that if it came back negative, she was sure it must be my reaction to the vaccine. Thursday January 28th: I stayed home per guidelines from employee health and still had all the symptoms listed on Monday. After a two hour afternoon nap, I finally felt like I was turning the corner. My sore throat felt better besides a huge lump still in my throat and my chest tightness with shortness of breath subsided. I still had bad myalgias, fatigue, headaches and a general sense of not feeling so great. Friday, January 29th: Feeling slightly better again, main symptom is bad myalgias, especially my neck and small lump in throat. I got retested around 12:30 pm and it came back negative for COVID as well as negative for strep. Saturday: Feeling almost 100% better besides sore neck still.
32 2021-02-02 flushing, tingling 5 minutes after receiving the 2nd COVID vaccine, patient states she felt a slight flush, lightheaded... Read more
5 minutes after receiving the 2nd COVID vaccine, patient states she felt a slight flush, lightheaded and heart palpitations. HR was 120-130s but returned back to normal now. She mentions that a couple days after the first shot she had some tingling on the side of her face. The patient was taken to the ED for monitoring . Workup in the ED was negative, and the patient was discharged home.
32 2021-02-02 flushing, pain in extremity Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain ... Read more
Pt +covid test 14Jan2021; Pt +covid test 14Jan2021; Tachycardia; Facial flushing; Fatigue; arm pain and swelling; arm pain and swelling; This is a spontaneous report from a contactable Other HCP. A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 12Jan2021 at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included attention deficit hyperactivity disorder (ADD), hypothyroidism and anxiety. Past drug history included allergy to cefprozil (CEFZIL). Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN XL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and levothyroxine sodium (SYNTHROID). On 12Jan2021, the patient had tachycardia, facial flushing, fatigue, arm pain and swelling. The events required a physician office visit. Therapeutic measures taken as result of the events included levocetirizine dihydrochloride (XYZAL) and diphenhydramine hydrochloride (BENADRYL). On 14Jan2021, the patient underwent a COVID-19 virus test (nasal swab) which resulted positive. The outcome of the events was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 12Jan2021, and COVID-19 test positive on 14Jan2021. No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use. Further information is needed for full medical assessment.
32 2021-02-02 pain in extremity Within 18 hours of the vaccine, I experienced: arm pain, fever, sore joints, skin hurt to the touch,... Read more
Within 18 hours of the vaccine, I experienced: arm pain, fever, sore joints, skin hurt to the touch, UTI sensation when urinating Within 2 days, I experienced: sore joints, skin hurt to the touch, UTI sensation when urinating, sore throat Within 3 days, I experienced: skin hurt to the touch, UTI sensation when urinating, sore throat, sores inside of mouth Within 4 days, I experience nausea and still had sores in my mouth
32 2021-02-02 difficulty speaking Within five minutes of injection mild headache. Within seven minutes of injection lightheadedness de... Read more
Within five minutes of injection mild headache. Within seven minutes of injection lightheadedness developed. At eight minutes severe burning within chest. This initial onset symptoms did resolve within five minutes, however recurred times for over the course of 20 minutes.. After 30 minutes post injection, right forearm and lower left abdomen with blotchy erythema. Throughout the rest of the day roof of mouth and throat mildly pruritic. Overnight severe diaphoresis. Following day mild Tonsillar lymphadenopathy, hoarseness of voice, sore throat, chest tightness.
32 2021-02-03 feeling hot, numbness, tingling Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbn... Read more
Face and arm on the side COVID vaccine given started tingling and got warm right away then had numbness and tingling after. For the first 15 mins also had heart palpitations. 12 hours later after waking up face sensation was dull and improved over the night.
32 2021-02-03 weakness High fever, chills, severe joint pain, moderate to severe muscle pain, headache, nausea, diarrhea, s... Read more
High fever, chills, severe joint pain, moderate to severe muscle pain, headache, nausea, diarrhea, swollen lymph node in left axilla, fatigue, weakness
32 2021-02-03 night sweats, migraine Migraine Headache; Body aches; Joint Pain; Chills; Night sweats; Anxiety; Fatigue; feeling as if hea... Read more
Migraine Headache; Body aches; Joint Pain; Chills; Night sweats; Anxiety; Fatigue; feeling as if heart is racing but when pulse was taken it was normal; This is a spontaneous report from a contactable nurse, who is also the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EK9231), via intramuscular route of administration in the right arm on 19Jan2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia and the patient had known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medication included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR), both from unknown dates, at unknown doses, for an unknown indications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EH9899), via intramuscular route of administration, in the right deltoid on 29Dec2020 for COVID-19 immunisation. On 20Jan2021 at 06:00 the patient experienced migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal. The patient did not receive any treatment for the events. The clinical outcomes of the migraine headache; body aches; joint pain; chills: night sweats; anxiety; fatigue; feeling as if heart is racing but when pulse was taken it was normal were recovered with sequelae (reported as "recovered with lasting effects") on an unknown date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
32 2021-02-03 hot flush Mild flu like symptoms started 1/5: low grade fever of 99.3-100.5, sore arm at injection site, body ... Read more
Mild flu like symptoms started 1/5: low grade fever of 99.3-100.5, sore arm at injection site, body aches, fatigued. 1/6: Fever and body aches gone. Hot flashes/sweating for half the day and tired. 1/7: all better, no more symptoms.
32 2021-02-04 tremor, numbness, feeling hot I got sudden sob, had trouble swallowing my water was driving on way back to work. Got pulled over. ... Read more
I got sudden sob, had trouble swallowing my water was driving on way back to work. Got pulled over. Heart was racing. Got hot starting shaking. Sob. Hands feet and face started to get numb. And almost passed out.
32 2021-02-04 cold sweat, feeling hot Overheated, cold sweats, aches, nausea.
32 2021-02-04 feeling cold, tingling, numbness Subjective: left arm numbness, tingling, feels cold in hand. Neuro exam in office is normal. Vaccine... Read more
Subjective: left arm numbness, tingling, feels cold in hand. Neuro exam in office is normal. Vaccine given in mid deltoid.
32 2021-02-07 pain in extremity, flushing About 30 minutes after the shot, my face became very red and flushed. I continued driving home and t... Read more
About 30 minutes after the shot, my face became very red and flushed. I continued driving home and took xyzal when I arrived. My face cleared up about an hour later. My left arm has been sore since the shot (3 days now). Also the next day after my shot, I was completely exhausted.
32 2021-02-07 discomfort Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt... Read more
Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization. Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.
32 2021-02-07 migraine Low grade temp 99.1; diarrhea; body aches; chills; migraine; sweats; severe fatigue; Dose Number 1, ... Read more
Low grade temp 99.1; diarrhea; body aches; chills; migraine; sweats; severe fatigue; Dose Number 1, Date of start of drug 21Dec2020/ Dose Number 2, Date of start of drug 20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration on 20Jan2021 07:30 at left arm, at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included isotretinoin (ACCUTANE), cetirizine. The patient previously took pediazole and experienced Known allergies: pediazole. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 21Dec2020 09:15, at Left arm, at single dose for covid-19 immunization. The patient experienced low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue at 20Jan2021 12:00. No treatment was received for events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue. The outcome of the events low grade temp 99.1, diarrhea, body aches, chills, migraine, sweats, severe fatigue was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
32 2021-02-07 numbness, tingling Tingling or numbness on nose.
32 2021-02-07 pain in extremity significant pain in the arm; headache; Mild lightheadedness; nausea; This is a spontaneous report fr... Read more
significant pain in the arm; headache; Mild lightheadedness; nausea; This is a spontaneous report from a non-contactable healthcare professional. A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient, on an unspecified date, experienced significant pain in the arm starting approximately 4 hours after injection lasting into the next day; a headache a few hours within injection; mild lightheadedness and; nausea. No treatment was received for these adverse events and the patient recovered from these events on an unspecified date. The adverse events were assessed as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination. The patient has been COVID-tested post vaccination on an unspecified date with unknown results. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
32 2021-02-08 numbness Numbness of left ear, cheek and jaw, happened suddenly one morning around 8am. This week I've also b... Read more
Numbness of left ear, cheek and jaw, happened suddenly one morning around 8am. This week I've also been experiencing moderate right hip pain making me limp. Started on prednisone treatment right away outpatient, still no change. Also taking Ibuprofen 800mg with little to no change in pain.
32 2021-02-09 tingling, pain in extremity Difficult breathing; Started getting pins/needles/tingling/pain on both of my hands; Started getting... Read more
Difficult breathing; Started getting pins/needles/tingling/pain on both of my hands; Started getting pins/needles/tingling/pain on both of my hands/Pins/needles/tingling/pain throughout my body; Chest tightened; Pins/needles/tingling/pain throughout my body; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm on 22Jan2021 13:45 at single dose for COVID-19 immunization. Medical history included birth control. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (LEVORA) for birth control. The patient previously took the first doe of BNT162B2 on 31Dec2020 administered at the left arm. The patient got the vaccination on 22Jan2021 and in less than 5 minutes she started getting pins/needles/tingling/pain on both of my hands. Then suddenly her chest tightened and had difficult breathing which lasted for 2-3 mins. Now (22Jan2021), she has pins/needles/tingling/pain throughout her body. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab and SARS-CoV-2, RT-PCR on 21Jan2021 and both are negative. The outcome of the event general body pain was unknown and recovered for the rest of the events.
32 2021-02-09 migraine Migraine, redness, pain, and large lump at injection site, runny nose, fatigue
32 2021-02-10 pain in extremity I had a sore arm, chills and fatigue about 48 hours after the vaccine.
32 2021-02-10 feeling cold chills, fatigue, nausea, body ache, vomiting lasted 3 days. took Ibuprofen after 24 hours to help wi... Read more
chills, fatigue, nausea, body ache, vomiting lasted 3 days. took Ibuprofen after 24 hours to help with symptoms.
32 2021-02-11 bell's palsy Minor Bell's Palsy- Increase in numbness/tingling of the tongue over the past two days. Lips started... Read more
Minor Bell's Palsy- Increase in numbness/tingling of the tongue over the past two days. Lips started to numb today. Pain is increasing in left ear. No noticeable drooping of facial muscles yet, but symptoms may increase in the next 24 hours.
32 2021-02-11 weakness tachycardia Short of breath Weakness
32 2021-02-15 tingling, numbness, flushing Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection... Read more
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremities)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: tingleness and numbess on left arm-Mild, Additional Details: Patient stated she felt tinglyness, numbness, slight chill, along with a little bit bumps along her left arm where the vaccine was given (L). I monitored the patient for an extra 30 minutes and gave the patient one dose of benadryl. I checked back with her after 30 minutes and she was doing fine and felt good and able to leave.
32 2021-02-16 tingling, numbness 15 min after injection my arm was tingling, I notified the pharmacist and was cleared to leave. 40 m... Read more
15 min after injection my arm was tingling, I notified the pharmacist and was cleared to leave. 40 minutes after injection my hands and face went numb, my heart rate elevated for 10 minutes, I was unable to breathe through my nose. 1 hour after injection I regained feeling in my face and hands; my hands shook for 2 hours after.
32 2021-02-17 numbness, tingling Tingling and numbness in arms and legs; Tingling and numbness in arms and legs; This is a spontaneou... Read more
Tingling and numbness in arms and legs; Tingling and numbness in arms and legs; This is a spontaneous report from a contactable consumer. A 32-years-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), Lot number=EL9263, via an unspecified route of administration, in left arm (at the age of 32 years-old) on 23Jan2021 at 17:00 as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19.Concomitant medications included escitalopram oxalate (LEXAPRO), minerals nos, vitamins nos (PRENATAL VITAMINS). The patient previously took epinephrine and experienced a drug allergy. On 23Jan2021 at 17:15, the patient experienced tingling and numbness in arms and legs. The patient was not hospitalized for the events nor was treatment received. The clinical outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
32 2021-02-18 feeling hot 10 minutes post vaccination, patient began feeling a warm sensation under her left cheek and the tip... Read more
10 minutes post vaccination, patient began feeling a warm sensation under her left cheek and the tip of her tongue became itchy. No other signs or symptoms reported or noted. She was offered Benadryl but she stated her symptoms were waning and not worsening. She denies any history of allergies except having hay fever as a child. She denies any PMHX and she is not currently on any prescribed or OTC meds. Her vitals were stable and after 10 mins into observation, her symptoms began to wane. Patient was monitored for 45 mins and was stable prior to leaving the vaccination POD. She was educated on what signs and symptoms to monitor. She was advised to follow up with her PCP and or allergist for further evaluation. Patient was informed her 2 nd dose if cleared by her PCP would have to be in an observation facility with a higher level of care. Patient understood and agreed with the above. Patient does not want to evaluated by local ER facility.
32 2021-02-21 seizure, cold sweat Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, ca... Read more
Lightheaded. Skin was clammy, convulsions started, Epi pen administered, she had tongue swelling, came around then eyes rolled back in head, nausea, blood pressure high.
32 2021-02-21 migraine Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took... Read more
Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took ibuprofen at onset of symptoms, headache subsided but the rest lingered for another 24 hours.
32 2021-02-22 difficulty speaking 1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop roc... Read more
1/7 vaccination Within a couple minutes after vaccination, my tongue started to tingle. like pop rocks in mouth. I got extremely nauseous. Within 5 minutes, everything was spinning. Continued progressing. HR 180. Within 10 min, i was in ER. They gave my epi pen but it didn't work right away. They were about to start an epi pen and to knock me out, they gave me Benadryl IV, Pepcid?, and they were 30 seconds from intubating me. My vocal cords; broncho spasms. I slowly started to get better. They monitored me for 7 hours. *Still experiencing, daily, SOB. My voice gets harsh. I run out of breath walking, talking, etc. I use prednisone, 2 inhalers daily; Advere and Rescue inhaler. I also suffer from EXTREME HA since then and am on 2 medications for the HA.
32 2021-02-22 pain in extremity 12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. To... Read more
12/17 vaccination 12/18 within 24 hours, arm was hurting. Immense pain to arm. Flu like symptoms. Took Motrin. Symptoms lasted for 3 days.
32 2021-02-22 unresponsive to stimuli, tremor PT STATES THAT SHE WAS FEELING WEIRD . PT WAS PALE, STARTED SHAKING AND SAYING THAT SHE WAS GOING TO... Read more
PT STATES THAT SHE WAS FEELING WEIRD . PT WAS PALE, STARTED SHAKING AND SAYING THAT SHE WAS GOING TO PASS OUT. PT SLUMPED IN HER CHAIR, SUPPORTED BY 2 RNS, PT UNABLE TO ANSWER PROMPTS. PT TRANSFERRED TO ED. BEDSIDE VITALS IN OBSERVATIONBP 90/66 HR 79
32 2021-02-22 tingling, numbness The evening after obtaining the covid vaccine, I started experiencing mild tingling and numbness ... Read more
The evening after obtaining the covid vaccine, I started experiencing mild tingling and numbness to my left arm, left leg, and left side of my mouth and cheek. The left side if where I received my injection. The numbness and tingling resolved after the first day to my arm and leg, but has continues around the left side if my upper lip. The sensation is only intermittent and can last a few hours. No treatments have been tried.
32 2021-02-23 migraine, feeling hot, feeling of body temperature change After I got the vaccine, I started feeling warm and it felt like needle pricks in my muscles. Body w... Read more
After I got the vaccine, I started feeling warm and it felt like needle pricks in my muscles. Body was painful. I lost my appetite but wasn't vomiting or having nausea. I had a migraine and fever and body aches and chills (I was either freezing or hot) - couldn't get warm enough - these symptoms I noticed about midnight - it woke me up after a couple hours of sleep and then I couldn't sleep. These symptoms lasted through to Monday. Tuesday, I wasn't feeling fantastic but I went back to work. Fever broke on Sunday morning. Migraine lasted five days. I took Tylenol for fever and ibuprofen for other symptoms. I had a virtual Dr appt on Friday, the 8th. I took migraine medicine but it wasn't really helping. I met again with Dr on 11th - virtual. I chose to go back work even though I wasn't better - felt fatigue and the headache on and off for a couple of weeks. Just since the beginning of February do I feel like fatigue has gone away. When I work out, I do still notice that I get tired faster.
32 2021-02-23 pain in extremity Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monda... Read more
Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.
32 2021-02-23 pain in extremity, tingling My left hand turned blue and the veins in that hand looked very dark (almost purple); soreness acros... Read more
My left hand turned blue and the veins in that hand looked very dark (almost purple); soreness across entire arm, especially at injection site; swollen injection site; tingling across entire arm; soreness across entire arm; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 27Jan2021 16:00 (lot number: EN5318), via an unspecified route of administration in the left arm at single dose for COVID-19 immunization in public health department. The patient's medical history includes sciatic nerve pain, allergic to cats and some dogs, back pain from scoliosis and anemic, all from an unknown date and unknown if ongoing. The patient had no concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medications the patient received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The patient stated her left hand turned blue and the veins in that hand looked very dark (almost purple) seconds after receiving the vaccine in the left arm on 27Jan2021 16:00. Her left hand turned blue like it was cold, but she was not cold anywhere on my body. Her left hand's veins were also mostly purple in the fingertips. The side effect was not painful and lasted about 30 minutes. Other symptoms experienced because of the COVID-19 vaccine in left arm were soreness across entire arm, especially at injection site occurred upon injection and was slowly getting better. The patient took two 200mg of ibuprofen two days (however the patient also reported no treatment was received for the events) after the injection because the pain randomly got worse without any outward cause, swollen injection site occurred upon injection and is the same at this time. Tingling across entire arm occurred upon injection and stopped seven hours later at 11pm. The consumer assessed the events as non-serious. The outcome of the event tingling across entire arm recovered on 27Jan2021 at 11 PM and "my left hand turned blue and the veins in that hand looked very dark (almost purple)" was recovered on 27Jan2021 and outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
32 2021-02-24 cold sweat Headache, dizzy, sore throat, sore neck, chills, sweats, low grade fever, clammy this all lasted for... Read more
Headache, dizzy, sore throat, sore neck, chills, sweats, low grade fever, clammy this all lasted for about 48 hours
32 2021-02-24 numbness Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic t... Read more
Immediately after getting the vaccine, I noticed a strong metallic taste in my mouth. The metallic taste lasted for approximately 5 days, decreasing in strength over time. Within 10-15 minutes of getting the vaccine, parts of my face went partially numb (primarily under my lips and along my right cheek). The numbness was largely improved after 1.5 weeks, but I continue to experience it intermittently 3+ weeks later. I also had severe jaw pain that lasted for about 2 weeks, on and off. Within about an hour of receiving the vaccine, I noticed a small amount of rectal bleeding as well; this resolved within the same day. Beyond that, my symptoms were "normal" -- pain at the injection site, mild nausea and chills on the day of the vaccine. I spoke with 5 different doctors about the facial numbness, and none of them were able to advise me on why that might have happened. My primary care physician recommended against getting the second shot until we have more information about what would cause these side effects.
32 2021-02-24 nerve pain On Sunday, 2/21 both forearms, wrists, and thumbs began swelling and experiencing stiffness, tension... Read more
On Sunday, 2/21 both forearms, wrists, and thumbs began swelling and experiencing stiffness, tension, and pain (6/10) that was both burning/nerve pain and achy muscle pain. Previously, my DeQuervein's had been steadily improving through occupational therapy, home exercise, reduced tech use (scrolling/typing), and splinting. By Tuesday, 2/23, range of motion on the Left hand, wrist, and thumb was reduced to almost 0 and the pain reached an steady 9/10 on both arms. As of writing this, the stiffness, swelling, nerve pain, and tension remain at a level higher than the initial level that drove me to seek out occupational therapy back in January. Basically, I went from being close to being discharged to worse than I started. Overall the left side was worse than the right but both sides were impacted. Occupational therapy (ultrasound, fascial release, and assisted stretching) splinting, stretches, and ice were used as treatments. NSAIDs are contraindicated due to Crohn's disease. As of writing this at 16:04 on Thursday, 2/25 none of this has resolved. Pain is a 7/10 on both sides. Range of motion and ability to complete daily care tasks (e.g. dressing, showering, cooking and eating) is nonexistent to minimal.
32 2021-02-24 tremor Severe body aches and trembles for the first 36 hours. Followed by diarrhea and nausea. Have had a c... Read more
Severe body aches and trembles for the first 36 hours. Followed by diarrhea and nausea. Have had a continuous headache the entire duration of time since getting the vaccination. As well as two days with a fever of 102°, that Tylenol nor Motrin could relieve.
32 2021-02-24 tingling Site: Pain at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
32 2021-02-24 migraine throat started to get swollen and raw within two hours with a migraine within 6 hours it was very di... Read more
throat started to get swollen and raw within two hours with a migraine within 6 hours it was very difficult to breathe or talk.
32 2021-02-25 pain in extremity "Covid arm" large rash, red, itchy, warm, sore
32 2021-02-25 pain in extremity Red swelling of entire arm. Pain over the entire arm. Red rash and swelling on the upper back. Itchi... Read more
Red swelling of entire arm. Pain over the entire arm. Red rash and swelling on the upper back. Itchiness.
32 2021-02-25 migraine soreness at injection site, migraine, second day on menstrual cycle - heavy bleeding, extra hungry, ... Read more
soreness at injection site, migraine, second day on menstrual cycle - heavy bleeding, extra hungry, feeling tired, itchiness, hives around neck area
32 2021-02-26 muscle spasms Spotting between period, cramping, now late period, Confirmed not pregnancy by 2 sources.
32 2021-02-28 feeling hot, feeling cold Pt felt dizzy, lightheaded, body aches, hot and cold, fatigue right after getting the vaccine. Also ... Read more
Pt felt dizzy, lightheaded, body aches, hot and cold, fatigue right after getting the vaccine. Also some slight nausea but is slowly going away. She is still feeling symptoms about an hour after dose was given.
32 2021-03-02 tingling, speech disorder Cloudy; forgetful; entire right side of body sore; tingling; words jumbled, speech impediment; extre... Read more
Cloudy; forgetful; entire right side of body sore; tingling; words jumbled, speech impediment; extreme dizziness; tachycardia; This is a spontaneous report from a contactable nurse (patient). This 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 01Jan2021 at 13:00 (at the age of 32-years-old) as a single dose in the right arm for COVID-19. The patient had no medical history and was not pregnant. The patient did not have COVID-19 prior to vaccination. The patient had no concomitant medications and did not receive any other vaccines within 4 weeks prior to the vaccine. The patient did not have any known allergies. On 01Jan2021 at 14:00, the patient experienced "cloudy," forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness. The patient did not receive any treatment for the events. The clinical outcome of "cloudy," forgetful, tachycardia, entire right side of body sore, tingling, words jumbled, speech impediment, and extreme dizziness was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
32 2021-03-02 migraine Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare pro... Read more
Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot: EL3247), intramuscular on the left arm (at the age of 32years) on 27Jan2021 at 14:00 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraines, kidney stones and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The reported adverse events were fever, migraine, nausea, and throwing up on 31Jan2021 with no treatment received on all events. The patient considered the events as non-serious. Did not results in death, non- life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was unknown.
32 2021-03-03 tremor Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify:... Read more
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Mild, Additional Details: PATIENT REPORT ITCHING IN HER THROAT AREA WITH A LITTLE TIGHTNESS AFTER COVID VACCINE, SO GAVE HER BENADRYL. A FEW MINUTES AFTER THAT, SHE WAS A LITTLE SHAKY AND DIZZY. EMS WAS CALLED, AND TENDED TO HER IN THE PHARMACY AREA. SHE WAS OK AFTER
32 2021-03-05 pain in extremity Body aches Malaise Arm soreness Chills
32 2021-03-07 tremor, feeling cold Breathing feels slowed/ not enough, afraid to sleep in case I'm not breathing well enough, intense f... Read more
Breathing feels slowed/ not enough, afraid to sleep in case I'm not breathing well enough, intense fatigue, intense sense of trembling like when your blood sugar is low, cold mouth, chills
32 2021-03-07 feeling hot, seizure, hot flush, flushing Client seated in observation Client lost consciousness (passed out) and fell out of her chair Clie... Read more
Client seated in observation Client lost consciousness (passed out) and fell out of her chair Client fell onto the floor on the left side hitting the side of her head (left temple area) Witness nearby reports the client had a seizure first prior to falling out of the chair Seizure activity was not witnessed by the nurse Client was assisted into a wheelchair and evaluated further in a private area by EMT EMT was present. EMT assessed client and vitals were taken at 9:36 : O Sat 99%, Pulse 53, BP 112/56 Client was able to report that she felt flushed and hot. Client is visibly sweating Client states that she felt like her heart was racing and that she was dizzy Client reports that she has no history of seizures. Client was offered water Nurse called for an ambulance (EMS) and spoke with dispatch Client drove herself and has no one with her The client?s status given included details regarding client?s vehicle Client voiced concern about the cost of an ambulance but decides that she would like to be taken to hospital which is in network with her insurance At 9:43 Client reports that she feels ?heat inside her head? and is feeling very dizzy A 9:46 EMS arrives on site At 9:49 Client was transported via stretcher
32 2021-03-07 hot flush Headache, fatigue, nausea and vomiting, hot flashes/chills from about 2am the night after the shot u... Read more
Headache, fatigue, nausea and vomiting, hot flashes/chills from about 2am the night after the shot until about 5pm
32 2021-03-08 pain in extremity Arm pain, muscle aches, swelling lymph nodes right arm only, headache, change in smell sensitivity v... Read more
Arm pain, muscle aches, swelling lymph nodes right arm only, headache, change in smell sensitivity vs a metallic/chemical smell?-onset with headache 2 hours post vaccine. This also happened with first vaccine but thought was a coincidence.
32 2021-03-08 pain in extremity, tingling I developed pain and tingling (pins and needles sensation) in my hands and feet the day after receiv... Read more
I developed pain and tingling (pins and needles sensation) in my hands and feet the day after receiving the vaccine. The pain initially interfered with my ability to type and use my hands for normal activity. The pain and tingling has subsided in severity, but continues to occur sporadically. Now, approximately 4 weeks later, I still experience occasional tingling/pin and needles sensation in my arms, hands, legs and feet. I have spoken with my primary care doctor and decided to delay and possibly skip the second dose. My PCP has also referred me to a neurologist.
32 2021-03-09 muscle spasms Began with spasm in lower back following day of shot, spasm came on again and were debilitating. The... Read more
Began with spasm in lower back following day of shot, spasm came on again and were debilitating. These pains never went away. Glands in groin area swelled up. Pain began inside hips and up spine. Pain behind collar bones. Pain shooting down left leg. I am now 5 days in and still have spasms and severe pain in lower back, between shoulder blades and inside hips that won?t go away.
32 2021-03-09 numbness Fever, numbness of injection arm
32 2021-03-10 numbness Body pain more reminiscent of radiating nerve pain than flu body aches. Its the worst around my sac... Read more
Body pain more reminiscent of radiating nerve pain than flu body aches. Its the worst around my sacrum and radiating down the backs of my legs to the soles of my feet. I also have pain radiating up my spine over the top of my head and down the backs of my arms to my palms. My skin is hypersensitive and everything that touches it feels like sand paper. I started getting chills so bad my hands and feet went numb.
32 2021-03-10 pain in extremity, migraine Fatigue 3 hours later, migraine for two days, nausea for 3 days, sore arm for three days
32 2021-03-10 weakness I received the vaccine on Friday, February 26th, 2021, around 10:20am. I was fine throughout the da... Read more
I received the vaccine on Friday, February 26th, 2021, around 10:20am. I was fine throughout the day. I was also fine all day on Saturday, February 27th, 2021. Sunday, February 28th, 2021 at 1:30am, I woke up from sleep with double vision, dizziness, and lightheadedness. I went to use my bathroom, and began to feel week. I was still very lightheaded, and weak. I felt as though I was going to faint. My ears started to feel really warm, and I then vomited. I started feeling lightheaded and weak once again, and then suddenly had diarrhea. I was so dizzy, but managed to head to my bed to sleep. Every single day since, I have been dizzy and losing my balance. I wake up, walk around, and sleep dizzy. Then on Friday, March 5th, 2021 I developed a large lump directly under my armpit. I could not take the dizziness any longer and I went to the ER on Monday, March 8th. I was then diagnosed with vertigo and told that I most likely had lymphodenopathy. Till this day, I am still having dizziness and will be seeing an ENT doctor. I also still have the lump under my armpit. My next dose is, March 19th, 2021.
32 2021-03-10 tingling, numbness Woke up on Wednesday, 2/24, approx. 12:00am to my entire left arm numb. Woke up and numbness changed... Read more
Woke up on Wednesday, 2/24, approx. 12:00am to my entire left arm numb. Woke up and numbness changed to tingling m. Tingling began to move up arm into neck and upper back then mid back. Then into left side of face and teeth. (No paralysis or Bells palsy - went away in 45 min) By Thursday morning tingling traveled to right right rib cage and feet, settling into hands and feet. Blurry, hard to focus vision. Went to ER on Thursday, 2/25. Not admitted. Discharged with recommendation to do MS workup. Tingling in hands turned to weakness in both hands on Friday. Left wrist and elbow joint pain. Tingling and numbness have persisted in hands and feet. Burning sensation on skin.
32 2021-03-11 weakness Light headed and weak lasting for about 2 hours before going to sleep. Felt better the next morning.
32 2021-03-11 unresponsive to stimuli Once in the monitoring area, the patient (who is a Facility staff member) was sweating profusely, ha... Read more
Once in the monitoring area, the patient (who is a Facility staff member) was sweating profusely, had increased BP, was unresponsive (but was conscious). She was tended to by the Facility Director of Nursing. The facility called 911, EMT's took pt to hospital. She was released after 2 hours and was back at work the next day.
32 2021-03-12 tenderness Arm swelling red and hot. Within 12 hours. Also severe muscle soreness of upper body. Tender to the ... Read more
Arm swelling red and hot. Within 12 hours. Also severe muscle soreness of upper body. Tender to the touch. Headache. All within 12 hours of the vaccine
32 2021-03-12 numbness, tingling Neck was stiff and back of head/left side jaw/lips were numb and tingly on Thursday, 2/4. Tingly and... Read more
Neck was stiff and back of head/left side jaw/lips were numb and tingly on Thursday, 2/4. Tingly and numbness went away by Friday, 2/5. Neck stiffness and sore back lasted until Tuesday, 2/9. Patient called on-call doctor and her PCP office and was informed to take Benadryl, but that did not help...patient took ibuprofen and reports that it helped reduce symptoms.
32 2021-03-14 cold sweat, tingling Immediately after the shot, Pt. felt clammy, had blurred vision and tingling of both hands, then lo... Read more
Immediately after the shot, Pt. felt clammy, had blurred vision and tingling of both hands, then lost consciousness. Fell to floor, hit forehead, left knuckle and left knee. Was assisted to supine position and symptoms improved. (Admits to feeling anxious and not eating enough before the shot and feels that was related to her reaction.) Left facility after observation, and got food before driving self home. Reports soreness and stiff neck from fall injuries. Reports soreness of injected arm and the same "clamminess and sweating" the following morning with fatigue, but without the tingling, lasting only a few hours, then resolved with no further sequelae.
32 2021-03-15 tingling Paresthesia. Intense pins and needles originating in thighs. Sensation spread to arms and cheeks. La... Read more
Paresthesia. Intense pins and needles originating in thighs. Sensation spread to arms and cheeks. Lasted less then one hour after initial injection but has returned within the past 72 hours sporadically. Also experiencing muscle pain in legs, which is a known side effect. Left leg and calf more effected.
32 2021-03-15 flushing dizziness, flushing. Evaluated by EMS-Cleared
32 2021-03-15 throat numbness numbness (throat). Evaluated by EMS-Cleared
32 2021-03-16 tingling Tingly left hand and tingly in both feet.
32 2021-03-18 pain in extremity Extreme nausea, mild headache, arm soreness
32 2021-03-18 nerve pain, seizure Recvd vaccination on 3/16/21 woke up on 3/17 with mild flu like symptoms nausea, headache low fever ... Read more
Recvd vaccination on 3/16/21 woke up on 3/17 with mild flu like symptoms nausea, headache low fever began having intense nerve pain/seizure like activity 3/18 and continuing. Used to have nerve pain seizures on daily basis but has not had seizure in over 14 months prior to 2nd vaccination.
32 2021-03-19 hot flush Pfizer-BioNtech COVID 19 Vaccine EUA 2nd COVID vaccine 1/16/21 Within 24 hours headache, nausea, vom... Read more
Pfizer-BioNtech COVID 19 Vaccine EUA 2nd COVID vaccine 1/16/21 Within 24 hours headache, nausea, vomiting, & hot flashes without fever. Sx resolved and headache returned 1/23/21. Headache has been constant since 1/23/21 (No relief despite OTC, px, consults, chiropractic care, etc)
32 2021-03-19 pain in extremity Sore arm, hard time taking deep breath, felt like end of a chest cold for several days after Patie... Read more
Sore arm, hard time taking deep breath, felt like end of a chest cold for several days after Patient also breastfeeding
32 2021-03-21 weakness Dizziness Muscle pain Weakness Tierdness A monthly cycle of 13 days, Menstruation preceded by 11 day... Read more
Dizziness Muscle pain Weakness Tierdness A monthly cycle of 13 days, Menstruation preceded by 11 days
32 2021-03-21 muscle twitching, cold sweat, involuntary muscle movements c/o twitching/jerking/clammy skin with minimal responsiveness to commands immediately after vaccine ... Read more
c/o twitching/jerking/clammy skin with minimal responsiveness to commands immediately after vaccine administration
32 2021-03-22 tingling paresthesia and lumbago
32 2021-03-23 tingling, pain in extremity 3 hours after injection, tingling/throbbing/pain in right pinky
32 2021-03-23 pain in extremity Arm is sore. Within 45 minutes of getting shot my throat felt like it was very swollen
32 2021-03-23 feeling cold Dizziness - Started at 5:30am lasted 11hrs. I had to sit/laydown that entire time, moving around mad... Read more
Dizziness - Started at 5:30am lasted 11hrs. I had to sit/laydown that entire time, moving around made it worse. Nausea - lasted 4-5hrs. Chills - started at 4pm, temperature was 98.5. Hives - Started around 4pm 03/23/21 and are still cover half my body.
32 2021-03-23 tingling My right ankle started tingling and mildly swelling. Went away after a few hours, and elevating my f... Read more
My right ankle started tingling and mildly swelling. Went away after a few hours, and elevating my foot was enough to keep the swelling down in the meantime. I take amlodipine and used to have a problem with ankle swelling when I was on a much higher dose of it, so I was thinking the drugs may be interacting. I did not accidentally take a second dose of amlodipine or anything yesterday, just my usual 5mg that has never caused ankle swelling before.
32 2021-03-23 burning sensation, numbness Patient developed numbness of lips within 2 hours and left side of face. patient developed a burning... Read more
Patient developed numbness of lips within 2 hours and left side of face. patient developed a burning sensation on Left side of head later that day. Right foot started going numb 3 days later and then spread to shin after 3 days and by 1 week spread to waist and Left side of chest also. Patient then developed numbness in left leg and in perineal area. MRI lumbar spine was done to evaluate patient's history of herniated disc which had no significant change from previous MRI. So a brain MRI was ordered and patient was referred to a Neurologist
32 2021-03-23 tingling, numbness Received the shot at 2:30PM....started experiencing increasing pain at injection site from 8-10PM. A... Read more
Received the shot at 2:30PM....started experiencing increasing pain at injection site from 8-10PM. At 1AM started experiencing tingling and numbness from left arm all the way down to left toes.
32 2021-03-23 tingling, numbness Redness and swelling of the face, rash on chest arms, and face. Tingling and numbness in face. Subsi... Read more
Redness and swelling of the face, rash on chest arms, and face. Tingling and numbness in face. Subsided with taking Claritin and Benadryl over the counter
32 2021-03-23 tremor Reported substernal no shortness of breath b/p 130/84 @5:08 pm b/p 132/86 @5:22 5:26 has subsided, s... Read more
Reported substernal no shortness of breath b/p 130/84 @5:08 pm b/p 132/86 @5:22 5:26 has subsided, shakey
32 2021-03-23 pain in extremity Started around 9am yesterday with a sore arm and some fatigue, quickly developed a fever (100.6), he... Read more
Started around 9am yesterday with a sore arm and some fatigue, quickly developed a fever (100.6), headache, chills, body aches, and nausea. symptoms were improved by tylenol but came back each time it wore off. Fever broke around midnight. Today I still have severe body aches and a headache, as well as fatigue
32 2021-03-23 cold sweat Vaccine was administered at 2:51pm. While patient waiting 15 mins she began to feel dizzy and clammy... Read more
Vaccine was administered at 2:51pm. While patient waiting 15 mins she began to feel dizzy and clammy. At 3 pm, had patient lay down, while we elevated feet and applied a cool compress to her forhead. After 5 mins, sat up to a sitting position. After another 5 mins, moved to a chair to sit for a while longer. At 3:13pm patient felt dizzy again. Had patient lay down and elevate legs again. At 3:23pm patient moved back to sitting position with no additional issues.
32 2021-03-23 weakness, feeling jittery, tremor Within 10 minutes of receiving vaccine, got very lightheaded in waves. Got very shaky, felt weak. Fe... Read more
Within 10 minutes of receiving vaccine, got very lightheaded in waves. Got very shaky, felt weak. Felt heart palpitations, increased respirations, shallow breathing Recovered within 30 minutes and returned home. Symptoms have continued since receiving vaccine to include chest pain, feeling jittery/shaky and weak in the limbs
32 2021-03-23 numbness headache 1 hr after fatigue after 24 hours numbness in left arm after 24 hours fever after 24 hours ... Read more
headache 1 hr after fatigue after 24 hours numbness in left arm after 24 hours fever after 24 hours dizziness after 24 hours
32 2021-03-24 speech disorder Dizziness; Muscle weakness in arms and legs; speech difficulty; headache; mental fog and confusion; ... Read more
Dizziness; Muscle weakness in arms and legs; speech difficulty; headache; mental fog and confusion; mental fog and confusion; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 17:00 as a single dose for COVID-19 immunisation. Medical history included COVID from an unknown date prior vaccination. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient experienced dizziness muscle weakness in arms and legs, speech difficulty, headache, mental fog and confusion on 01Mar2021 09:45AM. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for four (4) days. Treatment included, MRI, CT scan, and "migraine cocktail" on unspecified date. Outcome of the events was not recovered. The patient had a nasal swab Covid test post vaccination on 01Mar2021 with Negative result. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
32 2021-03-24 flushing Face flushed
32 2021-03-24 pain in extremity, numbness I still had lingering back pain and the feeling that something was sitting on my chest since the fir... Read more
I still had lingering back pain and the feeling that something was sitting on my chest since the first dose of my vaccine. The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lower and mid back. My arm became swollen to the size of a baseball around the site of injection. It was a lump on the side of my arm and my arm was numb every once in a while. My arm was very painful and swollen and itchy. I had the issues with my arm for 10 to 14 days after each dose of the vaccine. I have been having severe backache and like something is sitting on my chest. I still very fatigued after 10 weeks and I have severe back ache. I have been using Lidocaine for the pain and Naproxen and a muscle relaxer at times.
32 2021-03-24 sensory loss Per patient, lips began tingling, progressed to tongue, then loss of sensation. Then felt throat cl... Read more
Per patient, lips began tingling, progressed to tongue, then loss of sensation. Then felt throat closing, and unable to get air. Pt went to the ER. Was given Benadryl, Prednisone, and Pepcid and sent home.
32 2021-03-24 flushing Pt developed a flushed feeling and dizziness shortly after recieving the vaccine. She was visibly pa... Read more
Pt developed a flushed feeling and dizziness shortly after recieving the vaccine. She was visibly pale and needed to recline in her seat. BP noted to be 110/60, HR: 75, SP02 99%. She recovered within minutes and symptoms completely resolved. She elected to driver herself home. and did not require EMS services.
32 2021-03-24 tingling, weakness Severe headache on left side of the head and neck, and weakness and tingling on left side started Th... Read more
Severe headache on left side of the head and neck, and weakness and tingling on left side started Thursday after vaccine. Last night I started having the same problem in the right side.
32 2021-03-24 pain in extremity The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lo... Read more
The day after the dose of the vaccine I had a headache and body aches with severe back pain in my lower and mid back. My arm became swollen to the size of a baseball around the site of injection. It was a lump on the side of my arm and my arm was numb like maybe a nerve was damaged. My arm was very painful and swollen and itchy. I had the issues with my arm for 10 to 14 days after each dose of the vaccine. I have been having severe backache and like something is sitting on my chest. I still very fatigued after 10 weeks and I have severe back ache. I have been using Lidocaine for the pain and Naproxen and a muscle relaxer at times.
32 2021-03-24 bell's palsy, feeling hot The day after the second dose I felt sweaty hot and nauseous. I was still really sleepy on the third... Read more
The day after the second dose I felt sweaty hot and nauseous. I was still really sleepy on the third day. My eye started hurting and I could hear a buzzing sound in both ears. It got worse and worse by day six and I was having trouble seeing out of my right eye. It was really painful underneath my eye on the inside corner with swelling on the top lid. The Steroids seemed to help the problem with my eye. The doctor suspected Bells Palsy. On week two I was prescribed steroids from Lymphadenopathy. I still have the ringing in my ears which is increasing after it had subsided for a little time. I also felt pressure in my ears which is very uncomfortable. Whenever I stop taking the Steroids the ringing in my ears returns like Tinnitus. I plan to reach out to a doctor again because the ringing in my ears has returned after it had improved but was still present after 10 weeks. I did not have any of the same symptoms after the same dose. I have seen a lot of professionals.
32 2021-03-24 weakness, numbness, tingling The patient is a healthy 32 yo with a history of AE after Pfizer Covid vaccine #2 (lot #EL1284, rec... Read more
The patient is a healthy 32 yo with a history of AE after Pfizer Covid vaccine #2 (lot #EL1284, receipt 06 January). She reports receipt of vaccine at about noon. She developed nausea about 30 minutes later. She developed headaache about 1-1 1/2 hours later. She fetl lethargy and fatigue about 4-5 pm and was asleep by 18:00. She slept through until noon the next day when her mother awoke her due to concern for her breathing pattern. She said she felt exhausted and unwell like 'a terrible hangover'. She could not stand and her limbs felt weak and flaccid. Family called the nurse help line who instructed to call EMS. She was soaked in sweat, but no fever and reports she was told her BP was elevated, her extremities were numb but tingled as they improved, and she recalls very severe headache and breathing was hard due to feeling 'heavy'. She felt better as she got near the hospital. She notes her recall of the events is hazy. She was treated with IVF and Toradol and discharged with tylenol, motrin and zofran. She denies emesis, but recalls severe myalgias, knee arthralgias which continued with fatigue for about 10 days, and still has discomfort to her right knee. She reports chest tightness with exertion, which resolved. She denies cough, diarrhea, or any immediate reaction suggestive of IgE. She reports local site reaction of erythematous plaque with smaller peripheral macules, centrally located at the injection site with smaller macules peripherally down her arm. She denies history of AE with other vaccines. Per ER notes, states EMS report HR 114, diaphoretic, HTN,, febrile, tachypneic, received 500 cc bolus. Triage states crying, anxious and tachypnic, guided in deep breathing, BP 95/65, HR 100, RR 26 sat 97%, T 98.3; documented as ill appearing. cc: fatigue, weakness, sweating, nausea, malaise, headache. Only diagnostic is EKG which was normal. She was treated with Ofirmev, in addition to IVF and Torrodol.
32 2021-03-24 numbness dizzy after vaccine, numbness in face, tachycardic
32 2021-03-25 paralysis, tension headache 35 wks pregnant, noticed these symptoms the morning after having the vaccine: right side of the face... Read more
35 wks pregnant, noticed these symptoms the morning after having the vaccine: right side of the face is slightly paralyzed, when blinking only the left eyes blink and right eye does not fully close, right side of the tongue slightly numb but still able to taste, when smiling or manipulating mouth only the left side is fully engaged, right side if about 70% engaged, feel tightness on the back of right side of the head
32 2021-03-25 pain in extremity A few weeks after the vaccine I noticed my legs were covered in Peticia which began spreading up the... Read more
A few weeks after the vaccine I noticed my legs were covered in Peticia which began spreading up the legs. I was sent to the ER for a CBC but was sent home. My Dermatatologist performed 2 Punch Biosypies. I began having joint pains in my legs and stomach pains. The peticia begin going and coming. And the test results for the Punch Biopsies revealed I had HSP "Henoch Schonline". I began having GI issues with bloody stool, blood in my urine which prompted I be started on a high dose Steroid of Prednisone. On 3/24 I saw a Nephrologist who advised there was still blood in my urine and a kidney biopsy may have to be perfomed if the steroids does not improve or resolve the issue. Ive been having nose bleeding also but is unsure if its associated as well and I am scheduled to see and ENT for on 4/2 for that.
32 2021-03-25 feeling hot After vaccine, I felt really hot, my fingers remained ice cold. The same evening I had elevated temp... Read more
After vaccine, I felt really hot, my fingers remained ice cold. The same evening I had elevated temperature and headache. The next morning, my fingers and left lower leg (vaccine received into left arm) were swollen. Headache and elevated temperature continued. On 3rd only mild headache. Treated symptoms with Ibuprofen. This was not severe and it is my understanding that these side affects are common. I just wanted to report these in case it can help others.
32 2021-03-25 numbness In the middle of the night I am waking up feeling dizzy. The whole room is spinning. To the point wh... Read more
In the middle of the night I am waking up feeling dizzy. The whole room is spinning. To the point where I feel like I?m going to black out. Then I am unable to sleep after this happens. Lots of restlessness. I used to sleep 8 hours straight no problem before. I also experienced numbness in my legs during the first 24 hours.
32 2021-03-25 pain in extremity Patient had Pfizer dose #1 on 3/5/21, same night she started to develop left leg swelling and pain. ... Read more
Patient had Pfizer dose #1 on 3/5/21, same night she started to develop left leg swelling and pain. Patient went to ER on 3/8/21, showed superficial venous thrombosis with occlusion of left greater saphenous vein, currently on Eliquis
32 2021-03-25 flushing Patient received the COVID vaccine (Pfizer dose 1, Lot# ER8732, exp 7/31/2021) at 1316. Client repor... Read more
Patient received the COVID vaccine (Pfizer dose 1, Lot# ER8732, exp 7/31/2021) at 1316. Client reported ?my temperature is going up? at 1327. EMT and RN responded. Client ambulated to the chair next to the EMT station with a steady gait. Client appeared flushed and diaphoretic. No complaints of shortness of breath, dizziness, numbness, or tingling. No appearance of hives or swelling. No loss of consciousness. Client has a history of multiple sclerosis and hypertention. Client was unaware of his baseline blood pressure ranges. Client takes no regular medications. The client has allergies to sulfa and seafood. At 1327, the client?s blood pressure was 140/110, with a pulse of 81, respiration rate of 18, and pulse oximeter reading of 98%. Eyes PERRLA, client was alert and oriented x4. Client was given orange juice and a bottle of water. The client reported not eating any food yet and only drinking some coffee and water before. Vital signs taken again at 1336, with a blood pressure of 150/110, 20 breaths per minute, heart rate 83, pulse oximeter reading 98%. At that time, the client?s color returned to normal and he was no longer diaphoretic. The client stated he felt ?much better.? Repeat blood pressure reading for the client at 1347 was 145/95. Final blood pressure reading for the client was 140/82 at 1352. The client stated he felt ?back to normal.? Education provided regarding emergency management and when to call 911. Client encouraged to follow up with his primary care provider within 24 hours. Client denied any further questions, was escorted to his car by EMT at 1357. The client left the facility with a steady gait and proceeded to drive himself home.
32 2021-03-25 tingling, numbness Vasovagal within 2 minutes. Sweats blurred vision almost syncope. Numbness and tingling in arms last... Read more
Vasovagal within 2 minutes. Sweats blurred vision almost syncope. Numbness and tingling in arms lasting 10 minutes.
32 2021-03-26 pain in extremity Developed arm pain that is mild but occurs when lifting arm above head especially with heavier objec... Read more
Developed arm pain that is mild but occurs when lifting arm above head especially with heavier objects or when brushing hair. Have a lump beneath injection site that when pressed on is tender and has nerve pain associated with it down arm into hand.
32 2021-03-26 tremor Systemic: heart pounding and extremely anxious-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia... Read more
Systemic: heart pounding and extremely anxious-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient repoted with heart pounding and shakiness after receiving the 2nd dose of covid vaccine. patient appeared visibly anxious and patient requested ambulance to be called. patient never experienced difficulty breathing and towards the end stated she could have just been having panic attack. ambulance escorted the patient to further evaluate.
32 2021-03-27 numbness Nausea, light headed, Numbness in arms, hands. ALS assessment completed . Pt is SR on monitor. Vita... Read more
Nausea, light headed, Numbness in arms, hands. ALS assessment completed . Pt is SR on monitor. Vital signs stable. Said she is feeling better, and refusing transport to the hospital . Pt signed refusal. VS 82/61, 64, 18, O2 sat 100%, set 32 110/72, 89, 18, O2 sat 100%
32 2021-03-28 seizure Patient was wheeled in on a rolling chair(no wheelchair available at time) from nurse that administe... Read more
Patient was wheeled in on a rolling chair(no wheelchair available at time) from nurse that administered vaccine because of anxiety and a needle phobia that put the patient into a kind of shocked state. Patient was sweating profusely, white to the face, and not speaking very much but would answer questions correctly. EMT was speaking with the PT before walking away to continue other monitor duties when he turned back to see patient limp in chair, head back, eyes rolled back, and some twitching movements of the body. EMT called for rapid response because first thought of seizure and seizure like activity with the twitching movements. EMT got to patient, supported head up straight, and opened jaw to ensure airway was clear. Patient had no response to EMT trying to communicate. Sternum rub was performed where patient came back conscious nearly instantly. PT was unresponsive for roughly 10-15 seconds. Patient was told of what happened and vitals were taken on her, response team was cancelled with most them already on scene. PT was feeling better, sweating stopped, color to the face returned, and PT was speaking and understanding more clearly than before. PT was given a snack and water and was monitored by EMT for an additional 15mins before patient and staff were confident with her leaving.
32 2021-03-30 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female ... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, on 02Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 02Mar2021, the patient experienced sore arm. The patient's weight was 130 on an unspecified date. The event took place after the use of the product. The outcome of the event was unknown. Information on the lot/batch number has been requested.
32 2021-03-30 numbness, tingling metallic taste in my mouth; numbness in certain areas of my face, particularly around my lips/facial... Read more
metallic taste in my mouth; numbness in certain areas of my face, particularly around my lips/facial numbness; numbness in certain areas of my face, particularly around my lips; local anesthetic; noticed some sporadic tingling in my legs on the day of the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare profes-sional. A 32-years-old female patient received first dose of BNT162B2 (solution for injec-tion) via an unspecified route of administration on 01Feb2021 13:00 at single dose for for COVID-19 immunization. The patient medical history was not reported. Concomitant medica-tion included minerals nos, vitamins nos (PRENATAL VITAMINS), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), probiotics (PROBIOTICS), colecalciferol (VITAMIN D). The patient previously took erythromycin and experienced hypersensitivity. The patient experienced immediately after receiving the vaccine metallic taste in my mouth and numbness in certain areas of my face, particularly around my lips. The numbness isn't complete (I can still feel when I touch my face), but it feels like being partially recovered from a local anes-thetic. I also noticed some sporadic tingling in my legs on the day of the vaccine. The facial numbness issue persists on 01Feb2021 13:00. The event considered non serious. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
32 2021-03-30 bell's palsy tested positive for covid; tested positive for covid/ she has not experienced any Covid 19 symptoms;... Read more
tested positive for covid; tested positive for covid/ she has not experienced any Covid 19 symptoms; Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) at the age of 32-years-old, via an unspecified route of administration in right arm on 23Feb2021 at 12:00 at single dose for COVID-19 immunization. Medical history was not reported as none. She has no known allergies, was not pregnant, and has no COVID prior to vaccination. Concomitant medications included birth control and allergy medication. The patient has no other vaccine in four weeks. The vaccine was administered in a hospital. The patient experienced Bell's palsy on 13Mar2021 at 18:30 and tested positive for COVID on 14Mar2021. She is scheduled for the second dose on 16Mar2021, but she is not taking it as she was COVID19 positive and had Bell's palsy. She has not experienced any COVID-19 symptoms. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of Bell's palsy and included treatment with prednisone. The patient underwent lab tests and procedures which included nasal swab PCR which was positive and MRI which was clear, all fine on 14Mar2021.The outcome of the events was recovering.
32 2021-04-01 bell's palsy, pain in extremity left eye and left side of mouth was not working/Bell's palsy.; left ear was hurting all day; drainag... Read more
left eye and left side of mouth was not working/Bell's palsy.; left ear was hurting all day; drainage in patient left ear; neck down to elbow was sore; neck down to elbow was sore/soreness on arm; neck down to elbow was sore; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (non-pregnant) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 13Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation. Medical history was none. Concomitant medications included metformin and prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. About 30 mins after the shot patient neck down to elbow was sore. On 14Mar2021 the soreness on arm went away but patient neck was still sore. 14Mar2021 night there was drainage in patient left ear. On 15Mar2021 patient left ear was hurting all day. 16Mar2021 morning (07: 45 am) patient woke up with no more pain in left ear, but left eye and left side of mouth was not working. Patient went to ER and they said patient have Bell's palsy. Patient had no control of the left side of face by 18Mar2021. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Event Bell's palsy resulted in emergency room/department or urgent care, disability or permanent damage, and patient received unspecified medications as treatment for the event. Outcome of events pain in arm/elbow was recovered on 14Mar2021, outcome of event left ear was hurting was recovered on 16Mar2021, outcome of events Bell's palsy and neck pain was not recovered, and outcome of event drainage in patient left ear was unknown.
32 2021-04-08 pain in extremity bilateral joint pains in wrist, metacarpals, and ankles followed by bilateral petechial rash in lowe... Read more
bilateral joint pains in wrist, metacarpals, and ankles followed by bilateral petechial rash in lower extremities.
32 2021-04-10 grand mal seizure Thurs, 04/01/2021, She exhibited excitability episodes (no triggers) multiple times after vaccine, s... Read more
Thurs, 04/01/2021, She exhibited excitability episodes (no triggers) multiple times after vaccine, starting within 45 minutes. Fri, 05/02/2021, when she woke, she had first grand mal seizure in 4-5 years; called 911 EMS to ck her before driving her to urgent care. She was cked by Dr & no severe tongue injury noticed. He sent referral for neurologist to followup. Called her primary Dr. & was told Dr out for several days. Call back from another Dr who refilled ATAVAN script in case further seizures. Apt set w/neurologist, for Wed. 04/14/2021.
32 2021-04-14 weakness Allergy reaction, difficulty breathing, throat swelling, eyes and lips swelling, itchy eyes, dizzine... Read more
Allergy reaction, difficulty breathing, throat swelling, eyes and lips swelling, itchy eyes, dizziness/weakness diphenydrAMINE 50 ml, administered twice predniSONE was given once Inhaler was used 8 times when symptoms begins to help with breathing issues Stayed at the hospital for 2 hours, see improvement and was released Continues to take allergy medications for 2 days Allergy on the next day
32 2021-04-14 pain in extremity I have only been getting more sick since the vaccine. I had body aches those went away the soreness ... Read more
I have only been getting more sick since the vaccine. I had body aches those went away the soreness in my arm went away but then when they went away my chest started to burn I started hacking up thick brown gray stuff growing up and having abdominal pain from time to time I just need to know if the vaccine can cause flare-ups and people with an autoimmune disease or disorder.
32 2021-04-15 tingling Heavy breastmilk production Headache Tingling in extremities
32 2021-04-17 tremor, muscle twitching Psychosis, Ataxia, Confusion, headache, mental fog, tremulousness, muscle twitching, muscular weakn... Read more
Psychosis, Ataxia, Confusion, headache, mental fog, tremulousness, muscle twitching, muscular weakness 4 days after the second dose of the Pfizer vaccine was given
32 2021-04-20 discomfort I am 3 months post partum. The day after I received my shot, my pelvic area had a odd feeling. Almo... Read more
I am 3 months post partum. The day after I received my shot, my pelvic area had a odd feeling. Almost like my uterus felt a dull very very mild pressure. Day 2 after receiving my shot, I started to bleed. I am exclusively breastfeeding and I have never had a period start this early with all of my other children. Normal is 7 plus months for me. This period was also not a normal period. I had zero cramps. I felt nothing. I never have had a period with zero cramps. Lasted for 7 days.
32 2021-04-21 muscle spasms Neck pain, upper back pain, neck stiffness, spinal stiffness, upper back muscle spasm
32 2021-04-26 tingling Client received her first Pfizer dose of 0.3mL in left deltoid on 04/27/21 at 09:32am with lot numb... Read more
Client received her first Pfizer dose of 0.3mL in left deltoid on 04/27/21 at 09:32am with lot number EW0179 expiring on 08/31/2021. Client who is 32-year-old female with no race or ethnicity was disclosed, was brought to EMT station by ancillary staff after complaining of tingling in her toes. Client remained alert and tracking with her eyes and appeared in no apparent distress. Client had a chief complaint of tingling in her toes bilaterally at 10:01am on 04/27/2021. Client stated that she completed her 15-minute observation and was walking to her car, when she noticed tingling in her toes bilaterally and returned to the site/EMT station. toes that was painless and localized. Client's airway, breathing and circulation were intact. Client's initial set of vitals was blood pressure 132/84, pulse 80, alert and oriented to person, place, event and time, respiration 16, eyes equal and reactive to light and lung sounds clear bilaterally. EMT was unable to obtain an SPO2 due to client's acrylic fingernails. Client noted that she had spoken to her doctor recently and her doctor stated to her that she had "poor circulation," but did not specify any diagnosis. Client also stated that she tested positive for Covid in early January and has a history of seasonal allergies. No other pertinent medical history was noted or disclosed. Assessment revealed no swelling, pain, hives, shortness of breath, chest pain, discoloration, or other signs of anaphylaxis. Client consented to staying an additional 30 minutes for observation and vitals were monitored every 15 minutes due to the stability of the client and no signs or symptoms of allergic reaction. Vital signs at 1001 were blood pressure of 132/84, pulse of 80 and respiratory rate of 16 breaths per minute. Vital signs at 1016 were blood pressure of 128/80, pulse of 76 and respiratory rate of 16 breaths per minute. Client was provided with fact sheet and areas of interest were highlighted for convince. After approximately 15 minutes, client stated that her numbness had "gone away" and laughed stating "it's probably because I'm not walking." At the completion of her additional 30-minute observation, client remained stable and was instructed to follow up with her primary care doctor at the soonest possibility. Vital signs at 1031 were blood pressure of 128/80, pulse of 76 and respiratory rate of 16 breaths per minute. Client was also instructed to seek medical care or dial 911 if a severe reaction occurred in the future. Situation did not warrant EMS and client declined service being offered. No interventions or medications were administered or indicated. Client acknowledged what she was told and exited Border View YMCA at 1032 in positive disposition by self.
32 2021-04-26 pain in extremity Site: Pain at Injection Site-Medium, Additional Details: pt recieved covid vaccine today...verified ... Read more
Site: Pain at Injection Site-Medium, Additional Details: pt recieved covid vaccine today...verified location of the shot and it is right in the right deltoid of the right arm. pt immidiately after felt pain at the injection site that radiates to her hand. it has persisted for at least 30 minutes while we monitored pt in store. pt says its hard to hold things because of pain by forearm. referred pt to see primary care to see if any additional treatment is needed
32 2021-04-30 numbness Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on t... Read more
Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; Dizziness, vertigo, numbness on the left side of my body, nausea.; This is a spontaneous report received from a contactable consumer (patient). A 32-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 15Mar2021 at 13:30 (at the age of 32-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included lupus. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. On 17Mar2021 at 12:00 the patient experienced dizziness, vertigo, numbness on the left side of the body, and nausea. The patient visited a doctor or other healthcare professional office/clinic and an emergency room/department or urgent care as a result of the events. The patient did not receive any treatment for the events. The outcomes of dizziness, vertigo, numbness on the left side of the body, and nausea were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
32 2021-04-30 numbness, pain in extremity, feeling hot, tingling tingling; numbing; diarrhea; feel the liquid squirting into my arm which is unusual; Fainted; nauseo... Read more
tingling; numbing; diarrhea; feel the liquid squirting into my arm which is unusual; Fainted; nauseous; Memory lapse upon waking up; Breathing was slow; hot; sweaty; Arm pain; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0158), via an unspecified route of administration, administered in the left arm on 09Apr2021 at 10:30 AM at the age of 32-years-old as single dose for COVID-19 immunization. Vaccine facility type was reported as "Other". The patient had no COVID prior vaccination. The patient was not pregnant. The patient had no medical history and no known allergies. There were no concomitant medications. The patient had no other vaccine in four weeks and had no other medications in two weeks. On 09Apr2021, the patient fainted within 2 minutes if receiving vaccine. The patient had memory lapse upon waking up. Her breathing was slow. The patient was extremely nauseous, hot, sweaty. The patient was unable to sit up due to nausea for 1 hour. The following 2 days, the patient experienced nausea and diarrhea. Arm pain lasted for 7 days including tingling/numbing sensation down her entire arm on the 4th day (13Apr2021). At time of vaccine (09Apr2021 at 10:30 AM), she could feel the liquid squirting into her arm which was unusual. The patient reported that she gets lots of vaccines for traveling and have never had these reactions or sensations. The patient has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures (unspecified) were taken as a result of the events. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
32 2021-05-02 migraine Early menstruation (2 weeks early). Migraine lasting for 7 days.
32 2021-05-03 pain in extremity, numbness, migraine, tingling I was admitted to the ER with a complex migraine and parathesia in my right arm; I was admitted to t... Read more
I was admitted to the ER with a complex migraine and parathesia in my right arm; I was admitted to the ER with a complex migraine and parathesia in my right arm; after about three days of flu-like symptoms; after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); after about three days of flu-like symptoms (nauseau, tiredness, body aches); My throat felt restricted; I had hives and raised bumps and bruising on my left arm where the shot went in; I had hives and raised bumps and bruising on my left arm where the shot went in; I was having difficulty breathing; my body felt like it was swelling up everywhere; allergy symptoms manifest/allergic reaction; I had the normal side effects of numbness and soreness in my left arm; I had the normal side effects of numbness and soreness in my left arm; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient (No pregnant) received 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: ER8737) on 05Apr2021 06:15 PM at single dose on Left arm for covid-19 immunization. Medical history was Immunocompromised, chronic migraines. Known allergies: Just seasonal allergies. Wheat and soy allergy, restricted diet. Concomitant medications (in two weeks) included fluticasone propionate (FLONASE) for allergies (nasal spray), mirtazapine (REMERON). No other vaccine in four weeks. Patient stated that I had the normal side effects of numbness and soreness in my left arm from 05Apr2021. Three days later I had allergy symptoms manifest, Thursday (the shot was on a Monday), and had to go get allergy medication. My throat felt restricted, I was having difficulty breathing, and my body felt like it was swelling up everywhere. I had hives and raised bumps and bruising on my left arm where the shot went in from 09Apr2021 ( reported as 08Apr2021 12:00 PM). Swelling noticeably went down after the allergy medication and breathing returned to normal. On Tuesday, 13Apr2021, after about three days of flu-like symptoms (nauseau, tiredness, body aches), I was admitted to the ER with a complex migraine and parathesia in my right arm, though the shot was in my left arm, and the migraine was in my left side of my head. I feel that this was an allergic reaction that happened belatedly and is a much stronger reaction than anyone else I have seen take the same dose and the same vaccine. AE resulted in Emergency room/department or urgent care. Treatment was Allergy medication from 08Apr2021 to 13Apr2021 two IV's + Benadryl. Outcome of the event was Recovering. No Covid prior vaccination. No Covid tested post vaccination. No follow-up attempts needed. No further information expected.
32 2021-05-04 weakness Overall, wellbeing "off" and crying for no reason. brain fog and confusion. general weakness, easily... Read more
Overall, wellbeing "off" and crying for no reason. brain fog and confusion. general weakness, easily winded walking upstairs, fatigue, severe muscle pain/soreness. originated underarms and back on 24th & 25th. ended in the left calf and occasionally entire left leg and sometimes right.
32 2021-05-06 pain in extremity Headache and arm soreness right after shot. Developed in the hour after. 8 Days after the shot cal... Read more
Headache and arm soreness right after shot. Developed in the hour after. 8 Days after the shot called the COVID triage line at work because I had swelling on the left shoulder (above vaccine site/same arm). I went to my PCP the next day, and they took pictures. It's been two weeks and I am still managing intermittent pain in my left shoulder and arm. It has become more painful in the last 3 days. 5/5.
32 2021-05-07 seizure Seizures; Memory issues; Epilepsy; This is a spontaneous report from a contactable nurse (patient). ... Read more
Seizures; Memory issues; Epilepsy; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant (including at the time of the vaccination) female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 19Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the physician's office. Medical history included depression and anxiety. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication and therapy dates. She had no COVID-19 prior to vaccination. The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 29Dec2020 01:30 PM (Batch/Lot number was not reported) on the right arm as COVID-19 immunization. Then, received the 2nd dose on 19Jan2021. The patient was then diagnosed with epilepsy in Feb2021 a month after getting 2nd dose. On 08Mar2021 10:30, the patient had seizure and memory issues. The patient was brought to the emergency room/department or urgent care due to the events. Then was admitted in the hospital on 08Mar2021. The patient had nasopharyngeal swab on 05Mar2021 and showed negative. The patient received an unspecified treatment for the events but not yet recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Epilepsy.,seizures, memory impairment. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
32 2021-05-11 bell's palsy Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (p... Read more
Bell's Palsy; swollen tongue; itchiness; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 14:30 (Batch/Lot Number: EL9262) (at the age of 32 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included immunoglobulin g4 related disease (IGG4-RD) and rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took rituximab (RITUXAN) and experienced drug allergy and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1686) in the left arm on 07Jan2021 at 02:30 pm for COVID-19 immunization and experienced rash in face and back. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 01Apr2021, the patient experienced Bell's Palsy, swollen tongue and itchiness. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 3 days. The patient received treatment for the reported events. Since the vaccination, it was unknown if patient has been tested for COVID-19. The outcome of the events was recovering.
33 2021-01-01 muscle spasms, numbness At 15 minutes post vaccination, I became dizzy, short of breath and felt like I might lose conscious... Read more
At 15 minutes post vaccination, I became dizzy, short of breath and felt like I might lose consciousness. I was hypertensive, had cramping in my fingers and felt numbness in my toes. I laid flat on the floor for 30 minutes in observation and began to feel better by 11. The same thing happened 3 more times throughout the day.
33 2021-01-01 pain in extremity Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just a... Read more
Large welt from injection site. Increasing pain in arm that received the vaccine. It began as just around the actual injection site. It has been 9 days and the pain has slowly increased and now aches from the injection site, my entire bicep muscle, and just below my elbow
33 2021-01-02 muscle twitching Vibration in left thigh that last all day and first half of following day
33 2021-01-03 flushing, feeling hot, difficulty speaking 15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash ... Read more
15 min after the vaccine I was flushed and felt hot , ears felt hot as well. I had a macular rash on chest and arms. My throat felt itchy and they immediately gave me benedryl. I was tahycardic as well. When I got home from the ER that night I had to take more benedryl and then the next morning I was still itchy and my voice was hoarse so I took more xyzal and famotidine. The rash subsided and I continued taking xyzal twice a day , benedryl and famotidine for a week. After my vaccine the itching did not subside for about 48 hours and it was very difficult to control. I had to take max doses of antihistamines to control the hoarseness In my voice and itching
33 2021-01-03 weakness General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Ras... Read more
General weakness requiring assistance to stand.; General weakness requiring assistance to stand; Rash on chest/neck; This is a spontaneous report from a contactable Pharmacist. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730), intramuscularly on 22Dec2020 13:15 at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The facility type vaccine was hospital. None medical history. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine nor received any other medications within 2 weeks of vaccination. The patient experienced rash on chest/neck. General weakness requiring assistance to stand on 22Dec2020 17:00 with outcome of recovered in Dec2020. The date report was first received from source was 23Dec2020. Patient received Fluid bolus, IV benadryl, IV steroid as treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The events were reported as non-serious.; Sender's Comments: The reported events rash on chest/neck and general weakness requiring assistance to stand were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-03 feeling hot Symptoms - Felt hot and nauseas, difficult to swallow, itchy skin. Vax admin said I had red patches ... Read more
Symptoms - Felt hot and nauseas, difficult to swallow, itchy skin. Vax admin said I had red patches on face. Took vitals. Administered Benadryl. Monitored for 1.5 hours. Still itchy. Went home, took more Benadryl. Itchiness subsided by the following day.
33 2021-01-03 pain in extremity mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from ... Read more
mental cloudiness; bruising of injection site; arm pain; fatigue; This is a spontaneous report from non-contactable Pharmacist (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at right arm on 19Dec2020 08:15 at single dose for Covid-19 immunization. The Covid-19 vaccine was administered in a hospital facility. Medical history included seasonal allergies, heartburn, and allergies to ethanol. The patient has no Covid prior vaccination. Concomitant medication included cetirizine, esomeprazole, melatonin; all from unspecified date for unspecified indication. The patient did not receive other vaccines in four weeks prior to the Covid vaccine. On 19Dec2020 at 15:00, the patient experienced bruising of injection site (x 1 week), arm pain, fatigue, mental cloudiness (approximately x 1 day). The patient was not tested post vaccination. The patient did not received treatment due to the events. The outcome of the events mental cloudiness, bruising of injection site, arm pain and fatigue was recovered in Dec2020. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event mental impairment cannot be excluded. The information available in this report is limited and this case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
33 2021-01-04 feeling hot 25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and i... Read more
25 minutes after injection got light headed, BP was taken by RN 139/91, face then got red, hot and itchy. II was taken to the Emergency Department for further observation. I I also experience some nausea, my tongue was slightly itchy, I had a stomach ache and some redness/swelling round the injection site. At the ED I was given 25 md Benadryl PO and observed for another hour and a half before being discharged.
33 2021-01-04 numbness, tingling Immediate onset of numbness and tingling in 4th and 5th digits, left hand. Followed by a burning pa... Read more
Immediate onset of numbness and tingling in 4th and 5th digits, left hand. Followed by a burning pain Seen via telehealth 12/30/20 Recommended conservative measures Started on NSAIDs Examined 1/4/21 Script for PT provided
33 2021-01-04 pain in extremity Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole ... Read more
Received covid vaccine 1/2 at 2pm. Around 7pm that night, left arm pain and slight itching of whole body. did not think much of it. woke up once in middle of night at 4am with racing heart but went back to sleep. Around 9 am next morning started getting chills, initially mild then severe and developed severe myalgias; could not get out of bed or lift arms or limbs. having chest tightness and shortness of breath. pressing on chest wall hurts, hard to take deep breath. Temps of 99.5 most of morning. started taking tylenol total of 1 gram. 1 hour after tylenol shaking and rigors with sweating. had temp of 101 after tylenol. HR 110 at this time (my baseline is around 60s). O2 sat remained normal. Went to ER for testing for covid in case this was covid--test negative. Felt a little better morning of 1/4--no fever. tried to work 1/2 day; called out sick. lots of brain fog, fatigue mental slowing. still having intermittent chest tightness and sob; feel like i cannot expand my lungs. deep breath makes me cough. had few small red bumps on left antecubital fossa that resolved. i'm a physician, i'm concerned this was a severe reaction and was advised to report this.
33 2021-01-04 pain in extremity really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was... Read more
really tired; heart pounding; couldn't sleep; Headache; sore arm; She couldn't sleep because she was anxious.; almost felt like her blood pressure was up.; Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EIC9231), via an unspecified route of administration on 29Dec2020 11:30 at single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient was calling to report that she got the COVID vaccine yesterday, and she wanted to put input in on the effects she experienced last night. She is a pharmacy transition specialist. She doesn't have a prescribing doctor. A few hours after, she was really tired. She could have fallen asleep at her desk. Then, last night, her heart was like pounding but not beating fast if that makes since. Her heart rate wasn't up that much, but it felt like it was going to come out of her chest. She couldn't sleep because of it. She had a headache. She received the vaccine at 11:30. She is not as tired today. Yesterday, she could have just laid head back and went to sleep. The rest of the side effects started right after dinner. She couldn't sleep because she was anxious. Her heart rate is usually 60-65 bpm, but last night it was up to 75-80 bpm. It almost felt like her blood pressure was up. This happened right around after dinner. The headache is hanging over into today. It could be still there because she didn't sleep. Her arm is sore still. It isn't serious. The handwriting was bad on her card so it was hard for her to read the lot number. The outcome of the event Headache, sore arm was not resolved, the outcome of the event really tired was resolving, the outcome of the event heart pounding was resolved in Dec2020, while the outcome of the other events was unknown.
33 2021-01-05 nerve pain 103 fever, chills, severe muscle pain, hypersensitive nerves, chest pain, headache, lightheaded
33 2021-01-05 pain in extremity Arm was sore for 48 hours post injection. Ibuprofen was used for treatment
33 2021-01-05 flushing Chest Tightness, Flushing, Difficulty breathing
33 2021-01-05 pain in extremity Left arm pain and headaches and tiredness
33 2021-01-06 cold extremities, tingling, numbness 1420: Vaccine administered. 1425: Reported right arm numbness distal from injection site. Circulatio... Read more
1420: Vaccine administered. 1425: Reported right arm numbness distal from injection site. Circulation intact. ROM intact. 1452: Complains right arm numbness, right hand cooler to touch than left. 1500: Complains of right arm numbness- temp 97.0 Resp 16 HR- 67 BP- 130/85 1515: Reports somewhat improvement of numbness. Temp- 97.2 Pulse- 78 Resp- 16 BP- 124/86 1530: Reports somewhat improvement of numbness. Temp- 97.5 Pulse- 70 Resp- 18 BP- 114/79 1545: Reports right arm still tingling no more or less than previously reported. Temp- 97.1 Pulse- 74 Resp- 17 BP- 116/79
33 2021-01-06 pain in extremity I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/2... Read more
I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/21 & 12/22 I was SUPER tired in the afternoon/evening. Seems better 12/23. Felt totally fine otherwise, but definitely had significant fatigue that is not normal for me at all. I still plan to get the 2nd dose as scheduled.
33 2021-01-06 hot flush, pain in extremity Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes... Read more
Moderate headache, back pain, R arm muscle soreness, moderate fatigue, loss of appetite, hot flashes/chills alernating
33 2021-01-06 feeling cold SkinRash COLD SENSATION RADIATES DOWN LEFT ARM Narrative:
33 2021-01-06 paralysis The morning after I received the shot in my right arm, I woke up and jumped out of bed to turn off m... Read more
The morning after I received the shot in my right arm, I woke up and jumped out of bed to turn off my alarm. My right leg buckled and completely gave out. It felt like there was not a muscle or bone in the leg. I melted down on top of my leg, twisting my ankle and my knee. I ended up with my knee twisted behind me as I hit the floor and my nightstand. I don't know if you would call it muscle fatigue or weakness, it felt like muscle paralysis, but it only lasted less than a minute before it was gone, however, the damage was already done. I hurt my knee very badly because I had no control over my leg muscles. I've never had anything like that happen before.
33 2021-01-07 flushing, feeling hot 4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy. pt denies breathi... Read more
4: 50 pm - 20 minutes after injection, pt reports feeling flushed, hot and itchy. pt denies breathing trouble. 5: 03 pm pt was evaluated by EMS BP 162/105, P91, O2 sat 100%, EKG done 5: 09 pm BP 136/84 P 86, O sat 100 %. Pt reports reports feeling better, declined transport to ED. Pt left AMA.
33 2021-01-07 pain in extremity Arm soreness, flu like symptoms, chills, sinus pain, overall sick feeling.
33 2021-01-07 tremor Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of ... Read more
Began feeling light headed the evening of the vaccine, overnight developed shaking chills, fever of 104 with headache. Took ibuprofen which brought temperature down to 99. Still (on day 2) having some sweats & nausea.
33 2021-01-07 tingling Developed rash, itching on arm and on chest, tingly feet and dry cough, dry mouth
33 2021-01-07 pain in extremity Headache, muscle/joint pain, low fever 99.4, chills, two episode of presyncopal events, and nausea. ... Read more
Headache, muscle/joint pain, low fever 99.4, chills, two episode of presyncopal events, and nausea. This started at 10pm 1/6 the night of the vaccine and continued untill Friday 1/8 12 noon. It is now the evening and my arms and back are still sore.
33 2021-01-07 feeling hot With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very ... Read more
With in 10 mins of receiving 1st dose, I started to feel hot and light headed, my body became very hot, I started to sweat and then my throat started to dry up and close. I notified the provider on watch that was monitoring me during my 15 mins after injection and as the walked me to the room I became more and more dizzy, my throat continued to swell and close, my mask was removed where my face was covered with a rash and hives . The dr. Gave me 50 mg benedryl, and a shot of epinephrine. After wards 911 was called, my heart rate was eventually brought down with the epinephrine as my symptoms began to be controlled. An inhaler was administered because I was short of breath. 3 hours later I was stabilized. I then was recommended to go to urgent care rather the emergency room since the wait was 13 hours to be monitored at the local hospital MLK. I went to urgent care near my home at Hoag hospital and they monitored me and gave me a steroid injection IM. I was discharged with an epi pen just in case abs to take benedryl every 6 hours . The following morning 1/8/21, at 8 am the swelling of my throat retuned I became light headed abs my tongue became numb. I was taken to fountain valley hospital where an IV was started, 500 mg of iv benedryl, another epinephrine injection was given abs I remained under surveillance for another 6 hours. They stated that a lot of people are coming with reoccurring episodes of anaphylaxis after the phizer injection.
33 2021-01-07 flushing Within 5 minutes of administration felt tongue/throat tingling, then felt them starting to swell, ma... Read more
Within 5 minutes of administration felt tongue/throat tingling, then felt them starting to swell, making it difficult to swallow, flushing feeling, felt like I was getting tunnel vision (how you feel before you pass out). Reported symptoms to RN who administered shot. Given PO liquid benadryl and epi pen injection quickly- symptoms started to fade within 10-15 minutes, tongue tingly for a few hours. Monitored x 1 1/2 hours with frequent VS checks- HR/BP/SaO2 remained within normal limits
33 2021-01-08 flushing Extreme arm fatigue and limited range of motion, hives and flushing of face and ears
33 2021-01-08 tremor Pt developed a large red itchy rash on her neck / chest area, she stated she felt fine but was obser... Read more
Pt developed a large red itchy rash on her neck / chest area, she stated she felt fine but was observed trembling. She was transported to ED (5 min transport) She was treated with: Benadryl 25mg IV X1, Solumedrol 60mg IVX1, famotidine 20mg IV X 1 - diagnoses was allergic reaction Pt improved after treatment She was observed from 09:11 until 10:33
33 2021-01-09 muscle spasms Fever. Chills. Dizziness. Vomiting. Cramping
33 2021-01-09 tenderness Swollen, tender axilla of right arm. Same arm as injection. The swelling started a few hours after v... Read more
Swollen, tender axilla of right arm. Same arm as injection. The swelling started a few hours after vaccine administration and remains unchanged. The area is still swollen, tender and right arm has little range of motion. Currently taking tylenol and motrin for pain. Submitting request for primary MD appointment to assess area but have not been seen by healthcare professional related to issue as of 1/10.
33 2021-01-10 feeling hot Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swal... Read more
Anaphylaxis within 5 minutes of dose given. Tachycardia 130-140s, hot body temperature, trouble swallowing, lightheaded/dizzy, ekg changes, feeling like I was going to pass out even when in bed. IV fluids, benedryl, soul-medrol, famotadine and IM epi given.
33 2021-01-10 weakness Chills, fever, body aches, weakness, fatigue, fever, headache. All lasting about 24hrs.
33 2021-01-10 pain in extremity Main in Arm , Fatigue Was tested positive for Covid 9 days later
33 2021-01-10 pain in extremity On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my... Read more
On Sunday 12/20 I started to get a significant sharp headache on the left side that radiated down my left neck and arm to the point of injection site. My left arm was also sore as to be expected with typical injection but this sensation was different. It caused a sharp neuromuscular pain that was also itchy/burning. Extended in the region of sternocleidomastoid site. No rash development but seemed like symptoms of shingles. Continued through until approx 12/26/20. Improved with heat pack, Tylenol and Motrin. Was evacuated by physician on 12/21/20 with no testing or medication provided as symptoms were unclear.
33 2021-01-10 flushing Patient experienced flushing and headache approximately 15 minutes post-vaccination. Patient's vital... Read more
Patient experienced flushing and headache approximately 15 minutes post-vaccination. Patient's vital signs were WNL. Patient provided analgesic for headache, but declined antihistamine.
33 2021-01-10 feeling cold, tingling Patient noted upper lip tingling at 12 minutes after dose. She subsequently noticed tingling down he... Read more
Patient noted upper lip tingling at 12 minutes after dose. She subsequently noticed tingling down her left arm. Her BP was recorded at 139/81, Po2 97%, pulse: 80, T: 98.8 Also right hand felt cold for 2 minutes. Prior to exit, tingling resolved. Discharged at 2:32p
33 2021-01-10 feeling cold, weakness, migraine, tingling Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills ... Read more
Red, swollen, itchy arm for 4days straight Migraine day 2 Fever 102 afternoon of day 2 with chills and pins and needles sensation over entire body weakness/tiredness late afternoon
33 2021-01-10 tingling, weakness Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on... Read more
Redness, itching, swelling, hot to the touch at injection site 4days in a row, fever 102degrees F on 2nd day with chills and tingly/prickly feeling all over, weakness/dizziness
33 2021-01-10 tremor fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever,... Read more
fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever, loss of bladder control due to uncontrollable shaking from fever, body aches. Fever up and down. Currently 48 hours out from vaccine and still overall not feeling well and currently febrile at 100.9
33 2021-01-10 pain in extremity malaise, fever, total body aches, chills, fatigue, extremity pain, ankle pain, spine pain, pain at i... Read more
malaise, fever, total body aches, chills, fatigue, extremity pain, ankle pain, spine pain, pain at injection site, muscle pain
33 2021-01-10 tingling, feeling hot patient felt dizzy and nauseous a few hours after the injection. later felt hot and sweaty, increase... Read more
patient felt dizzy and nauseous a few hours after the injection. later felt hot and sweaty, increased dizziness, leg weakness, tingling in thighs
33 2021-01-11 pain in extremity - Arm pain after initial injection for 2 days - Significantly swollen lymph nodes on Monday after sh... Read more
- Arm pain after initial injection for 2 days - Significantly swollen lymph nodes on Monday after shot. Lymph nodes visible on left side of neck.
33 2021-01-11 discomfort 24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the t... Read more
24 hours after inj L axillary LN enlarged about the size of a baseball very tender and warm to the touch. Also swelling on L side of chest. Taking nsaid ATC but pain and swelling has persisted - pressure radiates to L scapula.
33 2021-01-11 weakness, muscle twitching, tremor As per Vaccine recipient -incident happened at home , Initial onset of dizziness, shortness of breat... Read more
As per Vaccine recipient -incident happened at home , Initial onset of dizziness, shortness of breath and heart racing. Then respirations were slowing and patient felt like she was going to pass out , like that pending doom sort of feeling. Patient turned very pale and was presenting black and bluish under her eye region with blue lips. At that time ,she tried to hyper ventilate herself to pink back up again, after a few minutes she regained color but was still very weak and was trembling, her respirations returned to mostly normal at that time me . She laid down to rest and then her toes started involuntarily twitching , they eventually stopped after 10-15.Whole episode lasted about half hour to 45 mins.
33 2021-01-11 numbness, tingling Bruising at site of injection, swelling, numbness in vaccinated arm and tingles.
33 2021-01-11 pain in extremity Sore arm noted on vaccine day 0 and 1 Day 7 I developed a knot at injection site with associated red... Read more
Sore arm noted on vaccine day 0 and 1 Day 7 I developed a knot at injection site with associated redness at injection site. Area of redness was oval shaped about 2 inches in length and 1" wide. No treatment was used. Area cleared within 2 days.
33 2021-01-12 cold sweat Around 12:00 pm not feeling well. Clammy, nauseated, dizzy and felt like was going to pass out. To e... Read more
Around 12:00 pm not feeling well. Clammy, nauseated, dizzy and felt like was going to pass out. To emergency department for evaluation. Treated with IV fluids and antiemetics and discharged home.
33 2021-01-12 numbness, bell's palsy, tingling Bell?s palsy Trigeminal nerve tingling and numbness started about 4 hours after vaccine. Treated wi... Read more
Bell?s palsy Trigeminal nerve tingling and numbness started about 4 hours after vaccine. Treated with prednisone and valtrex. Improved after three days on medication.
33 2021-01-12 migraine Body aches, chills, migraine, nausea, fatigue >48 hours.
33 2021-01-12 weakness, tingling Developed dizziness, chest pain, tingling of hands/feet, headache, trouble swallowing, weakness, sti... Read more
Developed dizziness, chest pain, tingling of hands/feet, headache, trouble swallowing, weakness, stiff joints. Went to ED.
33 2021-01-12 feeling hot, tenderness Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swe... Read more
Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swelling in left neck per employee larger than tennis ball, tender to touch,warm to touch slightly painful to touch . Size has decreased daily to now the size of tennis ball today. Did not report until today. Covid EHS notified and employee will also call them.
33 2021-01-12 discomfort Felt "heavy" and dizzy. Blood pressure was low. Observed and discharged at 1:25.
33 2021-01-12 muscle spasms Fever, chills, nausea, headache, fatigue, and body cramps.
33 2021-01-12 tingling, flushing Flush face, blotchy skin, high blood pressure, rapid pulse, tingly fingers. Given 50mg Benadryl
33 2021-01-12 feeling hot PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT wait... Read more
PT sts after first dose she did not experience any Sx. Second dose in series 28 days later, PT waited in observation area. While seated, she began to feel lightheaded and "hot." BP 114/70, HR 74, RR 16. Drank water on provider orders,. Neg LOC or confusion observed. STS cool air helps. By PT request, she attempted to stand which brought back symptoms. PT observed to have blanched appearance and was placed on stretcher with feet raised on 2 LPM O2, second vitals set 1115/74, HR 72, RR 18. When attempting to sit up after 15 minutes dizziness returned and nausea began. 3rd vitals set 119/79, HR 63, RR 18, O2 increased to 3 LPM by provider, PT occasionally sat up to drink water as her mouth felt dry and dizziness was persistent. 30 minutes after symptoms began, medical staff noted new onset of confusion. PT sts Sx began to resolve 55 minutes after onset. PT removed from O2 and was able to walk without aid to awaiting vehicle.
33 2021-01-12 tingling, numbness Patient reported symptoms started ~15 mins s/p dose. Symptoms reported LUE and LLE numbness/tingling... Read more
Patient reported symptoms started ~15 mins s/p dose. Symptoms reported LUE and LLE numbness/tingling, and notable tachycardia
33 2021-01-12 tenderness Patient reports baseball size mass/lump to left axillary/breast area 1 day after vaccine administrat... Read more
Patient reports baseball size mass/lump to left axillary/breast area 1 day after vaccine administration. Patient states lump was sore and tender and pain aggravated by movement of left upper extremity. Lump is progressively getting smaller.
33 2021-01-12 feeling hot Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredne... Read more
Pfizer-biontech covid-19 vaccine eua Dizzy, light headed, hot, ears ringing, mild headache, tiredness, fatigue,
33 2021-01-12 tremor Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing st... Read more
Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies. Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water. Called 911. After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same) Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
33 2021-01-12 pain in extremity Started with a mild dull headache that progressed to throbbing, stabbing, headache that was aggravat... Read more
Started with a mild dull headache that progressed to throbbing, stabbing, headache that was aggravated by lights, sounds, movement. Balance was affected and was unsteady on feet, legs were weak and painful to move/stand or walk. Needed assistance to walk or move. Body chills noted that no matter how many layers applied or blankets or hot shower/bath helped. Nausea was reported but no diarrhea. Along with the leg pain, back and body aches were noted that made standing, sitting or laying extremely uncomfortable.
33 2021-01-12 pain in extremity Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms las... Read more
Systemic: itching, swelling, pain, redness of left hand (received vaccine in left arm); symptoms lasted 0 days
33 2021-01-12 pain in extremity Vaccine at 1630. vomiting, lightheaded at 1650. BP dropped 20 points over the course of 37 minutes. ... Read more
Vaccine at 1630. vomiting, lightheaded at 1650. BP dropped 20 points over the course of 37 minutes. Throbbing left arm at 1718. Scratchy throat at 1735. Abdominal cramping at 1740. Epi 0.3 mg IM given 1741. Transported to ED .
33 2021-01-12 feeling hot Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She sai... Read more
Within minutes of receiving the vaccine Pt said she developed a "fruity" taste in her mouth. She said she got dizzy, extremely hot and felt like she was "swaying" She said she also got what she described as "menstrual like cramps" that radiated all around her abdomen and back. She was under observation as advised per Pfizer protocol. An associate of the Pt noticed she passed out for a second she then turned beet red from her head to her neck as we could see. The associate yelled for us to grab a BENADRYL. They hooked her up to a BP machine and she did present with a spike in BP. After a few minutes, the redness and symptoms subsided. She was observed by the medical staff at the facility.
33 2021-01-12 feeling hot headache that comes and goes and was just there; Nausea; Feeling unwell; Had some fatigue as well; I... Read more
headache that comes and goes and was just there; Nausea; Feeling unwell; Had some fatigue as well; In few minutes I started feeling really hot; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: "EL324U"), via an unspecified route of administration on 03Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced headache that comes and goes and was just there, nausea, feeling unwell, some fatigue, and feeling hot. The patient took ibuprofen and acetaminophen (TYLENOL) for the headache; but did not seem to help. The clinical outcomes of headache, nausea, feeling unwell, fatigue, and feeling hot were unknown.
33 2021-01-12 face paralysis, tingling muscle weakness on one side of her face; On 06Jan2021 I suddenly have tingling and muscle weakness o... Read more
muscle weakness on one side of her face; On 06Jan2021 I suddenly have tingling and muscle weakness on one side of my face.; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=eh9899), intramuscularly on left arm at 07:15 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history included high blood pressure and asthma, no allergies to medications, food, or other products. Concomitant medication included lisinopril and non-hormone birth control. The patient suddenly had tingling and muscle weakness on one side of her face at 07:30 AM on 06Jan2021. All events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
33 2021-01-12 numbness per patient about 15 minutes after receiving dose she experienced some numbness in her face and some... Read more
per patient about 15 minutes after receiving dose she experienced some numbness in her face and some dizziness similar to how she feels after eating calamari. Patient was talking OK but was given 50mg oral diphenhydramine at 1:03pm, did not report feeling any worse/was feeling slightly better after 30 minutes
33 2021-01-13 feeling cold Achy, feeling cold, headache, TMAX 99.8. No treatment and no improvement. Outcome: Will continue to... Read more
Achy, feeling cold, headache, TMAX 99.8. No treatment and no improvement. Outcome: Will continue to monitor symptoms.
33 2021-01-13 night sweats Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare p... Read more
Chills; Night sweats; Body aches; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL1284) intramuscular in left arm on 05Jan2021 at 14:00 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Jan2021 at 19:00, the patient experienced chills, night sweats and body aches. No treatment given.The outcome of the events was recovering.
33 2021-01-13 pain in extremity Fever, painful arm, severe headache, chills, muscle aches, initial nausea
33 2021-01-13 tremor I received my first dose on 12-21-2020 and at night I had a high fever, tachycardia, tremors. I also... Read more
I received my first dose on 12-21-2020 and at night I had a high fever, tachycardia, tremors. I also had joint pain, myalgia.
33 2021-01-13 hot flush Pfizer-BioNTech COVID-19 Vaccine EUA nausea flush/heat chest
33 2021-01-13 muscle spasms Right eye and cheek is swollen; Right eye and cheek is swollen; right sided headache; right sided ne... Read more
Right eye and cheek is swollen; Right eye and cheek is swollen; right sided headache; right sided neck muscle spasm and tightness.; right sided neck muscle spasm and tightness.; This is a spontaneous report from a contactable Other HCP. This Other HCP (patient) reported that the 33-year-old female patient who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Arm right on 30Dec2020 at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Asthma and Behcets syndrome. No Known allergies to medications, food, or other products. Concomitant medications included the patient received within 2 weeks of vaccination: Albuterol inhaler (Inhalation vapour, solution), Magnesium, ergocalciferol (VIT D), Ashwagandha. Facility type vaccine was Hospital. No other vaccine in four weeks. The patient experienced right eye and cheek is swollen, right sided headache and right sided neck, muscle spasm and tightness from 07Jan2021 07:00AM. No COVID prior vaccination. No COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was received for the adverse event included OTC ADVIL, PPI, Sudafed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered. Information on the lot/batch number has been requested.
33 2021-01-13 tingling Tingling in extremities
33 2021-01-13 feeling hot Within seconds I felt an extreme hot sensation; dizziness; This is a spontaneous report from a conta... Read more
Within seconds I felt an extreme hot sensation; dizziness; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient not pregnant received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number unknown, via an unspecified route of administration on 08Jan2021 h 11: 00 at single dose for COVID-19 immunization. Medical history was reported as none. Patient had no known allergies and had no COVID prior vaccination. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive other concomitant medications within 2 weeks of vaccination. On 08Jan2021 patient experienced an extreme hot sensation and dizziness lasted a minute (within seconds I felt an extreme hot sensation and dizziness, as reported). No treatment administered for the events. Since the vaccination patient had not been tested for COVID-19. Patient recovered from both events on 08Jan2021. Information on the Lot/Batch number has been requested.
33 2021-01-13 difficulty speaking about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided w... Read more
about 10 hours after administration, I developed SOB, mild chest pain, hoarseness, and right sided wheezes. I self treated with albuterol (2 puffs) inhaler that I have on hand in case of environmental allergy triggers (I rarely have to use it- last use 3 years ago). The wheezing resolved and chest pain improved but the hoarseness remained. Over the next 2-3 hours I developed headache, malaise, mild dizziness, arthralgia, myalgia, and eventually fevers and chills (by 13 hours after vaccine administration). When fever reached 101 I self treated with naproxen 250mg. I slept for 4 hours and awoke diaphoretic, but the fever had resolved and I felt much better. However, I developed urticaria that started on my flexor surfaces of the elbows, hips, and knees, and spread to my adbomen, thighs, and face, with swelling about my right eye. I self treated with 25mg benadryl and itching and urticaria improved to the point that I was able to sleep. When I awoke the next morning my symptoms had largely resolved with the exception of mild headache, body aches, hoarseness, slight chest tightness, and mild residual swelling of the right eyelid.
33 2021-01-13 feeling cold body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to ... Read more
body is cold; Occasionally some nauseous sensation but didn't throw up; Eyes feel so tired; hard to concentrate; it bother my sleep; first dose on 19Dec2020, second dose on 06Jan2021; heaviness in the head when I woke up next day; some hot/spicy sensation around eyes area; didn't even have good appetite during lunch time on day 2; sever headache started at night of day one; This is a spontaneous report from a contactable Other HCP (patient). A 33-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EK9231), on 06Jan2021 14:30 via an unspecified route of administration in the left arm at single dose COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730) on 19Dec2020 09:45 in the left arm at single dose for COVID-19 immunisation. On 06Jan2021 at 23:00, started at night of day one, the patient experienced severe headache. The patient experienced also heaviness in the head when she woke up next day (07Jan2021) and had some hot/spicy sensation around eyes area (07Jan2021). The patient needed to take paracetamol (TYLENOL) to get some relieve and she did not even have good appetite during lunch time on day 2 (07Jan2021). On unspecified date the patient had no fever and her body was cold; occasionally some nauseous sensation but didn't throw up. Eyes feel so tired and hard to concentrate. Hopefully those symptoms go away soon as days pass since it bothered patient sleep. The patient had a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient took also guaifenesin (MUCINEX). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.
33 2021-01-13 breast pain feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swolle... Read more
feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; had a slightly elevated Hemoglobin; soreness in the left arm where she received injection; This is a spontaneous report from a contactable consumer. A 33-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231) in the left arm via an unspecified route of administration on 29Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included supraventricular tachycardia from 2015 (It is under control currently. She was diagnosed in 2015 and she had ablation right away). The patient got the flu vaccine which was required by her workplace was Oct2020. She had flu symptoms, sore throat, and a little headache. Concomitant medication included colecalciferol (VITAMIN D) from 2020 and ongoing. The main side effects was soreness in the left arm where she received injection for one to two days. She couldn't lift her arm. Soreness in the left arm started around 17:00 on 29Dec2020. The patient had a physical on Monday (04Jan2021) and everything was perfectly fine. When she did all the blood work and everything was fine. She had a CBC count on Monday (04Jan2021) and the white blood count was normal. She had a slightly elevated Hemoglobin. All other test like calcium and blood sugar were all normal. Swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore. Then on 06Jan2021 when she looked in the mirror she flexed her arm and saw a line around the breast and it was a little swollen. She got the injection in the left arm. She clarified that she has swollen lymph nodes in the right axillary area and the right breast. There is no swelling on the left. The patient stated today (08Jan2021) the swollen lymph nodes and breast is worse. She is feeling fatigue and can't palpate nodes in breast or axillary area. When she lifts her arm there is a line on the right breast. The outcome of Swollen lymph nodes was not recovered; of other events was unknown.
33 2021-01-14 pain in extremity 12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a f... Read more
12/20: 10 mins after the injection my arm started hurting so I was moving it around and suddenly a felt a tickle in my throat, swallowed and felt like I swallowed the wrong way and was coughing to the point of feeling like I was going to vomit. Per everyone around I was bright red and I looked weird. The ER nurse said my heart rate was 125 and my systolic BP was elevated at 130s (normally in the 110s). After sitting for 45 mins heart rate was back to 60s. Still felt like I was in a fog but felt ok. Once I walked to my car I felt alot of nausea again and was on and off the rest of the day. In the middle of the night I woke up short of breath laying on my back had to lay on my side. 12/21. I was moving pavers and got short of breath. Checked my heart rate and it was 100. O2 sat was 99%. If I sat and didn't move I was fine as soon as I started moving it started again. Also felt nauseating all day. I was having a hard time concentrating and my husband was getting frustrated that I wasn't understanding what he was saying. My left arm hurt really bad all day 12/22 By the afternoon felt more normal except my arm still hurting really bad. 12/26 was shoveling dirty and suddenly my arm where I got the injection started hurts and I got very nauseated again. On 12/29 the cdc called me because I did the vsafe program. They were wondering if I was actually going to get the second vaccination because they said my reaction is a severe reaction. 12/30 my arm started itching had chills and temp right after 1/1 rapid test was negative for covid 1/2 pcr was negative
33 2021-01-14 pain in extremity Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everyw... Read more
Chills; fatigue; muscle aches so bad it made me cry; muscle aches so bad it made me cry; pain everywhere even clothes against my skin hurt/it was all I could do to physically get to bed, which hurt with every step; temp of 99.7; malaise; profound sleepiness; Arm pain at injection site; Arm pain at injection site; This is a spontaneous report from a contactable Physician reported for herself. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular at Left arm on 08Jan2021 09:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included reported as none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historic vaccine included the first dose of BNT162B2 on 18Dec2020 08:00 AM intramuscular at Left arm for covid-19 immunization. The patient experienced Chills, fatigue, muscle aches so bad it made her cry, pain everywhere even clothes against her skin hurt, temperature of 99.7, malaise, profound sleepiness, and it was all she could do to physically get to bed, which hurt with every step. Arm pain at injection site for 2 days now, could not sleep on that side, adverse event start date was provided as 08Jan2021 09:00 AM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
33 2021-01-14 weakness Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that... Read more
Immediate headache and pressure at base of skull into neck. L Arm stiffness/weakness/tenderness that goes down into my hand and left side neck tightness/stiffness (muscular), upper back & B/L shoulder aching and muscular stiffness. Feels almost like a dull ?electrical shock? feeling across my upper back and down my left arm. Joint pain on the L side of my body-elbow, hip and knee. All symptoms continue into the night on day 2 after the vaccine (past 24 hrs after receiving).
33 2021-01-14 numbness Numbness on the face; Numbness along the left side of her mouth; This is a spontaneous report from a... Read more
Numbness on the face; Numbness along the left side of her mouth; This is a spontaneous report from a contactable consumer (patient). This 33-year-old female consumer received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was Mar2021) on 08Jan2021 12:30 (at the age of 33-years) as single dose, unspecified route in left arm for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Jan2021 16:10 she started to experience numbness on the face and numbness along left side of mouth. The outcome of event numbness on the face was unknown, and numbness along left side of mouth was unknown.
33 2021-01-14 pain in extremity, tenderness On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever ... Read more
On Sun 12/27 around 12pm I had left arm tenderness and I was fatigued and then at 5pm I had a fever starting at 99.5 and by 11pm 103.5 I had body aches chills, rigers, fever did not break with tylenol or advil . I had the fever until Monday afternoon and it broke for a few hours and came back and did not budge from 101. I called occupational health and asked questions about my fever, monday night at 8pm I had a bad dry cough and SOB and chest tightness and sinus congestion, no sneezing or runny nose, still with a fever. I called occupational health again and they said to come in to get covid tested and results were positive Tuesday 29th AM. On Thursday I started taking medicine: 5 day course of singulair, slow vent albuterol prn teflex antibiotic and calcium, Zinc and Vitamin D. The fever started to break around Monday the1st to the 4th around 99 to 100 . The 4th I lost sense of taste and smell and Monday the 28, 2020 I had neuromuscular pain in stiffness in legs and I had trouble walking and when fever got lower I realized I was having pain in my feet and hips. I think the infection triggered the unknown neuromuscular condition. I was supposed to go to work the 11th but since I was still having leg issues and my leave was extended one more week. I do not believe these reactions were due to the vaccine I think it was just a coincidence I contracted COVID prior to getting the vaccine
33 2021-01-14 flushing, feeling hot Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per o... Read more
Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per observation RN who was checking pulse. Went to ED, EKG and bloodwork normal, released home.
33 2021-01-14 flushing, feeling hot Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per o... Read more
Went to stand up after 15 mins of observation. Felt flush, hot, dizzy. Heartrate was irregular per observation RN who was checking pulse. Went to ED, EKG and bloodwork normal. Patient released home.
33 2021-01-14 inability to speak, tingling Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a fe... Read more
Within one hour of shot: Mild facial tingles especially surrounding L eye, mild fatigue Within a few hours: increased fatigue, mild ?brain fog? with some word finding difficulty, mild pressure behind eyes 3am, ~16 hours post: mild to moderate body aches, low grade fever 98-99 degrees 8am, ~21 hours post: mild body aches, back to normal temp, continued fatigue, TERRIBLE headache! 7-8/10 pain for about 10 hours. Throbbing in temples, eye pressure, pressure on top of head, worsened when I would bend over. Did not take any medication, worried it would impact immune response. Drank a lot of water, slept, did some sled massage, and gentle yoga/stretches. By that evening pain level had dropped down to about a 4. Woke up the next morning with 2-3 level pain, was able to go to work without being distracted by pain. Still felt more pressure behind eyes and top of head when I bent over. Next day all symptoms resolved, except very minor tenderness at injection site only when palpated.
33 2021-01-14 difficulty speaking fever and chills the following day, then progressive sore throat, cough and hoarseness that has last... Read more
fever and chills the following day, then progressive sore throat, cough and hoarseness that has lasted since
33 2021-01-15 flushing ABOUT 20 MINUTES AFTER INJECTION BEGAN TO FEEL ITCHING ALL OVER BODY, SHORTNESS OF BREATH, FLUSHING,... Read more
ABOUT 20 MINUTES AFTER INJECTION BEGAN TO FEEL ITCHING ALL OVER BODY, SHORTNESS OF BREATH, FLUSHING, HIVES AND NAUSEA - TAKEN TO ER FOR OBSERVATION AND ADMINISTERED DIPHENEHYDRAMINE - RECOVERED AND DISCHARGED
33 2021-01-16 pain in extremity 1. left arm soreness, started ~8 hours after injection, lasted 48-72 hours after injection. Treated ... Read more
1. left arm soreness, started ~8 hours after injection, lasted 48-72 hours after injection. Treated with tylenol, message 2. left axillary lymphadenopathy, started about 24 hours after injection, lasted about 5-6 days after injection 3. muscle aches, started about 16-24 hours after injection, lasted about 36 hours after injection, treated with tylenol, rest 4. nausea (mild), started about 16-24 hours after injection, lasted about 36 hours after injection, treated with bland diet, hydration
33 2021-01-16 pain in extremity 1. left arm soreness. Moderate soreness. Started 12-16 hours after injection. Significant improvemen... Read more
1. left arm soreness. Moderate soreness. Started 12-16 hours after injection. Significant improvement in 48-72 hours after injection. Resolved before 96 hours. 2. left axillary lymphadenopathy. Started (or became aware of once arm soreness lessened) ~24 hours after injection. Resolved about 5 days after injection.
33 2021-01-16 tingling, flushing Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of v... Read more
Patient reported trouble breathing, tachycardia, tingling in face and lips, flushing on the day of vaccination. That day she took 25 mg of Benadryl, then another 25 mg of Benadryl 5 minutes later. Her symptoms got slightly better, but she had to take another 25 mg in the evening. She reports having a headache, muscle aches and pains for 3 days after vaccination.
33 2021-01-16 burning sensation Tingling and burning sensation on tongue, back of throat and left side of face when awoke after a li... Read more
Tingling and burning sensation on tongue, back of throat and left side of face when awoke after a little over 48 hours post vaccination. I took Benadryl which took the edge a little off of the sensation. The discomfort lasted throughout the day.
33 2021-01-17 pain in extremity, feeling cold Arm soreness at vaccine site that night; moderate pain. Was exposed to COVID 20 hours after 1st vacc... Read more
Arm soreness at vaccine site that night; moderate pain. Was exposed to COVID 20 hours after 1st vaccine. Developed symptoms of COVID that Monday - five days after vaccine. Tested COVID positive that same day. Started with headache, then I had a fever over 101. Chills - bad chills. Lost my taste and smell a couple days after that and that lasted a long time (about three days to get smell back and 10 days for taste). Just took Tylenol for the fever and headache. Also got leg pain - muscle type aches - painful - started on the 29th of December. Leg pain lingered and the pain went away by about the 7th of January. Took Tylenol as needed for that pain.
33 2021-01-17 pain in extremity Arm soreness; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant;... Read more
Arm soreness; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; I received the first dose of the Pfizer covid vaccination/currently 14 weeks pregnant; Dose/Frequency: 0.3mcg IM X 1; This is a spontaneous report from a contactable Pharmacist. A 33-year-old pregnant female pharmacist reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE also reported as Covid-19 Vaccine) intramuscular left deltoid on 19Dec2020 09:10 (lot number: EJ1685; expiration date: Mar2021) at 0.3 mcg [ug] single dose and second dose was via intramuscular 09Jan2021 (unknown lot number and expiration date) at 0.3 mcg [ug] single dose for COVID-19 immunization. Medical history included ongoing seasonal allergies since 01Jan1991, ongoing pregnancy and ongoing GI health (gastrointestinal disorder). The patient reported that her last menstrual period was 10Sep2020 and estimated date of conception was 29Sep2020 and estimated delivery date is 17Jun2021. The patient's gestational period at time of initial exposure was 3 months (14 weeks, 17 weeks). The patient does not smoke, drink alcohol and use illicit drugs during this pregnancy. The patient had two live births and two C-sections with no complications. The patient has no maternal medical history and no family history of genetic abnormalities on either maternal or paternal. The patient did not have treatment for infertility. The results of serology tests (e.g., rubella, toxoplasmosis, etc) was negative. Ante-natal check-up included ultrasound at 8 weeks and at 14 weeks with both normal results. Since the patient has not delivered the baby yet, no information about the neonatal information, delivery information and baby details. There is no paternal medical history and history of genetic abnormalities. The father does not take any drugs during the wife's pregnancy. The father does not smoke or use illicit drugs during the mother's pregnancy but drinks alcohol 1 drink per week during the wife's pregnancy. History of all previous immunization with the Pfizer vaccine included MMR [Measles, Mumps, and Rubella vaccine], Tdap (Tetanus, Diphtheria, Pertussis vaccine), Varicella (Varicella vaccine), Hepatitis B (Hepatitis B vaccine) and Gardasil. Ongoing concomitant medication included cetirizine hydrochloride (ZYRTEC) and fluticasone propionate (FLONASE), both since 01Jan2010 for seasonal allergies; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) since 09Jan2020 for pregnancy; and probiotics since 01Jan2015 for GI health. The patient 14 weeks pregnant at the report time. The patient volunteer to have any information collected from her be used to inform recommendations on pregnant patients receiving the covid vaccine. As of 08Jan2021, the patient reported that she did not report adverse events with the use of the product as there was no adverse event that occurred. The patient had arm soreness at 17:00. The patient did not visit the emergency room or the physician's office. The patient did not have any vaccination within 4 weeks prior to vaccination. The patient did not have lack of efficacy or a primary infection site. No antipyretic was used. The patient mentioned that she does consider the Pfizer product had a causal effect to the adverse events. The outcome of the events was unknown. The information on the lot/batch number has been requested. Amendment: This follow-up is being submitted to amend previously reported information: the coding of event 'The patient 14 weeks pregnant' was recoded from 'Exposure during pregnancy' to 'Maternal exposure during pregnancy'. Follow up (08Jan2021): New information received from a contactable pharmacist (patient) reported in response to HCP letter sent via email included: patient details, medical history, partner medical history, product details, lab data, new events (0.3 mcg single, arm soreness) and clinical course of the events.
33 2021-01-17 breast pain Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; ... Read more
Breast feeding/first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; She was also breast feeding; first dose 24Dec2020 14:30/second dose 11Jan2021 07:30; Fever of 101.7/ temp is still a little elevated at 99.5; full body aches; Chills; Headache; Breast feeding and experienced painful let down; This is a spontaneous report from a non-contactable nurse (patient) reported for herself. This Nurse reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL1283) via an unspecified route of administration on 11Jan2021 07:30 at single dose for COVID-19 immunization. The patient received the first dose on 24Dec2020 14:30 at age of 33 years old at single dose for COVID-19 immunization, and only had a sore arm and maybe fatigue. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101.7, full body aches, chills, headache. She was also breast feeding and experienced painful let down at the time (she did not have mastitis). She had all these symptoms on 11Jan2021 16 hrs after receiving second dose. Now at 24 hours all symptoms have resolved except her temp is still a little elevated at 99.5. No treatment was received for the adverse event. Events outcome of full body aches, chills, headache, painful let down at the time (breast feeding) was recovered, for fever was recovering, while for others was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
33 2021-01-17 tingling Ear swelling, hives on face and neck, facial tingling, rash on cheeks, tingling and itchiness in thr... Read more
Ear swelling, hives on face and neck, facial tingling, rash on cheeks, tingling and itchiness in throat and face - 45-60 minutes after injection. Waiting for 30 minutes and no adverse effects until leaving facility
33 2021-01-17 tingling Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has receive... Read more
Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and prickly sensation on her chest and feeling "off". Felt dizzy, developed small hives on her chest. She was attended to immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably. Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking. Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably, speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About 16:30 patient reported her tingling, prickly sensation In her chest is getting worse, developed sensation of lump in her throat, able to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition.
33 2021-01-17 pain in extremity Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous r... Read more
Sore arm; Fatigue; Patient also breast feeding; Patient also breast feeding; This is a spontaneous report from a non-contactable nurse. This patient reported information for both herself and her baby. This is a mother report. A 33-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding, asthma, Anaphylaxis to tree nuts. Concomitant medication included bifidobacterium lactis (PROBIOTIC) and prenatal multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. For the first dose the patient only had a sore arm and maybe fatigue. No treatment received for the adverse event. She was also breast feeding. Events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021027460 Mother/Baby case
33 2021-01-17 pain in extremity The same night as the vaccine, I developed a fever greater than 101.5 and developed bad chills throu... Read more
The same night as the vaccine, I developed a fever greater than 101.5 and developed bad chills throughout entire night. Could not sleep because of chills. Next morning, developed severe legs pains and deep muscle pain - both legs - both calves, both sides. Resulted in me having to miss that day of work. I called my Dr's office and they advised to go to ER for severe leg pain. I didn't because I had a pharmacist that I work with who had advised me that I could wait. Similar symptoms to when I got COVID (on Dec 28th). Did have the same moderate arm pain in location of vaccine. Fever stayed above 100 for 48 hours. And the chills went away after 12 hours. Around the clock Tylenol that stated when I got the vaccine - 1000 mg every six hours scheduled. Fever resolved after 2 days. Chills after 12 hours. Leg pain from severe on 15th - to moderate pain next day and on 18th the pain is more mild. Pain in legs haven't resolved entirely but much better.
33 2021-01-17 tremor allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous r... Read more
allergic reaction; large red itchy rash on her neck / chest area; trembling; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration (lot number: EL1283) in the arm right on 07Jan2021 09:00; at single doses for COVID-19 immunization. Medical history included known allergies: latex. Concomitant medications included magnesium oxide (MAG OXIDE) at 200 mg, daily (every day) and cetirizine hydrochloride (ZYRTEC) at 10 mg, daily (every day); and toprolol at 25 mg, every day (pending clarification for the drug). The patient previously received first dose of BNT162B2 on 17Dec2020 (lot number: EK5730) for COVID-19 immunization. Patient was not diagnosed with COVID-19 prior to vaccination; and has not been tested for COVID-19 since vaccination. Within the 15-minute observation period on 07Jan2021, the patient developed a large red itchy rash on her neck and chest area; she stated she felt fine but was observed trembling. She was transported to ED (emergency department, 5 min transport). She was treated with diphenhydramine hydrochloride (BENADRYL) at 25mg IV X1 (intravenous), and methylprednisolone (SOLUMEDROL) at 60mg IV X1 and famotidine 20mg IV X 1. Patient diagnosis was allergic reaction on 07Jan2021. Patient improved after treatment and was discharged (after being in Emergency room/department or urgent care) as she was observed from 09:11 until 10:33. Final outcome of the events was all recovered on unspecified date.; Sender's Comments: Based on the time association, the allergic reaction, rash erythematous and trembling are possibly related to suspect BNT62B2 administration.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-01-18 pain in extremity After receiving the Pfizer-BioNTech around one 1.5 hrs my stomach was loose and I got diarrhea the s... Read more
After receiving the Pfizer-BioNTech around one 1.5 hrs my stomach was loose and I got diarrhea the same day. The following day I woke up with a sore arm, chills and mild headache.
33 2021-01-18 inability to speak Beginning one day post Pfizer COVID vaccine dose 2 on 1/9/21, experienced dyspnea /increased work of... Read more
Beginning one day post Pfizer COVID vaccine dose 2 on 1/9/21, experienced dyspnea /increased work of breathing with very mild exertion (i.e. ambulating around the house). Intermittently unable to talk in full sentences with ambulation one-day post administration. Shortness of breath generally resolved with sitting down, lasted 72 hours in total, and was accompanied by fatigue, chills, body aches, stomach cramps, and headache. Home pulse ox showed O2 saturation at 98% during periods of dyspnea, HR 100. Contacted primary care provider's office on day 3 post vaccine to notify of symptoms and determined COVID-19 test was clinically indicated. Test obtained day 4 post-vaccine with negative results. Of note, unable to report post vaccine side effect data in V-Safe day 1 post administration due to error in V-Safe system.
33 2021-01-18 pain in extremity Started with sore arm and fever, chills, nausea, muscle and body aches, and dizziness. fever lasted ... Read more
Started with sore arm and fever, chills, nausea, muscle and body aches, and dizziness. fever lasted until 1/14/2021. and every thing else lasted 1/15/2021.
33 2021-01-18 weakness Syncope Fatigue Malaise Chills Weakness when walking Dizziness Lethargic
33 2021-01-18 migraine had nausea, dizziness and went to the ED due to Migraine.. . Her vaccine was 1/12/2021.
33 2021-01-18 numbness left sided facial numbness, feels like her previous symptoms of Bell's Palsy. Bell's Palsy not discl... Read more
left sided facial numbness, feels like her previous symptoms of Bell's Palsy. Bell's Palsy not disclosed at time of vaccination.
33 2021-01-19 feeling hot Approx. 5 min post administration recipient complained of not feeling well. On exam patient was bra... Read more
Approx. 5 min post administration recipient complained of not feeling well. On exam patient was bradycardic, diaphoretic, pale and altered. Patient appearance worsened, and level of responsiveness continued to decrease. Patient was hot and indicated difficulty breathing, and nodded in confirmation when asked if her throat felt tight. Patient given 0.3mg epinephrine IM via autoinjector in the right thigh. Patient condition improved rapidly and regained awareness. Patient transported to ER for ekg and monioting, discharged without incident.
33 2021-01-19 weakness, pain in extremity, night sweats Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness... Read more
Fever night sweats; Fever night sweats; severe anxiety from 12 am -5 am, anxiety subsiding; weakness; muscle pain; Dizziness; Now having swelling lymph nodes under left arm; pain down entirety of the arm; This is a spontaneous report from a contactable other health care rofessional (HCP) (Patient). A 33-year-old female patient not pregnant received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Intramuscular Left arm on 07Jan2021 02:00 PM at a single dose for COVID-19 immunization, Lot number: unknown. Medical history was reported as none. Patient had no known allergies. Concomitant medications were not provided. First vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 02:00 PM Intramuscular Left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient received any other vaccine within four weeks prior to the vaccination. Patient had not been tested for COVID-19 post vaccination. The patient received purified protein derivative (PPD) within two weeks prior to the vaccination on unknown date in Jan2021 (reported as last week), unknown results. On 08Jan2021 12:00 AM patient experienced fever night sweats, severe anxiety from 12 am -5 am, anxiety subsiding, residual fever, weakness, muscle pain and dizziness for the next 48 hours. Now having swelling lymph nodes under left arm and pain down entirety of the arm. No treatment received for the events. At the time of the report anxiety was recovering and patient had not recovered from the other mentioned events. Information on the Lot/Batch number has been requested.
33 2021-01-19 pain in extremity Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left uppe... Read more
Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left upper arm edema and pain/tenderness.; This is a spontaneous report from a contactable nurse reported for herself. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231 via an unspecified route of administration on 09Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Vaccine location: left arm, dose number 2, facility type vaccine: hospital. Historical Vaccine bnt162b2 (BNT162B2) Lot number EL0140 on 21Dec2020 14:45 vaccine location left arm, dose number 1, facility type vaccine: hospital. The patient medical history was not reported. There were no concomitant medications. The patient experienced left upper arm edema and pain/tenderness onset within 3 hours of receiving the 2nd dose of the vaccine. In addition: full body myalgia, fatigue, diaphoresis and fever. Symptom duration was about 12 hours. Symptoms were relieve with Tylenol and Ibuprofen. The action taken was not applicable.
33 2021-01-19 weakness Onset 10-12 hours after dose on 1/18/21 Body aches, chills awakening from sleep. Fever 100.5 after a... Read more
Onset 10-12 hours after dose on 1/18/21 Body aches, chills awakening from sleep. Fever 100.5 after acetaminophen. Weakness, dizziness, mild Pre-syncope, nausea. Persisted through the night and early morning and gradually improving the next day. 24 hours after symptom onset, temp was still 99.5. Much improved with residual generalize muscle soreness upon awakening on 1/20/21
33 2021-01-19 feeling hot approx. 5 min after receiving vaccine patient complained of not feeling well. on exam patient was br... Read more
approx. 5 min after receiving vaccine patient complained of not feeling well. on exam patient was bradycardic at 56, diaphoretic, hot, and altered. Patient continued to deteriorate in mental status. Patient indicated yes by nodding and clutching throat to airway constriction. Patient given .3mg epi via auto injector in the left thigh. Patient status improved markedly after adminstration. Patient taken to Er for observation and EKG. Patient was discharged without incident.
33 2021-01-20 numbness 1/30/21: 20 minutes after injection, complaints of lightheadedness and numbness left side of face o... Read more
1/30/21: 20 minutes after injection, complaints of lightheadedness and numbness left side of face orbital region; Patient states she returned to clinic area and the staff gave no advice to manage symptom & ?just continue to carry epilepsy?; 1/21/21: Patient stayed she received a telephone call from the pharmacist who administered shot who instructed her to file a report with CDC; 1/21/21 5:25pm Patient reported that her sight in right eye has become blurry and feels pressure in eye I recommended to go to ED and contact physician
33 2021-01-20 migraine 5 days post injection I started to have intense nausea and a headache with GI disturbance as well. T... Read more
5 days post injection I started to have intense nausea and a headache with GI disturbance as well. The following day I was extremely fatigued with the same symptoms. The 7th day I experienced a migraine headache that was so intense and still fatigued. I am lactating and breastfeeding and the baby seemed more bothered as well during this time..
33 2021-01-20 difficulty speaking MORNING AFTER VACCINE, DEVELOPED CHILLS, BODY ACHES, HEADACHE, NAUSEA, AND RASPY VOICE.
33 2021-01-20 seizure Patient experience a 3 seizures following administration of vaccine. Vaccine was administered at 10:... Read more
Patient experience a 3 seizures following administration of vaccine. Vaccine was administered at 10:35am, seizures started at 10:40am, EMS arrived at the 10:52am.
33 2021-01-20 pain in extremity Sore upper left arm that lasted no more than 24 hours
33 2021-01-20 discomfort extreme discomfort; sharp pain in my upper back primary on the right side of my body; sharp pain in ... Read more
extreme discomfort; sharp pain in my upper back primary on the right side of my body; sharp pain in my upper back primary on the right side of my body; Most of the sharp pain was when coughing; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer PAA156051; lot number: EK9231) via an unspecified route of administration at right arm on 08Jan2021 at 09:30 AM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was reported as none. No known allergies. No other vaccine in four weeks. Other medications in two weeks included birth control. Facility type vaccine was other. The patient was not pregnant. The patient felt extreme discomfort and sharp pain in her upper back primary on the right side of her body starting Friday 08Jan2021 evening until late Saturday night 09Jan2021. Most of the sharp pain was when coughing or inhaling and while sitting and laying down only. I did not have extreme plain when standing up. The start date of events was reported as 08Jan2021 at 05:30 PM. Treatment received included OTC Bayer for the pain. The outcome of events was resolved on 09Jan2021. No covid prior vaccination and no covid tested post vaccination.
33 2021-01-20 pain in extremity, feeling cold sore arm, body aches, low grade fever 99.9, feels like im freezing
33 2021-01-20 pain in extremity sore left arm, body aches, and low grade fever 99.9
33 2021-01-20 feeling cold wednesday i developed bilateral breast swelling overnight at 0200. chills, headache, fever to 104.1F... Read more
wednesday i developed bilateral breast swelling overnight at 0200. chills, headache, fever to 104.1F at 5pm. antibiotics started to rule out mastitis by OB. decreased milk production (breast feeding mother for 8 months, no history of mastitis). i did go to patient first on thursday where my rapid covid was negative, flu was negative, WBCs were not elevated (9). covid PCR pending.
33 2021-01-21 tingling Numbness and tingling sensation with tongue, lips, and around lip area.
33 2021-01-21 migraine Terrible migraines, body aches, malaise for several days following vaccine
33 2021-01-22 hypersensitivity of all senses Woke up about 2 am rigoring, with terrible pain and itching at injection site and awful body aches. ... Read more
Woke up about 2 am rigoring, with terrible pain and itching at injection site and awful body aches. I took 650 mg Tylenol, fell back asleep, woke up at 330 am sweating and less achy. Awoke again at 7 am with terrible headache, nausea and upset stomach. Injection site swollen, reddened and painful to touch; took another 650 mg of Tylenol without much relief. Entire body was extremely sensitive to the slightest bit of touch or pressure. Had a hazy feeling in my head, felt mildly dizzy for hours. Around 230 pm on 1/19/21 I began sweating profusely for about 15 minutes and when that ceased I felt almost back to normal immediately. By the following day I was feeling 100% OK other than injection site discomfort. Today, 1/23, is the first day since receiving my second dose that my arm Only slightly hurts and itches.
33 2021-01-22 muscle spasms, tremor fever of 103.3, chills, nausea, shaking, headache, jaw ache, joint pain, cramping lasting 8-10 hours... Read more
fever of 103.3, chills, nausea, shaking, headache, jaw ache, joint pain, cramping lasting 8-10 hours. took tylenol and advil
33 2021-01-23 feeling cold Muscle aches, fever and chills
33 2021-01-23 flushing Patient was dizzy, lightheadedness, flushed, warm, and nauseated. This occurred about 15 to 20 minut... Read more
Patient was dizzy, lightheadedness, flushed, warm, and nauseated. This occurred about 15 to 20 minutes after receiving the vaccination.
33 2021-01-23 weakness Severe Myalgias x24 hrs Fever to 102F x72 hours Fatigue/Weakness/Brain Fog/Malaise/Cognitive Dysfunc... Read more
Severe Myalgias x24 hrs Fever to 102F x72 hours Fatigue/Weakness/Brain Fog/Malaise/Cognitive Dysfunction for greater than one week, ongoing
33 2021-01-23 weakness recieved first dose of pfizer covid vaccine on 1/14/2021. 48 hours later I began to feel weakness, e... Read more
recieved first dose of pfizer covid vaccine on 1/14/2021. 48 hours later I began to feel weakness, extreme fatigue, sore throat, chills, headaches and body aches. Today is 10 days s/p first vaccination dose and still symptomatic. Tylenol, Motrin, Dayquil, Vitamin C, Zinc have been taken with no relief of symptoms.
33 2021-01-24 tingling After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on ... Read more
After vaccination - I was noticing eczema flare up - but not bad; and then 27th, I got blisters on left cheek likes pins and needles poking my face; next day the blisters popped and created crater on my skin and area was getting bigger and it was oozing and I felt that stinging poking on that affected area. Next day after that, I went to my dermatologist for a consultation and he said it was Herpes Simplex. Along with that, 2 days after the blisters started appearing on my face, before I went to my dr's office - was having 101. fever, chills, body aches , and severe cough with vomiting and not able and so I got tested the day I went to my Dr. and it was a negative COVID test. Treatment: Antiviral medication for one week; Topical ointment: Bacteralban ointment; I still have the face color with the Herpes was.
33 2021-01-24 feeling cold, tremor At 8pm I felt tried and went to bed- starting at 9pm I began having shivers and could not get warm. ... Read more
At 8pm I felt tried and went to bed- starting at 9pm I began having shivers and could not get warm. My temperature was 102, then my fever rose to 104.5 for most of the night. I did not sleep because my body was shaking and shivering. My body ached all over, especially my lower back. It felt like a very bad flu. My fever continued onto the next day and stayed around 103.7. I slept most of the day- had to call out of work. Tuesday morning my fever was gone and I went to work then went home because my fever spiked again to 101 about mid day. I slept all day and took Tylenol. By Wednesday my Fever was gone but I was still very lethargic. Thursday I felt fine.
33 2021-01-24 weakness Febrile starting at 2am (13 hours post vaccine) with full body chills. Pain at injection site lastin... Read more
Febrile starting at 2am (13 hours post vaccine) with full body chills. Pain at injection site lasting about 36 hours post injection. Full body aches, weakness and over all fatigue starting 12 hours post vaccination until 30 hours post vaccination. Symptoms improved some with naps and two tablets of Aleve. Swollen lymph in right armpit which developed about 24 hours post vaccination and finally disappeared 4 days after vaccination.
33 2021-01-24 feeling hot, muscle spasms passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode... Read more
passed out briefly; a fruity taste in her mouth; turned "Beet red" on her neck/face; have an episode of hypertension; feeling hot; was "swaying"; had menstrual like cramps that radiated from her abdomen to her entire body; had menstrual like cramps that radiated from her abdomen to her entire body; This is a spontaneous report from a contactable pharmacist. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Within in minutes of receiving the vaccine on 13Jan2021, the patient reported a fruity taste in her mouth, turned "Beet red" on her neck/face, and passed out briefly. When she regained consciousness, she was given Benadryl, and also was reported to have an episode of hypertension. She reported feeling hot and was "swaying" and had menstrual like cramps that radiated from her abdomen to her entire body. The outcome of events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the event "passed out briefly". The impacts of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021027150 same reporter/drug, similar event, different patient
33 2021-01-25 pain in extremity Approx 8 hrs after injection i developed sore arm. After that my entire body began to ache, mild at ... Read more
Approx 8 hrs after injection i developed sore arm. After that my entire body began to ache, mild at first and then like I had been hit by a truck. Around 10 pm I developed chills and the feeling I couldn't get warm and felt exhausted. Sore body and chills lasted all night, I developed a fever sometime in the night and when checked was 101.9. Took 2 doses of tylenol to bring it down to 99. Ive been sweating profusely, severe headache, accelerated heart rate reaching 100 bpm at complete rest along with feeling exhaustedand body aches that lasted all day and into the night. It is now 930 am on the 26th and I feel better. Still sweating and body aches mildly with some tiredness.
33 2021-01-25 feeling hot Body felt on fire Headache and severe Joint pain
33 2021-01-25 tingling Headache / Jaw pain / tingling of mouth and tongue then chin, face, neck and arms / nausea
33 2021-01-25 numbness Left facial numbness that progressed to Right facial numbness. Possible belly's palsy
33 2021-01-25 numbness Swollen lymph node in underarm of injected arm. About the size of a nickel, mildly painful when I mo... Read more
Swollen lymph node in underarm of injected arm. About the size of a nickel, mildly painful when I moved and causing slight numbness down my arm. The pain upon moving/numbness went away after a couple days. Swollen lymph still present as of today, mild and periodic throbbing pain still persists.
33 2021-01-25 pain in extremity The next day, Friday January 22, 2021 around midday both of my legs began to ache in my thighs. Ove... Read more
The next day, Friday January 22, 2021 around midday both of my legs began to ache in my thighs. Overnight it went away and I was fine Saturday and I worked a 12hr shift 7am to 7pm. Sunday I worked from 7am to 3pm and my legs started to ache when I got home around 4:30pm until 10pm when I went to bed.. I had to take some ibprofen that evening. I was again fine all day Monday. Now today 1/26/2021,my legs began to ache again this morning around 8:30am.
33 2021-01-25 flushing Within an hour but after the 30 minute waiting period the patient began to experience lightheadednes... Read more
Within an hour but after the 30 minute waiting period the patient began to experience lightheadedness, flushing, and nausea. Recieved 50 mg of IM benadryl(works in medical facility). Patient improved and was discharged to family.
33 2021-01-25 tenderness, pain in extremity fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lum... Read more
fever, chills, body aches to right side of body, Tenderness under arm, Right buttock soreness, Lump near right side of neck, next to clavicle. Ibuprofen for body aches taken sunday , Monday. Today Tuesday 1-26-21 continues with soreness to right underarm, injection site and lump on neck.
33 2021-01-26 feeling cold, weakness, seizure, inability to speak, tremor Approximately an hour after receiving he shot I began experiencing early signs of a headache, and sl... Read more
Approximately an hour after receiving he shot I began experiencing early signs of a headache, and slight fatigue which slowly increased throughout the evening. I woke at 1am (approx. 10 hours after receiving the second Pfizer vaccine) shaking and shivering uncontrollably, freezing and at times convulsing. I was experiencing mild nausea and was unsure if I was having a seizure due to level of shaking and convulsing. Through approx. 4pm the next day I was running a high fever, was almost incapable of speaking or moving due to level of fatigue and weakness. After my fever broke i remained feeling sick through the following day. I needed to take advil for the following 3 or 4 days to manage continual headache, and mild body aches.
33 2021-01-26 pain in extremity I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little b... Read more
I had a headache starting at 5 Pm same day. Body aches/muscle aches in chest and back and a little bit fatigued. Symptoms lasted about 24 hours. I had a little arm soreness too and that lasted two. Pregnancy: May 4 expected due date and totally normal pregnancy.
33 2021-01-26 tingling, numbness Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, like... Read more
Patient reports tingling/numbness in upper left arm at injection site down to left finger tips, likened to "arm being asleep and waking up". Writer performed stroke assessment due to patients reported symptoms. Assessment negative. Assessment of injection site negative. Patient remains A&O x4 (person, place, time, and situation). Patient reports improvement with continued movement with arm. Patient released to self to home after reported symptoms subsided - ~30 minutes from start to finish
33 2021-01-26 pain in extremity, tenderness right neck swelling; tenderness; it was a lymph node thing; right sided Neck Pain; Right sided armpi... Read more
right neck swelling; tenderness; it was a lymph node thing; right sided Neck Pain; Right sided armpit pain; arm pain; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received the first dose of BNT162B2 (lot number: EH9899, Expiry Date: 15Dec2021) via an unspecified route of administration in right arm on 20Dec2020 at single dose for COVID-19 immunisation. She received the second dose on 11Jan2021. There was no medical history. There were no concomitant medications. The patient got the first dose on 20Dec2020. It was after the second dose she had symptoms. The second dose was on 11Jan2021. The right sided neck and armpit pain started yesterday 12Jan2021 and she still has it at the moment. She further clarifies that she actually had this symptom on Dec2020 after the first vaccine dose also, she had the right neck swelling and tenderness, the same side as where she got the vaccine on. When she got the First Dose on 20Dec2020 she had the right sided neck pain and arm pain on Dec2020 she received the vaccine on the right side, she was going to the ear doctor asking about it, it occurred about 2 days after the first vaccine dose and hung around a long time, it lasted more than a week, she guess it was a lymph node thing. She has never been tested for COVID or had any Antibody tests. She has had no issues with vaccines in the past. The patient was not pregnant. Events outcome of right sided Neck Pain and Right sided armpit pain was not recovered, while for others was unknown.
33 2021-01-26 seizure seizure after vaccine
33 2021-01-27 involuntary muscle movements, seizure Approximately 10 mins post Pfizer vaccine patient notified EMT she was going to have a seizure. She ... Read more
Approximately 10 mins post Pfizer vaccine patient notified EMT she was going to have a seizure. She was placed in a safe position, seizure lasted about 30 seconds. Mild body movement, patient urinated, no physical injury. Mother was present, primary historian. Described course of seizure as regular and last seizure 6months ago. As EMT began taking vitals, she expressed feeling nauseous, and vomited. Afterwards patient stated feeling very tired and wanted to leave. Refused paramedics to be called. Patient wanted to rest, left at 3:00PM. Alert and oriented, no complaints besides feeling tired, able to walk with steady gate. Counseled patient to follow up with provider as soon as possible.
33 2021-01-27 weakness I received the second dose in the afternoon and work up the next day feeling drained. Within the nex... Read more
I received the second dose in the afternoon and work up the next day feeling drained. Within the next couple of hours I had chills (did not check for fever), fatigue, headache and overall weakness. Most of the symptoms subsided after 12ish hours later- the head ache lingered for an additional 24 hours. I also experienced upper abdominal pain around30 hours after receiving the vaccine. I was seen by my healthcare provider and they believe the abd pain was related to an ulcer separate from the other symptoms.
33 2021-01-27 weakness, pain in extremity IMMEDIATELY DEVELOPED ELEVATED BLOOD PRESSURE, NAUSEA, HEADACHE. ON DAY 2, HAD FEVER OF 101.3, FATIG... Read more
IMMEDIATELY DEVELOPED ELEVATED BLOOD PRESSURE, NAUSEA, HEADACHE. ON DAY 2, HAD FEVER OF 101.3, FATIGUE, WEAKNESS, SORE ARM, HEADACHE, NAUSEA, AND WAS UNABLE TO WORK.
33 2021-01-27 numbness, tingling The patient received the Pfizer vaccine first dose on 12-21-2020 in her left deltoid. She experience... Read more
The patient received the Pfizer vaccine first dose on 12-21-2020 in her left deltoid. She experienced numbness, tingling and weakness of the LUE. Onset was a few hours after the injection. They lasted 2 weeks. She also experienced isolated soreness to the site of injection. No other systemic complaints. Symptoms progressively resolved and she received the second dose on 1-9-21 in the thigh with no complications.
33 2021-01-27 pain in extremity This dose coincided with my period. However, along with the arm pain which I expected from my first... Read more
This dose coincided with my period. However, along with the arm pain which I expected from my first dose, I have had really bad stomach cramps, headaches and tiredness. My period is also much heavier than normal and has already lasted 7 days when it usually lasts 4 and and is light to spotting due to birth control pills.
33 2021-01-27 burning sensation, tingling tingling in my throat; tingling on the tongue and bottom lip; Burning sensation in my throat, on the... Read more
tingling in my throat; tingling on the tongue and bottom lip; Burning sensation in my throat, on the tongue and bottom lip and on the left side of the face as well; tingling sensation developed on the left side of the face; This is a spontaneous report from a non-contactable pharmacist reporting for herself. A 33-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El1283), via an unspecified route of administration on 14Jan2021 at single dose in left arm for COVID-19 immunisation. Patient age at time of vaccination was 33 years. The vaccine was administered in the Clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history included migraine very infrequent. Concomitant medications included norethisterone (NORETHINDRONE). The patient had no known allergies. She reported that slightly over 48 hours post injection on 17Jan2021 she developed a tingling and burning sensation in throat, on the tongue and bottom lip. A burning or tingling sensation developed on the left side of the face as well. Treatment for the events included Benadryl. The patient had not recovered from the events at the time of the report. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
33 2021-01-28 burning sensation 1ST TIME - INJ 1/6/21 EL0142 (throbbing headache after I left the hospital. It didn't go away until ... Read more
1ST TIME - INJ 1/6/21 EL0142 (throbbing headache after I left the hospital. It didn't go away until I took 2 Exedrin & went to bed. I also had some nausea as well and was fatigued). 2ND VACCINE - INJ 1/29/21 EL324 (much worse - fatigue, muscle pain, extreme nausea, headache, and metallic taste in mouth after 15 min wait passed. i also had an inj site reaction. my right arm was burning and i had a stinging pain)
33 2021-01-28 numbness, tingling 2nd reaction- numb and tingling on right upper arm fingers, toes, foot, tongue and upper lip. Moved... Read more
2nd reaction- numb and tingling on right upper arm fingers, toes, foot, tongue and upper lip. Moved to left side hand and foot with numbness, tingling. Today this still continues with hands and feet of numbness and feet
33 2021-01-28 weakness Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; ... Read more
Joint aching; feeling of weakness in forearms, fingers, left hip and toes; not actively exercising; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, intramuscular on 09Jan2021 16:45 at single dose on left arm for COVID-19 immunization. The patient is not pregnant and has no medical history, no known allergies and no prior vaccination. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC). The patient experienced joint aching and feeling of weakness in forearms, fingers, left hip and toes; not actively exercising on 13Jan2021 at 14:00. The patient had no treatment received. The outcome of the events was not recovered.
33 2021-01-28 seizure Multiple Seizures unable to breathe still continuing at times still taking normal seizure meds along... Read more
Multiple Seizures unable to breathe still continuing at times still taking normal seizure meds along with Ativan when needed
33 2021-01-29 muscle spasms Chills, cramps, diarrhea. Lasted about 2 hours
33 2021-01-29 pain in extremity Mild arm soreness, fatigue, and joint/muscle pain on first day. Woke up on 1/30 the day after with ... Read more
Mild arm soreness, fatigue, and joint/muscle pain on first day. Woke up on 1/30 the day after with severe headache, fatigue, swollen lymph nodes, very pronounced joint and muscle pain
33 2021-01-29 feeling cold Rash distal. Vértigo Dolor muscular y articular generalizado Fiebre Gripe Escurrimiento nasal Cefal... Read more
Rash distal. Vértigo Dolor muscular y articular generalizado Fiebre Gripe Escurrimiento nasal Cefalea Dolor abdominal Diarrea Náuseas Disgeusia Fatiga
33 2021-01-30 weakness Fever 103, rigors, body aches, sever headache, generalized weakness, fatigue
33 2021-01-30 seizure, discomfort Injection site pain, tiredness, headache, severe aches and pains throughout body joints and muscles,... Read more
Injection site pain, tiredness, headache, severe aches and pains throughout body joints and muscles, chills so bad that I was convulsing, injection site swelling, nausea, feeling sick for more than 2 days, swollen lymph nodes in left arm pit, chest feeling tight and lungs feeling heavy
33 2021-01-30 burning sensation Small Burning rash on neck 24 hours after injection. Went away after 3 days.
33 2021-01-31 pain in extremity Patient came in for her second dose, and reported that she had terrible arm pain after 1st dose. Als... Read more
Patient came in for her second dose, and reported that she had terrible arm pain after 1st dose. Also stated she had terrible pain over body since vaccination 3 weeks prior. Stated that on a pain scale of 1-10 (10 being the highest), that her pain was over a 10. This had been intermittent over the past 3 weeks. She stated that she would take Tylenol, and after the Tylenol would wear off the pain would come back greater than before. I told her she needed to see her primary care provider before the second dose would be administered due to her pain being higher than a 10 after 3 weeks of 1st dose.
33 2021-01-31 tingling Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injec... Read more
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
33 2021-02-01 tremor, weakness, feeling cold, flushing, numbness I received my second dose of Pfizer on 01/11/2021 @6:30pm. I started feeling my whole body aching an... Read more
I received my second dose of Pfizer on 01/11/2021 @6:30pm. I started feeling my whole body aching and my face was flushed @8:00am on 01/12/2021 @6pm I felt really bad I had a fever of 102.5 that would not go down, my body was so weak I was unable to move I couldn't feel my feet only my legs, I was shaking from chills I felt really cold but my body was really hot to the touch and my temp was really high, I felt pressure on the left side of my head like it was going to pop. @ 5am on 01/13/2021 I woke up like nothing ever happened and have been good ever since.
33 2021-02-01 weakness Staff reported generalized muscle aches and weakness, along with sleepiness. She noted injection sit... Read more
Staff reported generalized muscle aches and weakness, along with sleepiness. She noted injection site redness. On 1/14/20 at 15:30, her temperature was measured at 100 degrees F. Slightly elevated temp resolved on its own with increased fluids. She rested at home and symptoms resolved.
33 2021-02-02 cold sweat, migraine - [ ] Day 1: severe migraine (2-2.5 hours after the shot) - [ ] Day 2: muscle aches, nausea, fatigue... Read more
- [ ] Day 1: severe migraine (2-2.5 hours after the shot) - [ ] Day 2: muscle aches, nausea, fatigue - [ ] Day 3: muscle aches, migraine, serious heartburn, nausea, dizziness, cold sweats, fatigue, loss of breath, abdominal/chest pain (questioned if it was a heart attack) - [ ] Day 4: nausea, cold sweats, fatigue, abdominal pain, mild muscle aches, dry mouth - [ ] Day 5: woke up at 1100. Already very fatigued and cold sweats. Dizzy. Napped from 1415-1545. Dry mouth. - [ ] Day 6: fatigue, nausea, dry mouth, injection arm numb/tingly. - [ ] Day 7: fatigue, nausea, dry mouth, mild migraine, lower abdominal pain - [ ] Day 8: nausea, abdominal pain
33 2021-02-02 tremor 1/27 afternoon -Foggy, forgot what she was doing . 1/27 evening -full body shaking. Felt she could n... Read more
1/27 afternoon -Foggy, forgot what she was doing . 1/27 evening -full body shaking. Felt she could not grasp with right hand. Right eye pain, throbbing.1/29 Loose stool. 1/30 Loose stool , nausea,shaking, lethargy. 1/31 - felt better. Right hand grasp still felt off.
33 2021-02-02 flushing, feeling hot Pt. verbalizes experiencing flushing, light headiness, and rush of warmth running over face. SPO2 99... Read more
Pt. verbalizes experiencing flushing, light headiness, and rush of warmth running over face. SPO2 99%, 132 HR, BP 122/73 (left arm, manual). Treatment included sitting employee down, with legs elevated, and deep breathing exercises implemented. Pt. stayed an entire hour sitting. At 1030 retook vitals, BP 122/73, and HR 102, 99% for SPO2. Employee communicates that her heart rate runs between 99-105. Extended observation and sent home. Advised to notify PCP ( has not followed up with PCP.)
33 2021-02-02 pain in extremity Sore arm, fever > 101, chills, sweating, muscle aches started approximately 2 hours after vaccinatio... Read more
Sore arm, fever > 101, chills, sweating, muscle aches started approximately 2 hours after vaccination and continued for 48 hours
33 2021-02-03 feeling cold, numbness, tingling About 5 minutes after receiving the vaccine I felt a rush of numbness/tingling/cold starting from my... Read more
About 5 minutes after receiving the vaccine I felt a rush of numbness/tingling/cold starting from my feet that worked it's way up to my head. Once the feeling got to my chest my HR increased. Some SOA, suspected due to feeling of panic. Feeling passed after about 3 minutes but kept coming back in waves about every 10-15 minutes. Took Benadryl 25 mg at about 2:30 to see if it would help, symptoms calmed down at about 4:00. The following morning on 1/30, the immediate symptoms had gone away. By 1/30 evening, starting developing constant numbness to BLE below knee. As of today, 2/4. The numbness is still present.
33 2021-02-03 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old ... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3247, expiration date was unknown), via an unspecified route of administration on the left arm on 20Jan2021 at 08:45 at a single dose for COVID-19 immunization administered at the clinic. Relevant medical history included allergies to Penicillin. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient experienced sore arm, which was assessed as non-serious. The patient did not receive any treatment for the adverse event. The outcome of the event was unknown.
33 2021-02-04 weakness Brain fog with disorientation starting the day after the injection and lasting for two days. Abdomin... Read more
Brain fog with disorientation starting the day after the injection and lasting for two days. Abdominal pain/cramps starting the day after the injection that lasted for 5-7 days that ended with a bout of energy draining diarrhea for several hours on the last day of abdominal pain/cramping.
33 2021-02-04 pain in extremity Fever 102.5, Severe body aches, chills, Nausea, vomiting and diarrhea. All symptoms lasted consisten... Read more
Fever 102.5, Severe body aches, chills, Nausea, vomiting and diarrhea. All symptoms lasted consistently for 2 days. on days 3-7, symptoms continued to come in waves. I would feel better than worse and so on. It was a cycle. Was given anti-nausea medication and pain reliever/fever reducer medication and sent home from work x2 days. Symptoms resolved 100% after 7 days. After symptoms resolved, I did not notice my arm where I received the injection was very sore. This lasted another 3-4 days after feeling better, so about 10-12 days after the vaccine was given.
33 2021-02-04 flushing, feeling hot Flush & Feeling warm
33 2021-02-04 numbness, tingling Patient experienced Nausea and tingling sensation in the arm and Numbness in the arm and finger imme... Read more
Patient experienced Nausea and tingling sensation in the arm and Numbness in the arm and finger immediately after vaccination of Covid-19 Pfizer Vaccine. Patient was observed closely for 30 minutes and patient walked out of vaccine site awake and oriented. Patient did not vomit after feeling nauseated .
33 2021-02-04 pain in extremity Report fever (101.1) HA, body aches, left arm pain 10 hours post vaccination and funny taste in mo... Read more
Report fever (101.1) HA, body aches, left arm pain 10 hours post vaccination and funny taste in mouth 10 minutes after vaccination. Funny taste resolved. Treatment: Tylenol with mild improvement. Outcome does not interfere with ADLs.
33 2021-02-04 migraine, weakness Severe bilateral headache that woke up from sleep; Light and sound affected like a migraine; Also ex... Read more
Severe bilateral headache that woke up from sleep; Light and sound affected like a migraine; Also extreme fatigue and weakness (climbing stairs makes short of breath).; Also extreme fatigue and weakness (climbing stairs makes short of breath).; Also extreme fatigue and weakness (climbing stairs makes short of breath).; This is a spontaneous report from a contactable pharmacist (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number El 9262), via an unspecified route of administration from 20Jan2021 14:00 at left arm at single dose for covid-19 immunization. Patient received the first dose of vaccine on 31Dec2020 10:00 AM (lot number Ek5730) at left arm for covid-19 immunization, the first dose age was also 33 years old. Patient is not pregnant. The facility type vaccine was workplace clinic. Medical history included asthma, eczema. known allergies included Metronidazole, SSRIs. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient's concomitant medications included bupropion, birth control, multivitamin, esomepaz. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe bilateral headache that woke up from sleep, treated with ibuprofen and Tylenol but still remained. Light and sound affected like a migraine. Also extreme fatigue and weakness (climbing stairs makes short of breath). The event onset date was reported as 21Jan2021 02: 00 AM. The treatment included ibuprofen and Tylenol. The outcome of events was reported as not recovered.
33 2021-02-05 pain in extremity Chills, aches, headache, fatigue, cough, sore arm, nausea, dizziness started at 5pm and progressed t... Read more
Chills, aches, headache, fatigue, cough, sore arm, nausea, dizziness started at 5pm and progressed throughout the night. Continued throughout all of Thursday, the day after the vaccine. Today on Friday I?m feeling much better yet still light headed, fatigued and have a cough
33 2021-02-05 weakness I was eating food that I normally eat and I looked down at my right arm and saw decent amount of hiv... Read more
I was eating food that I normally eat and I looked down at my right arm and saw decent amount of hives. Then I check the rest of my body and found more. I took benadryl and zyrtec on the 5th and then feel asleep. I woke up in the middle the night to see that they had doubled eone in my private parts. I went to urgent care and they gave me a steroid injection, prescriptions for pepcid, a steroid pack and told me to continue to take the benadryl and zrytec. The hives have gone down, but I feel very weak and tired. It occured around 8:30 Friday night (2/5) and I am sorry I didn't fill out the form last night. i got the shot this morning at 8:30 am. I had a slight fever this morning.
33 2021-02-05 pain in extremity Leg pains at night, left arm pain (injection arm), fatigue for four days after first dose of Pfizer.
33 2021-02-05 pain in extremity Nausea. Arm pain. Slight headache. Tired.
33 2021-02-06 involuntary muscle movements, hot flush, feeling cold It started out as general body aches. Then twelve hours post vaccine I got a fever of 103.4. My feve... Read more
It started out as general body aches. Then twelve hours post vaccine I got a fever of 103.4. My fever was consistent for almost 36 hours. After it broke I would be fine and then have hot flashes and then become cold. I had a horrible pain between my shoulder blades that radiated into my left chest. I had a headache that lasted for 4 days. No matter the pain reliever used nothing touched the pain. My head hurt so bad it made me nauseous and dizzy. I had excruciating left sided jaw pain. It hurt to open my mouth. It shot up through my jaw into my teeth. I was unable to chew anything on that side due to pain, but I ate very little.
33 2021-02-06 tingling, numbness, pain in extremity, burning sensation Two hours after receiving vaccine the same side of my forearm felt burning and tingling. Pain per... Read more
Two hours after receiving vaccine the same side of my forearm felt burning and tingling. Pain persisted the next few hours into my hand and my wrist, palm of my hand and fingers felt numbness and tingling. The pain and numbness in the next couple of days radiated to the back of my elbow and to my underarm. The pain continued for 2 weeks after getting the vaccine. I saw a NP on 1/26 and got a prescription for a 6 day dose of steroids. It helped initially the pain resolved while taking the medication. 2 days after completion of the steriods the pain returned but not as strong. I continue to have intermittent numbness and tingling in my hands and pain in my wrist, palm and arm. I am waiting to see my PCP in March.
33 2021-02-07 weakness 1st 2 days- Fatigue, weakness, muscle aches. 7 days later on 2/6/2021: Severe Lt hip pain, pain w/ d... Read more
1st 2 days- Fatigue, weakness, muscle aches. 7 days later on 2/6/2021: Severe Lt hip pain, pain w/ direct pressure or walking. 9 days later on 2/8/2021: Continuous Lt hip pain as well as new onset of Rt hip pain.
33 2021-02-07 numbness and pain in extremities Approximately 3 hours after receiving the vaccine, patient developed slight soreness at injection si... Read more
Approximately 3 hours after receiving the vaccine, patient developed slight soreness at injection site (noticeably less than following dose 1 of this vaccine). Then, at approximately 12 hours post-dose, developed the following symptoms lasting the entirety of the night: generalized/dull headache, photosensitivity, generalized myalgias/arthralgias, subjective fever/chills alternating with cold sensitivity. All symptoms except headache resolved by the next morning, but at approximately 24 hours post-dose, all symptoms returned and lasted for the remainder of that day. By the next day, all symptoms had completely resolved and have since not recurred.
33 2021-02-07 tingling, numbness Feeling of electrical jolt, tinlgy, numb, pins and needles across different body parts (arms, hands,... Read more
Feeling of electrical jolt, tinlgy, numb, pins and needles across different body parts (arms, hands, back, thighs, feet, face, scalp). The feeling spreads in the particular area and last from 5 seconds to 20 seconds. The feeling is very uncomfortable and at times painful.
33 2021-02-07 burning sensation burn-like lesion on top of right foot/started as a welt/looks like a blistered burn; sensation of lo... Read more
burn-like lesion on top of right foot/started as a welt/looks like a blistered burn; sensation of low-grade current flowing through hands and sporadically throughout limbs; This is a spontaneous report from a contactable consumer reporting for herself. A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1283/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 at 14:45 (at the age of 33 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included latex allergy and allergy to some white cheeses. Concomitant medication was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021, the patient experienced sensation of low-grade current flowing through hands and sporadically throughout limbs, mostly for 2hrs following the shot, then occasionally afterward. On 21Jan2021 at 22:45 the patient experienced a burn like lesion on top of right foot, which started as a welt approximately 8 hours after the shot. By morning of second day after shot (23Jan2021), it looks like a blistered burn the size of a dime. The patient did not receive any treatment for these events. The outcome of the events sensation of low-grade current flowing and burn-like lesion on top of right foot/started as a welt/looks like a blistered burn was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
33 2021-02-07 numbness and pain in extremities nipples are more sensitive/tender; increase in cold and heat sensitivity (possible neuropathy) in he... Read more
nipples are more sensitive/tender; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes/gotten more noticeable since the second vaccine; This is a spontaneous report from a contactable consumer. A 33-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as COVID 19 vaccine brand Pfizer, lot EL9261), via an unspecified route of administration in right arm 20Jan2021 13:00 at SINGLE DOSE for Covid-19 immunisation . The patient's medical history was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Covid-19 prior to vaccination, not been tested for COVID-19 prior to vaccination. Concomitant medications were not reported. She had her first dose of bnt162b2 (lot EJ1686) on 30Dec2020 via unknown route in the right arm. The patient's concomitant medications were not reported. She reported an increase in cold and heat sensitivity (possible neuropathy) in her fingers and toes since the first vaccine (Dec2020) but it has gotten more noticeable since the second vaccine. She has also reported that her nipples are more sensitive/tender since vaccination (20Jan2021). No treatment was given to the events. The outcome of events was not recovered.
33 2021-02-07 pain in extremity swollen left arm pit which is also slightly tender to touch; swollen left arm pit which is also slig... Read more
swollen left arm pit which is also slightly tender to touch; swollen left arm pit which is also slightly tender to touch; sore arm; low grade temperature (37.8 C); fatigue; chills; Second dose administered on 10Jan2021; first dose was administered on 29Dec2020; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9Z61), intramuscular (left arm) on 10Jan2021 15:00 at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL1284) intramuscular (left arm) on 29Dec2020 (02:00 PM) for Covid-19 immunization. The patient's medical history included Covid-19; no known allergies. Concomitant medication included citalopram hydrobromide (CELEXA) taken PO (oral) daily before, during and after vaccination period. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no issues on day zero; on day 1 (11Jan2021) she had sore arm, low grade temperature (37.8 C), fatigue, and chills. All have resolved by 6am on day 2 (12Jan2021). On day 3 (13Jan2021), she noticed swollen left arm pit which is also slightly tender to touch but not bothersome. No other lymph areas are noticeably swollen or tender at this time. There was no treatment received for the adverse event. The outcome of events sore arm, low grade temperature, fatigue, and chills was recovered on 12Jan2021; the outcome of events swollen left arm pit which is also slightly tender to touch was recovering. The patient has not been tested for COVID-19 since the vaccination.
33 2021-02-08 tingling, hot flush 1:15pm HR 99 SPO2 100% BP 130/68 1:20pm HR 100 SPO2 100% EE SOB, flushed/hot, Heart racing, facial t... Read more
1:15pm HR 99 SPO2 100% BP 130/68 1:20pm HR 100 SPO2 100% EE SOB, flushed/hot, Heart racing, facial tingling 1:22 Benadryl 1 tablet 25mg po given 1:24pm complaint of dizziness and vertigo 1:25pm HR 103 SPO2 100% BP 133/69 1:33pm HR 92 SPO2 100% BP 128/62 1:49pm HR 102 SPO2 100% 1:55pm HR 88 SPO2 99% BP 119/59 2:00pm went to restroom 2:05pm returned to work
33 2021-02-08 cold sweat 1:19: Dizziness/seeing spots/SOB monitor of VS HR 125 BP 132/95 SPO2 100% RR 20 1:24 Feeling "not ... Read more
1:19: Dizziness/seeing spots/SOB monitor of VS HR 125 BP 132/95 SPO2 100% RR 20 1:24 Feeling "not right" clammy/sweaty monitor of VS HR 92 BP 138/90 SPO2 100% RR 16 1:29 BP 131/79 HR 96 SPO2 100% RR 16 1:34 BP 135/80 HR 88 SPO2 100% RR 16 1:37 BP 134/77 HR 90 SPO2 100% RR 16
33 2021-02-08 tingling, tremor, pain in extremity Caregiver received first Pfizer dose and immediately started to feel bad. Started having racing hear... Read more
Caregiver received first Pfizer dose and immediately started to feel bad. Started having racing heart, nausea, abdominal pain, shaky and "pins and needles feeling." CG vitals taken, HR noted to be in 1-teens but reduced to 80s shortly after, BP was 120/80, O2 sat 99%. CG stayed for 1 hour post vaccine and states her symptoms resolved. Today just has a sore arm and a little nausea.
33 2021-02-08 tremor, flushing Patient was received her Covid vaccination in her right arm approximately 9:15am. With about 5 minu... Read more
Patient was received her Covid vaccination in her right arm approximately 9:15am. With about 5 minutes she became shaky, sweaty, flushed, and stated she had a ?medication taste in mouth?. She had eaten breakfast, but was given a snack & juice. Nurse reported slightly elevated BP (exact numbers not given). Patient was taken to ER for care.
33 2021-02-08 weakness Pfizer-BioNTech COVID-19 Vaccine EUA: After receiving vaccination, patient became pale and felt weak... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: After receiving vaccination, patient became pale and felt weak. Pt hypotensive. EMS monitored patient for 30 minutes, no intervention required. Patient recovered with no intervention and ambulated out of building with spouse.
33 2021-02-08 pain in extremity Sore arm 4pm (2/8/2021) -12pm (2/9/2021) Muscle Aches 9pm (2/8/2021) -9am (2/9/2021) Chills and Feve... Read more
Sore arm 4pm (2/8/2021) -12pm (2/9/2021) Muscle Aches 9pm (2/8/2021) -9am (2/9/2021) Chills and Fever 1030pm (2/8/2021) - 9am (2/9/2021) Headache 1am-9am (2/9/2021) Nausea 1030pm (2/8/2021) -9am (2/9/2021)
33 2021-02-08 flushing Systemic: Other- Flushing, numbness, labored breathing, slightly elevated BP, anxiety, pt had not ea... Read more
Systemic: Other- Flushing, numbness, labored breathing, slightly elevated BP, anxiety, pt had not eaten all day
33 2021-02-09 tingling, numbness Systemic: Other- numbness and tingling in left arm and fingers of left arm
33 2021-02-09 pain in extremity Toes swollen; painful feet; itchy; red on bilateral feet; This is a spontaneous report from a contac... Read more
Toes swollen; painful feet; itchy; red on bilateral feet; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 33-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN53.8), via an unspecified route of administration in left arm on 23Jan2021 12:30 at single dose for Covid-19 immunization in facility type of other. The patient's medical history included dysthymia, and there was no allergies to medications, food, or other products. Patient did not have any allergies to medications, food, or other products. Concomitant medication included bupropion within 2 weeks of vaccination in 2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient experienced toes swollen, painful feet, itchy, red on bilateral feet on 26Jan2021 08:00. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events was not recovered.
33 2021-02-09 pain in extremity sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes; s... Read more
sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes; sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes; mild chills; This is a spontaneous report from a contactable other healthcare professional (patient) reported that a 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982) second dose in left arm via an unspecified route of administration on 29Jan2021 at 04:15 PM at single dose for COVID-19 immunization. Medical history included hypertension, diabetes type 2, migraine, ADHD/Attention deficit hyperactivity disorder. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), metformin, losartan, amlodipine, nabumetone. The patient previously took lamotrigine (LAMICTAL) and had allergies; also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) first dose at the age of 33 years in left arm on 08Jan2021 at 04:15 PM for COVID-19 immunization. On 30Jan2021 10:30 am, the patient experienced sharp shooting pain in bicep that goes down her arm into her hand on the arm. Pain comes and goes. No pain at injection site. Experiencing mild chills. No treatment was received for the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered.
33 2021-02-11 numbness, numbness and pain in extremities LEFT ARM NEUROPRAXIA/NEUROPATHY ... PATIENT WITH COMPLETE NUMBNESS TO LEFT ARM, WEAKNESS TO LEFT ARM... Read more
LEFT ARM NEUROPRAXIA/NEUROPATHY ... PATIENT WITH COMPLETE NUMBNESS TO LEFT ARM, WEAKNESS TO LEFT ARM.
33 2021-02-14 tingling Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead ski... Read more
Won't let me type everything. Long story short. Face tingled for a few days after shot, forehead skin got tight and dry, now I've lost vision in my right eye! Today is exactly 2 weeks after 1st vaccine and sight in my right eye is worse and painful
33 2021-02-14 tingling tingling on the left side of her face below her eye and lower half of her face/facial tingling on th... Read more
tingling on the left side of her face below her eye and lower half of her face/facial tingling on the left side of her face; This is a spontaneous report from a contactable Consumer (patient) A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose in her left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Jan2021 patient noticed facial tingling on the left side of her face below her eye and lower half of her face. The final outcome of the event was unknown.Patient would like to know if her symptoms were normal and would like to know what she should do about her symptoms. She wanted to know if she should be worried about that and if it was a known side effect. information on the batch number has been requested
33 2021-02-15 pain in extremity, tingling, numbness 1 hour after injection on 2/15/21 - facial numbness and tingling, starting in nose and spreading thr... Read more
1 hour after injection on 2/15/21 - facial numbness and tingling, starting in nose and spreading through face. Symptoms resolved in a couple hours The morning following vaccination 2/16/21 - pain in left arm spreading from injection site down the back of shoulder and arm. Widespread pain in joints. Muscular fatigue. Some relief with NSAIDs. Currently managing at home
33 2021-02-15 tremor 24 hrs after the vaccine I was about to have lunch and started feeling dizzy, couldnt hear the peopl... Read more
24 hrs after the vaccine I was about to have lunch and started feeling dizzy, couldnt hear the people in the room and began to fall as I was advised and someone in the room caught me. I was laid down and administered water until I felt better. I went back to my worksite while having to use the hand rails because my vision was blurred and I finally made it to my desk. I was then transported to the ER and my BS was taken which was 85. I was given IV fluids, a chest xray was performed, a UA and pregnancy test was done, EKG and a CBC done which all was negative and normal. From my knees down felt shaky the remainder of the week. I had a visit with my PCP the following week on Tuesday and had a sugar test done which was also normal and by the end of that week all symptoms had resided
33 2021-02-15 migraine Chills and fatigue next morning, migraine headache for about 4 days
33 2021-02-16 tingling Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this ... Read more
Received 2nd Pfizer dose on 2/5/21 at 0700. On 2/6/21 around 1930 temp was 102 took Tylenol at this time at 2200 temp was 103.7 took Advil at this time. Temp stayed 102-103.7 with Tylenol and Advil round the clock until 2/8/21 around 1300 at this time temp had gone down to 101. Noticed once fever started to drop my left toes started to tingle. Tingling got worse over the next few days until 2/11/21 my whole leg went extremely heavy (could not lift at all). Admitted to hospital 2/12/21.
33 2021-02-16 night sweats, speech disorder, tingling, nerve pain, numbness, inability to speak Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal.... Read more
Vertigo, dizziness, joint pain, rash, foggy brain, inability to speak, think and memorize as normal. Sore throat, fluid in ears and lungs. Muscle weakness, headaches...difficulty walking. Insomnia. Flu like symptoms for 2 weeks after dose2. Nerve pain (shooting sensation down both arms. Difficulty standing for more than a few minutes, light headed. Ear pain, nausea, night sweats and unable to grasp normally. Tingling in face. Numbness in face.
33 2021-02-17 numbness, tingling started to feel a little lightheaded like my blood sugar was low; started to feel a little lighthead... Read more
started to feel a little lightheaded like my blood sugar was low; started to feel a little lightheaded like my blood sugar was low; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; tongue started tingling, which then progressed to lips, face, and then halfway back the scalp; some mild numbness of my tongue, face, and scalp; some mild numbness tongue, face, and scalp; some mild numbness tongue, face, and scalp; headache; This is a spontaneous report from a contactable physician (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3248), via an unspecified route of administration on 21Jan2021, on 15:45 as single dose for covid-19 immunisation . The patient medical history was not reported. Concomitant medications included multivitamin. No other vaccines were given within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies, amoxicillin and experienced urticaria. on 22Jan2021, at 17:30, the patient started to feel a little lightheaded like my blood sugar was low, tongue started tingling, which then progressed to lips, face, and then halfway back the scalp, some mild numbness of my tongue, face, and scalp and headache; the events were reported as non-serious. The events were elaborated as follows: the patient indicated started to feel a little lightheaded like her blood sugar was low. About 15 minutes after, she had initially started to feel lightheaded, her tongue started tingling, which then progressed to her lips, face, and then halfway back of her scalp. The paresthesias were intermittent in those areas and then some mild numbness of the tongue, face, and scalp followed. All the symptoms subsided after about 30-40 minutes. She said she may have had a mild headache afterwards. No motor symptoms were noted. Purely sensory and it seemed in the trigeminal nerve distribution. The outcome of the events was 22Jan2021; no symptoms have occurred since the 22Jan202. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19.
33 2021-02-18 tingling, pain in extremity 2/18 Employee (EE) woke at 6:45am -arm felt like "pins and needles as if asleep" from elbow to finge... Read more
2/18 Employee (EE) woke at 6:45am -arm felt like "pins and needles as if asleep" from elbow to fingers. EE felt like she may have slept wrong on the arm. Symptoms remained at 09:25am. EE was able to work . EE did not seek medical follow up at this time
33 2021-02-18 tenderness Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swe... Read more
Employee received first Covid19 vaccination on 12/31/2020. Five days post vaccination developed swelling in left neck per employee larger than tennis ball, tender to touch,warm to touch slightly painful to touch . Size has decreased daily to now the size of tennis ball today. Did not report until today. Covid EHS notified and employee will also call them.
33 2021-02-18 weakness Shoulder injury related to vaccine administration. Within 2 hours of receiving the shot, I experie... Read more
Shoulder injury related to vaccine administration. Within 2 hours of receiving the shot, I experienced intense and nauseating shoulder pain as well as decreased strength and range of motion. I could not lift my arm. The pain radiating down to my wrist and up to my neck. I could not operate a motor vehicle. 10 days later, today, I am still experiencing pain with any should movement, particularly any heavy lifting. The pain is severe enough it is interfering with my sleep.
33 2021-02-19 weakness Fever, headache, feel weak/light headed, sore muscles
33 2021-02-21 tingling, numbness Grávida 2. EDD:7/15/21. Numbness/tingling to face for about 45 min.
33 2021-02-21 flushing, tremor Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency r... Read more
Patient became dizzy with palpitations. Developed flushing, sweating and shaky, take to Emergency room where a patient developed minimal residual erythema
33 2021-02-21 muscle spasms Severe headaches exhaustion depression, crying spells, mental breakdown severe muscle spasms over th... Read more
Severe headaches exhaustion depression, crying spells, mental breakdown severe muscle spasms over the neck, upper, middle, and lower back Knee pain
33 2021-02-22 numbness, tingling, pain in extremity Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm s... Read more
Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm symptoms lasted approximately 48 hours from on-set. Also experienced fatigue, headache and arm soreness
33 2021-02-22 flushing Patient presented at 5:05 with complaints of burning sensation in chest, tachycardia, throat irritat... Read more
Patient presented at 5:05 with complaints of burning sensation in chest, tachycardia, throat irritation and itching, mild cough, flushing of chest and face. No SOB. Pulse 120. O2 sat 99%. BP 110/70. She had a history of serious allergic reactions to foods in the past, and was familiar with the symptoms. She was provided a 25mg dose of diphenhydramine (she had previously taken 25mg prior to her vaccine, in addition to her daily allergy medication in the morning) and she was observed. over a 30 min observation period her pulse came down to under 100, her flushing and throat irritation resolved. She was feeling back to baseline and she was allowed to leave.
33 2021-02-22 weakness Whole body aches, fatigue, headache, weakness
33 2021-02-23 hot flush 9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and... Read more
9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction. On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.
33 2021-02-23 feeling hot Pt complained of itching and warm feeling no sob or dizziness. Was evaluated by EMS, they recommende... Read more
Pt complained of itching and warm feeling no sob or dizziness. Was evaluated by EMS, they recommended giving liquid benadryl 25mg. Pt vitals sign BP 132/78 R 20 P 78 o2 97%. PT reported feeling better after receiving the benadryl waited an additional 30 mins before leaving. Refused any other treatment.
33 2021-02-23 numbness, pain in extremity have had intermittent right neck pain and right hip/back pain, radiating to right leg since receivin... Read more
have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine.; numbness at times in her right foot; This is a spontaneous report from a contactable nurse reporting for herself. A 33-years-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EK9231, via an unspecified route of administration on 28Dec2020 16:45 (33 years old) as a SINGLE DOSE for COVID-19 immunization. Medical history included High blood pressure from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included sertraline, melatonin, colecalciferol (VITAMIN D), folic acid, iron (PRENATAL). The facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, has the patient has not been tested for COVID-19. On 07Jan2021, the patient experienced have had intermittent right neck pain and right hip/back pain, radiating to right leg since receiving my 1st dose of the vaccine. Patient also had some numbness at times in her right foot on 07Jan2021. She has not been able to see her primary care provider but has an appointment in Feb to be evaluated. The events were non-serious. No treatment was received for the events. Outcome of the events was not recovered. The patient received the second dose on 19Jan2021 in the Left arm lot EL3302.
33 2021-02-24 pain in extremity, feeling hot 5 minutes after the injection, I began to feel a sense of panic. My eyes started to ?white out.? I f... Read more
5 minutes after the injection, I began to feel a sense of panic. My eyes started to ?white out.? I felt extremely hot, nauseous, and light headed. I vomited after a few minutes. Paramedics took my vitals and stated that my blood pressure was very low, in the 70s. I felt dizzy and nauseous for at least 30 minutes. Once I felt better, they gave me some Gatorade and I was able to go home. The next morning, I woke up with a sore neck, sore arm, headache, and slight chills.
33 2021-02-24 muscle twitching Frequent upper muscle twitching in vaccinated arm.
33 2021-02-25 weakness Patient reports receiving the 2nd dose of the Pfizer vaccine yesterday around 9:10am. Patient starte... Read more
Patient reports receiving the 2nd dose of the Pfizer vaccine yesterday around 9:10am. Patient started to noticed mild symptoms about 8 hours afterwards, including a mild headache and backache. She reports then feeling fatigued so she went to sleep early around 8pm. The patient reports waking up at 11pm having to go the bathroom. She notes feeling weak when walking to the bathroom, though as she was on the toilet voiding she felt nauseous. When she got up to wash her hands she felt that she was going to pass out feeling LH and dizzy. She sat down on the bathroom floor as she has a history of orthostatic hypotension, and eventually needed to lay completely flat on the ground. She reports this is when she felt as though she blacked out. She was then able to wake up and walk back to bed feeling better, and fell back to sleep.
33 2021-02-25 pain in extremity sore arm for two days; This is a spontaneous report received from a non-contactable consumer (patien... Read more
sore arm for two days; This is a spontaneous report received from a non-contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, in Jan2021 (lot number and expiry date unknown), at single dose, for covid-19 immunization, at the hospital. There were no medical history and concomitant medication. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. The patient experienced sore arm for two days in Jan2021. Treatment included two doses of Advil. The patient recovered from the event in Jan2021. No follow-up attempts are possible; Information about lot and batch number could not be obtained. No further information is expected.
33 2021-02-26 tingling, muscle spasms I awoke on 2/26 with tingling in my left arm with no other explained cause. I also had muscle twitch... Read more
I awoke on 2/26 with tingling in my left arm with no other explained cause. I also had muscle twitching in my left hand. I had heard the vaccine might be able to cause tingling and twitching so I wanted to report it.
33 2021-02-26 tingling Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Tingling (spe... Read more
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: After the injection I noticed a swelling and a little red on the injection site. After monitoring her pt stated that she has some tingling on her right thumb and monitored by NP for about 40min to an hour and felt ok and went home and an hr later called for follow up and she was 100% better. she was given water while here. rph spoke to her family member while she was here. and I called her about 8:39pm and spoke with her and she said she is doing ok.
33 2021-02-27 pain in extremity Vaccine received at 4pm on 1/31. Nausea, headache, fatigue, marked arm soreness, and injection site ... Read more
Vaccine received at 4pm on 1/31. Nausea, headache, fatigue, marked arm soreness, and injection site lump started the following morning. Normal temperature. All symptoms, including arm soreness and lump, resolved in 48 hours. 7 days post vaccine, on 2/7, Injection site lump returned, and became larger than initial reaction. Area around lump (~6in in diameter) was red and extremely itchy. Area was painful, but much less so than initial reaction. Resolved on own within 3 days.
33 2021-02-27 pain in extremity Vaccine received at 4pm on 2/21. Nausea started the next morning, followed later by fever (highest a... Read more
Vaccine received at 4pm on 2/21. Nausea started the next morning, followed later by fever (highest at 101.8), body aches, chills, headache, and mild arm soreness. All symptoms resolved within 24 hours, except mild arm soreness. Arm soreness continued for 5 days, and a red, itchy, and painful area was noted approximately 2 inches away from injection site during this time. All symptoms resolved on own.
33 2021-02-28 tingling, burning sensation, facial paralysis, numbness brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and ti... Read more
brain fog; Bell's palsy on left side of face; vision has been off/ Vision is blurry; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; Numbness and tingly/burning sensation in right leg; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9264 and Expiration Date: May2021), via an unspecified route of administration in the left arm on 02Feb2021 at 17:45 at 33-years-old at a single dose for COVID-19 immunization; with no other vaccines administered within four weeks of the bnt162b2 administration. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included alprazolam (XANAX) taken for an unspecified indication from an unspecified date to an unspecified date, prednisone (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified date to 16Feb2021. The patient experienced the following events and outcomes: Bell's palsy on left side of face (medically significant) on 06Feb2021 12:00 with outcome of recovering, vision has been off/ vision is blurry (medically significant) on 06Feb2021 12:00 with outcome of recovering, numbness and tingly/burning sensation in right leg (medically significant) on 06Feb2021 12:00 with outcome of recovering, brain fog (medically significant) on an unspecified date with outcome of unknown; all of which required a physician office visit. The clinical course was reported as follows: The patient received the first dose of the Pfizer COVID 19 vaccine, she began having symptoms on the following Saturday and was seen by her doctor and diagnosed with Bell's Palsy. The patient stated she has reported this via VSafe and the Pfizer website. The patient also reported other symptoms that have not been reported as follows: had tingling in both legs, brain fog, and vision has been off. The patient was not sure if it was related to the vaccine or steroids. The patient wanted to know if she should get the second dose. The patient had been on a steroid, so she did not know if she should wait to get the second dose. The patient just stopped the steroid on 16Feb2021, and the second dose was scheduled for 23Feb2021. The patient also said she had other symptoms that she had not reported and she said she had tingling that started in one leg now in both legs, brain fog and her vision was off and she was not sure if that was related to the vaccine or the steroid (later clarified as prednisone). The patient was not taking the steroids at the time of diagnosis. "Correct I mean it started after the vaccine, but I was also on medication (Clarified as Prednisone) so I am not really sure what the difference is at this time." Treatment in response to event: the patient stated, "No I mean for the tingling in my leg I have been just putting heat and Ice on it but I have not done anything actual big treatment and then for my eyes no, my doctor is not sure what is related to the Bell's Palsy and what is to medication." The patient underwent lab tests and procedures which included lab work: unknown result on an unspecified date (patient stated, "Yes, I have many"). Therapeutic measures were taken as a result of facial paralysis, hypoaesthesia, burning sensation, and paraesthesia; which included steroids and anti-viral and anti-nausea medicine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
33 2021-02-28 feeling hot she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a... Read more
she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a spontaneous report from a contactable consumer (patient's father) and a non-contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and dizziness from an unknown date and unknown if ongoing, Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN) for dizziness, ethinylestradiol, norethisterone (DASETTA 1/35) for birth control and multivitamins, all from an unknown date. The patient previously received first dose BNT162B2 (lot number EH9899) on 05Jan2021. On 26Jan2021 (about 10 in night) the patient experienced she threw up, diarrhea, body pain, and chills, she experienced slight headache, feeling hot and feverish on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of the events vomiting, diarrhea, body pain, chills, headache, feeling hot and fever was recovering (reported as getting a little better now).
33 2021-03-02 speech disorder Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normal... Read more
Vertigo; fluid in ears and lungs; fluid in ears and lungs; muscle weakness; inability to walk normally; dizzy; nauseous; flu like symptoms; shooting sensations down both arms; memory issues; joint pain; headaches; varying rashes; trouble speaking, thinking, and understanding; trouble speaking, thinking, and understanding; This is a spontaneous report from a contactable nurse (the patient). A non-pregnant 33-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the right arm on 11Jan20210 at 07:30 AM (at the age of 33-years) as a single dose for COVID-19 immunization. Medical history included migraines. The patient had known allergies to Sulfa, and codeine. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), on unspecified date for COVID-19 immunization. On 11Jan2021 at 10:15 AM, the patient experience vertigo (reported as caused disability); fluid in ears and lungs, muscle weakness, inability to walk normally, dizzy, nauseous, flu like symptoms for two weeks, shooting sensations down both arms, , memory issues, trouble speaking, thinking, and understanding, joint pain, headaches, varying rashes that she have never experienced on my body in various areas. The patient visited the physician office and had an emergency room visit due to the events. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient was tested for COVID-19 and it was negative on 03Feb2021.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the vertigo and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including Head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-03-03 hot flush Initial reaction occurred approximately ten hours after the vaccine, chills and injection site soren... Read more
Initial reaction occurred approximately ten hours after the vaccine, chills and injection site soreness, exhaustion next day hot flashes and body pain, following day (day3) just tired thought it was getting better then day 4 extreme dizziness, nausea, exhaustion, increased body pain especially behind left shoulder day 5 and today same
33 2021-03-03 feeling hot Patient developed severe itching and hives. Felt warm, no SOB. 10ml(liquid) Benadryl administered... Read more
Patient developed severe itching and hives. Felt warm, no SOB. 10ml(liquid) Benadryl administered PO and 911 called. Assessed by the medics: 141/86, SR - 92, O2Sat 100% Transported to the emergency room for further assessment
33 2021-03-04 pain in extremity Arm redness, swelling and soreness
33 2021-03-04 numbness I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30... Read more
I received my first dose of the Pfizer COVID-19 Vaccine on 3/2/2021 in my left arm. After approx. 30 minutes of receiving my shot my left side of my face felt numb including the left side of my tounge as well as muscle pain and soreness on the left side on the back of my neck. Today is 3/5/2021, my face is slowly becoming less numb over time and rest. I also experienced fatigue and injection site soreness. I am particularly concerned about my face becoming numb shortly after receiving my vaccine and I am wondering if I should get a second dose when I need to?
33 2021-03-04 muscle twitching Intermittent muscle twitching throughout body.
33 2021-03-04 pain in extremity My left arm hurts every time I move it, I cannot move my arm back or out away from my body without p... Read more
My left arm hurts every time I move it, I cannot move my arm back or out away from my body without pain. My vaccine was on 2/10/21 and I am in still in pain.
33 2021-03-05 weakness Fever, extreme joint pain, bruising at injection site, arm fever at injection site, week and then mo... Read more
Fever, extreme joint pain, bruising at injection site, arm fever at injection site, week and then mobile for a day.
33 2021-03-06 burning sensation Throat swelling and closing, burning sensation on my face, and tingling lips (all reactions began ap... Read more
Throat swelling and closing, burning sensation on my face, and tingling lips (all reactions began approximately 10-15 min after injection). Provider at PHARMACY gave me oral Benadryl, which has helped, but I still don't feel 100% (it has been 1 hour 45 minutes)
33 2021-03-07 migraine, weakness 3/7/2021 7:00 AM - Experiencing weakness, fatigue, chills, nausea, chest pain upon inhaling, rashes ... Read more
3/7/2021 7:00 AM - Experiencing weakness, fatigue, chills, nausea, chest pain upon inhaling, rashes on other parts of the body. 3/8/2021 Experiencing sore throat, weakness, fatigue, headache, migraine, dizziness, brain fog, nausea, decrease in appetite, and rashes on other parts of the body.
33 2021-03-07 breast pain Mastalgia, as severe/sharp/stabbing pain in the left breast, started ~36 hrs following administratio... Read more
Mastalgia, as severe/sharp/stabbing pain in the left breast, started ~36 hrs following administration of the 2nd dose of the vaccine, some lymphadenitis noted in the right armpit ~10 hrs following receiving the dose, no adverse reaction noted following the 1st dose (21 days ago).
33 2021-03-07 night sweats On 3/5 @ 10pm, the patient experienced fatigue and sore throat On 3/6, she experienced muscle aches ... Read more
On 3/5 @ 10pm, the patient experienced fatigue and sore throat On 3/6, she experienced muscle aches in the calves and sore throat. She also produced green mucus. She developed a low grade fever temp 100 F for which she took Tylenol. She also had night sweats. The symptoms have resolved since then and her COVID test was negative.
33 2021-03-08 weakness, numbness I began feeling dizzy and nauseous about 2 hours after injection and tried to lie down but was unabl... Read more
I began feeling dizzy and nauseous about 2 hours after injection and tried to lie down but was unable to rest. I felt like I had taken adrenaline or steroids and couldn?t sleep that might. The next morning I did not want to get out of bed. My body, particular along my spine, was in so much pain that I began crying. On Monday I called in sick to work. I had almost total numbness in my left arm arm, hand, and upper body. Periodically my heart would race and feel as if was about to beat out of my chest. I started to black out in the grocery store and continue feel dizzy and weak. This is my second day off of work and I have only gotten out of bed to perform essential tasks. I am nauseated and am having trouble eating. I feel like I?ve been run over by several cars and can?t feel my left pinkie. I don?t remember ever feeling this bad for any past illness.
33 2021-03-08 tremor I woke up 2am on 2/10 around 18 hrs from second dose with fever 100.9. I exp really bad cold, shakes... Read more
I woke up 2am on 2/10 around 18 hrs from second dose with fever 100.9. I exp really bad cold, shakes, and extreme nausea. On various parts of my body exp body aches and regular headache.I was fatigue had to cancel some job projects.When the Tylenol would wear off my fever would come back into the 99 area. I continued to administer Tylenol and took Zofran for nausea.The next day on 2/11 I felt better not as severe as day before no symptoms.My OBGYN was contacted everything was normal.(estimated date of delivery 9/30/2021).
33 2021-03-08 pain in extremity Sore arm, nausea (throwing up), headache. Self treated at home with over the counter medications (ty... Read more
Sore arm, nausea (throwing up), headache. Self treated at home with over the counter medications (tylenol & advil)
33 2021-03-08 pain in extremity The injection site is raised and the size of a quarter. It?s red and has a fever. My left arm is in ... Read more
The injection site is raised and the size of a quarter. It?s red and has a fever. My left arm is in sore. It has felt this way since a few hours after getting my shot yesterday morning. Also I have been tired since getting the shot yesterday.
33 2021-03-08 numbness, tingling numbness and tingling in left arm that lasted about 2 hours
33 2021-03-09 tremor, flushing Fever, chills, lightheaded, trouble breathing, feeling flushed, shaking.
33 2021-03-09 pain in extremity Immediately after vaccination (2/27) I felt a lot of pain in my left arm. The soreness lasted for a... Read more
Immediately after vaccination (2/27) I felt a lot of pain in my left arm. The soreness lasted for about 48 hours then went away. I had other symptoms (headache, body aches, dizzyness, nausea, exhaustion). After about 4 days, I had no more symtpoms. I was regularly exercising during this time, so symptoms were not debilitating. On Sunday 3/7 I woke up to a lot of pain in my armpit and side chest. It hurt a lot. I still went for a run (7 miles). On Monday 3/8 I went for a 4 mile walk. After walk, the site of vaccination (upper left arm) was swollen and red, felt sunburned. It appeared very suddenly midday. I noticed there was a large lump under the skin. I felt aches in my hand, left shoulder, and left side of chest. No respitory problems, only muscular. On tuesday 3/9 the pain did not go away. I went to urgent care and was told it was a delayed allergic reaction. Vitals were said to be okay. Doctor advised usling a sling to relieve weight/pressure. Told to take Benadryl.
33 2021-03-10 feeling cold, tremor 5 minutes after receive the dose, patient complaint not feel good. Her BP was normal. No rash. She... Read more
5 minutes after receive the dose, patient complaint not feel good. Her BP was normal. No rash. She coughed, felt nausea and throwed up. We monitor her closely, and then she stared shaking and felt so cold. At that time we gave her 2 tablets of 500mg acetaminophen. 10 minutes later, she complain of difficult of breathing, and felt something in her throat, we call 911 and administer 1 dose of epi-pen. 10 minutes later, EMT arrived and took her to the hospital .
33 2021-03-10 numbness, tremor, tingling Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: numbness and tingling in hands
33 2021-03-11 pain in extremity 7 days after vaccine, after injection site/arm pain had subsided, vaccination site and surrounding a... Read more
7 days after vaccine, after injection site/arm pain had subsided, vaccination site and surrounding area on arm became extremely sore, sensitive, itchy, and burning -- almost like a bee sting. This area of my arm is very heavily tattooed so it's a bit tough to what's going on on the skin itself, but it appeared there may have been a rash -- bumps/texture and possible redness. This lasted about 3 days and then resolved completely.
33 2021-03-11 feeling hot Anaphylaxis, lightheadedness 33F with hx epilepsy, asthma, and multiple food and drug allergies who... Read more
Anaphylaxis, lightheadedness 33F with hx epilepsy, asthma, and multiple food and drug allergies who reported that she was experiencing chest pain/heaviness as well as feeling warm and throat tightness shortly after receiving her first COVID vaccine.
33 2021-03-11 tremor, feeling hot, feeling cold Within 5 minutes, I felt burning sensation in my chest; in 10 minutes - I started getting chills and... Read more
Within 5 minutes, I felt burning sensation in my chest; in 10 minutes - I started getting chills and within 15 minutes chills were a lot worse. They placed me on a gurney, and the chills started getting so bad I was shaking and out of control and I was really cold. After about 25-30 minutes after I felt like my blood pressure dropped and I actually passed out and once I passed out I don't know how long I was out for. Maybe less than a minute, I couldn't breathe and I was hyperventilating and they put a oxygen mask on me. They took me to ER (Hospital) and I recognized I was in there when I "woke up" - they were trying to get an IV in me but I was shaking so much it took several attempts. They gave me several medications because I was nauseated as I wanted to vomit and they gave me anaphylactic medications. I was having chest pains. I fell asleep. They were going to admit me but I kind of refused to be admitted and they let me go with Zofran, prednisone and one other medication. One of coworker took me home. I slept the rest of the day and night. The next day, Really fatigued and chest pain was semi getting better. Breathing - was pretty okay after that. By day 3, I was fine.
33 2021-03-11 tingling tingling in arm. Felt woozy. VSS. Observend and symptoms resolved within 20 minutes. Released home
33 2021-03-12 feeling hot Large hard red spot, sore, hot, full body burning up, tiredness.
33 2021-03-12 numbness, tingling, pain in extremity The day after second injection, I started having sensitivity to temperature on hands and feet, left ... Read more
The day after second injection, I started having sensitivity to temperature on hands and feet, left arm pain(not just at the injection site), and numbness of hands and feet on and off. When cold air hit my legs I would get a bone chilling pain. When washing my hands if the water got above warm it was was painful. My hands and feet were falling asleep at night and waking me up due to being uncomfortable.. This lasted about two weeks. A week in I called the vaccine clinic who contacted my doctor. My doctor had me wait another week before setting up an appointment. I want to urgent care in the mean time due to anxiety over the situation and the doctor there diagnosed a pinched nerve in my neck. I met with my regular doctor a few days later and symptoms were at a minimal. She told me to fill out this form and take Advil if the pain continued.
33 2021-03-13 breast pain This is more like a side effect no adverse effect as of today. Since my first dosage during my last ... Read more
This is more like a side effect no adverse effect as of today. Since my first dosage during my last two ovulations months I have experience more intense breast pain and I never feel like that. After ovulation is over pain goes away as normal.
33 2021-03-14 burning sensation I am currently 21 weeks pregnant. is due July 24th, 2021. This is my first pregnancy and I?ve had no... Read more
I am currently 21 weeks pregnant. is due July 24th, 2021. This is my first pregnancy and I?ve had no complications. NIPT results indicated no sign of issues. My 20 weeks ultrasound right after my first dose of the Pfizer vax went fine. I developed a rash on my chest days later. 9 days after receiving the vaccine. This is the first time this has ever happened to me. The rash on my chest is red, burning, and itching and has been there for 3 days now.
33 2021-03-14 pain in extremity In a few minute after vaccine, I felt shooting pains in right arm, and some discomfort and intermitt... Read more
In a few minute after vaccine, I felt shooting pains in right arm, and some discomfort and intermittent pain/soreness. Soon after my hand and arm was stiff and impossible to move/bend without discomfort and soreness. It felt arthritic and stiff. My left arm also had a similar less pronounced reaction. I also became tired and a bit disoriented
33 2021-03-14 flushing, tingling, muscle spasms, involuntary muscle movements, feeling hot, pain in extremity Within 15 minutes - hot and flushed, headache. Dizzy. Fever onset first night. Lowgrade, sub 100.4.... Read more
Within 15 minutes - hot and flushed, headache. Dizzy. Fever onset first night. Lowgrade, sub 100.4. General bad feeling. Exhaustion, sore, muscle aches. Felt very hot and flushed even though fever was only 100. These symptoms lasted for 7 days. On day 3, Tuesday, I developed a dull aching pain in both arms. The feeling was like that of a charlie horse in your leg. Dull, painful, like slowly being crushed. Also felt hot pinpoints that itched all over my hands. My hands felt like they were burning, and the itchy pinprick feelings were mostly on my palms and fingers, but would sometimes present up towards my elbows. My hands were somewhat shaky, and still are. Once or twice my hand would flick involuntarily. The sore hurting arm feeling extends all the way up to my shoulder blades. On day 7 I went they gave me a steroid shot and a round of antibiotics. They said it was likely a sinus infection. The symptoms persisted one more day but then the fever resolved Wednesday night, Tylenol took it down and it didn't come back Thursday. The headache, sore back and neck, and arm pain persisted. It is now day 10. I am most concerned about the arm pain, tingling, and shaking. Please advise on whether I should get my second dose. I might go to a hospital for further testing if this doesn't resolve or if it progresses.
33 2021-03-15 tingling 33y/o female presents with difficulty swallowing <10min after receiving the Pfizer vaccine in the le... Read more
33y/o female presents with difficulty swallowing <10min after receiving the Pfizer vaccine in the left arm on 3/16/21. She reports associated throat tightening, difficulty swallowing liquids, shortness of breath, nasal congestion, upper extremity/chest tingling, blurring of vision and feelings of anxiety. She denies lip/tongue swelling/tingling, itching or pain at site of injection. She has h/o allergies to shellfish, cats and bees. No known allergies to medications. Physical Exam: Vitals: BP 174/122, HR 78bpm Skin: non-pruritc erythematous rash of chest, generalized light redness of upper extremities bilaterally. No itching. Cardiac-regular heart rate and rhythm. Radial pulse 2+ Lungs-clear to auscultation bilaterally Plan: EMS was contacted immediately when PT reported difficulty swallowing. EMS placed patient in the ambulance at ~6pm and transported patient to Doctor's Hospital.
33 2021-03-15 numbness, pain in extremity Arm went numb about an hour after receiving vaccine. Approximately 4 hours after vaccination I bega... Read more
Arm went numb about an hour after receiving vaccine. Approximately 4 hours after vaccination I began having sharp pains in lower back, hips, down right leg, and feet. I had a full blown flare up for 3 days following vaccination. Soreness in under arm of left arm.
33 2021-03-15 pain in extremity Body Aches - felt like it was all the way to the bone Chills Fever for 24 hours + Fever of up to 10... Read more
Body Aches - felt like it was all the way to the bone Chills Fever for 24 hours + Fever of up to 104 Fatigue Headaches Sore Arm Hallucinations
33 2021-03-15 weakness Weakness
33 2021-03-16 weakness, cold sweat, nerve pain, pain in extremity - HR spiked within first few minutes of shot; fluctuated up to 180 that day. Both hands were immedi... Read more
- HR spiked within first few minutes of shot; fluctuated up to 180 that day. Both hands were immediately weak and aching. Went to ER to monitor for reaction. - Continuing elevated HR episodes for first week; strong left arm pain?couldn?t move or touch for first few days - Panic attack-like responses approx. once per day for first week. Rush of heat through hands, throat, face, rapid HR, dizziness - Increasing joint and muscle pain; also describe as a deep ?bone pain.? Started in feet, wrists/hands and progressed to both legs, hips, back, neck. Acceleration of symptoms starting on or about 3/14. - Saw PCP multiple times for pain; went to ER on 3/16 for severe pain, weakness. Have been confined to bed or in bath with Epsom salts due to pain. Starting steroid treatment and nerve pain treatment today 3/17. - Also experiencing extreme dry mouth and clamminess. For first week after shot, had tingling/irritated feeling in my tongue any time I ate or drank ? no changes in diet.
33 2021-03-16 pain in extremity Arm and hand swelling, arm pain, headache, muscular pain across back, wheezing off and on (have take... Read more
Arm and hand swelling, arm pain, headache, muscular pain across back, wheezing off and on (have taken albuterol), pain in my chest and down my sides. Shortness of breath and become very winded just moving. Have taken Tylenol. Following up with physician in the morning.
33 2021-03-17 numbness, bell's palsy About 10 min later, I got up to use the bathroom and I was stumbling b/c I was so dizzy. I was sent ... Read more
About 10 min later, I got up to use the bathroom and I was stumbling b/c I was so dizzy. I was sent back to work and eventually sent home for sever dizziness. I was also sent home Sunday and then severe chills along with dizziness and severe fatigue. I literally laid in bed for days after the shot b/c I felt like I was about to throw up when I moved. I ended up being diagnosed with Bell's Palsy. The side of my face was drooping. My doctor is saying that I ended up with positive Hep C results, which he thinks if false and due to the Bell's Palsy from the vaccine. I am still having issues. I still have days where the right side of my face will numb and droop. I was told it could take up to 6 months to heal or it could be permanent.
33 2021-03-17 numbness Heart racing, extreme lightheadedness and dizziness, extreme sweating, numb/tingly arms and hands, m... Read more
Heart racing, extreme lightheadedness and dizziness, extreme sweating, numb/tingly arms and hands, moderately swollen tounge.
33 2021-03-17 difficulty speaking thirsty sensation, dizzy, throat hoarse, denies any breathing problems,
33 2021-03-18 muscle spasms, weakness Experienced the following symptoms in the 24 hours after receiving the second dose: Elevated tempera... Read more
Experienced the following symptoms in the 24 hours after receiving the second dose: Elevated temperature, diarrhea, sore throat, cough, headache, sinus inflammation, dizziness, nausea, muscle pain, weakness, body aches and muscle spasms, lack of energy, trouble breathing, insomnia.
33 2021-03-18 pain in extremity, numbness, tingling Five minutes after administration, patient states arm felt numb and tingled. Ten minutes later she ... Read more
Five minutes after administration, patient states arm felt numb and tingled. Ten minutes later she felt pain and tingle in fingers. After 45 minutes patient has soreness on hand and palm
33 2021-03-18 flushing Flushing, tachycardia Exam: General: Alert, no acute distress HEENT: airway patent Cardiovas... Read more
Flushing, tachycardia Exam: General: Alert, no acute distress HEENT: airway patent Cardiovascular: RRR Respiratory: Normal effort, CTAB Extremities: Moves all fours equally Skin: No rash Neuro: Oriented x 3 Interval Time: 1145A Reports she feels better
33 2021-03-18 breast pain Monday, I got a fever and my breast was hurting. I thought it is Mastitis again, so called OB and wa... Read more
Monday, I got a fever and my breast was hurting. I thought it is Mastitis again, so called OB and was given antibiotics.
33 2021-03-19 difficulty speaking 33 yr.. female AAO x4, CC possible allergic reaction. Pt. had Pfizer Covid-19 vaccination (lot EP695... Read more
33 yr.. female AAO x4, CC possible allergic reaction. Pt. had Pfizer Covid-19 vaccination (lot EP6955 exp 06/31/21) and started to experience some tightness in her throat. Paramedics on site evaluated and of medical site lead a decision was made to activate EMS due to pt. advising her bottom lip was swelling a little and her voice was changing slightly. Crew showed up scene, evaluated pt. and got an AMA release with the caveat that her mom would drive her direct to the hospital. On site paramedics also advised pt. Had wheezing in upper R lobe, which resolved upon arrival. Pt. has medical hx of anaphylaxis to peanuts (carries EpiPen) and bipolar type ii disorder, medications of Lamictal and bupropion. Tx: pt was administered 25 mg Benadryl PO . Pt was further evaluated with course listed as above. Vitals were BP 110/72, P 90 R 16 97% on RA Pox. Follow-up: pt went, was seen in ED and was given diphenhydramine, Pepcid and a steroid. Pt. discharged to home with no further incident. Pt. advised to advise vaccination staff of reactions she had for second appointment.
33 2021-03-19 pain in extremity On the second day of the vaccine, I experienced a severe headache, muscle pain in both of my legs, a... Read more
On the second day of the vaccine, I experienced a severe headache, muscle pain in both of my legs, and a mild fever, on Wednesday I felt better, but on thursday I began to have a mild headache with shooting pain to the back of my head near my right ear and it has been painful ever since.
33 2021-03-20 muscle twitching Night of second dose, I had involuntary twitching in my arms and legs throughout the night that caus... Read more
Night of second dose, I had involuntary twitching in my arms and legs throughout the night that caused me to not be able to sleep. On 3/15, I began to feel pain on my skin. I developed a shingles rash on 3/16. I was diagnosed with shingles on 3/18.
33 2021-03-21 numbness Numbness on left side of neck (same side shot was administered), numbness comes and goes throughout ... Read more
Numbness on left side of neck (same side shot was administered), numbness comes and goes throughout the day
33 2021-03-21 unresponsive to stimuli Per vaccinator's account, patient became unresponsive immediately following IM injection at 1440 int... Read more
Per vaccinator's account, patient became unresponsive immediately following IM injection at 1440 into left deltoid and slumped down in chair. Vaccine Floor Manager (reporter of this Adverse Event) was called over who then radioed for the on-site paramedics to respond. Vaccinator verified patient was still breathing. She was bradycardic with a pulse in the 40's per vaccinator. Within 15-20 seconds of becoming unresponsive, patient became responsive as paramedics came into vaccine room. Paramedics took vitals and measured a systolic blood pressure of 80 and pulse 44-50 BPM, 98% oxygen. Patient was alert and oriented at this time, transferred to a transport chair and sent to on-site Emergency Room for further evaluation. As staff were leaving the clinic site at approximately 1630 (including this reporter), we encountered patient self-ambulating in no apparent distress back to her car having been discharged from the emergency room.
33 2021-03-21 weakness, pain in extremity Received shot ~12:15pm on March 21st. Only symptom throughout the day was sore arm, but tolerable. A... Read more
Received shot ~12:15pm on March 21st. Only symptom throughout the day was sore arm, but tolerable. Around 10:30 PM, I was in bed and noticed that I feel "agitated" and restless. Looked at my FitBit and noticed that my heartrate was unusually high and climbing. My normal resting heartrate is 60-70 bpm. Last night from 10 PM and onward, it rose from 75 pm up to 130 bpm while I was laying down in bed. Soreness in my arm became much worse and more uncomfortable. I focused on breathing slowly and deeply to try to relax myself but did not have any effect. Throughout the night I could feel my heart racing, fluttering and palpitating. Sometimes I could feel "pinching" like sensations too. Every time I was able to fall asleep, I was quickly jolted awake by those fluttering and racing sensations in my chest. I got up ~2 hours later to get a drink of water and had a low-grade panic attack (lost sense of hearing), felt very weak and light-headed, started sweating profusely. Those symptoms let up a bit around 4AM and I was able to sleep lightly. I continued to feel "agitated" and restless all morning until about noon today, a full 24 hours after the shot, 12 hours after symptoms started. My resting heart rate finally started to return to normal at about that time as well. Felt fine and pretty normal by about 1:30ish PM today.
33 2021-03-21 discomfort Severely itchy and red skin (rashes) on the front neck at night during sleep. It's gone better after... Read more
Severely itchy and red skin (rashes) on the front neck at night during sleep. It's gone better after waking up, but it is still bothersome and itchy (not as severe as at night).
33 2021-03-22 tension headache Dizziness, tightness in head. Patient states that symptoms eased after 10m minutes. She ate some p... Read more
Dizziness, tightness in head. Patient states that symptoms eased after 10m minutes. She ate some pretzels.
33 2021-03-22 hot flush It started about 20 minutes after vaccination. I started to feel a rush of heat like a hot flash and... Read more
It started about 20 minutes after vaccination. I started to feel a rush of heat like a hot flash and my heart was racing while I was driving home. My cheeks and lips were swelled up. My tongue was starting to swell but I could still breathe. I was wheezing so I took a Benadryl and then took another four hours later. I felt very light headed for the rest of the day. The light headedness and dizziness stayed for a few days with a headache. I did not have second dose on the recommendation of my doctor. I ended up contracted Covid-19 three weeks after the vaccine.
33 2021-03-22 feeling hot, tingling, paralysis, inability to speak While I was waiting during the 15 minute window, I started to feel light headed and saw black spots.... Read more
While I was waiting during the 15 minute window, I started to feel light headed and saw black spots. I told the nurse I didn't feel well and wanted to wait a little longer. Within 10 minutes or so, I started to experience tingling sensation all over my face and then it spread to my neck and then to the rest of my body. My face started to feel stiff and I became really hot. My tongue felt swollen and my entire jaw felt very stiff. I lost my ability to speak and then eventually had full body paralysis. I could not move any limb. I could hear and see, but I could not verbalize a response or move any part of my body. I remained in this state for about 1.5 hour. Afterwards, I regained my motor skills and my speech.
33 2021-03-23 burning sensation 3/2/21-Low grade fever and headache. 3/3/2021-Itching covering entire body started around 7PM. 3/5-... Read more
3/2/21-Low grade fever and headache. 3/3/2021-Itching covering entire body started around 7PM. 3/5-Hives started on face. 3/6- Injection site remained swollen, red, warm and firm to the touch. From 3/6-Present had hives moving all over body. Intense itch/burn at times that have been painful. Have been prescribed Atarax 25mg (3/6/2021) and increased to 50mg 3/10/2021, 7 day Medrol Dose Pak(3/10/2021), and a steroid injection (3/18/2021). As of today (3/24/2021) there has been no resolution. Hives continue to move over body, intense itching, and some pain.
33 2021-03-23 weakness, bell's palsy Bell's Palsy; headache; very low energy; This is a spontaneous report from a contactable consumer wh... Read more
Bell's Palsy; headache; very low energy; This is a spontaneous report from a contactable consumer who reported for herself. This 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) at single dose for COVID-19 immunisation on 19Feb2021 04:00 PM. Relevant history and concomitant drugs were unknown. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. No known allergies to medications, food, or other products. The patient stated on the day of my vaccine, she felt fine. She had a slight headache that worsened into the next day, but it was managble. She also felt very low energy, so she laid low. The next day when she woke up on 21Feb2021 she felt fine, no headache and had my energy back. She was feeling fine until she was diagnosed with Bell's Palsy on 05Mar2021 in the Emergency Room at 9:00 AM. She had numbness in her tongue earlier in the day and at night was not able to drink out of a straw or eat off a spoon. Her smile was crooked and so she went in. They ruled out a stroke and tumor and then diagnosed her with Bell's Palsy. The left side of her face was the impacted side with weakness of that side of her face and pain behind her left ear. The patient received medication as treatment. The outcome of event Bell's Palsy was not resolved. The outcome of events headache and low energy was resolving. The reporter considered the events were non-serious. The patient was not diagnosed with COVID-19 prior vaccination; Nor COVID tested post vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Nor any other medications the patient received within 2 weeks of vaccination.
33 2021-03-23 tingling EMS narrative: RESPONDED TO A SPECIAL EVENT1 CALL AT VACCINE CLINIC SITE- CONVENTION CENTER, FOR A ... Read more
EMS narrative: RESPONDED TO A SPECIAL EVENT1 CALL AT VACCINE CLINIC SITE- CONVENTION CENTER, FOR A 33 Y/O F, CC OF AN ALLERGIC REACTION. PT AMBULATED TO SE1 FIRST AID STATION AND REQUESTED SPECIAL OBSERVATION DUE TO ADVERSE/ALLERGIC REACTION AFTER HER 1ST COVID-19 VACCINE INJECTION. PT STATED THAT SHE HAD SWELLING ITCHING AND HIVES AFTER THE 1ST INJECTION, AND HER SYMPTOMS DEVELOPED PAST THE 15 MINUTE OBSERVATION WINDOW, AND PERSISTED FOR THE NEXT 1-3 HOURS, WITH PROGRESSIVE RELIEF FROM ADMINISTERED BENADRYL. SE1 AT THAT TIME ADMINISTERED 1 25MG ORAL BENADRYL, WITH POSITIVE EFFECT ALBEIT SLOW EFFECT. PT ARRIVED AT FIRST AID IMMEDIATELY AFTER RECEIVING HER SECOND VACCINE DOSE, AND REPORTED NO IMMEDIATE SYMPTOMS. AFTER 15 MINUTES PT STATED HER BACK AND EXTREMITIES WERE " A LITTLE ITCHY, AND SHE FELT PIN PRICKS IN HER FINGER TIPS." PT DENIED ANY SOB, CP, NAUSEA, VOMITING, HIVES, OR AIRWAY IRRITATION/COMPROMISE. PT WAS ADMINISTERED 25MG ORAL BENADRYL AT 1015, AND PT WAS OBSERVED FOR 45 MINUTES. PT STATED SHE FELT MUCH BETTER AND DID NOT WISH TO BE TRANSPORTED AT THIS TIME. PT WAS INFORMED OF THE CONDITIONS OF REFUSAL AND THAT NOT SEEKING FURTHER MEDICAL TREATMENT COULD BE DETRIMENTAL TO HER HEALTH, UP TO AND INCLUDING DEATH. PT WAS ADVISED SHE COULD CALL 911 ANYTIME IF HER CONDITION CHANGED OR WORSENED. PT STATED SHE UNDERSTOOD AND SIGNED THE PAPER REFUSAL FORM.
33 2021-03-23 feeling hot Patient developed a sensation of feeling "warm" and reported to the checkout station. I was at the ... Read more
Patient developed a sensation of feeling "warm" and reported to the checkout station. I was at the patient's side and a pulse ox was placed immediately. She appeared otherwise well w/o signs of distress, SOB, or AMS. Patient was given cold water and monitored. SPO2: 99% HR: 73. Within 15 minutes her symptoms improved and patient required not additional monitoring or treatment. She was released from the facility with strict follow up precautions.
33 2021-03-23 pain in extremity Soreness in my arm for a few days, exhaustion 3 hours after injection, and itchiness around the inje... Read more
Soreness in my arm for a few days, exhaustion 3 hours after injection, and itchiness around the injection site around day 2
33 2021-03-24 tingling, numbness 10-15 minutes after dose given: numbness and tingling in both arms and hands 3 hours after dose give... Read more
10-15 minutes after dose given: numbness and tingling in both arms and hands 3 hours after dose given: numbness and tingling spread to left leg from buttocks to toes 4 hours sheet dose given: numbness and tingling in entire left side of body from scalp to toes, including left side of face, back etc. Right arm has intermittent numbness and tingling.
33 2021-03-24 migraine Fever; Chills; Migraine; Vomiting; Nausea; Body aches; This is a spontaneous report received from a ... Read more
Fever; Chills; Migraine; Vomiting; Nausea; Body aches; This is a spontaneous report received from a non-contactable pharmacist (patient, reported herself). A 33-year-old female (who was not pregnant at the time of vaccination), received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 3n6203, and Expiration date was unknown), via an unspecified route of administration, in arm right, on 10Mar2021, 09:00 AM, as a single dose for COVID-19 immunization. Medical history included allergies to NSAIDs. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: El9266, and Expiration date was unknown), via an unspecified route of administration in right arm, on 17Feb2021 09:00 AM for COVID-19 immunization. Patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. It was reported that on 10Mar2021 at 10:00 PM, the patient experienced Fever, Chills, Migraine, Vomiting, Nausea and Body aches. The patient was treated with Zofran ODT, Tylenol and oral rehydration as corrective treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. however, the contribution of underlying medical conditions cannot be excluded with the available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
33 2021-03-25 pain in extremity Hello, immediately after the shot I began Having pain in the arm which I expected. On the third day... Read more
Hello, immediately after the shot I began Having pain in the arm which I expected. On the third day after the shot, I began Having red swelling skin , with a rash that was itching and the skin is hot to the touch. I am Now 11 days after the shot and the injection site is still hot to the touch, itching, red and now swollen. I am A bit concerned as I did Not think the reaction would last this long. I also Still have soreness in the arm. I thought the symptoms would decrease , not increase. Can I please Speak with someone on your staff about this please?
33 2021-03-25 tingling, tremor, numbness I felt some numbness and tingling in the cheeks and nose of my face. I had quick jabby/stabby type p... Read more
I felt some numbness and tingling in the cheeks and nose of my face. I had quick jabby/stabby type pains in my brain (nothing too intense). And light tremors in my legs that made them feel a little weak and hard to walk on. All of my symptoms subsided in about an hour.
33 2021-03-26 feeling hot fatigue, hot skin, weakness, light headed, dizzy, brain fog for 5 days
33 2021-03-29 weakness Severe Cold; Fever; headache; heavy head; tiredness; weakness; This is a spontaneous report from a n... Read more
Severe Cold; Fever; headache; heavy head; tiredness; weakness; This is a spontaneous report from a non-contactable consumer. A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Left Arm on 23Feb2021 11:00 (Batch/Lot number was not reported) as SINGLE DOSE ( at the age of 33 years) for covid-19 immunisation. The patient took dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 04Feb2021 at 09:30 in the left arm. The patient was not pregnant at the time of vaccination. Since the vaccination, the patient has not tested for COVID-19. Medical history included COVID-19 from an unknown date. There were no Allergies to medications, food, or other products and no other medical history. The patient's concomitant medications were not reported. The patient experienced severe cold on 23Feb2021 21:30 with outcome of recovering, fever on 23Feb2021 21:30 with outcome of recovering, headache on 23Feb2021 21:30 with outcome of recovering, heavy head on 23Feb2021 21:30 with outcome of recovering, tiredness on 23Feb2021 21:30 with outcome of recovering, weakness on 23Feb2021 21:30 with outcome of recovering. No treatment was given for the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
33 2021-04-01 bell's palsy, facial paralysis, pain in extremity, numbness, tingling I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due ... Read more
I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation. I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
33 2021-04-06 unresponsive to stimuli On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unrespo... Read more
On the evening of 4/3/2021 the patient was at home, prone in bed, gasped suddenly and became unresponsive. EMS was called and unable to resuscitate. She expired.
33 2021-04-06 pain in extremity second dose produced sore arm, nausea and a headache; second dose produced sore arm, nausea and a he... Read more
second dose produced sore arm, nausea and a headache; second dose produced sore arm, nausea and a headache; second dose produced sore arm, nausea and a headache; This is a spontaneous report from a contactable Nurse. A 33-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EJ1485), via an intramuscular route of administration, anatomical location Arm left Deltoid left On 12Jan2021 12:55 at single dose for Covid-19 immunization. The patient medical history included HSV I Onset date 01Apr2008 Ongoing outbreaks 6xyear, exacerbated with viral infection, Onset date: 05Apr2020 no change in breastfeeding frequency or output, on 19Dec2020 Viral illness, sore throat, congestion. 23Dec2020 05:00 soreness, headache, myalgias fatigue. The patient historic vaccine include first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EJ1685, Expiration Date: unknown), via an intramuscular route of administration, On 22Dec2020 at single dose for COVID-19 immunization. Concomitant medication included Prenatal vitamin DHA Start date: 03Aug2019 Indication: dietary supplement, ibuprofen 200-400mg 12Jan2021 Indication: Body aches, Tylenol 500mg Indication: headaches. The patient experienced second dose produced sore arm, nausea and a headache. Vaccination facility type, at Hospital. On 21Dec2021, the patient underwent lab test SARS-CoV-2 test Nasal Swab result-negative. The outcome of event was recovering.
33 2021-04-06 tension headache, migraine the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was ... Read more
the back (mostly left side) of her head gets so tight and sore; felt like the back of her skull was fractured/the back (mostly left side) of her head gets so tight and sore; all color drained from her face; tunnel hearing; tunnel vision; felt the worst feeling about to faint; felt a "static" feeling all over her body; throwing up; fever; migraine; aches; Chills; hot sweats; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6207), via an unspecified route of administration in the left arm on 13Mar2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma and lactose Intolerance- not allergy though (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: fluticasone propionate/ salmeterol xinafoate (ADVAIR), loratadine, bupropion hydrochloride (WELLBUTRIN), and vitamins (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EN6200), via an unspecified route of administration in the left arm on 20Feb2021 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunization. The patient stated that 24 hours after her second dose (14Mar2021 12:00), she felt the worst feeling about to faint, all color drained from her face. She got tunnel vision/hearing and felt a "static" feeling all over her body. Then started throwing up. She took a nap and woke up an hour later with 101.2 (degree) fever (14Mar2021) and fought that, along with migraine, aches, chills, hot sweats (14Mar2021). About 8 hours after initial fever (14Mar2021), it spiked to 102.4 (degree) for two hours. It came down quick. The next day, 15Mar2021, it felt like the back of her skull was fractured. And since then (unspecified date), the back (mostly left side) of her head gets so tight and sore especially when laying down. She has been sleeping on heating pad for 10 days now, and it got a little better but still super sore (head). The events involved a doctor or other healthcare professional office/clinic visit. Treatment was received for the back (mostly left side) of her head gets so tight and sore. There was no treatment for the other events. The outcome of the events was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
33 2021-04-08 bell's palsy Bells Palsy. Started 1 hour and 20 minutes after my second vaccine dose was administered. Currently ... Read more
Bells Palsy. Started 1 hour and 20 minutes after my second vaccine dose was administered. Currently hospitalized and having tests run.
33 2021-04-10 pain in extremity Fatigue and bilateral leg discomfort for 2 days after second dose. Then, 4 weeks later developed sev... Read more
Fatigue and bilateral leg discomfort for 2 days after second dose. Then, 4 weeks later developed severe fatigue, back , buttocks and bilateral leg pain and weakness going down to feet. At this point almost 4 weeks after second set of symptoms appeared, I am in constant moderate to severe pain and weakness in my back, buttocks and both legs and can barely walk. I am using a walker for support.
33 2021-04-11 seizure Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Patient felt diz... Read more
Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Additional Details: Patient felt dizzy for 5 minutes after getting the vaccine, she got on her knees, and then passed completely out. Her body was rigid and was unresponsive for about 30 secs. The patient woke back up and thought she has urinated. We took her vitals and her BP came up 141/131 Pulse 88. The paramedics arrive ad when they took her BP it was 137/82. She refused transport to the hospital. When she left the store she was feeling normal.
33 2021-04-12 flushing pericarditis; SOB; facial edema; wheezing; flushing; tachycardia; received the first dose of BNT162B... Read more
pericarditis; SOB; facial edema; wheezing; flushing; tachycardia; received the first dose of BNT162B2 via subcutaneous; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient received the first dose of BNT162B2 (Lot Number: EJ1686), subcutaneous, administered in right arm on 20Jan2021 13:15 (at the age of 33-year-old) as single dose for COVID-19 immunization. Medical history included penicillin allergy and COVID-19 on 28Dec2020. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021 13:30, the patient experienced SOB, facial edema, wheezing, flushing, tachycardia and pericarditis. The adverse events resulted in Doctor or other healthcare Professional office/clinic visit, Life Threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the events which included Epinephrine, prednisone, albuterol, diphenhydramine. The outcome of the events was recovered with sequelae.
33 2021-04-14 flushing person reported being 5 months pregnant. no previous known allergies to foods or medications. receiv... Read more
person reported being 5 months pregnant. no previous known allergies to foods or medications. received her 1st covid vaccine; in obs area and within 15 min she reported feeling flushed and having trouble breathing. No hives or airway swelling; diaphoretic, bp 80/40, dizzy, nauseous complaining of throat closing. Transported to ED by 911. Reportedly released from ED.
33 2021-04-15 pain in extremity Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; severe ... Read more
Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; severe nausea; pain down from injection site; pain down from injection site to in between 3rd and 4th fingers; pain also moving up into neck and upper spine that began; Neck pain/whiplash like neck pain/pain also moving up into neck / Neck tenderness persisted; This spontaneous report from a contactable Nurse (Patient). A 33-year-old female patient (non-pregnant) received second dose BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in Right arm on 02Feb2021 07:30 AM for COVID-19 immunisation. The patient medical history not reported. Concomitant medications included ibuprofen (The patient received ibuprofen within 2 weeks of vaccination). There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient received first dose of BNT162B2 (PIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL5249), via an unspecified route of administration, administered in Right arm on 12 Jan 2021 09:00 AM for COVID-19 immunisation. On 02Feb2021, 9:30PM, the patient had neck pain stemmed from injection site approximately 14h post vaccination, along with severe nausea. 24h post vaccination whiplash like neck pain that lasted approximately 24h. Neck tenderness persisted, although not severe after 24H. "Tingly" pain down from injection site to in between 3rd and 4th fingers, pain also moving up into neck and upper spine that began about 4 days post vaccination. Unable to get relief with Tylenol, Motrin or muscle relaxers. At the time of this report event outcome was not recovered.
33 2021-04-16 paralysis Patient experienced paralysis from the lower chest to toes 12 hours after vaccination. She was take... Read more
Patient experienced paralysis from the lower chest to toes 12 hours after vaccination. She was taken by ambulance to the Hospital, then transferred to another Hospital. She will now be transferred to the a Clinic.
33 2021-04-22 tenderness After I received my first dose I started to experience my first symptom on March 30, 2021. I noticed... Read more
After I received my first dose I started to experience my first symptom on March 30, 2021. I noticed that I had a small lump on the left side of my rib cage beside my left breast which was about the size of a sausage link. The area wasn't painful, slightly tender to the touch and soft. By 4/3/21 the area has expanded to the upper portion of the scapula and it was no longer located on the side of my rib. It was about the size a pear and it was inflamed and very tender to the touch. I couldn't raise my arm and it was pertruding from my clothing and preventing me from sleeping at night on that side. By 4/5/21 the mass had turned into a different shape and direction and it was no longer just primarily on my scapula.. This current shape favored a boomerang and it started on my lower scapula and wrapped around my arm going directly into the middle of my arm pit.. It was about an 1.5 inches wide, inflamed, painful and wouldn't allow me to fully lift my arm or lay on it.. The mass was hard and didn't move, I visited a prompt care and they couldn't decipher what it was. I began to take tylenol and use cold compress and over a few days the mass began to decrease in size and I was able to increase my range of motion obtaining full extension on 4/17/21. The mass is now smaller than a pencil on 4/22/21 and hardly noticable but it was quite an experience.
33 2021-04-27 pain in extremity Mini Stroke/blockage in left eye; Mini Stroke/blockage in left eye; Sore arm for 1 day after 1st dos... Read more
Mini Stroke/blockage in left eye; Mini Stroke/blockage in left eye; Sore arm for 1 day after 1st dose; Diagnosed with CRVO of the eye; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN1199), via an unspecified route of administration, administered in left arm on 09Mar2021 12:30 (at the age of 33-years-old) as single dose for COVID-19 immunisation. The patient had no known allergy and no other medical history. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm for 1 day. She was diagnosed with CRVO of the eye. On 30Mar2021 she had mini stroke/blockage in left eye. Symptoms noticed about 1 week prior to 30Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for events. The patient did not have COVID prior vaccination and she was not COVID tested post vaccination. The outcome of events was not recovered.
33 2021-04-27 migraine, paralysis loss of consciousness plus all the normal symptoms; paralysis/partial paralysis; Fever of 103.7; dia... Read more
loss of consciousness plus all the normal symptoms; paralysis/partial paralysis; Fever of 103.7; diarrhea; nausea; dizzy; joint pain; migraine; throat swelling; nose swelling; eyes swelling; This is a spontaneous report received a contactable consumer, the patient. A 33-year-old adult [non-pregnant] female received the second dose of BNT162b2 (solution for injection; Lot ER8729 and expiry information not reported) in the right arm via unspecified route on 06Apr2021 at 09:45 (at 33 years-old) for COVID-19 immunisation. Relevant medical history included asthma, allergies, penicillin and adhesive tape allergies, and high blood pressure. Concomitant medications included lisinopril. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (Lot ER7531) in the right arm on 16Mar2021 at 09:45 (at 32-years-old). The patient previously received treatment for an unspecified indication with hydrocodone bitartrate/paracetamol (NORCO) and experienced an allergy. The denied being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at time of vaccination, and the patient denied receiving any other vaccine within four weeks of this vaccine. On 06Apr2021 at 20:00 the patient experienced fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms. The patient reported as a result of the events the patient sought care with a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was tested for COVID-19 since the vaccine with nasal swab test on 07Apr2021 and was negative. Treatment for the events received in the emergency room (ER) included diphenhydramine HCl (BENADRYL), ibuprofen, and acetaminophen (TYLENOL). The outcome of the events, fever of 103.7, diarrhea, nausea, dizzy, paralysis, partial paralysis, joint pain, migraine, throat swelling, nose swelling, eyes swelling, loss of consciousness plus all the normal symptoms, was not recovered.
33 2021-04-28 weakness 33 year old female with no significant past medical history presents to the ED with syncope s/p rece... Read more
33 year old female with no significant past medical history presents to the ED with syncope s/p receiving first COVID-19 vaccination this evening at 1758. The patient states that she completed her 15 minutes of observation when she suddenly felt dizziness after standing and had a syncopal episode, waking up on the ground. Per the nurse at the scene, the patient hit the back of her head. The patient does not remember hitting the back of her head as she lost consciousness prior to falling. Since then, the patient has been experiencing symptoms of generalized weakness and intermittent nausea, but denies symptoms of headache, visual changes, vomiting, neck pain, back pain, shortness of breath, chest pain, or abdominal pain. The patient has had normal PO intake today. She reports that she has had three separate syncopal episodes s/p getting her blood drawn in the past, but denies syncopal episode s/p receiving vaccinations in the past. The patient is an otherwise healthy individual with no known drug allergies, taking no daily medications, and denies the use of alcohol, tobacco, or drugs. Her last normal menstrual period was completed recently and she denies any chance of pregnancy, recent pregnancies, or currently nursing.
33 2021-04-29 tingling Dizziness, temporary shortness of breath, has to lay down as for vasovagal response, tingly abs temp... Read more
Dizziness, temporary shortness of breath, has to lay down as for vasovagal response, tingly abs temporarily, nausea 10 minutes
33 2021-04-30 facial paralysis my face was paralyzed slightly due to Bell's palsy; my tongue had a sore; I got pain in my jaw and p... Read more
my face was paralyzed slightly due to Bell's palsy; my tongue had a sore; I got pain in my jaw and pain in my left side of my neck for about 3days; I got pain in my jaw and pain in my left side of my neck for about 3days; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7534) via an unspecified route of administration, administered on the left arm on 17Mar2021 13:00 at a single dose for COVID-19 immunisation. Medical history included Bell's palsy (prior case, 9 1/2 years ago). The patient's concomitant medications were not reported. On 21Mar2021 12:00 PM, within the 3rd day her tongue had a sore. It went away and she got pain in her jaw and pain in the left side of her neck for about 3days. Then, her face was paralyzed slightly due to Bell's palsy. It went away within a week and a half. Treatment was received for the events which included medication to help with Bell's palsy. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The facility where the vaccine was administered was in a Public Health Department. No known allergies. Outcome of the events was recovered on an unspecified date in 2021.
33 2021-05-04 tremor, migraine Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head ... Read more
Presyncope severe disequilibrium; Presyncope severe disequilibrium; vertigo; nausea; migraine (head and ear pressure); migraine (head and ear pressure); migraine (head and ear pressure); tinnitus; tremors; Vestibular disturbances; This is a spontaneous report from a non-contactable Nurse (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 07Apr2021 10:00 AM at single dose for COVID-19 immunisation in Pharmacy or Drug Store. Medical history was none. If No other vaccine in four weeks. No Known allergies. No other medications in two weeks. Patient was not pregnant. Patient experienced Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors. Vestibular disturbances lasting for Weeks. Adverse event start date was 14Apr2021 03:15 PM. event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No covid prior vaccination. no covid tested post vaccination. Treatment received for the events with Steroids, Xanax, Benadryl, ibuprofen. Patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of Presyncope severe disequilibrium, vertigo, nausea, migraine (head and ear pressure), tinnitus, tremors and Vestibular disturbances due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
33 2021-05-05 migraine, muscle spasms, pain in extremity Migraine, muscle spasms, heart palpitations, arm soreness. All set in swiftly within a 30 minute per... Read more
Migraine, muscle spasms, heart palpitations, arm soreness. All set in swiftly within a 30 minute period, two and a half days after the vaccine was administered.
33 2021-05-06 paralysis, tremor, tingling, pain in extremity, numbness, facial pain, burning sensation, weakness Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck... Read more
Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head; new and sudden onset of popping joints; Temporary paralysis and numbness upon waking up in the morning; Temporary paralysis and numbness upon waking up in the morning; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands; Heart rate spike to 180; dizziness; sweating; sudden aching and weakness in both hands, progressed upwards through legs, hips, arms, back, neck and head; sudden aching and weakness in both hands; Severe head and facial pain; Severe head and facial pain; Pain, tingling, burning, and weakness in extremities and limbs; Pain, tingling, burning, and weakness in extremities and limbs; Vibrations/tremor-like sensation in upper back; Tingling tongue; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EN6200, first dose) solution for injection intramuscular in the left arm on 27Feb2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. Medical history included SVT (supraventricular tachycardia). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 27Feb2021, the patient experienced heart rate spike to 180 within first 2-3 minutes of vaccine with dizziness, sweating and sudden aching and weakness in both hands; severe head and facial pain, pain, tingling, burning, and weakness in extremities and limbs; vibrations/tremor-like sensation in upper back; tingling tongue; severe muscle fatigue; experiencing pain, weakness, and tingling in upper back, both arms and hands, sent to ER for monitoring. Continued heart rate spikes for approx. 7 days afterwards. Severe pain and weakness in extremities that progressed upwards through legs, hips, arms, back, neck and head over 1 week period. On 09Mar2021, 10 days after vaccination; two more ER visits. Severe head and facial pain. Pain, tingling, burning, and weakness in extremities and limbs. Vibrations/tremor-like sensation in upper back. Tingling tongue, new and sudden onset of popping joints, temporary paralysis, and numbness upon waking up in the morning. Multiple lab work orders, X-rays, MRIs - all ruled out other causes/conditions in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, with disability or permanent damage due severity of symptoms required 4 weeks of medical leave from work. Treatment for the events included medication and physical therapy. The outcome of the events was not recovered. Post vaccination, a Nasal Swab, Covid test result was negative in Mar2021.
33 2021-05-06 flushing Tachycardia, dizziness, sweating, flushing, vitals wnl Given 4 ounces of juice.
33 2021-05-12 tingling This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregna... Read more
This is a spontaneous report from a contactable consumer (patient herself). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in left arm on 06Feb2021 at 14:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's disease, hypertension, known allergies: Food allergies (known allergies: Banana, kiwi), known allergies: Histamine reaction. Concomitant medications included levothyroxine, cetirizine hydrochloride (CETRIZINE), ergocalciferol (VITAMIN D), iodine (KELP), metopro; All drugs were received in two weeks within the vaccination. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that, the patient experienced itchy rash all over body, 2 days after vaccination small pustules, strange tingles on 08Feb2021 at 16:00. No fever. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with IV fluids and medications. The outcome of the events was recovering.
34 2020-12-31 numbness I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a... Read more
I received the vaccine at 10:30 am. About two hours later I noticed a minor headache. By 4pm I had a moderate pounding headache. Around 4:30pm, I noticed minor unilateral scalp, facial and neck numbness on the left side. These symptoms lasted about a week, but slowly improved. Four days after the vaccine I had very tender lymph nodes on the left ear area. Today marks two weeks exactly since I received the vaccine and two days ago I noticed slight increase in numbness on the left cheek again which again, is slowly improving. However, I also wear Invisalign at sometimes notice that I bite my cheek while asleep. I also wear N95 masks four days of the week which are quite tight on the face. The injection site (Left deltoid) was moderately sore for the first few days and still two weeks later has minor soreness the comes and goes.
34 2020-12-31 tingling, flushing, feeling hot It was almost the end of my 15 minutes when my limbs became tingly and that feeling made its way tow... Read more
It was almost the end of my 15 minutes when my limbs became tingly and that feeling made its way towards my torso. I started to feel flush and my heart rate rapidly increased. I felt it was nothing so i tried to calm myself and watch my heart rate on my watch and it continued to increase. It started at 100 and within a minute was at 130. I finally honked my horn for assistance and my symptoms continued. I became very faint and nauseous and felt as though i was going to throw up. open my door and took my mask off to help with getting air and it didn't do much to help. I felt very light headed and uncomfortably closet o passing out than i ever have. This lasted for a good 10 minutes until it slowly passed. Faint, nauseous, hot and rapid heart rate of 130 were my main symptoms and were very uncomfortable.
34 2021-01-01 tingling Received the Pfizer COVID-2019 vaccine and within 5 minutes developed tingling and felt like pins an... Read more
Received the Pfizer COVID-2019 vaccine and within 5 minutes developed tingling and felt like pins and needles in the ring finger and hand of the arm injected (right arm). Started to improve about half an hour later, completely resolved within 2 hours. I was evaluated by our employee health services NP and my HR was slightly elevated but no other concerning symptoms noted.
34 2021-01-02 night sweats About 12 hours after the vaccine, I started developing chills and joint pain. That night, I develop... Read more
About 12 hours after the vaccine, I started developing chills and joint pain. That night, I developed fevers that persisted for about 24h (spiked about 5 separate times - highest fever was 102). Then, on the third night after the vaccine (about 60 hours post vaccine), I had two separate episodes of night sweats (clothes were drenched, no fever). Later that night I had a bowel movement with bright red blood. I then went to an urgent care where they drew labs, send a Covid swab, ordered stool studies, and ordered a CT abdomen.
34 2021-01-02 tingling, sensory loss Approximately 1 week following vaccination, patient developed new onset of right sided hemisensory l... Read more
Approximately 1 week following vaccination, patient developed new onset of right sided hemisensory loss and paresthesia with feeling of mild vertigo. This worsened over the following 4-5 days prompting patient to come to hospital on January 3, 2021 for further evaluation.
34 2021-01-02 tingling, cold extremities, numbness At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting gene... Read more
At 1606 Patient reporting lightheadedness, bilateral hand tingling and numbness. Also reporting generalized headache 6/10. States that she has not eaten any food today except coffee. BP 88/49. HR 45 Patient was laid flat and legs elevated. Repeat BP 1613 101/59. Patient reported bilateral arms feeling "cold".   O: Patient alert and oriented, following commands, no focal weakness. BUE cool to touch.   EMS called at 1609. ED arrival 1620. Repeat VS 1620 105/65 HR 55   Upon EMS arrival patient declined to receive further treatment and signed AMA paperwork.   Discussed with patient to return to ED for any further worsening of symptoms.
34 2021-01-02 pain in extremity On Tuesday 12/28 I started to have severe leg pain in my right leg. The next morning the pain was s... Read more
On Tuesday 12/28 I started to have severe leg pain in my right leg. The next morning the pain was still in the right leg and had moved up through my right side in my joints to my knee, hip then went to the with shoulder down that arm. My forearm became very painful on 12/30 and started to swell then radiated into my wrist joint and finger joints. 12/31 the pain continued in all those areas and had moved to my left side of my body starting with the left arm following the same course as the right side. On 1/1 the pain has persisted and I am unable to perform any ADL's. I saw an urgent care physician who told me to take ibuprofen. I have been taking ibuprofen and Tylenol with no relief. Now all my joints are swelling in bilateral hands, wrist. On 1/2 my bilateral ankle joints and feet started to have similar pain. Know all my extremities are difficult to use and it is hard to walk due to the pain. Because of the pain in my hands things feel heavier than what they should. I am a medical provider and this almost seems like polyarthralgia rheumatica, I am going to go see a physician on Monday
34 2021-01-03 sensory loss, numbness 12/21 had covid vaccine (dose 1). On evening of 12/29 had sudden onset of mild neck pain and signifi... Read more
12/21 had covid vaccine (dose 1). On evening of 12/29 had sudden onset of mild neck pain and significant weakness and numbness of left arm, weak hand grip, clumsiness in hand . Did not improve after trying to shake arm/move around , and took prednisone 40mg oral. Went to ER and had CT Cspine which did not show evidence of cervical pathology. Continued with corticosteroids, sought consultation with PMR and neurology specialists, and steroid dose increased to 60mg/day. Some improvement in strength , but still have diminished sensation and strength in left hand/arm. Unable to perform full job tasks as I am left hand dominant. Likely brachial neuritis / parsonage turner syndrome per both specialists seen. Continuing with corticosteroids at this time, pending bloodwork and OT evaluation
34 2021-01-03 flushing, feeling hot, cold extremities Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her... Read more
Flushing; she noticed that there was a ringing in her left ear; Experienced a weird heaviness on her upper chest and arms/ heavy legs and arms/really heavy arms and legs; experienced a weird heaviness on her upper chest and arms; really cold hands; felt really hot at the injection site/really hot sensation at injection site; lightheadedness/Light-headed; Palpitations; Feeling faint; shortness of breath; Her blood pressure went up to 134/100; paleness; went up to her face; felt tired/She was really tired and slept it off; This is a spontaneous report from a contactable nurse, who is also the patient. This 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK5730) intramuscular in the left deltoid on 20Dec2020 at single dose for COVID-19 immunisation. Relevant medical history included ongoing asthma (diagnosed as a teenager with sports asthma and uses an inhaler). There were no concomitant medications. The patient experienced lightheadedness/light-headed (medically significant) on 20Dec2020 with outcome of recovering, palpitations (medically significant) on 20Dec2020 with outcome of recovered on 20Dec2020, feeling faint (medically significant) on 20Dec2020 with outcome of recovered on 22Dec2020, flushing (medically significant) on 21Dec2020 with outcome of recovered on 22Dec2020, she noticed that there was a ringing in her left ear (medically significant) on 21Dec2020 with outcome of recovering, shortness of breath (medically significant) on 20Dec2020 with outcome of recovering, her blood pressure went up to 134/100 (non-serious) on 20Dec2020 with outcome of recovered on 20Dec2020, she experienced a weird heaviness on her upper chest and arms (non-serious) on 21Dec2020 with outcome of recovering, really cold hands (non-serious) on 21Dec2020 with outcome of not recovered, paleness (non-serious) in Dec2020 with outcome of unknown, felt really hot at the injection site/really hot sensation at injection site (non-serious) on 21Dec2020 with outcome of recovered on 23Dec2020, went up to her face (feeling hot) (non-serious) in Dec2020 with outcome of unknown, heavy legs and arms/really heavy arms and legs (non-serious) on 21Dec2020 with outcome of not recovered and felt tired/she was really tired and slept it off (non-serious) in Dec2020 with outcome of unknown. The patient specified that she experienced a moderate reaction after having the COVID-19 vaccine. She had the vaccine last Sunday morning 20Dec2020. She was told to wait 20 minutes before leaving. In the waiting area, she felt lightheaded, had palpitations and was feeling faint. After 20 minutes she started feeling better. Then she started to have more intense light headedness. She went to the ER and was given oxygen. Her blood pressure was 134/100 on 20Dec2020. She had an EKG on 20Dec2020 that was normal. They gave her steroids and Benadryl. She had another episode while being injected with the steroids. On Monday 21Dec2020, she experienced a weird heaviness of her upper chest and arm. She had really cold hands and flushing. On Monday night 21Dec2020 she went to work. She experienced a really hot sensation to the injection site that went to her neck and face. Her left ear was ringing. This lasted until Tuesday 22Dec2020. She took Benadryl again on Tuesday 22Dec2020. She had shortness of breath which started on 20Dec2020 and on 22Dec2020 she had shortness of breath that lasted until 11am. She had really heavy legs and arms and went back to the ER. She had a chest X-ray and D-dimer on 22Dec2020 that were normal per the ER. The night before the report, she had some of the same symptoms. She was really tired and slept it off. She didn't take anything. The morning of the report, she was feeling good and better. She still has heavy feeling on upper chest and arms. Caller clarifies that she did not have a heavy feeling in her legs. Her arms feel heavy if she holds her phone too long. She continues to have ringing in her ear. The flushing went up to her face. The patient specified that she developed sports asthma as a child and uses an inhaler. She gets short of breath if she overexerts herself. Additional laboratory investigations on 20Dec2020 included blood work with unknown results and Troponin which was normal. She was provided with a general steroid. She did not know the name of it. She was also given Benadryl and monitored on telemetry. She was given IV fluids again on 22Dec2020.; Sender's Comments: Based on the compatible temporal association and the known pattern of response, the Company considers the reported events are possibly related to vaccination with BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-03 feeling hot Hot and lightheaded
34 2021-01-03 feeling hot, tingling Patient received Pfizer COVID vaccine 0.3 mL IM x1 on 1/4/2021 @0808. Patient had NKDA and was obser... Read more
Patient received Pfizer COVID vaccine 0.3 mL IM x1 on 1/4/2021 @0808. Patient had NKDA and was observed for 15 minutes after administration with no adverse reactions observed. Patient returned to work and noticed swelling in left arm around 0900. Patient returned to clinic complaining of left sided arm tingling and feeling hot. Also edema to ear lobe and arm. Patient given Benadryl 50 mg po x 1 liquid @0916. No sign of respiratory distress, blood pressure 134/84, and no other signs of advancing allergic reaction.. Patient discharged to husband @1021.
34 2021-01-03 flushing, burning sensation SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; f... Read more
SOB day of vaccination; not critical. Flushing of ears and face roughly 9 hours after vaccination; followed by fevers 101.0-101.5 overnight. Next day chills, ?feeling of burning from the inside out bilaterally in my lower extremities,occassionally drifting to arms.? Also fatigue.
34 2021-01-03 pain in extremity Slight headache a few ours later after vaccination. The next morning I had headache, some joint/mus... Read more
Slight headache a few ours later after vaccination. The next morning I had headache, some joint/muscle pain, right arm pain and a Fever. That evening/night Fever and chills. The following morning still had a fever and chills. All symptoms were gone later that evening (within 48 hours of initial vaccination time)
34 2021-01-04 feeling hot, pain in extremity, flushing, hot flush Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved... Read more
Felt hot/flushed almost immediately after vaccine. Continued to have hot flashes (afebrile) relieved by Tylenol through the following Tuesday (5 days after vaccine). Hot flashes are intermittent. Also feel fatigued starting Saturday 1/2, improved 1/3, worsening 1/4 into 1/5. Sore arm for about couple days, very mild.
34 2021-01-04 pain in extremity Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other ... Read more
Fever; chills; fatigue; body aches; sore arm; This is a spontaneous report from a contactable other health professional (patient). A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 24Dec2020 09:15 at single dose on left arm for COVID-19 immunization in hospital. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, fatigue, body aches, sore arm from 24Dec2020 21:00. No treatment received for the adverse events. The outcome of the events was recovered on an unspecified date in Dec2020. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.
34 2021-01-04 weakness Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatig... Read more
Light headedness/Dizziness/Feeling like I am going to faint; Body weakness like uncontrollable fatigue; Body weakness like uncontrollable fatigue; severe stomach pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: 30Mar2021), via an unspecified route of administration on 27Dec2020 at single dose for COVID-19 immunization. Medical history included Hashimoto's thyroiditis and fibromyalgia. Concomitant medication included duloxetine hydrochloride (CYMBALTA) as thyroid medication (when probed for thyroid medication, consumer stated, "CYMBALTA." (Indication was not clarified further)) and the patient also took her thyroid medications, medication for fibromyalgia. Consumer stated that she just got the COVID vaccine, her first COVID vaccine yesterday (27Dec2020) and she was experiencing some side effects that were more severe than just pain in my arm. When clarified if had pain in arm, consumer stated "No", she was experiencing light headedness, dizziness, feeling like I am going to faint, severe stomach pain, body weakness like uncontrollable fatigue in Dec2020. The outcome of the events was unknown.
34 2021-01-04 nerve pain Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lowe... Read more
Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), via an unspecified route of administration on the right arm on 18Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included Gyn issues, migraine and headaches but otherwise healthy. The patient also had allergies with sulfa, leminine, and latex sensitivity but not anaphylactic. Concomitant medications included elagolix sodium (ORILISSA), and calcium carbonate, colecalciferol, phytomenadione (VIACTIV). It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination. On 19Dec2020 14:00, the patient experienced nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
34 2021-01-05 pain in extremity 1/6/2021 1245 am: chills, fever. Body ache, left arm aching, headache, fatigue 1:30pm: chills, fev... Read more
1/6/2021 1245 am: chills, fever. Body ache, left arm aching, headache, fatigue 1:30pm: chills, fever, body aches, headache fatigue
34 2021-01-05 feeling cold, tremor 12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so... Read more
12 hours after vaccination I got a low grade fever of 101. I had severe body back aches that were so severe I had a difficult time walking. My injection site (Left deltoid) was swollen and sore, although not more than usual after receiving a vaccine. I had no headache at all. The major concern was the fever and the backaches. I could not get warm, and I was shaking badly because I was so cold. I had ZERO relief despite taking 700 Mg of Tylenol. Side effects finally subsided after about 5 hours.
34 2021-01-05 tingling, numbness, pain in extremity At the time of injection, patient felt pain and a "zinger" at the injection site that traveled up in... Read more
At the time of injection, patient felt pain and a "zinger" at the injection site that traveled up into the left shoulder and down the left arm. A numbness and tingling sensation has continued in the left arm and then all over the body- bilateral upper and lower extremities intermittently since time of injection until current. The sensations are occurring randomly about every 1 minute. No associated muscle weakness or any other neurological changes. Patient has been referred to a neurologist for further evaluation and management.
34 2021-01-05 numbness, tingling Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This... Read more
Bilateral numbness and tingling on entire body; Bilateral numbness and tingling on entire body; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK9231) solution for injection in the left arm on 30Dec2020 at 17:30 (at the age of 34-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included multiple sclerosis. Concomitant medications included fingolimod hydrochloride (GILENYA) and vitamin D3. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 18:00, the patient experienced bilateral numbness and tingling on entire body. It was unknown if treatment was provided for events bilateral numbness and tingling on entire body. The outcome of the events bilateral numbness and tingling on entire body was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
34 2021-01-05 pain in extremity Left armpit pain without mass for 4 days, delayed reaction that did not start until 7 days after vac... Read more
Left armpit pain without mass for 4 days, delayed reaction that did not start until 7 days after vaccine. Initial vaccine reaction w mild sore arm on side of vaccine
34 2021-01-05 numbness, tingling The day after the vaccination, woke up at 0600 and noted numbness and tingling down right lower extr... Read more
The day after the vaccination, woke up at 0600 and noted numbness and tingling down right lower extremity from thigh down to toes. Leg was completely ?asleep? and unable to bear weight. Lasted for approximately one hour. Tingling in extremity lasted throughout day and continued for about 1 week. Also noted minor tingling in left toes and right side of face.
34 2021-01-05 tingling face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous r... Read more
face puffy; Tingling that started at nose and spread across cheeks and lips; This is a spontaneous report from a contactable healthcare professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration in the right arm, on 28Dec2020 at 17:30 (at the age of 34-years-old) at a single dose for COVID-19 immunization. Medical history included sulfonamides allergy. The patient was not pregnant at the time of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks prior to vaccination, included ascorbic acid (VIT C; MANUFACTURER UNKNOWN), curcuma longa (TURMERIC), and collagen (MANUFACTURER) taken as supplement. Additional concomitant medications included unspecified multivitamin (MANUFACTURER UNKNOWN). The patient previously took azithromycin (MANUFACTURER UNKNOWN) and experienced allergy and vortioxetine hydrobromide (TRINTELLIX) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced tingling that started at nose and spread across cheeks and lips on 28Dec2020 at 18:00 and face puffy on 29Dec2020. The events were reported as non-serious. Therapeutic measures were taken as a result of tingling that started at nose and spread across cheeks and lips, which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of tingling that started at nose and spread across cheeks and lips was recovered in Dec2020 and of and face puffy was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
34 2021-01-06 pain in extremity 1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered t... Read more
1) fever/chills/feverish ~96 h 2) severe myalgia ~36h 3) Chest Pain ~1-2 h 4) SOA ~24 h 5) Altered taste ~12h 6) No appetite ~48h 7) Fatigue (couldn't stay out of bed) ~24h 8) Nausea, intermittent ~24h 9) Brain fog ~6h 10) Nasal congestion ~72h 11) Full body COVID like rash with itching on 1/2 ~36h 12) Arm sore/stiff (severe) ~24h 13) Vasovagal episode ~10min
34 2021-01-06 tingling, discomfort, numbness 12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUM... Read more
12/21 VACCINE 11:30. BY 12:30 , TINGLING/NUMBNESS ON L CHEEK BONE. 12/22 I STARTED FEELING MORE NUMBNESS AND PRESSURE ON L CHEEK, TINGLING OF LIPS ON L SIDE, HA ON L SIDE. WENT TO THE ER AROUND 5PM. I TOOK SOME IBUPROFREN, TYLENOL. 12/23 SOMEWHAT RESOLVED FOLLOWING WEEK; SWOLLEN LYMPHNODES ON L SIDE , BACK OF HEAD. COVID TEST; NEGATIVE
34 2021-01-06 pain in extremity Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore... Read more
Day 1 (1-5-21): sore arm bruise Day 2 (1-6-21): more severe sore arm and bruise Day 3 (1-7-21): sore arm that's getting better. Red, inflamed, hot to touch at injection site. 1in x 2in in size.
34 2021-01-06 feeling hot, flushing Estimated due date: 04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for... Read more
Estimated due date: 04/10/2021 I started to get very flush and warm, dizzy so I had to sit down for a moment (I had to stop the procedure I was doing in order to sit down and drink some water). I kept trying to hydrate and had a headache the rest of the day and it went through the evening and night. I did not take anything and went to bed with the headache and woke up and felt fine.
34 2021-01-06 breast pain Felt a faint pain behind my left breast around 30 minutes after receiving the vaccination. I also go... Read more
Felt a faint pain behind my left breast around 30 minutes after receiving the vaccination. I also got the vaccine on my left arm. The dull or faint pain is not constant and I will randomly feel it since receiving the vaccine. This is some thing that I have experience in the past when I have had too much caffeine but in the past it was more prominent whereas right now it?s very light and faint and dull
34 2021-01-06 pain in extremity Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbea... Read more
Increased BP, nausea, lymph node under right arm swollen, fever,aches, chills, dizziness. Also unbearable pain in that arm. Ended up with a trip to the ER with diagnoses of cellulitis to the right arm, (same as vaccinated arm). Currently taking antibiotics.
34 2021-01-06 numbness, tingling Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling... Read more
Light tingling/numbness on Right side down to hands and toes, then through whole body. Began feeling light-headed briefly. Narrative: Patient sat through most of anticipated monitoring time without incident, the reported tingling and numbness developing on the right side which fairly quickly expanded to entire body. Reported mild light-headedness. Continued to monitor closely without other intervention required. Patient stood up, reported feeling better and resolution of symptoms with that movement. Continued to monitor a few more minutes. Patient left area symptom-free at 12:00 with teaching of appropriate calls to make or where to return to should she be further symptomatic.
34 2021-01-06 feeling hot Myalgia all over the body, headache, nausea, vomiting x1, intermittent sheivering and feeling hot
34 2021-01-06 numbness, tingling Patient reported tingling and numbness to one side of face and spreading down her neck. Patient tra... Read more
Patient reported tingling and numbness to one side of face and spreading down her neck. Patient transferred to E.D. for observation.
34 2021-01-06 numbness numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus patholog... Read more
numbness and weakness in left arm; numbness and weakness in left arm; had a brachial plexus pathology; her grip and fine motor are affected in her left arm/she could not do her job; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration in right arm on 21Dec2020 at single dose for Covid-19 immunisation. Medical history included ongoing birth control. No other medical history. Concomitant drug included other medication she took for birth control. On 29Dec2020, the patient experienced numbness and weakness in left arm, had a brachial plexus pathology, went to the emergency department on 30Dec2020 and was seen by one of the facility doctors and stated this doctor had her on steroids for treatment. She got the vaccine in her right arm, stated her grip and fine motor are affected in her left arm. States this was disabling since she could not do her job. She was following up with neurology on Monday (unspecified), that she had a CT scan of her neck and it was normal. Only other medication she was taking was for birth control, but she did not feel like it was relevant. The outcome of events numbness and weakness in left arm was recovering, while outcome of other events was unknown. This case was reported as serious, seriousness criteria was disabling.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-06 numbness and pain in extremities, tingling peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous ... Read more
peripheral neuropathy type symptoms; tingling of the feet, legs, hands, arms; This is a spontaneous report from a contactable Other Health Professional (patient). A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at Left arm on 22Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medication included levothyroxine and multivitamin. No other vaccine in four weeks. The patient was not sure if this was related to the vaccine or not. The patient didn't know if anyone else was having peripheral neuropathy type symptoms such as tingling of the feet, legs, hands, arms. The symptoms started a few days ago. The patient did not even sure if it related to the vaccine. Adverse event start date was 27Dec2020. Covid was not tested post vaccination. The outcome of the events was not recovered. No treatment received for the events. Information on the lot/batch number has been requested.; Sender's Comments: The temporal relationship between the onset of the event and administration of the vaccine does not support a causal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-01-07 difficulty speaking AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE ... Read more
AWOKE DAY 2 FOLLOWING VACCINE WITH POSSIBLE ALLERGIC REACTION: THROAT SORENESS/TIGHTNESS AND HOARSE VOICE, EYES SWOLLEN, ITCHY AND RED. C/O DIFFICULTY BREATHING. DENIED FEVER, CHILLS OR BODY ACHES. MEDICATED WITH BENEDRYL 50 MG AND NO RELIEF. SENT TO ER WITH DIFFICULTY BREATHING.
34 2021-01-07 tingling Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swel... Read more
Administered on Saturday January 2, 2021. On Tuesday started with some ear pain and lymph node swelling. Wednesday much worse lymph node swelling and right side of face with some swelling. Tingling began and bumps with red line formed on forehead. Thursday-same except swelling I'm lymph nodes was so painful it woke me up. Today, Friday January 8th I went to a doctor's care. Diagnosed with shingles.
34 2021-01-07 difficulty speaking Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soren... Read more
Anaphylactic reaction 6 days post vaccine 24Dec2020; I had severe chest tightness; SOB; throat soreness; hoarse voice; mouth swelling; This is a spontaneous report from a contactable physician, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140), via an unspecified route of administration in the left arm on 18Dec2020 at 15:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included severe dust mite allergy (based on skin test). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (NORCO), ibuprofen (MANUFACTURER UNKNOWN), and ondansetron (ZOFRAN); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020 at 10:00, 6 days post vaccination, the patient experienced anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling; all reported as life threatening. The events led to an emergency room visit and she was given epinephrine (EPI-PEN), methylprednisolone (SOLUMEDROL), and diphenhydramine hydrochloride (BENADRYL) as treatment. The patient stated that she developed the reactions 45 minutes after she took premedications for a dilatation and curettage procedure. The premedications included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron. She stated she had taken these medications several times before and this was the first time she had this reaction. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the anaphylactic reaction, severe chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling were recovered on unknown dates.; Sender's Comments: Anaphylactic reactions presented as chest tightness, shortness of breath, throat soreness, hoarse voice, and mouth swelling, developed 45 minutes after premedications including included ibuprofen, hydrocodone bitartrate/paracetamol, ondansetron for a dilatation and curettage procedure and 6 days post vaccination with BNT162B2, the event therefore is most likely attributed to these premedications unrelated to the vaccine use. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-07 numbness, weakness, pain in extremity For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyac... Read more
For the first 10 hours I had a sore arm. 10-12 hours I began having weakness, fevers, chills, bodyaches, low back pain, intermittent neck pain. Following day I had the same symptoms in addition to left sided axillary lymphadenopathy w/ numbness of L hand 4th & 5th fingers and mild cough. Currently I am about 52 hours post vaccine with left sided axillary lymphadenopathy and intermittent numbness of left 4th and 5th fingers. Other symptoms have improved.
34 2021-01-07 throat numbness, tingling Headache, NauseaVomiting, lightheadedness, throat numbness, facial tingling Narrative: 12/28 Onset o... Read more
Headache, NauseaVomiting, lightheadedness, throat numbness, facial tingling Narrative: 12/28 Onset of lightheadedness within 5 minutes of vaccine followed by nausea. After 35 min she felt tingling on her face and felt like her throat was numb. She drank water with no problem. She checked her O2 sat and it remained 91 - 93%. She just had an O2 meter because her Mother-in-law gave it to her. No underlying lung problem. She continues to have mild nausea but other symptoms have resolved. She has been able to eat some food which is making her feel better. She says she is developing tenderness in her temples which feels like she's developing a headache.
34 2021-01-07 tingling, numbness Numbness and tingling over entire body. Settled to left side. Still present 9 days post vaccinatio... Read more
Numbness and tingling over entire body. Settled to left side. Still present 9 days post vaccination.
34 2021-01-07 tingling Paresthesia in lips, hands and feet 15 mins to 3 hours post vaccine Narrative:
34 2021-01-07 pain in extremity Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, ne... Read more
Severe muscle pain and soreness on opposite side of vaccine.; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Pain and soreness to shoulder, arm, neck and back; Range of motion highly affected not responding to self treatments or other meds; This is a spontaneous report from a contactable nurse reporting on herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 29Dec2020 at 11:00 AM (at the age of 34 years old) as a single dose for COVID-19 vaccination. Relevant medical history included anxiety. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected. not responding to self treatments or other meds. The events resulted in a physician's office visit. The patient did not receive any treatment for the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back. The patient received treatment for the event range of motion highly affected but it was not responding to self-treatments or other medications. The outcome of the events severe muscle pain and soreness on opposite side of vaccine, and pain and soreness to shoulder, arm, neck and back and range of motion highly affected was not recovered. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
34 2021-01-07 tingling, numbness The following was reported by the vaccinated individual: I received my first dose of Pfizer Covid v... Read more
The following was reported by the vaccinated individual: I received my first dose of Pfizer Covid vaccination in my right deltoid on Monday January 4, 2021. 30 minutes post injection I began experiencing numbness and tingling in my left cheek, left arm and hand, and left leg & foot. This continued on Jan 5th. On Jan. 6th the symptoms resolved.
34 2021-01-07 tingling a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated... Read more
a left sided nystagmus; urgent MRI showing multiple brain lesions consistent with Acute disseminated encephalomyelitis; Patient developed paresthesias on entire right side of body / The paresthesias continued, not progressing; a brief headache; episode of dizziness / developed severe dizziness; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) intramuscularly at right arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history included known allergies to sulfa meds. The patient's concomitant medications included multivitamins [vitamins nos] within 2 weeks of vaccination. Patient developed paresthesias on entire right side of body after a brief headache and episode of dizziness, all since 29Dec2020 15: 00. The paresthesias continued, not progressing, but patient was advised to obtain an MRI Brain and C spine as an outpatient. On 02Jan2021, the patient developed severe dizziness and a left sided nystagmus. She went to the ER and underwent urgent MRI showing multiple brain lesions consistent with acute disseminated encephalomyelitis. Lumbar puncture (LP) was performed, awaiting final results. Patient was admitted and was receiving IV steroids (solumedrol). Duration of hospitalization was 5 days since Dec2020. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures, which included Nasal Swab and Rapid covid swab, both on 02Jan2020 with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on temporal association and lack of other provided etiology, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported acute disseminated encephalomyelitis, paraesthesia, headache, dizziness and nystagmus. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-07 involuntary muscle movements about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became t... Read more
about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became tingling and a bit numb. Soon right after my heart rate was very fast, highest 160's. My throat felt weird but I never had any difficulty swallowing or breathing and my mouth, lips, or tongue never became swollen.
34 2021-01-07 flushing feeding flush with increased heart rate 99; feeding flush with increased heart rate 99; B/P114/24; T... Read more
feeding flush with increased heart rate 99; feeding flush with increased heart rate 99; B/P114/24; This is a spontaneous report from a contactable nurse. A 34-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular at left arm on 28Dec2020 11:44 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the vaccine at 11:44 AM, approximate 10 mins later (28Dec2020 11:54), the patient complained of (reported as c/o) feeding flush with increased heart rate (HR) 99, respiratory rate (reported as R) 18, blood pressure (B/P) 120/80, oxygen saturation (reported as sats) 99%. On 28Dec2020 11:49 AM, lab data included B/P 114/24, HR 76, R 16, sats 99%, temp 98.1. On 28Dec2020 11:54 AM, lab data included B/P116/75, HR 70. No treatment received for the adverse events. The events outcome was recovered on an unspecified date in Dec2020. No COVID prior vaccination, it was unknown if the patient had been tested for COVID-19 since the vaccination. It was not reported as serious.
34 2021-01-07 hot flush, tingling increased heart rate, SOB, Tingling, Hot flushed, Red chest, mouth dry
34 2021-01-07 migraine soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migr... Read more
soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migraine); nausea; general body aches; chills; low grade temp 100; tired; general feeling unwell; This is a spontaneous report from a contactable health care professional nurse, the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), intramuscular in the left arm on 31Dec2020 16:15 as a single dose, for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing and Know Allergy to Latex. Concomitant medication included budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), magnesium (MAGNESIUM), cyanocobalamin (VIT B12). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Jan2021 04:30, the patient experienced soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell. No treatment was given for the event. Laboratory test include Body Temperature 100 on an unspecified date. The clinical outcome of Soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell recovered Jan2021. .
34 2021-01-08 muscle twitching, facial paralysis, tingling At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow a... Read more
At around 11:45pm tingling started in my left eyebrow. I thought there was something in my eyebrow and after time of wiping it a few times I went to look into the mirror and realized that nothing was there. about and hour later I got a drink and a snack to eat and I realized I had a numb sensation in the left corner of my lip. As a nurse I went though the signs of a stroke with 2 other nurses I called. Everything was normal other than that sensation. Thinking I was just overly tired I went to bed. When I woke up the next day I felt okay until I went to drink some coffee and the numb sensation in my corner lip was still there. Now I was concerned and called employee health and was instructed to go to the ER to role out a stoke. I followed employee health's instructions and went to the ER. I was diagnosed with facial paresthesia and discharged with instructions to come back if symptoms got worse. Symptoms persisted all day and around 7 I called my mom on video chat to show a visual facial twitch on the left side of my face. right after I got off the phone with her the left side of my face drooped and my fiance immediately drove me to the closest ER. I was seen immediately and they decided to admit me. The did labs and head CT. They admitted me to labor and delivery because there were no other rooms. The next day I was seen by a neurologist and many doctors.
34 2021-01-08 feeling cold Symptoms started about 3 hours after injection, and worsened over the course of the following 36 hou... Read more
Symptoms started about 3 hours after injection, and worsened over the course of the following 36 hours. Symptoms include fever (Tmax 104 F) unresponsive to antipyretics, chills, severe myalgias, headache, and sore throat.
34 2021-01-09 pain in extremity 1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible fro... Read more
1/8/21. Second Pfizer dose. Immediately felt soreness in the arm radiating to the neck. Possible from technique vs actual vaccine 1807 - Neck pain, 3/10, left arm pain 3/10. Left cervical lymph node inflamed 2035 - ringing on right ear 2244 - dizziness 1/9/21. Injection site 1cm diameter bump. Pain in left arm, neck, shoulder 1156 - headache, sharp right parietal 3/10 1730 - pain 8/10 on left upper arm, radiating to lower arm, shoulder, neck. Improved to 4/10 after Advil 800mg once. 1/10/21. Woke up with pain in left arm 7/10. Injection site has induration of 4cm, reddened, warm, tender to touch. Pain improved after Advil 800mg and Tylenol 500mg
34 2021-01-09 pain in extremity 16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injec... Read more
16 hr post injection: sore arm, headache 20 hr post injection: body aches, headache 26 hr post injection: body aches increase, chills, fever (Tmax 101.2 36 hr post injection: back to normal baseline state
34 2021-01-09 migraine, night sweats 20 hours after injection: Injection site soreness Fever Night sweats Back pain Fatigue Migraine
34 2021-01-09 migraine At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe b... Read more
At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe body aches, Hips, and knees were the worst. Paid scale would be 8/10. at 16 hours added fever was 102.5 , sever headache over the whole head, at hour 24 same. Hour 36 fever is down to 99.7 however, muscle paid have subsided and migraine is better. Pain scale 3/10
34 2021-01-09 pain in extremity Employee became very itchy on left arm after vaccine administered. Left arm very red. Itchiness spr... Read more
Employee became very itchy on left arm after vaccine administered. Left arm very red. Itchiness spread throughout her body.
34 2021-01-09 migraine Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches... Read more
Fever 102, severe migraine, dizziness, stiff neck, enlarged axillary lymph nodes, chills, body aches.
34 2021-01-09 electric shock sensation, tremor I had headache, joint and body aches. The the night of the 2nd vaccination, I was awoken to what fel... Read more
I had headache, joint and body aches. The the night of the 2nd vaccination, I was awoken to what felt like electrical jolts in my body. One time I woke up jumping so high of my bed that it felt like I was being tased. I woke up the next morning and felt like electrical currents were running through my body. My right hand had a tremor too
34 2021-01-10 burning sensation, feeling hot, feeling hot About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feel... Read more
About 10 minutes after vaccination, patient stated her left arm and fingers started burning and feeling warm. Burning sensation followed up to left side of face. Second dose of injection given on left side. Patient states she has a scratchy throat. Vitals taken at 1311: 98.9, 152/98, HR 80, 99% on room air. 50mg IM Benadryl given at 1312 in right deltoid. Laid patient down on stretcher. Patient also stated she developed cold like symptoms after her first Covid vaccine injection, and tested negative for Covid. Vitals rechecked again at 1322: 130/86, 99% on room air, pulse 75. Told patient to say for another 15 minutes in waiting room. Patient left at 1345. Patient stated the burning and warmness had gone away.
34 2021-01-10 feeling hot After 1st dose: bad headaches that wouldn't go away with NSAIDS, shoulder blade pain. After 2nd dose... Read more
After 1st dose: bad headaches that wouldn't go away with NSAIDS, shoulder blade pain. After 2nd dose: bad headaches that wouldn't go away with NSAIDS, chest pain, hot diaphragm, fatigue. She reports still having these symptoms and it is day 4 after the vaccine.
34 2021-01-10 muscle spasms I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hour... Read more
I developed a headache about 1 hour after the vaccine. I developed a fever of 100.4 about three hours after my first dose of the COVID-19 shot. Shortly after this I had moderate GI upset including diarrhea, cramping for about 24 hours. Over the course of 48 hours after the vaccine I had swelling at the injection site, tenderness of the injection area to the point where I was not able to put pressure on the area or sleep on my left side and severe fatigue/malaise. All symptoms resolved after 48 hours. I am a person and wanted the reaction information to be part of the trial data.
34 2021-01-10 hypersensitivity of all senses, weakness, night sweats Joint and Muscle aches, chills, Hypersensitivity of skin, Fatigue, weakness, Malise, Sweating in sle... Read more
Joint and Muscle aches, chills, Hypersensitivity of skin, Fatigue, weakness, Malise, Sweating in sleep
34 2021-01-10 numbness, weakness Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in... Read more
Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
34 2021-01-10 weakness Patient became dizzy, nauseous, weak, and had a headache within 2 hours of vaccination.
34 2021-01-10 burning sensation Patient had no issues with the first injection. States she felt like her face was burning, she was h... Read more
Patient had no issues with the first injection. States she felt like her face was burning, she was having trouble breathing, and felt light headed. Denies any prior anaphylactic reactions, denies vagal experiences after blood draws. Symptoms started within 5 minutes of the vaccination. Vistaril given, patient monitored for one hour in the emergency department with no further incident and returned to work,.
34 2021-01-10 feeling hot, tingling Within 45 minutes of receiving the vaccine - red face with tingling; recipient got "extremely warm".... Read more
Within 45 minutes of receiving the vaccine - red face with tingling; recipient got "extremely warm". Resolved quickly once patient received Benadryl 100mg.
34 2021-01-10 feeling hot, tingling Within 45 minutes of vaccination - developed red face with tingling; recipient felt "extremely warm"... Read more
Within 45 minutes of vaccination - developed red face with tingling; recipient felt "extremely warm". Patient was medicated with Benadryl 100mg and felt fine after a short period of time.
34 2021-01-11 difficulty speaking -0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it wa... Read more
-0715 vaccine administered. -0735 started to feel dizzy/off and right side of tongue felt like it was mildly swelling and itchy. -0735 asked to have blood pressure taken as know when I am having anaphylaxis my blood pressure escalates. -0740 took blood pressure and it was 141/86 in right arm. Normal is 110s/60s-70s. No anxiety feelings. -0740 throat started to have increased mucous production. Had the tickle and tightness in throat. Asked and received 25mg Benadryl with cup of water. -0742 started clearing throat frequently and slight cough. Knew it was anaphylaxis and told the team I need to go to the ER. Asked for additional 25mg Benadryl. Also took 20mg Famotidine and 2 puffs Albuterol inhaler--this is my prescribed anaphylaxis routine. Had Epipens on standby. -0743 put on O2 saturation monitor and watched O2 drop into 90-92 range. Asked for epipen on standby as I know when I need to start it. Didn't want to take that when I knew I was about to get it in the ER and knowing self hadn't progressed that far. Felt chest tightness and shortness of breath. Voice started becoming hoarse. -0800 EMS arrived (delay as team didn't know if they were supposed to call 911 or a Code--they chose EMS even though in hospital). Then staff at COVID vaccine clinic kept emphasizing need to go in ambulance while EMS and self fought to go through hospital (much quicker route). Finally cleared to go through hospital to ER. To get some air via breathing in had to sit up leaning forward. Voice completely hoarse by this time. -About 0817 arrived to ER bay. At this time, frequently coughing and cough started to sound stridorous. Difficulty getting breaths in. Had chest pain near heart. Greeted by MD, 2 RNS, and technician. -0819 received IM epinephrine. Attached to 5 lead EKG monitoring and O2 monitoring. Blood pressure done again. Higher than previous. -About 0821 had working IV (previous two attempts failed as veins were constricting). Given IV Solumderol. Started bolus of 1L Normal Saline. -Not sure how long after by cough subsided, increased mucous production subsided, as well as hoarseness decreased. -Held for observation for 2hours (would be longer if not resolved). - Discharged around 1015. At this time, hoarseness almost all gone. Minimal throat clearing. Cough resolved. -Prescribed epipen inhalers (mine expired) and Prednisone. Prednisone is PRN for mild breathing difficulties if it starts again tomorrow 1/13/21. -At 1400 took 50mg Benadryl and 20mg Famotidine as previously prescribed for anaphylaxis maintenance. Will continue this as previously prescribed every 6hours until symptoms stay resolved. -Made follow up appointment with Primary Care Physician per protocol
34 2021-01-11 numbness 3 minutes after receiving 1st dose Covid vaccine experienced paresthesias of lips and oropharynx tha... Read more
3 minutes after receiving 1st dose Covid vaccine experienced paresthesias of lips and oropharynx that self-resolved within 5-10 minutes. Also developed paresthesias of bilateral hands and feet with stomach discomfort.
34 2021-01-11 numbness, pain in extremity 40 minutes after the vaccine administration, I experienced numbness on the right side of my face. A... Read more
40 minutes after the vaccine administration, I experienced numbness on the right side of my face. Around my eye, to the side of my nose and around my mouth, only on the right side. Also on the right side of my tongue. This resolved after an hour and a half. It reoccurred about 6 hours later, at 4:00 p.m. . And continued for 48 hours. 12 hours post vaccine, a fever as high as 102 degrees Fahrenheit, severe body aches targeting especially the lower extremities, and chills occurred. The fever and chills lasted 24 hours. The body ach es lasted 48 hours.
34 2021-01-11 weakness During the overnight hours after recurrent my vaccine i developed fever, cold, and headache. All ... Read more
During the overnight hours after recurrent my vaccine i developed fever, cold, and headache. All day I have had a low grade fever up to 100.9 as well as headache and weakness/ fatigue.
34 2021-01-11 feeling hot, flushing Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded... Read more
Feeling of flushing/warmth from head to toe, mild itching throughout body, and dizziness/lightheaded. Blood pressure was elevated >180/90, HR 110-120. Gradually decreased and at approximately 30minutes post injection, blood pressure was <145/90 and HR 84. Took 25mg of benadryl approximately 1 1/2 hour after injection time. Symptoms persisted mildly for another 30-45 minutes after benadryl and seem to be gone 5 hours later. Blood pressure 5 hours after was 134/85 which is still a slight elevation from my norm.
34 2021-01-11 numbness, tingling, flushing, feeling hot, weakness I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs an... Read more
I feel hot after 15-30 minutes of the injection. I turn red and flush. I feel tingling to my legs and arms. And numbness to the left side of my face. I felt like my heart was beating fast. The administrator gave me bendryl. I felt better, but I felt weak. I was able to go home 2 hours after the administration.
34 2021-01-11 tremor I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itchi... Read more
I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; I had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left arm on 30Dec2020 at 11:00 as single dose for an unspecified indication. Medical history included penicillin allergy, sulfa allergy and allergy to nuts from an unspecified date. There were no concomitant medications. The patient experienced allergic reaction, throat pain, swollen uvula, itching in mouth and throat and shaking that was reported as "had an allergic reaction within 10 minutes and was taken to the emergency room. Throat pain, itching in mouth and throat, shaking, swollen uvula" on 30Dec2020, at 11:15. The events were reported to have resulted in emergency room/department or urgent care. The events were reported as non-serious. Therapeutic measures were taken as a result of the events: treatment included antihistamine and steroids. Prior to vaccination, the patient had not diagnosed with COVID-19, not had she been tested for COVID-19 since the vaccination. The outcome of events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
34 2021-01-11 weakness Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fat... Read more
Pain and swelling at injection site, fever, chills, muscle and joint aches, dizziness, weakness, fatigue
34 2021-01-11 tension headache Patient vaccinated on 1/5/21 in am. Reports onset of symptoms on 1/9/21. Patient says she experien... Read more
Patient vaccinated on 1/5/21 in am. Reports onset of symptoms on 1/9/21. Patient says she experienced body aches, involuntary head nodding that she describes similar to muscle twitches. Patient reports chills with no fever, nausea and diarrhea that has not stopped. She also described pain in her spine that wrapped around into her chest like a sharp shooting pain and fatigue and a headache that feels like a band wrapped around her head. Symptoms started 1/9/21 and are still present 1/12/21.
34 2021-01-11 pain in extremity Temperature to 100.2, sore arm, fatigue
34 2021-01-11 pain in extremity feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Sore... Read more
feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy. Concomitant medications included fluticasone propionate for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-01-12 numbness After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks ... Read more
After 1st dose : flu like symptoms two days with facial bilateral cheek numbness lasting two weeks After 2nd dose : lightheaded myalgia fever axillary lymph node swelling and redness, nausea, body aches for two days. Still on day four currently : lightheaded/severe dizziness and fatigue
34 2021-01-12 pain in extremity Beginning 12 hours after my 2nd dose, I woke up with myalgias, chills, and drenching sweats on 1/9. ... Read more
Beginning 12 hours after my 2nd dose, I woke up with myalgias, chills, and drenching sweats on 1/9. Later that morning 6:30am, I developed severe fatigue, dizziness upon standing and walking, a L sided headache, L sided arm pain extending from elbow to sternocleidomastoid muscles on the L side, and axillary lymphadenopathy in the same arm as the vaccine (left). I took 650mg of Tylenol and went to work. Walking at a normal pace, my heart rate was 145. At rest inside the hospital it was in the 110s (measured by watch). the headache lasted all day on 1/9 and 1/10 and my neck felt slightly stiff (it was difficult to turn my head to look at traffic behind while driving). I took additional doses of Tylenol on 1/9 and 1/10 and by the AM of 1/11, all of my symptoms had resolved except for the L axillary lymphadenopathy.
34 2021-01-12 pain in extremity Headache, L arm soreness, full body muscle pain, full body joint pain, severe fatigue, diarrhea
34 2021-01-12 pain in extremity I had arm pain in the left arm that lasted for 2 hours, chills, abd pain, nausea, muscle aches & mal... Read more
I had arm pain in the left arm that lasted for 2 hours, chills, abd pain, nausea, muscle aches & malays. My estimated date of deliver is 03/05/2021 and I am 32 weeks gestation.
34 2021-01-12 tingling, numbness I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left ... Read more
I had the vaccine at 12:23 PM and felt fine. At 2 am that same night I woke up sweating and my left side of my face was numb and tingling. I am able to move it but is continuing to tingle only on my left side. My lips, the very side of my tongue, my bottom jaw and my check bone constantly tingle and feel numb, when I talk some spit comes out on that side and my side of my nose also feels numb. As time goes on it isn't getting any better but not much worse. today my bottom lip just feels more numb
34 2021-01-12 flushing, tingling, pain in extremity, muscle spasms, numbness, feeling hot LUE pain at injection site, muscle spasms of left arm, numbness and tingling of left hand, episode o... Read more
LUE pain at injection site, muscle spasms of left arm, numbness and tingling of left hand, episode of burning across chest x 1 when symptoms first started. Brief period of muscle spasms along left neck, back left arm and left lower extremity on first day of vaccination. Brief episode of right hand numbness and tingling. On day 2 very flushed and hot feeling, temp 37.9 at 1am on 01/12/21. Sever muscle spasms and pain from left trapezius to sternocleidomastoid, to left upper extremity, left thorax and abdomen to left lower extremity with extreme fatigue. Headache throughout day. Now with residual left lower extremity numbness and tingling, pain improved and muscle spasm frequency decreasing although episode of chest pain with muscle spasm did occur yesterday evening. At this point the left lower extremity tingling is most worrisome. Muscle spasms and pain slightly improved.
34 2021-01-12 tremor, discomfort, numbness, pain in extremity Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was... Read more
Patient reports to clinic after receiving the COVID-19 Vaccine at today. Patient states that she was given the vaccine at 0915 today and about 5 mins after started to have symptoms of a hot sensation from head to toe, heart racing, ears burning, and chest tightness, no breathing difficulty. Patient notified staff and was given O2 and allowed to drink her water. Her symptoms did improve and she was sent to the waiting area again. After about 10 mins her chest tightness came back. Patient states she can feel her blood flowing, "kinda like when your limb is numb". Patient also had symptoms of chills, body shakes, loss of smell, and a metallic taste in mouth. Patient states that she was seen again by staff and laid on a cot for 20 mins, and was then cleared to head back to work around 1000. Patient was seen in the clinic at 1157, and her symptoms since it started have improved. Currently she has the following symptoms: can't taste/smell, (L) arm is sore, H/A, with constant ache, localized to back of neck up to behind the both eyes. Body feels worn out, everything feels heavy, takes a few second to focus when she looks around "like there is a delay". Patient was sent home to recover and to let medical staff know if her symptoms return.
34 2021-01-12 tingling, hot flush Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "... Read more
Pfizer Vaccine; Cough, SOB, uvula swelling, tachycardic, hot flashes, facial tingling and itching, "cotton ball" in back of throat, dry mouth; administered Epinephrine 0.3 mg IM x3, solumedrol 125 mg, diphenydramine IV 50 mg and 25 mg, famotidine 20 mg, racemic epi, ativan; reaction started 5 min after dose; discharged with epi pen and prednisone
34 2021-01-12 night sweats Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without... Read more
Post shot: 1/11/21 10pm I had a headache and mild chills 1/12/21 12am-2am chills and rigors without fever 2am-6am fever, chills with rigors at time, nausea, headache, joint pain, fatigue, dizziness, double vision, drenching night sweats 6am-11pm continuing mild fevers and chills without rigors , joint pain, nausea, headache. Last fever was approx 6pm that day but the chills continued 1/13/21 12am-6am chills and fatigue. No fevers. Drenching night sweats 6am- present fatigue and slight headache Motrin was able to help the fevers and I stay well hydrated
34 2021-01-12 pain in extremity Vaccine given on 1/9/21 around 12:45 pm in Left deltoid chest swelling started 5 to 6 hours later sw... Read more
Vaccine given on 1/9/21 around 12:45 pm in Left deltoid chest swelling started 5 to 6 hours later swelling in arm & neck with pain. Has been taken Ibuprofen & muscle relaxer. Symptoms still persistent on 1/12/21.
34 2021-01-12 pain in extremity arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted ap... Read more
arm soreness day after vaccine, developed full body aches/chills about 25 hours later that lasted approximately 2 hours then passed.
34 2021-01-12 tingling dizziness, tingling in face to neck and nausea; rested and refused emergency department
34 2021-01-12 flushing tachycardia and feeling flushed that started approximately within 5 minutes of the vaccine
34 2021-01-13 migraine 1/07@1920 INJECTION RECEIVED 1/8 @ 1100 CHILLS BEGAN @1130 102 FEVER RECORED; 1000MG ACETAM... Read more
1/07@1920 INJECTION RECEIVED 1/8 @ 1100 CHILLS BEGAN @1130 102 FEVER RECORED; 1000MG ACETAMINOPHEN TAKEN @1300 MIGRAIN BEGAN @1700 NAUSEA BEGAN @1900 CHEST PAIN STARTED @2100 WENT TO THE ER
34 2021-01-13 feeling hot, tremor After the vaccine was administered the patient sat in the waiting room for less than 5 minutes and t... Read more
After the vaccine was administered the patient sat in the waiting room for less than 5 minutes and then felt a fast HR, she felt hot and was worried that she was going to faint. She also felt shaking in her hands and her arms felt heavy. She came back to the nurse that had administered her vaccine at 1:10pm where her oxygen level was monitored and she was given a cold cloth and water to drink. This lasted for about 20 minutes. Her oxygen level was monitored (~97%), her BP was checked at 1:45pm and it was 125/90. Her hotness, elevated HR, and shakes went away. At 2:00pm her BP was checked again and it was 139/96 and then again at 2:05pm where it was 132/90. The patient stated that she felt fine and normal by now and also said that she had a BP cuff at work and at home and said that she would monitor it. All 3 of 3 follow up options discussed with patient: virtual care, the CDC, and/or 911 depending on her condition. The patient left at 2:15pm and patient was called 1 hour later for follow up. On the follow-up call the patient stated that she was feeling fine and that her BP was 126/90. She said she would continue to monitor her BP and follow-up with virtual health if it wasn't back to normal by tomorrow.
34 2021-01-13 flushing, tremor Flushed, itching, rash over arms, trunk, Felt shaky
34 2021-01-13 cold sweat Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). N... Read more
Hypotension 91/71 with orthostatic hypotension <80 SBP ( my BP cuff doesn?t read lower than that). Near syncope at 0615. Loss of vision, tinnitus, lowered to the ground and followed by nausea and sweating. Resolved in minutes. Continue to be dizzy today with clammy and dizzy upon standing
34 2021-01-13 pain in extremity, feeling cold, tremor I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went... Read more
I started experiencing soreness to left arm about 1-2 hours after injection but nothing else. I went to bed around 11pm. Then I was woken up in the night around 3am violently shaking, teeth shattering and unable to even stand straight from shaking so bad. I felt like I was freezing but skin was hot to touch. I didn't have a thermometer to take temperature at that time because it was in another family member's room. I felt nauseated as well. I took 600mg ibuprofen and tried to lay back down. At 3:59am my aunt woke and brought the thermometer downstairs. I could tell the ibuprofen was working some and fever was less as the shaking had calmed. I was able to check my temperature and it was 100.8F (an hour after the ibuprofen). I still took 100mg tylenol at that time. As of this morning (after 7am) I am sore all over, tired and have a headache, temp 99.2F.
34 2021-01-13 pain in extremity L arm pain and numbness from injection site to shoulder, temp 99.0-99.5 F
34 2021-01-13 weakness Muscle aches, joint pain, headache, nausea, weakness. Lasted ~24 hours.
34 2021-01-13 numbness, bell's palsy R facial numbness with inability to fully open R eye onset 1/13/21. Seen in urgent care, Dx Bell's P... Read more
R facial numbness with inability to fully open R eye onset 1/13/21. Seen in urgent care, Dx Bell's Palsy, treated with steroids.
34 2021-01-13 numbness, throat numbness, tingling Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.... Read more
Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Saturday had. Sweating. Chills. Headache. Nausea.; Sunday had emergency appendectomy for actuate appendicitis.; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat; Post surgery had allergic reaction unknown reason with head to toe rash; Post surgery had allergic reaction unknown reason with head to toe rash; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular (lot number: EL1283) on left arm on 08Jan2021 at 6:30 AM at single dose for covid-19 immunisation. The relevant medical history included celiac, anemia, known allergies: Sulfa and Gluten. Concomitant medications were not reported. The patient received first dose of BNT162B2 via intramuscular (lot number: Ek5730) on left leg on 18Dec2020 at 11:00 AM at single dose for covid-19 immunisation. The patient previously took Codeine, fish oil and experienced allergies. Friday at 3pm, the patient had numbness and tingling to left hand, lips and throat. On Saturday the patient had sweating, chills, headache, nausea. On Sunday had emergency appendectomy for actuate appendicitis. Post surgery had allergic reaction unknown reason with head to toe rash. It was also reported that the adverse event started on 08Jan2021 at 03: 15 PM (as reported). The patient had 1-day hospitalization. The patient received treatment for the events. The adverse events resulted in Emergency room/department or urgent care. The events were reported as serious due to life threatening and hospitalization. The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. Medications administered during appendectomy may confound reactions experienced post-surgery. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-01-13 pain in extremity Sore arm around 1300. Fatigue around 1600. Chills at 2300, relieved by 2 tabs tyelenol. Woke up at 3... Read more
Sore arm around 1300. Fatigue around 1600. Chills at 2300, relieved by 2 tabs tyelenol. Woke up at 300 next morning in hot sweat. Next day 1/12, body tension from chills precious night- relieved by advil. fatigue from poor nights sleep.
34 2021-01-13 weakness Weakness, muscle aches, headache, nausea, Had same reaction after 1st dose. More severe after 2nd do... Read more
Weakness, muscle aches, headache, nausea, Had same reaction after 1st dose. More severe after 2nd dose but improving.
34 2021-01-13 tingling, night sweats feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a con... Read more
feverish; lightheaded; tingling in my fingers; night sweats; This is a spontaneous report from a contactable other hcp. A 34-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), intramuscular in left hand on 30Dec2020 14:15 at a single dose for COVID-19 immunization. Vaccination occurred in a Nursing Home/Senior Living Facility. The patient's medical history was not reported. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C), colecalciferol (VITAMIN D), and zinc (ZINC). The patient was feverish, lightheaded, had tingling in fingers and had night sweats on 01Jan2021 with outcome of recovered. The patient underwent lab tests and procedures which included sars-cov-2 test-nasal swab with a negative result on 04Jan2021. Information on the lot/batch number has been requested.
34 2021-01-13 pain in extremity left lower leg pain
34 2021-01-14 migraine 1/14/21- 6am - migraine, dizziness, nausea 1/14/21 - 9am - chills, body aches Lasted all day into 1/... Read more
1/14/21- 6am - migraine, dizziness, nausea 1/14/21 - 9am - chills, body aches Lasted all day into 1/15/21 1/15/21 - 6am -mild headache and body aches, seems to be getting better
34 2021-01-14 pain in extremity 12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, ru... Read more
12/22 evening I had severe arm soreness and light body aches, the next morning I felt congestion, runny nose , severe headache, mild palpitations, my whole body hurt. 12/24 I couldn't breathe through my nose at all , no taste or smell for 24 hours, 1 week after I wasn't getting better my lungs sounded junky , 12/31 I went to the urgent care, I got tested and was negative, I had pneumonia , I was sent home with antibiotic, steroids, inhaler.
34 2021-01-14 tingling, numbness Long lasting throbbing headache like non other, nose bleed, numbness on right arm, right shoulder, r... Read more
Long lasting throbbing headache like non other, nose bleed, numbness on right arm, right shoulder, right cheek & face, muscle aches, fatigue, and tingling on forehead. Also felt dizzy.
34 2021-01-14 burning sensation Patient describes shingles, burning in right side arm into the back and down the arm, rashy blisters... Read more
Patient describes shingles, burning in right side arm into the back and down the arm, rashy blisters on the back and onto arm on the right side.
34 2021-01-14 tingling, weakness Reaction started 40min after injection. It started with tingling above the lips and then numbness o... Read more
Reaction started 40min after injection. It started with tingling above the lips and then numbness on the whole face + redness on face and neck per coworker, then collapsed trying to go to the bathroom to look at the redness, then had generalized weakness for about 45 minutes (couldn't move at all or open mouth and eyes). I was finally able to open my eyes 1 hour after it started. Got discharged 2 hours after symptoms resolution. No medication was needed, symptoms gradually faded away.
34 2021-01-14 pain in extremity Symptoms ? EE reports around 10:00 PM on 1/13 pain and achiness to R arm and tired. EE reports woke... Read more
Symptoms ? EE reports around 10:00 PM on 1/13 pain and achiness to R arm and tired. EE reports woke up Thursday am with fever (Tmax 103) and chills. EE reports temp 99 at time of call. ? Last day of work and shift ? Friday (1/8/21) Home remedies? - Tylenol and motrin q4h, rest Any improvement? ? mild improvement Recommendation? EE encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive and to apply a cold compress to injection site. EE encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns. EE reports she called out of work today. EE educated to manage her RTW according to the Workplace policy. EE said she had a secondary exposure and requested to be tested through hospital but was told by EH unable to test so got COVID tested on Monday 1/11 at pharmacy and reports negative result. EE requesting RN to send her manager and email documenting call. EE notified RN will not be sending her manager an email but if manager needs proof of call, to contact EH. EE verbalized back understanding and denied further questions at this time.
34 2021-01-14 tremor Vaccine was received at 4:55pm. 8:30pm, I started to feel fatigued and disoriented. By 9am I started... Read more
Vaccine was received at 4:55pm. 8:30pm, I started to feel fatigued and disoriented. By 9am I started to feel muscle aches and sharp joint pain, as expected. By 1200 noon, the pain intensity was increasing, coming in waves, lasting 10-15 minutes. The pain waves were 10/10, very severe, and was causing me to shake, cry, and be unable to function or sleep. I was also very disoriented, but I think due to the pain. It was mildly relieved with ibuprofen/Tylenol alternating every 3hrs, but continued until 6pm. It began to subside at 6pm. I am an RN, and sought the advice of my employee health nurse, who advised me to seek medical care if it continued through the night. The pain began to subside, so I did not. However, if a non-healthcare person experiences that, they will think they are dying.
34 2021-01-14 flushing light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushe... Read more
light headed (airy/helium head feeling); hard to concentrate on more than one task at a time; Flushed; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on 22Dec2020 at 11:30 at a single dose on the left arm for COVID-19 immunization in a workplace clinic. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient also did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Dec2020 at 15:00, the patient was light headed (airy/helium head feeling), hard to concentrate on more than one task at a time, and flushed. No treatment was given to the patient. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date. The events were considered non-serious. No follow-up attempts are possible. No further information is expected.
34 2021-01-14 pain in extremity, cold extremities, numbness tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My ... Read more
tunnel vision; experienced a sudden onset of vertigo; presyncope; My hands became cold and numb; My hands became cold and numb; fatigue; sore arm, leg/thigh aching; sniffles; sore throat; brief dry cough; slight headache; neck ache; This is a spontaneous report from a contactable Nurse (patient). A 34-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 05Jan2021 at 12:30 at single dose in left arm for covid-19 immunization. Medical history included Mild ADHD/ADD. The patient's concomitant medications were not reported. Approximately 5 minutes after receiving vaccination, she was standing in the observation room (where they had all of them stay for at least 15 minutes to ensure no severe reactions) and experienced a sudden onset of vertigo, tunnel vision and pre-syncope. Her hands became cold and numb and she was trying to talk to another staff member who was arranging/scheduling her second vaccination dose at the same time when this event occurred, but it subsided quickly and she started to feel normal again. All these events occurred at 12:45 on 05Jan2021. She reported this event right away and they had her stay in the room longer. She was stable at that point but experienced these symptoms again but very mildly twice more while she walked back to her car to go home. Other side effects on 05Jan2021 that started in the evening and for the following 2-3 days included fatigue, sore arm, leg/thigh aching, sniffles/sore throat, brief dry cough and slight headache/neck ache. Very mild and tolerable symptoms. All events were reported as non-serious by reporter. The patient did not receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination. The outcome of all events was resolved in Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-15 migraine, numbness I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14... Read more
I received my first dose of the Pfizer COVID vaccine at approximately 9:15am on Thursday, January 14, 2021 in my right arm. Almost immediately, I felt a pain go down to my wrist and across my chest. We pulled into the waiting area and around five minutes after the injection the right side of my face went numb., the pain had left my arm and chest by the time. The nurse reacted by calling the emergency room and sending me there.
34 2021-01-15 numbness Left arm went completely numb. Left side of neck was completely numb and left side of face was compl... Read more
Left arm went completely numb. Left side of neck was completely numb and left side of face was completely numb. Duration was for about 3 hours.
34 2021-01-15 flushing, feeling hot Observed pt with symptoms of flushing, feeling hot, tingling feeling, felt like her HR was faster. ... Read more
Observed pt with symptoms of flushing, feeling hot, tingling feeling, felt like her HR was faster. Water, Observed for a total of 45 min. Felt the same but was okay. No worsening. Pulse Ox 97%, HR 77 .
34 2021-01-15 weakness Tiredness, Weakness, Sleepiness.
34 2021-01-16 pain in extremity I woke up around 11:30p (1/15) with aching in my legs. I took some Tylenol a d laid back down. I bec... Read more
I woke up around 11:30p (1/15) with aching in my legs. I took some Tylenol a d laid back down. I became restless and tossed and turned. My body started aching and by morning (7a 1/16) I had a blinding headaches, body and joint pain and a fever of 101.8. This continued throughout the day 1/16. I also had chills. My fever broke around 2am 1/17 and the body aches went away. I have had a headache and fatigue today (1/17).
34 2021-01-16 pain in extremity I woke up with pain in my legs, took a bath & some ibuprofen. Laid back down and just tossed and tur... Read more
I woke up with pain in my legs, took a bath & some ibuprofen. Laid back down and just tossed and turned for a few hours. When it was time to get up with my kids my whole body hurt. I took my temperature and it was 102.4. I took some Tylenol and drank water. I stayed in bed for the day. I ran a fever until late that night. (12/24) When I awoke 12/25 I did not have body aches only a headache and fatigue. By 12/26 I felt better.
34 2021-01-16 tingling Tingling lips, hands and feet for an hour after vaccine shot. It did not start right away, but short... Read more
Tingling lips, hands and feet for an hour after vaccine shot. It did not start right away, but shortly after I left Vaccination site. After about an hour my lips were tingly for the rest of the day until halfway through the next day. I still feel little twinges of tingling in my lips here and there. The sensation does not last long about a minute and goes away.
34 2021-01-17 muscle spasms Approximately 3 hrs after vaccine administration - developed full body aches, chills, malaise. Next... Read more
Approximately 3 hrs after vaccine administration - developed full body aches, chills, malaise. Next day these symptoms persisted and also developed stomach ache/nausea, fatigue, mild tachycardia, headache, and fever that peaked at 101.7 then broke before going to sleep. Day 2 post vaccine, continued fatigue and headache as well as sharp stomach pain/cramping. Day 3 post vaccine, fatigue and headache relieved with Tylenol - mild nausea about half the day before resolving.
34 2021-01-17 tingling, numbness Enlarged left axillary lymph nodes developed 6 days after first vaccine. Then approximately 10-15 mi... Read more
Enlarged left axillary lymph nodes developed 6 days after first vaccine. Then approximately 10-15 min after 2nd injection, upper arms became numb and tingly. Became dizzy. Sweating. Upper thighs tingling. Thready pulse. Alerted staff. Pulse ox checked normal. Symptoms improved after 30 minutes. Very tender and enlarged left axillary lymph nodes followed, have not resolved.
34 2021-01-17 inability to speak The nurse that gave the injection said immediately after injecting the medication the patient became... Read more
The nurse that gave the injection said immediately after injecting the medication the patient became anxious, short of breath, stated that her throat felt like it was closing and became red from the face down in all exposed skin that they could see. They called a rapid response and the patient was given epinephrine from an EpiPen. She also took 50 milligrams of Benadryl p.o.. She then was transferred to the emergency department for further evaluation. Upon arrival to the emergency department patient does not have recall of the events just after the injection, she states that she feels that her upper lip is swollen, her throat is swollen and she is short of breath. She seems very anxious and jittery from the epinephrine. Nursing reports that at the scene she was unable to talk, in the Emergency Department she is able to answer questions and speak full sentences. She states that she feels somewhat better on arrival however is not back to baseline.
34 2021-01-17 migraine, flushing, pain in extremity Two hours after vaccine, I felt abdominal pain and felt like I was going to get diarrhea and I got r... Read more
Two hours after vaccine, I felt abdominal pain and felt like I was going to get diarrhea and I got really flushed; shaky; face red. They put ice on back of neck. Arm started to hurt. Took Tylenol and sat down. And felt better 15 minutes later. Intervention was ice on back of neck so I wouldn't faint and rest. Overnight, first night - chills. Woke up with a headache. Took ibuprofen and Tylenol and had body ache and joint pain, too. Five days consistently (positionally) - when I laid down I would get it for five days. I had the vertigo which started 2 days after vaccine. Had a migraine 7 days after vaccine and I had to miss work because it was so severe. Had a typical migraine. Had an aura and it was so bad I couldn't see to drive to work. I don't ever get vertigo with my migraines and so this was different. After 7 days all symptoms were resolved. I am currently breastfeeding.
34 2021-01-17 weakness, flushing generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan20... Read more
generalized weakness; flushing; my BP is high; dose 1 start date 19Dec2020; dose 2 start date 8Jan2021; This is a spontaneous report from a contactable pharmacist. A 34-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular in left arm on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic HTN and allergies to baclofen and statins. The patient's concomitant medications were unspecified medications taken for hypertension. The patient previously received the first dose of bnt162b2 on 19Dec2020 via intramuscular in left arm, lot EL0140. On 08Jan2021, the patient was brought into ER as code MET. Patient was receiving her second vaccine for COVID-19 when she experienced generalized weakness and flushing. She stated that she knew her BP was high. Endorses hx chronic HTN, reports she took all three medications this AM. The patient denied any headache, new visual change, CP, SOB, or focal weakness. The events recovered on an unknown date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events.; Sender's Comments: Based on the time association, the events asthenia, flushing and hypertension are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-01-18 feeling cold 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nau... Read more
9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
34 2021-01-18 tingling Approximately 15 minutes after receiving vaccine, patient experienced stiffness and discomfort on le... Read more
Approximately 15 minutes after receiving vaccine, patient experienced stiffness and discomfort on left side of neck and shoulder and tingling/numbness in left arm. Patient received vaccine on left arm. Tingling progressed to stomach and left side of face and left side of forehead Temp=98.6F, O2=96% BP=153/106 HR=71 at 08:50am. BP=143/90 at 08:54. Tingling improved on left arm at 8:55am. Patient reported back becoming stiffness and tingling along both shoulders at 8:57am. Tingling in left arm and stomach improving. Patient released from clinic at 9:07am.
34 2021-01-18 pain in extremity First day after, 23rd, arm was pretty sore. 24th it was fine. Going in to the 25th - getting difficu... Read more
First day after, 23rd, arm was pretty sore. 24th it was fine. Going in to the 25th - getting difficult to walk; joints were very rigid. Both hips and both knees and ankles -whole lower body very rigid. Muscles were really tight and tense. It felt like all muscles were engaged stiff and wouldn't relax. Joints wouldn't bend (butt on down). I couldn't walk. During the day on 25th those symptoms still persisted but could walk a little - very challenging - couldn't ambulate well and it was painful to walk. Day of 26th and symptoms could still persisted and seemed like the morning wasn't as bad but by evening it was really bad again. I didn't equate it to the vaccine because on the 24th I felt fine. 28th I tried to work but left early to go to Dr because I had trouble walking that entire shift. Dr ran tests - Lyme Disease and CBC and SED rate and Rapid Strep test and Antistreptolycin - if any antibody in body for strep; rheutomoid factor ; TSH; C reactive protein; Uric Acid; pathology for Lyme Serology IG/IGG; ANA with Pathology - all was C reactive proteins was elevated - Put on Prednisone Pack and that made it better until most symptoms resolved and I felt like I could move again. I ran out on a Sunday and by Monday I back to not being able to move again. Got blood drawn Wednesday (Jan 6, 2021). And they rechecked CBC, SED rate; C reactive proteins and rheumotoid factor; CCP antibodies; and they did a comprehensive metabolic panel. And those were all normal except C reactive proteins was elevated but not as much as initial test. A week later added CK test - tested for muscle breakdown and that was normal Jan 6, 2021 - meloxicam was prescribed and that managed most of my symptoms but I can only use Tylenol with and not Ibuprofen (which doesn't work as well). Urgent care initially went to.
34 2021-01-18 flushing Flushed, lightheaded, increased heart rate, hives, shortness of breath
34 2021-01-18 weakness, tremor Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to h... Read more
Had severe body aches m, fever, headache, progressed into dizziness and "foggy memory", started to have some chest pain. Felt as if I was intoxicated, lasted the whole day. Woke up the next morning and still felt "out of it" and weak but thought it would get better, went to work (im a nurse). Started having continous vomiting, shortness of breath and chest pain at work. As well as severe tremors. I was taken to the hospital, given fluids and my QT was prolonged with my heart which i have never had before . Was given iv magnesium and waited for my heart rhythm to improve. Was told not to take anymore of my prescribed medications or nausea medications and follow up with my pcp the next day. Im still feeling horrible, nausea, body aches, low grade fever and I am 72 hours out. Now I have huge hospital bill to pay, can't work currently because I still feel bad and my heart has a weird rhythm. Hoping this helps as if this was what I was expecting I would have never got it.
34 2021-01-18 weakness Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out. She conti... Read more
Her firs was on 12/24 and she reports 7 hours later she had blurry vision and passed out. She continued to have nausea and couldn?t eat missed several days of work and lost 5 kg due to nausea. She received the second on 1/24 and she reports that 3 ½ hours later her heart rate was high, blurry vision and soa. She reports she does not remember much other than resting and her husband picking her up. She stated that she couldn?t remember much after that and was difficult to wake up by her family. Was off work a few days and is now back but feeling weak.
34 2021-01-18 pain in extremity Numbness in L hand developing 3 hours after the second dose, which occurred while I was asleep and ... Read more
Numbness in L hand developing 3 hours after the second dose, which occurred while I was asleep and then woke up and then went away within 5 minutes. Today, 1/18/2020, I developed dark red blotches on my L hand, especially visible near the knuckles (the metacarpophalangeal joints). It then went away within 3 minutes but then appeared on other parts of my hand, including on my R hand. The blotches all went away within 2-3 minutes but occurred consecutively in different parts of my hand (i.e., some area developed the blotchiness prior to others, and then other parts developed it)
34 2021-01-18 tingling, feeling hot Pt developed heat sensation in left buttock immediately following administration of vaccine, followe... Read more
Pt developed heat sensation in left buttock immediately following administration of vaccine, followed by constant tingling in left gluteus muscle with associated soreness in left gluteus. Symptoms lasted for about 3 hours and resolved with no treatment.
34 2021-01-18 numbness Pt developed left-sided facial numbness and LUE numbness within an hour of vaccination, but not with... Read more
Pt developed left-sided facial numbness and LUE numbness within an hour of vaccination, but not within the 15-minute post-vaccination waiting period. Physical exam remarkable for decreased sensation of left face, neck and LUE. No motor deficits and remainder of neurological exam normal. Concern for complex migraine due to migraine hx vs TIA vs stroke. Pt sent to ED for further evaluation. Had Head CT, EKG, labwork done in ED, all of which was normal. Pt was told vaccine likely triggered migraine. She was discharged home from ED on same day, and symptoms resolved same-day. No residual symptoms the following day, 14 Jan 2021.
34 2021-01-19 weakness HEADACHE, BODYACHES, WEAK
34 2021-01-19 feeling cold High fever, muscle pain, joint pain, headache, chills, swollen Lymph nodes in the arm of injection (... Read more
High fever, muscle pain, joint pain, headache, chills, swollen Lymph nodes in the arm of injection (armpit)
34 2021-01-19 cold extremities, numbness Starting the morning after my vaccine, at 0930, I had a headache and began to feel tired. I took tyl... Read more
Starting the morning after my vaccine, at 0930, I had a headache and began to feel tired. I took tylenol and a nap. Around 1100-1130, I started to feel a little feverish, but did not have a fever. Around 1200, I began to have chills, my headache returned, and my fingers and toes felt frozen/numb. I took a very hot bath for approximately 45 minutes and subsequently laid in the bed (with intermittent napping) for 2 hours. Upon full wake up around 1430, I had no more chills, no headache, and felt back to my normal self.
34 2021-01-19 cold sweat Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This... Read more
Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 18Dec2020 08:15 AM as a single dose for COVID-19 immunization, lot number: EL0140. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications in two weeks prior to the vaccination included Multivitamins, Vitamin C, Vitamin D3, zinc oxide and fluticasone propionate (FLONASE). On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. No treatment was received for the events. Patient recovered from all the events on unknown date in Jan2021. Patient had not been tested for COVID-19 post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015086 same patient/vaccine, different dose/event
34 2021-01-19 tingling TINGLING ARM ; RESOLVED
34 2021-01-20 muscle spasms Day 8 post vaccine immune response. Fever, chills, muscle spasms.
34 2021-01-20 numbness Flu-like symptoms; Bilateral cheek numbness; This is a spontaneous report from a contactable nurse (... Read more
Flu-like symptoms; Bilateral cheek numbness; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: El0140), intramuscular in right arm, on 18Dec2020 at 14:30, at a single dose, for COVID-19 immunization. The patient's medical history included was not reported. The patient's concomitant medication included ascorbic acid (VITAMIN C). The patient previously took benzoyl peroxide and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in a hospital facility. On an unspecified date after the first dose, the patient experienced flu-like symptoms for 48 hours plus bilateral cheek numbness for two weeks. The events were considered non-serious. No treatment was received for the adverse events. The patient underwent laboratory tests and procedures which included nasal swab for Coronavirus Pandemic 2019-NCOV (NAA) that was negative on 04Jan2021. The patient recovered from the events on an unspecified date.
34 2021-01-20 discomfort, pain in extremity On 1/16/2020 the patient was noted to have erythema on her hand which she noted was pruritic. She no... Read more
On 1/16/2020 the patient was noted to have erythema on her hand which she noted was pruritic. She noted additional swelling and discomfort and 2 days later area was raised, red/purple and noted as painful and itchy. She sought out help from a physician who noted the area as possible cellulitis and prescribed cephalexin. 2 days later the patient reported to Urgent Care noting more pain and worsening swelling at the site on her Right palm. It was also noted she had a swollen, red lesion on the Right side of her back adjacent to her right scapula. The patient was diagnosed with shingles and was started on Valtrex. Due to timeline and closeness to vaccination dose, consideration of an immune modulated reaction.
34 2021-01-20 feeling hot Patient received COVID vaccine and was sitting in the monitoring area. She was unable to sit still ... Read more
Patient received COVID vaccine and was sitting in the monitoring area. She was unable to sit still and flagged the RN monitor. She c/o feeling hot, itching, and "scratchy" throat making it "feel funny" to swallow. Strong pulses, patent airway, no hives noted, speaking in full sentences. ED Charge RN contacted and ED RN transported to ED without incident via wheelchair.
34 2021-01-20 hot flush, numbness Pt. noted onset of "numbness", heat and heaviness over her left facial cheek area with a 5X4 inch ar... Read more
Pt. noted onset of "numbness", heat and heaviness over her left facial cheek area with a 5X4 inch area. She denied any difficulty swallowing, no trouble breathing, no associated symptoms, no motor impairments of cranial nerves
34 2021-01-20 cold sweat Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle... Read more
Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; This is a spontaneous report from a contactable Nurse (patient). A 34-years-old female patient received second dose of bnt162b2 (BNT162B2 lot number=EK9231), via an unspecified route of administration on 08Jan2021 08:00 at SINGLE DOSE on arm left for covid-19 immunisation. The patient medical history was none. Known allergies: None. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d3 (VITAMIN D3), zinc (ZINC), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and Multivitamins. The patient previous received product=COVID 19, brand=Pfizer, Lot number=EL0140, Administration date=18Dec2020, Administration time=08:15 AM, Vaccine location=Left arm, Dose number=1. On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. After the second dose, the patient experienced severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling on 08Jan2021 19:00 with outcome of recovering. No treatment was received. The patient had no covid prior vaccination; no covid tested post vaccination.
34 2021-01-20 tingling Symptoms- tingling and numbness on the left side of face radiating down to left arm and hand. Intens... Read more
Symptoms- tingling and numbness on the left side of face radiating down to left arm and hand. Intense headache. Fatigue
34 2021-01-21 feeling hot About 10 minutes after injection the patient was feeling faint, racing heartbeat and was instructed ... Read more
About 10 minutes after injection the patient was feeling faint, racing heartbeat and was instructed to sit down. Never lost consciousness and was able to able to breath through the event and drink water after a couple of minutes. Patient also felt rapidly hot and dizzy. We had her sit down, take deep breaths, kept her talking, offered water, and got epinephrine ready. She recovered completely after a total of 30 minutes but did feel slightly dizzy throughout the day. Was able to continue with regular workday as we determined it was best she stayed with other people for the remainder of the day.
34 2021-01-21 weakness, electric shock sensation Felt like a electric shock at the moment of vaccination. On the next day, extreme weakness, severe b... Read more
Felt like a electric shock at the moment of vaccination. On the next day, extreme weakness, severe body pain, and dizziness. Felt like she was going to pass out in the bathroom so she called her husband to assist her. Stayed 1 day in bed. Didn't received treatment.
34 2021-01-21 face paralysis, feeling hot, tingling, numbness Immediately afterwards developed L-sided facial weakness/numbness, stiff neck, BUE/BLE paresthesia, ... Read more
Immediately afterwards developed L-sided facial weakness/numbness, stiff neck, BUE/BLE paresthesia, sensation of feeling hot (T 99 F). Was observed for 2 hours, given Benadryl. No longer feeling paresthesia or hot, but still has mild L-sided facial weakness, stiff neck, and in past 2-3 days having dizziness upon awakening, resolves after a few minutes. No dysphagia. Never had facial droop. BP 119/80. Spoke w/physician 2 days ago about her symptoms and was reassured they're due to vaccine.
34 2021-01-21 flushing Redness, flushing, tachycardia and hives within 5-10 minutes of receiving vaccine.
34 2021-01-21 flushing, burning sensation, feeling hot The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird... Read more
The day of my 1st vaccine, about 10 min after I was in the waiting room and I started feeling "weird" in my whole body and lightheaded. I got some juice. Then I started to get hot and was sweating, my whole face and neck were flushed; I also felt mild burning sensation on the R lower lung area. They took me in back and gave me more juice and water and put ice packs on me. It took 30+ minutes to feel better. They called a team to come do my vitals and my HR was in the 100s and they said my eyes were dilated. On my way home I had a weird throbbing pain in my L upper chest just above my boob. When I got home I had chills/felt freezing for a few hours and was fatigued. The next day (Sun) I had moderate joint pain, fatigue, and was very achy; my chest felt tight and I needed my inhaler and some tramadol. On Mon I felt better and went back to work, but then Tues I was achy again and my coworker said I looked pale; I took some tramadol and felt better, just tired. On wed I was having pains in my neck, shoulder, down my arm L arm, and down my scapula- the arm I had the injection. Throughout the day the pain was throbbing and ended up a 7/10 and edema in my neck/shoulder/axillary occurred; I couldnt carry anything heavy and was guarding that arm. Tramadol didn't help the pain and I eventually took 600mg ibuprofen and made a telemedicine visit w/ my MD for the next day. After 3 days the pain was subsiding but the edema took ~ 1 week- it subsided the weekend before my next vaccine. The day of my 2nd dose I did ok after the vaccine at 4pm. While they were injecting it I felt burning down my arm. I felt lightheaded and "weird" afterwards and warm, but no eye dilation or flushing. 3 hours after the vaccine at 7pm I felt tired and a little achy and slept from 7-9pm. At 9pm I woke up very achy, I had 1 itchy hive that popped up on my R inner forearm. The next day I had joint pain in every joint and very achy and fatigued. The joint pain subsided on day 2 after the vaccine but I was very achy and fatigued for a good 72 hrs. Vaccine was wed and saturday the pain in my neck returned and the edema came back and was a little worse than before, and the area where the edema was, was painful to touch. It started subsiding ~ a week after the vaccine, but a little bit is still currently here- but no pain to touch. My allergist has been following up w/ me this whole time.
34 2021-01-22 unresponsive to stimuli After mild vaccine reaction symptoms (myalgia, chills) I passed out and was unresponsive for 2 minut... Read more
After mild vaccine reaction symptoms (myalgia, chills) I passed out and was unresponsive for 2 minutes.
34 2021-01-22 weakness Extreme weakness, joint pain, chills, headache. I have not taken my temperature, but it feels like I... Read more
Extreme weakness, joint pain, chills, headache. I have not taken my temperature, but it feels like I may have a little increased temperature. The symptoms didn?t begin until about 36+ hours after the vaccine.
34 2021-01-22 tenderness, breast pain Recipient states, "On Thursday morning my right armpit was sore and throughout the day it became wor... Read more
Recipient states, "On Thursday morning my right armpit was sore and throughout the day it became worse and by evening it was swollen and really tender. On Friday morning 1/22/20 it is still really sore and swollen and the pain is progressing down into my right breast."
34 2021-01-22 migraine The day after I experienced brain fog and a minor headache. 24 hours after I had extreme joint pain... Read more
The day after I experienced brain fog and a minor headache. 24 hours after I had extreme joint pain in my shoulders, elbows, and even my jaw. 48 hours I developed a crippling migraine and throwing up constantly. I am now 53 hours post the 2nd injection and still have a migraine and nausea.
34 2021-01-22 pain in extremity The evening of the day I got the shot, I began to get tired and started to have a sore arm. Through... Read more
The evening of the day I got the shot, I began to get tired and started to have a sore arm. Throughout the night, the arm soreness got worse and I got joint pain. The whole next day, I experienced severe malaise, headache, chills, fever, and joint pain with the site soreness. The arm pain got worse. That night, I struggled to sleep. The whole day after that, I had less malaise and the fever had gone down but the injection site reddened and grew even warmer and more tender. That evening it was difficult to sleep as the soreness in my arm migrated to the shoulder, armpit and the right side of my chest, along where a bra band would go on the distal right side of the chest. The next morning (today) the entire armpit area and upper distal right side of the chest were hot and tender. This afternoon, I palpated the area and noticed at least one swollen lymph node. My arm still hurts.
34 2021-01-22 tenderness The lymph nodes in the injected arm (left arm), armpit are swollen, to about the size of a golf ball... Read more
The lymph nodes in the injected arm (left arm), armpit are swollen, to about the size of a golf ball, it is tinder to the touch
34 2021-01-23 grand mal seizure, unresponsive to stimuli COVID-19 vaccination - 2/2 in series. Reportedly, patient fainted following first dose. Approximat... Read more
COVID-19 vaccination - 2/2 in series. Reportedly, patient fainted following first dose. Approximately 5-6 minutes after patient received second dose, she become lethargic, progressing to non-responsive. A rapid response was called and patient was transferred to the emergency department. She was protecting her airway. En route to the ED, patient's eyes rolled backwards and she began having generalized tonic-clonic movement indicative of a seizure. Patient was turned onto her side until seizure activity subsided. Post-ictal state lasted approximately 5-10 minutes after seizure activity ceased and patient became alert and oriented and able to answer all questions. All lab tests and imaging were normal.
34 2021-01-23 flushing My upper back became flushed and a mild rash developed and disappeared about 30 minutes later. I had... Read more
My upper back became flushed and a mild rash developed and disappeared about 30 minutes later. I had small mild rashes on my stomach and back that that lasted until Saturday. My skin felt a bit itchy and prickly in some places.
34 2021-01-23 muscle spasms, pain in extremity Numb tingly mouth, skin felt like it was burned and hurt for anything to touch it, muscle aches and ... Read more
Numb tingly mouth, skin felt like it was burned and hurt for anything to touch it, muscle aches and spasms, headache, nausea, fever, sore arm
34 2021-01-24 tingling, facial paralysis On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I w... Read more
On Thursday 1/21/2021, around 10am: I felt my left lip and mouth had a numbing taste and effect, I was slowly throughout the day unable to drink out of a cup without dribbling, my right eye was constantly watering, around 4pm: my right arm started tingling and bothering me, around 9pm: I tasted a Novocain(numbing) like taste in my mouth, I showered and went to bed, while in bed around 10:30pm: I drank out of a water cup and immediately drooled water onto my shirt and my right arm was starting to tingle even more, I thought that was out of the ordinary and got up to look in the mirror, when I looked in the mirror, my first thought was to smile and the right side of my mouth drooped, my right eye was drooping and I was unable to smile or close my eye. At 12:30: I went to the ER for tingling on my face and right arm, I thought I was having a stroke. In between home and traveling to the ER, paralysis started on my right side of face
34 2021-01-24 numbness Pfizer-BioNTech COVID- 19 Vaccine EUA EMS states "Pt received 1st covid vaccine dose at the clinic. ... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA EMS states "Pt received 1st covid vaccine dose at the clinic. Had an anaphylactic reaction, SOB, throat swelled, abdominal cramps. Received epi injection and 25mg benadryl. BP 150/70. Was tachycardic but HR currently in the 90's." Patient reports similar reaction when she received an allergy shot. ED Physician Note: "She was given her injection and then within about 2 minutes felt palpitations, lightheadedness, whole body numbness, an odd tongue sensation, and stomach cramping. She was given epinephrine and benadryl" Patient was discharged from ED same day with resolution of symptoms.
34 2021-01-24 face paralysis, facial paralysis Right sided facial weakness paralysis. Headache radiating from right base of skull to right ear to t... Read more
Right sided facial weakness paralysis. Headache radiating from right base of skull to right ear to top of head.
34 2021-01-25 tingling, numbness About 15 min I felt numbness and tingling on my face. Gradually felt it in my whole body by 8:30PM ... Read more
About 15 min I felt numbness and tingling on my face. Gradually felt it in my whole body by 8:30PM that night, next day I tried to go to work but I had to leave because of the intense numbness and tingling. I also developed left leg weakness and had to even pick up my leg to be able to walk. The NP at my neurologist office (talked over the phone) said it was a pseudo effect due to my MS. My symptoms are still intermittent up to my second dose. It is all over the numbness and tingling, but as it is subsiding it is now flaring up my symptoms from 2 years ago and I feel it on my second side.
34 2021-01-25 tingling Chest pain, High blood pressure, Heart rate was fast and i also had tingley hands . It happened abo... Read more
Chest pain, High blood pressure, Heart rate was fast and i also had tingley hands . It happened about 45 Minutes after i had the vaccine. I was then sent out to the hospital.
34 2021-01-25 weakness I experienced weakness, fatigue, lightheadedness for the most of day after receiving the shot. Sympt... Read more
I experienced weakness, fatigue, lightheadedness for the most of day after receiving the shot. Symptoms reduced with rest, plenty of water. Symptoms resolved by morning of 1.26.2021
34 2021-01-25 facial pain Injection site red; Tennis ball sized hard lump; Injection site pain; Injection site Swollen; Facial... Read more
Injection site red; Tennis ball sized hard lump; Injection site pain; Injection site Swollen; Facial pain; Fatigue; Headache; This is a spontaneous report from a contactable other Health Professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), intramuscularly in left arm on 10Jan2021 08:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Known allergies: No. Other medical history: No. The patient was not pregnant. The patient's concomitant medications were not reported. If other vaccine in four weeks: No. Other medications in two weeks: No. Facility type vaccine: Hospital. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899) on 20Dec2020 for COVID-19 immunization. The patient experienced injection site pain, swollen, red, tennis ball sized hard lump, fatigue, headache, facial pain, all on 11Jan2021 06:00 with outcome of recovering. No treatment received for all the events. If COVID prior vaccination: No. If COVID tested post vaccination: No.
34 2021-01-25 numbness, tingling Soon after receiving the second dose just like the first one I started developing tingling and numbn... Read more
Soon after receiving the second dose just like the first one I started developing tingling and numbness on my face and arms, chest. On Sunday I also started feeling chest tightness so I went to the ER. EKG was normal. They told me to follow up with my neurologist. I still have lingering symptoms of tingling and numbness that come and go.
34 2021-01-25 tenderness Swelling and pain near right armpit for two days. Swelling and tenderness to touch for 1 day.
34 2021-01-25 discomfort This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Dec2020 15:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. On 23Dec2020 13:00, patient discovered a lump on the bottom of her left armpit, felt a lot of discomfort when touching it. It went away around 02Jan2021. Patient does not have COVID prior vaccination. COVID was tested post vaccination via nasal swab, COVID test date on 07Jan2021, and COVID test result was negative. No treatment was received for the events. The events recovered on 02Jan2021. Information on the lot/batch number has been requested.
34 2021-01-25 numbness, tingling had numbness/to her bottom jaw bone/switched between her cheek and jaw and then her nose; face start... Read more
had numbness/to her bottom jaw bone/switched between her cheek and jaw and then her nose; face started tingling/from her lower eyelid/switched between her cheek and jaw and then her nose; face started tingling and had numbness/from her lower eyelid; face started tingling and had numbness/affects her lips/and mouth sometimes; face started tingling and had numbness/affects her lips/and mouth sometimes; It is just very annoying/It is irritating; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL3284), via an unspecified route of administration in the left arm on 11Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included ongoing anxiety since she was 13 years old. The patient's concomitant medications were not reported. The patient received the vaccine on Monday at 12 o'clock. She got it for work. She doesn't have a prescribing doctor. She developed the side effect Tuesday at 2 am. The left side of her face started tingling and had numbness, which is the same side she received the vaccine on. She doesn't have weakness. It is not resolving. It is from her lower eyelid to her bottom jaw bone. When asked if it was improving persisting or worsening, she said it depends. Sometimes it gets worse and affects her lips, and sometimes it is on and off. It won't be completely gone. It switched between her cheek and jaw and then her nose and mouth sometimes. If she bends over, it tingles worse. It is just very annoying. It felt like if she had Novocain on the top and bottom of her mouth. It is irritating. She got it because she doesn't want COVID and she works as a nurse. She does have really bad anxiety. She has nothing else medical. She is just really nervous. It is not going away. She is freaking out. She would like more information. The outcome of the event "It is just very annoying/It is irritating" was unknown, while for the other events was not recovered.
34 2021-01-26 pain in extremity 25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low ... Read more
25 Jan evening-fatigue, sleepy, injection site red, HA, runny nose 26th Jan 2021-more fatigued, low back, hips, legs achy, runny nose, HA 27th January-SAME-nose stopped running, increased fatigue, site of injection-more red/swollen, rt armpit-achy & swollen Treatment-she said she took an aleve this AM-27th Jan, and she will get some PEDILYTE today to sip
34 2021-01-26 tingling Vaccine administered. Patient reported L upper arm paresthesias ~7 min after administration. States ... Read more
Vaccine administered. Patient reported L upper arm paresthesias ~7 min after administration. States she had the same reaction with first dose that self resolved by end of day. Patient was monitored for 30 minutes with improvement of symptoms and no development of new or worsening symptoms. Patient was advised to seek ER eval if she develops any throat itching or tightness, tongue swelling, shortness of breath or vomiting.
34 2021-01-26 tremor, feeling hot Within a few minutes of receiving vaccine, she reported feeling warm, lightheaded. Exhibited tremulo... Read more
Within a few minutes of receiving vaccine, she reported feeling warm, lightheaded. Exhibited tremulousness. Vitals were checked, bp was 170/101 and HR was 130, O2 sat was 98. She was noted to be taking shallow rapid breaths, however lungs were clear. No rash. Reported chest pain. Due to acharacteristic symptoms for anaphylaxis, hypertension and tachycardia, and history of arrhythmia, we elected not to administer epinephrine. 911 was called and she was transported via EMS to nearby hospital.
34 2021-01-27 pain in extremity About 48 hours after injection: arm still very sore, red at injection site, and developed swollen a... Read more
About 48 hours after injection: arm still very sore, red at injection site, and developed swollen and sore lymph nodes in right arm (site of injection)
34 2021-01-27 numbness, hot flush, flushing Had a hot flash or flushing sensation; Had a hot flash or flushing sensation; Tingles and a decrease... Read more
Had a hot flash or flushing sensation; Had a hot flash or flushing sensation; Tingles and a decreased sensation around her lips/numbness and a tingling to her lips and nose; Numbness and a tingling to her lips and nose; This is a spontaneous report from a contactable nurse. A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular (left arm) from 14Jan2021 16:30 to 14Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that 10 minutes after the injection, she had a hot flash or flushing sensation, as well as numbness and a tingling to her lips and nose. She explained having "tingles and a decreased sensation around her lips", which she also referred to as a "diminished sensation" during the interaction. She says that she has done no treatment for this. The outcome of the events was unknown.
34 2021-01-27 feeling of body temperature change Normal signs and symptoms at first, little hot and cold at first within the first 12 hours. 1/27...5... Read more
Normal signs and symptoms at first, little hot and cold at first within the first 12 hours. 1/27...5 days post vaccine I was really tired before going into work and overnight it became more noticeable the pressure on my chest, difficulty breathing in deeply without pain in the center of my chest and a sore throat by the end of my shift. Now approx 18 hrs from the initial onset it hurts my chest when I swallow and it passes through my esophagus. I?m really apprehensive about taking the other shot.
34 2021-01-27 numbness, weakness The evening that I received the vaccine, I started having some numbness in my hands. The following ... Read more
The evening that I received the vaccine, I started having some numbness in my hands. The following morning, I continued to have numbness in my hands but also in my face. By the evening , the day after I had received the vaccine, I felt like my swallowing was slightly impaired and I went to urgent care. I was able to complete all neurological tests and given a prescription for hydroxyzine, thinking that I may have had a slight histamine response. I slept approximately 10 hours that night and then fell asleep again from 8:30-11:30 this morning due to high levels of fatigue. Today (~54 hours later), the numbness in my hands and face seems to be getting slightly worse. I also feel some generalized weakness. I'm still able to do normal day to day activities but it feels abnormal.
34 2021-01-27 bell's palsy bells palsy left
34 2021-01-27 one side paralysis right hemiparesthesia of the face, seen at ED, given bolus LR, CT scan with contrast head and neck, ... Read more
right hemiparesthesia of the face, seen at ED, given bolus LR, CT scan with contrast head and neck, routine labs
34 2021-01-28 numbness, weakness 1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating... Read more
1/9/21 woke up with fever, body aches and fatigue. 1/10/21 developed right lower back pain radiating to right side and right lower quadrant without any known injury. Presented to ER on 1/11/21 and was found to have elevated liver enzymes. 1/12/21 woke up with right thigh numbness and was referred to spine specialist by PCP. Saw spine specialist on 1/14/21 and was referred to physical therapy and given medrol dose pack taper. Repeated liver enzymes after 1 week resulted with abnormal results and referred to GI doctor. 1/28/21 Developed worsening right thigh numbness with decreased strength to right leg and following up with spine specialist on 02/01/21.
34 2021-01-28 feeling hot Chest tightness, rapid heartrate, shortness of breath lasted for 2-3 minutes Warm sensation througho... Read more
Chest tightness, rapid heartrate, shortness of breath lasted for 2-3 minutes Warm sensation throughout body for 4-5 min lasting no more than 30 secs at a time.
34 2021-01-28 pain in extremity Evening of 1/25/2021 she experienced a sore arm and toss and turned through out hours of sleep. Repo... Read more
Evening of 1/25/2021 she experienced a sore arm and toss and turned through out hours of sleep. Reports significant s/sx onset this morning arounf 0100, 1/26/2021 to include chest tightness with a sharp pain when inhaling, all over body aches, chills, fatigue and sore arm. Employee states about 1 hr. post vaccination she tasted blood in her mouth and noticed when she . States supervisor referred to OH to be evaluated. Employee also reports hx. of COVID illness with a positive result on 12/27/2021. States onset of s/sx was on 12/26/2021. Patient reported to employee health clinic to report adverse event. On, 1/27/2021 patient was seen by her PCP for evaluation.
34 2021-01-28 pain in extremity Fatigue, arm pain, contractions (baby due date 7/30/2021)
34 2021-01-28 migraine Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. W... Read more
Injection site got sore after just a few moments. Site itched. Began experiencing extreme fatigue. Within the first 15 hours following the injection I began experiencing extreme full body pain, neck, back, arms, legs, hands, and fingers. As well as experiencing a major headache equivalent to migraine pain. The pain was intense and lasted around 36 hours. Pain had subsided within 48 hours excluding pain at injection site that continued but was significantly milder.
34 2021-01-28 sensory loss Injection was inproperly given in the back of my upper arm in the fleshy area. Unknown if it reached... Read more
Injection was inproperly given in the back of my upper arm in the fleshy area. Unknown if it reached muscle or only subQ tissue. Significant Unilateral swelling and decreased sensation noted to left side of face 2 days after receiving vaccine. Resolved on its own in 2 days.
34 2021-01-28 tingling, numbness Patient experienced facial numbness several hours after 1st dose of Pfizer lot# EK5730 on 12/18/2020... Read more
Patient experienced facial numbness several hours after 1st dose of Pfizer lot# EK5730 on 12/18/2020 which patient reports later resolved. Patient then came in for 2nd dose of Pfizer lot# EK 9231 on 1/18/2021 and experienced tingling and was kept for 45 minutes.
34 2021-01-28 pain in extremity, flushing Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed... Read more
Stiff, sore arm immediately lasting at least 48 hours. Hard and bruised at injection site. Developed low grade temp, flushed face, fatigue, muscle stiffness, body aches hours following vaccine. Aches and fatigue continues and it?s now day 8. The fatigue is constant but comes in waves. I?m taking unexpected naps which are abnormal for me. Caffeine and methylphenidate are ineffective. I?m still sore. I also have brain fog, maybe from the fatigue. I can?t think straight and it takes me longer to process and do tasks. I woke up 2 hours ago and I can?t wait to sleep again.
34 2021-01-28 tingling Tight/sore jaw; Tight/sore jaw; Tingling in cheeks; This is a spontaneous report from a contactable ... Read more
Tight/sore jaw; Tight/sore jaw; Tingling in cheeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3248), via an unspecified route of administration at site of left arm at 13:15 on 15Jan2021 at single dose for COVID-19 immunization. Medical history included asthma, gastrooesophageal reflux disease (GERD), obesity and known allergies: Sulfa. Concomitant medication included cannabidiol (CBD OIL) and paracetamol (TYLENOL), both received within two weeks of vaccination. The patient experienced tight/sore jaw and tingling in cheeks, both at 13:30 on 15Jan2021. The patient was not pregnant at time of vaccination. Facility type vaccine was in workplace clinic. No other vaccine in four weeks. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. The outcome of events was recovering.
34 2021-01-28 tingling light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a cont... Read more
light headed; Tingling of body and face; rash on right arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 34-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: El0142), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included COVID-19 (COVID-19 antibody test with positive result) and allergies; Iodine. Concomitant medication included vitamin c [ascorbic acid] and calcium. Both received within two weeks if vaccination. The patient experienced lightheaded, tingling of body and face and rash on right arm on 17Jan2021. Facility type vaccine was in hospital. No other vaccine received in four weeks. No treatment received for adverse event. No covid tested post vaccination. The outcome of events was recovering.
34 2021-01-29 facial pain 1/15/2021: received 2nd dose of vaccine at 5:45 PM 1/16/2021: woke up around 8:00 AM with fever, chi... Read more
1/15/2021: received 2nd dose of vaccine at 5:45 PM 1/16/2021: woke up around 8:00 AM with fever, chills, headache, body aches, fatigue (lasted approx. 24 hours) 1/17/2021: body aches and fatigue continued but improving 1/18/2021: body aches and fatigue continued but improving 1/19/2021: [7:00 AM] facial soreness to the touch, especially along cheekbones 1/20/2021: [7:00 AM] wake up with periorbital edema + face sensitive to touch (felt like pressing a bruise) 1/21/2021: [7:00 AM] face sensitivity improving but periorbital edema progressing + rash under eyes and on eyelids 1/22/2021: dermatitis remains but face sensitivity & periorbital edema improving; go to PCP at 9:30 AM; apply hydrocortisone 2% lotion at PM 1/23/2021: continued improvement; facial skin peeling under eyes; started Zyrtec 10mg in AM; used hydrocortisone 2% lotion at PM 1/24/2021: continued improvement; facial skin peeling under eyes; Zyrtec 10mg in AM; hydrocortisone 2% lotion at PM 1/25/2021: resolved
34 2021-01-30 feeling cold Woke up approx. 64 hours into second dose vomiting with chills. Residual left arm pit pain from fir... Read more
Woke up approx. 64 hours into second dose vomiting with chills. Residual left arm pit pain from first vaccine.
34 2021-01-31 numbness, tingling 12/28/2021 @ 08:25 AM: Numbness of left arm and tingling on fingers. Was kept in observation in obs... Read more
12/28/2021 @ 08:25 AM: Numbness of left arm and tingling on fingers. Was kept in observation in observation room and assessed in the urgent care. Feeling better and resolved on same day.
34 2021-01-31 feeling hot, throat numbness About 40 minutes after receiving vaccines, my body began to feel hot all over. My palms are very moi... Read more
About 40 minutes after receiving vaccines, my body began to feel hot all over. My palms are very moist/sweaty as well. I'm also suddenly feeling tired even though I was not tired before receiving the vaccine. I just generally feel like I wish I could lay down and sleep. I have a slight headache developing as well. My throat feels a bit odd as well. Its not a pain, it just feels kind of numb if that makes sense
34 2021-01-31 migraine Migraine (2 days now) - started Ibuprofen as needed Light sensitivity (1 day so far) while working ... Read more
Migraine (2 days now) - started Ibuprofen as needed Light sensitivity (1 day so far) while working from home Fatigue Injection site pain (1 day)
34 2021-02-01 feeling hot Patient rec'd vaccine and within 5 minutes began feeling hot & itchy. Patient had generalized rash ... Read more
Patient rec'd vaccine and within 5 minutes began feeling hot & itchy. Patient had generalized rash mostly on left cheek, back, and chest. Red & raised. Patient was taken to the ED - vitals were stable, patient was given Benadryl PO and Prednisone 60 mg PO. Pt was observed for a couple of hours and then released.
34 2021-02-01 tingling Tingling sensation to entire body, hands and feet. BP 187/96 HR 136. hreart palpitationsw, tinling i... Read more
Tingling sensation to entire body, hands and feet. BP 187/96 HR 136. hreart palpitationsw, tinling in legs;
34 2021-02-02 tingling, weakness 0845: generalized weakness, headache, and all over tingling sensation (hard to put into words,) 090... Read more
0845: generalized weakness, headache, and all over tingling sensation (hard to put into words,) 0900: noticed difficulty in swallowing and swelling bilateral side of the neck from top of the ear to bottom of neck. Throat felt slightly tight, not all he way around the esophagus; pressure from the sides. 0902 notified the desk that I was having a reaction 0902 was brought back into triage and vital signs were taken: heart rate in the 70's, blood pressure within normal parameters, oxygen was 100% on room air and respirations were within the normal parameters. The 2 nurses did an focused assessment, no hives or rash, swelling present face ( eye, lips, or face) Just swollen in the neck area. 0905 25mg Benadryl po -liquid was given 0915 vital signs were retaken and vital signs were in the same range as previously mentioned. The nurse asked if I could stay to monitor signs and symptoms. 0930: I felt like the swelling was going down slightly. 0955: Was rechecked by the nurses and was released. Was told to monitor symptoms at home and go to the er if anything should change. **times might slightly vary per what is stated, tried the best to my ability to recall the exact time line
34 2021-02-02 tingling 10min after vaccination, Pt began experiencing "body tingling" and mild runny nose, VSS and no other... Read more
10min after vaccination, Pt began experiencing "body tingling" and mild runny nose, VSS and no other complaints. Symptoms resolved in 15min without intervention . Pt DC'd home NAD after being monitored for 30min.
34 2021-02-03 flushing 5 min after shot had flushing, tachycardia and numb lips. 4 days later I developed tachycardia, ches... Read more
5 min after shot had flushing, tachycardia and numb lips. 4 days later I developed tachycardia, chest pain, dyspnea, body aches
34 2021-02-03 feeling cold Nausea, diaphoresis, cool, pale, light headed started 5 minutes after vaccination. Felt better a... Read more
Nausea, diaphoresis, cool, pale, light headed started 5 minutes after vaccination. Felt better after 10 minutes. Did not throw up or pass out. Vitals 106/70, pulse 81, RR: 12, o2 sat 99 %
34 2021-02-04 tremor Found sitting, short of breath, pale, shaky, tight chest. Initially with HR 150s, o2 sat 88%. Transf... Read more
Found sitting, short of breath, pale, shaky, tight chest. Initially with HR 150s, o2 sat 88%. Transferred to a gurney. Repeat vitals and color improved within 10 minutes, HR 100, 37.2, 142/95, o2 sat 100%. Employee was monitored for 1 hour. Still felt slightly dizzy so transferred to the emergency department for further observation.
34 2021-02-04 feeling of body temperature change Rapid heart rate of 116-120 about 15 min post vaccine. Scratchy throat about 30 min post vaccine. S... Read more
Rapid heart rate of 116-120 about 15 min post vaccine. Scratchy throat about 30 min post vaccine. Sensation of throat closing (lump in throat and getting harder to swallow). My husband dropped me at Emergency room. I was triaged into a room within a few minutes. Started to have a little shortness of breath. Exam performed and 1 liter normal saline given IV. 25mg Benedryl given IV about 3pm. Certirizine HCL 10mg given orally 3:46pm. Prednisone 40mg tab given orally 3:47 pm. Monitored for 4 hours and then discharged home to continue certirizine orally daily for next 2 days along with 40mg pred orally for next 2 days if needed. I took some sunday but not Monday. Did okay with on off hot/cold chills monday and tuesday but now ongoing hives.
34 2021-02-04 weakness Ten minutes after injection i became weak, dizzy, and had an elevated heart rate of 140 while sitti... Read more
Ten minutes after injection i became weak, dizzy, and had an elevated heart rate of 140 while sitting. Upon standing, my heart rate jumped to 163.
34 2021-02-04 numbness and pain in extremities Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pai... Read more
Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pain; tinnitus; This is a spontaneous report from a contactable other health professional (patient) reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248), intramuscular at left arm on 20Jan2021 at single dose for covid-19 immunization. Medical history was none. No pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 30Dec2020 for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was nursing home/senior living facility. The patient experienced transient bilateral lower extremity neuropathy, tinnitus, periorbital and facial neuropathy, severe low back pain on 20Jan2021 with outcome of unknown. No treatment was received for the adverse events. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
34 2021-02-04 weakness, feeling cold palpitations, chills, generalized weakness, drop of blood pressure
34 2021-02-04 pain in extremity sore arm x 2 days
34 2021-02-05 burning sensation Hives, burning sensation over skin, pain on roof of mouth.
34 2021-02-05 pain in extremity Sore arm, fever (102.5), fatigue, body aches, nausea, and mild GI discomfort. My symptoms are very s... Read more
Sore arm, fever (102.5), fatigue, body aches, nausea, and mild GI discomfort. My symptoms are very similar to when I had COVID-19 in November. I took Tylenol and am feeling a little better. Fever went down to 101.5 an hour after Tylenol.
34 2021-02-05 numbness Symptoms reported by patient as follows. About 30 to 45 minutes after I received my vaccine The rig... Read more
Symptoms reported by patient as follows. About 30 to 45 minutes after I received my vaccine The right side of my face went numb, my tongue slightly swelled and felt like it was burning. I had pain in my right ear, and body aches. most of my effects were gone after 24 hours. I do still have pain in my right ear, and slight numbness in my face Patient called primary care provider and the below note was documented. Call from patient she received the COVID vaccination and her side of face feels numb and side of tongue and lips. Explained this could be a side effect of the vaccine and if she develops any shortness or trouble breathing she should go to the Emergency room. Patient also states she has been using her incentive spirometer not often but maybe once a day and she feels like her cough is getting deeper. She has had to use her inhalers but is not using them routinely. Patient instructed to use incentive spirometer more often and that this sound normal after surgery. Did offer her a repeat chest xray but patient wishes to hold off on that now. Instructed patient to call with any other concerns. Also if any SOB with vaccine to go to ER
34 2021-02-06 pain in extremity Headache, tired, dizziness, red hot rash around neck, nausea, diarrhea, side redness and swelling, s... Read more
Headache, tired, dizziness, red hot rash around neck, nausea, diarrhea, side redness and swelling, site itching Immediately after first dose I had rapid heartbeat, dizziness then fever, nausea, diarrhea, muscle aches, sore arm,
34 2021-02-06 pain in extremity I received the injection in the left deltoid and have had joint pain in my left elbow since a few da... Read more
I received the injection in the left deltoid and have had joint pain in my left elbow since a few days after the injection. I have pain/discomfort each time I extend my left arm. I have used OTC pain medicine with no relief.
34 2021-02-07 feeling cold, feeling hot, cold sweat Blurry vision, racing heart, dizziness, hot/clammy, chills after being really hot, anxiety all withi... Read more
Blurry vision, racing heart, dizziness, hot/clammy, chills after being really hot, anxiety all within 20 mins from injections. At 7:30 when home, cold, dull ache at base of skull.
34 2021-02-07 tremor, pain in extremity, pain in extremity, tremor Intense chills, uncontrollable shaking & teeth chattering for 2 hours (hours 12-14 after injection),... Read more
Intense chills, uncontrollable shaking & teeth chattering for 2 hours (hours 12-14 after injection), leg aches so great unable to stand. Fever measured up to 100F while on 400mg ibuprofen, temperature not taken during the intense chills. Ongoing fever of around 100F from hours 14 - 24, chills, exhaustion, and general malaise. continued treatment with 400mg ibuprofen. Headache and exhaustion from hours 24 post vaccine through day 5. Ibuprofen and tylenol taken to mitigate symptoms with marginal benefit. Minimal muscle soreness at injection site.
34 2021-02-08 migraine Pain at injection site, severe chills, did not sleep much last night, migraine, and body aches on 2/... Read more
Pain at injection site, severe chills, did not sleep much last night, migraine, and body aches on 2/8.
34 2021-02-08 burning sensation Pain from shoulder down to wrist and up the side of neck on arm where vaccine was received. Burning ... Read more
Pain from shoulder down to wrist and up the side of neck on arm where vaccine was received. Burning pain under arm. Swelling under arm and above collarbone and redness on skin in that area. Onset was day after vaccine and improved slowly over next few days. Resolved completely four days later.
34 2021-02-08 tingling, pain in extremity, numbness Symptoms of nausea began day of, were moderate for several days. Did not eat much the day of the va... Read more
Symptoms of nausea began day of, were moderate for several days. Did not eat much the day of the vaccine due to these symptoms. Numb feeling, tingling in extremities for 2-3 days post vaccination. Still some occasional numbness and tingling in nose, facial area, and back of head/neck. Diarrhea for a couple of days. Continue to experience mild nausea 1.5 weeks later. Did not have problems with nausea previously. Moderate fatigue for about a week following vaccination. Still noticing mild fatigue, getting tired easily and earlier than usual. Arm was sore from the day after vaccination until about 4-5 days had passed. Still otice an occasional pain when moving arm around a certain way. For 4-5 days following vaccination noticed various body pains. Pain in lower back- not muscle pain but something else. Chest wall pain when breathing in from 1-2 days to about a week post vaccination. Headache for a day. Brain fog feeling, forgetfulness beginning the day after vaccination and was noticeable for about a week. Still noticing this mildly and feeling more lightheaded than usual. Over the last few days, I've noticed chest tightness and some mild coughing. It's also below zero here, so this could be related to weather and dry air, or possibly related to the vaccine. Generally, I recognize that the above symptoms are possible after this vaccination. However, the existing literature seems to suggest these symptoms should last 1-3 days and be mild. My experience has been that they were worse than mild, most lasted at least a week, and some seem to be continuing. I am also breastfeeding a 19 month old. He had a brief bout of redness on about half of his body (underarms, forearms, thighs, knees) for about 30 minutes a week after I received the vaccine. He has never had that before for no apparent reason, and it did not continue, although he has reacted to lotions and certain brands of diaper wipes in this way previously. We have also noticed that he's been more irritable lately- throwing tantrums easily, sleeping more often, and getting inconsolable. We haven't tied this to any illness, although we do recognize that toddlers can through periods where they have more challenging behaviors. This is unusual for him though, he's generally happy and agreeable. I thought I'd mention it just in case there's been some sort of pattern that other breastfeeding moms have noticed.
34 2021-02-09 tingling, flushing, migraine Chest pain/pressure; Flushing; General fatigue; Presyncopal event; Migraine; Left arm tingling; Ches... Read more
Chest pain/pressure; Flushing; General fatigue; Presyncopal event; Migraine; Left arm tingling; Chest pain/pressure; This is a spontaneous report from a contactable nurse reporting for self. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3302), intramuscular on 20Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included coeliac disease, polycystic ovaries, migraine, drug hypersensitivity to Sulfa. Concomitant medication included clarithromycin (MACROBID [CLARITHROMYCIN]). The patient experienced flushing and general fatigue. Presyncopal event and migraine on day 3 without prior indication 23Jan2021. Left arm tingling and chest pain and pressure. Therapeutic measures Motrin were taken as a result of flushing and migraine. Patient had Covid test type post vaccination on 23Jan2021 with negative result. Outcome of events was recovering. All events resulted in emergency room visit.
34 2021-02-09 tingling, numbness Vaccinated 1/11/21 1/12/21: while at work patient became symptomatic and was sent to the ED - report... Read more
Vaccinated 1/11/21 1/12/21: while at work patient became symptomatic and was sent to the ED - reports "heart was racing, I felt dizzy and nauseous". Patient recently had 2nd dose of COVID vaccine yesterday morning and recently found she is pregnant. Patient states her heart rate went to 188 and her hands and feet were numb & tingling She took deep breaths, but remained tachycardic In ED SVT resolved with vagal maneuvers Repeat EKG shows sinus tachycardia
34 2021-02-09 pain in extremity arm pain; headache; back pain; tiredness; This is a spontaneous report from a contactable consumer, ... Read more
arm pain; headache; back pain; tiredness; This is a spontaneous report from a contactable consumer, reporting for herself. A 34-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261), via an unspecified route of administration at the left arm on 23Jan2021 13:15 at a single dose for COVID-19 immunization. Vaccination was done in a Workplace Clinic. The patient medical history was not reported. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and estradiol. The patient previously took Keflex and codeine and experienced drug allergy. On 23Jan2021 15:00, the patient experienced arm pain, headache, back pain and tiredness. No treatment was received. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
34 2021-02-09 weakness, feeling cold, hot flush body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, an... Read more
body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); hot and cold flashes; hot and cold flashes; light runny nose (light, yellowish/green); extreme fatigue; inability to concentrate; loss of appetite; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the left arm on 21Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered at other facility (as reported). The patient was not pregnant. The patient had no medical history (reported as none). The patient had no COVID prior to vaccination. The patient has no known drug allergies. Concomitant medication included tocopherol (VITAMIN E), cetirizine hydrochloride (ZYRTEC), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), and prenatal vitamins. The patient had no other vaccine in four weeks. On 23Jan2021 at 08:00 AM, the patient experienced body aches and weakness, especially in areas that she had previous issues with (low back, ankle, and knee), hot and cold flashes, light runny nose (light, yellowish/green), extreme fatigue, inability to concentrate, loss of appetite, and soreness at injection site. The patient has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.
34 2021-02-09 night sweats fever; night sweats; chills; headache; nausea; administration date=21/01/2021. dose number=2/adminis... Read more
fever; night sweats; chills; headache; nausea; administration date=21/01/2021. dose number=2/administration date=04Jan2021. dose number=1; This is a spontaneous report from a contactable physician (patient). A 34-years-old female patient (no pregnant) received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular on 21Jan2021 11:30 at SINGLE DOSE at left arm for covid-19 immunisation. The patient received the first dose of bnt162b2 on 04Jan2021 for covid-19 immunisation. Medical history included gastrooesophageal reflux disease, allergy to Sulfa. Concomitant medication included pantoprazole, spironolactone, and multivitamin. The patient experienced fever, night sweats, chills, headache, nausea on 22Jan2021 02:30. The patient received ibuprofen and acetaminophen for fever, night sweats, chills, headache, nausea. The outcome of events was recovering.
34 2021-02-10 discomfort, feeling cold Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous r... Read more
Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ3247), via an unspecified route of administration in the left arm on 23Jan2021 at 15:20 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included gestational diabetes (first pregnancy) from an unknown date to an unknown date and two pregnancies on unknown dates. Concomitant medications included unspecified post-natal multivitamins and paracetamol (TYLENOL; Lot Number: SBA22; Expiration Date: Jan2023) taken before getting the vaccine on 23Jan2021 to prevent soreness. The patient previously received the first dose of BNT162B2 on 03Jan2021 (at the age of 34-years-old; Lot Number: EL0142) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 24Jan2021 at 04:00, the patient experienced chills and had a feeling like a heavy weight on her body. On 24Jan2021 at 07:00, the patient had a fever and headache. On 24Jan2021, she also had back pain. The clinical course was as follows: On 23Jan2021, the patient took paracetamol before getting the vaccine as she heard one can feel sore after getting it. The patient received the second dose on 23Jan2021 at 15:20. The patient was okay after she got the vaccine. However, early the next morning (24Jan2021), she had shivering without any fever (later referred to as chills). The chills were something she never experienced in her life. It was like she was in the cold. She could not move, it was that bad. She felt a heavy weight on her whole body. She could not get out of bed. A few hours later at 07:00, she checked her temperature and it was 102.5 degrees Fahrenheit. She took paracetamol. The headache started with the fever around 07:00. She stated she kept taking paracetamol. She did try to stop using paracetamol, but without it, the headache was still there. The back pain was also severe on 25Jan2021. The chills recovered on 25Jan2021 and the fever was recovered on 26Jan2021. The clinical outcomes of the headache and felt like a heavy weight on the body were unknown; while that of the back pain was not recovered. The events of chills, fever, headache, and back pain were reported as serious by the patient (nurse) for being medically significant. The patient (nurse) assessed the events of chills, fever, headache, back pain, and felt like a heavy weight on her body were related to the vaccine.; Sender's Comments: Based on a compatible temporal association and known BNT162B2 vaccine safety profile causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
34 2021-02-10 flushing Patient reported feeling flushed after the vaccine. Vitals below. Benadryl 25mg PO given. BP 110/70... Read more
Patient reported feeling flushed after the vaccine. Vitals below. Benadryl 25mg PO given. BP 110/70 Pulse 100 Noticeably red around the ears and neck, was itchy. Monitored for 20 minutes after Benadryl administration, discharge with father driving
34 2021-02-10 facial paralysis, migraine right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of h... Read more
right sided facial paralysis; headache/migraine from base of R skull radiating to R Ear and top of head; This is a spontaneous report from a contactable nurse. This 34-Year-Old female nurse (patient) received 2nd dose of BNT162B2 (lot number=EL3247) Intramuscular on 21Jan2021 00: 00 AM (reported as 20Jan2021 12:00 PM) on Right arm for covid-19 immunization. Medical history and concomitant drug were not reported. Past drug was Known allergies to doxycycline. Historical Vaccine was 1st dose of BNT162B2 (lot number=EL1284, on 31Dec2020, 12:15 PM, administrator route=Intramuscular, vaccine location=Right arm). No other vaccine in four weeks. Patient received vaccine on Wednesday 20Jan2021, went to ER on Sunday 24Jan2021 with right sided facial paralysis and headache/migraine from base of R skull radiating to R Ear and top of head from 23Jan2021 10:00 AM with outcome was Recovering. Treatment was medications prednisone and antiviral. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of facial paralysis due to temporal relationship and current drug safety profile. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-02-11 feeling cold, pain in extremity Prior to the first dose , I felt completely healthy. I received the first dose on a Saturday at 9am... Read more
Prior to the first dose , I felt completely healthy. I received the first dose on a Saturday at 9am. Felt fine most of that day other than my arm being sore, which improved with Ibuprofen. The following day, I woke up a little achy, but felt better after taking more Ibuprofen. Around 4-5pm on Sunday afternoon, I started feeling more achy with cold chills (highest temp was 99.5) and congestion. I would take Ibuprofen and Tylenol, which would help. On Monday, congestion continued, but the body aches and cold chills went away. I did feel a little tired, but also did not sleep well due to the congestion. Did not have any other symptoms other than the congestion and actually felt pretty good. I worked from home on Monday to be on the safe side. On Tuesday, I was still having congestion (still no other symptoms) and my work did not want me to return until I got checked by a doctor or get a negative covid test. Went to an urgent care where I was seen by a doctor and tested for covid (rapid test), which came back positive. The only other symptom that developed was loss of smell (but not sure if that was just due to the congestion -- it seemed to come and go. Some things I could smell, some things I couldn't). I did not lose my sense of test. The congestion lasted less than a week. My family quarantined for over 20 days. We tried our best, but it was hard to isolate myself, especially from my younger kids. No one else in the household ever developed any symptoms. Not sure how/where I picked it up at --- We are very careful. The only other people I saw the 2 weeks prior to testing positive were my parents and in laws at Christmas, all of which have been healthy.
34 2021-02-14 pain in extremity Arm soreness 2hrs after shot administered; subsided by hour 36 Fatigue 24hrs after shot administered... Read more
Arm soreness 2hrs after shot administered; subsided by hour 36 Fatigue 24hrs after shot administered lasting at least 24hrs Slight loss of hearing in left and then right ear 48hrs later, restored 12hrs later
34 2021-02-15 feeling hot Approx 12 hours after receiving second dose of covid vaccine, I experienced what I can only describe... Read more
Approx 12 hours after receiving second dose of covid vaccine, I experienced what I can only describe as moderate-strong flu symptoms. I had previously had a mild reaction to the first vaccine (fatigue, mild headache) so I was shocked at how incapacitated I was after the second vaccine. 9:00pm (Wednesday) (12 hours after vaccine) - after feeling ok all day, starting to feel sick, chills yet feeling hot (fever at 101.4), muscles and joints aching and headache; 9:00pm-4:00am - very intense flu like symptoms, muscle and joint aching extreme, burning and deep pain on arm at injection site, chills not going away. I eventually fall asleep. 7:00am (Thursday) - call my mother to come pick me up because I am still feeling poorly. Fever is gone but I have a major headache and body aches are persistent. I take Tylenol and some of the body aches are better. I continue to feel like this throughout the entire day off and on. 7:00am (Friday) - finally feeling better but I have a lingering sense of extreme nausea that won't go away. My stomach itself is "fine" but the nausea is persistent. I take dramamine and feel somewhat better. 7:00am (Saturday) - still feeling fatigued but almost feeling like myself again. Nausea is still present but has greatly diminished. 7:00am (Sunday) - finally feeling mostly "ok" again. No noticeable major effects that are interfering with my ability to go about my day.
34 2021-02-15 bell's palsy Bell?s palsy
34 2021-02-15 weakness I was throwing up all of Friday, had chills, fever, dizzy, weak, and exhaustion. These symptoms las... Read more
I was throwing up all of Friday, had chills, fever, dizzy, weak, and exhaustion. These symptoms lasted all day Friday. I could barely get out of bed. Saturday I was still dizzy, body was weak but no more throwing up. The effects lasted until Sunday but my stomach is still having issues and still a little weak.
34 2021-02-15 weakness Pervasive myalgia on 11 February lasting into 12 February; on 12 February a large moveable and painf... Read more
Pervasive myalgia on 11 February lasting into 12 February; on 12 February a large moveable and painful lump found in the left axillary, abdominal cramping, diarrhea, and a syncopal episode. (ER visit, all labs and diagnostics normal, 1000mL NS via IV and discharged); 13 February general weakness and continued myalgia across the chest and back into 14 February.
34 2021-02-15 tingling Tingling down arm from injection site. No redness, creepy crawly feeling. Evaluated by EMS 9:42. st... Read more
Tingling down arm from injection site. No redness, creepy crawly feeling. Evaluated by EMS 9:42. stay 15 more minutes. Now lightheaded essential. Had not eaten. Given candy and fruit snack. Feeling better now. Advised to eat somewhere on the way home. Escorted out by MRC. Arm feels the same.
34 2021-02-18 tremor A few minutes after receiving the initial Covid shot, I experienced elevated heart rate, nauseated, ... Read more
A few minutes after receiving the initial Covid shot, I experienced elevated heart rate, nauseated, and uncontrollable shaking. EMS was notified and they monitored me for 30 +mins with VS. My heart rate was 116 and BP was 164/109. I felt 100% calm inside, but my body was shaking all they way down to my feet, and I could not stop it. This was NOT an anxiety attack. I was breathing normal, just could feel my heart racing. My normal BP is never higher than 130/80. I was given the option to go to hospital or have someone drive me home. I declined , as symptoms stopped a little over 30 after vaccination. Lastly, for the future I was informed of the option for more monitoring for next dose, in 30 min reaction line.
34 2021-02-18 breast pain Bilateral breast pain
34 2021-02-18 feeling hot I was shadowing another interpreter on Jan. 11, 2021 and started to feel warm, nausea. I sat down a... Read more
I was shadowing another interpreter on Jan. 11, 2021 and started to feel warm, nausea. I sat down and the PA asked if I was ok and then I don't remember anything. I then fainted and my Heart rate was 30 and they called a code blue. They took me to the ER and ran test and gave me IV and everything came back normal. After that incident, there was at least two other times I had to sit down because I was getting all the same symptoms again and thought it would happen again. I did donate blood on January 8. I was feeling fine when prior and the following two days.
34 2021-02-21 numbness, tingling Face became tingly and numb - lasted about 10 minutes Later that night I also experienced tingling a... Read more
Face became tingly and numb - lasted about 10 minutes Later that night I also experienced tingling and numbness and heaviness of the left side of my body (specifically arm and leg) on the affected/vaccinated side, drouth, and sleeplessness for about 2 hours
34 2021-02-22 night sweats Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizzin... Read more
Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizziness, cannot exercise
34 2021-02-22 migraine I started experiencing high fever, (103) body aches, muscles, nauseated, diarrhea, and migraine.
34 2021-02-22 night sweats I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 ... Read more
I started having fatigue around 7 hours after the shot was administered. My temperature went up 1.5 degree. Then 14 hours later I had chills and aches. Then I woke up with night sweats that drenched my sheets and clothes. Then I had a stabbing pain in my chest on the left side.
34 2021-02-22 tingling, numbness Numbness and tingling of face and lips that got progressively worse. Throat swelling
34 2021-02-23 weakness Nauseous, more abdominal pain, weakness for at least 7 days after
34 2021-02-23 difficulty speaking, flushing Received the vaccine, and was in the monitoring area. Within ~5 minutes, I felt my throat was thick... Read more
Received the vaccine, and was in the monitoring area. Within ~5 minutes, I felt my throat was thickening. I asked for water to see if that would help the sensation. The sensation of thickness increased to a tightening and thickness and a very mild itchiness on the roof of my mouth. I continued to feel a strong need to drink water and became extremely cold. At about 20 minutes, my voice became hoarse. I was given benadryl at approximately 40 minutes post injection, however the staff were communicating with people at the ER and was told that I needed an Epipen and to be transported immediately to the ER given signs of analphylaxis with the vocal change. I received the epipen about 45 minutes after injection, and a few minutes after receiving the shot, my throat felt looser. My voice continued to be hoarse. They had a very difficult time finding a vein in my arm for an IV (an I am typically very veiny). I was transported to the ER, and given steriods and monitored. At approximately 4 hrs post vaccine, I started to have worsening voice again, in which they gave me additional benadryl. I continued to be monitored in the ER until 7 hrs post vaccine. My voice continued to have moments where it was better and then it would go away again. They offered to keep me for observation, however I declined and was discharged to home. At home, later that night, I developed entire body itchiness, particularly over my face, and trunk. This lasted for several days, with decreasing intensity. My face was also very flushed looking lasting for 2 days after the reaction. My voice returned to normal after 3 days.
34 2021-02-23 difficulty speaking SOB, Hives, Reddness, Swelling in throat and lips. hoarseness and wheezing
34 2021-02-25 numbness Progress Notes APRN (Nurse Practitioner) -- Family Medicine Cosign Needed Called patient for foll... Read more
Progress Notes APRN (Nurse Practitioner) -- Family Medicine Cosign Needed Called patient for follow up from her visit yesterday here at the vaccine clinic. Pt states she feels well. She did end up taking another benadryl yesterday evening "more out of precautions" rather than for symptoms. She reports she feels well today and has not had any problems. APRN Progress Notes APRN (Nurse Practitioner) -- Family Medicine Cosign Needed Expand AllCollapse All COVID VACCINE CLINIC 2/24/2021 Patient: Date: 2/24/2021 Subjective Patient is a 34 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience itching and bilateral hand numbness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, stridor, lightheadedness, dizziness, facial swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , hypotension, rapid progression of symptoms, respiratory distress, skin changes and tongue swelling. She developed more itching later in her visit. Including lip, scalp, ears and ears felt warm. ALLERGY REVIEW OF SYSTEMS: Patient complains of itching of skin Patient denies chills, malaise/fatigue, facial swelling, ear pain, sneezing, sore throat, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, vomiting, abdominal pain, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/24/21 1030 02/24/21 1050 BP: 124/67 113/69 Pulse: 75 72 SpO2: 100% 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Head: Comments: Pt noted to itch neck and scalp region Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Comments: Clear oral airway No tongue swelling. Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Comments: Injection site w/o erythema or swelling. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: antihistamines and water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Initially with zyrtec, she was not seeing improvement. Two doses of 25 mg of benadryl of 15 minutes within each other, pt was able to see improvement. Pt aware of when she is able to take more benadryl if needed. If symptoms worsen or do not respond to benadryl, pt aware to go to ED. APRN Electronically Signed 2/24/2021 11:14 AM
34 2021-02-25 pain in extremity Sore arm
34 2021-02-27 numbness, feeling cold About 10 minutes after receiving the vaccine, I had chest discomfort followed by the sensation that ... Read more
About 10 minutes after receiving the vaccine, I had chest discomfort followed by the sensation that there was ice around my heart, under my rib cage. The cold heart sensation lasted for roughly 20-30 minutes. Following the start of the cold heart sensation, I became dizzy, sweaty, lost peripheral vision, had numbness in my fourth and fifth fingers (ring and pinky fingers) in both hands, and vaccination site attendant mentioned my hands looked red. Dizziness and other symptoms lasted about 15-20 minutes. Now that over 24 hours have passed, my chest feels a bit tight when I breathe. Injection site is also sore.
34 2021-02-27 hot flush Bilateral rash with vomiting, tinnitus, neck pain and hot flashes
34 2021-02-27 numbness Numbness in both arms/hands beginning in bicep and down, and numbness in left foot
34 2021-02-27 bell's palsy On the 26th, I started noticing it was hard to close my right eye and when I woke up for work on Sat... Read more
On the 26th, I started noticing it was hard to close my right eye and when I woke up for work on Saturday the 27th, I realized I was completely numb and after visiting the Emergency Room it was determined that I had developed Bell's Palsy.
34 2021-02-28 muscle spasms COVID vaccine given Dec 24th, 2020 and second dose on Jan 16th, 2021. Conception occurred approx Ja... Read more
COVID vaccine given Dec 24th, 2020 and second dose on Jan 16th, 2021. Conception occurred approx Jan 11th, 2021 pregnancy diagnosed Jan 26th, 2021. ED Oct 4th, 2021. US confirmation of pregnancy with gestational sac on Feb 14th, 2021. Miscarriage/SAB/pregnancy loss occurred spontaneously on Feb 18th, 2021 with bleeding, cramping. Pregnancy loss confirmed by ultrasound with OBGYN.
34 2021-02-28 pain in extremity Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professi... Read more
Sore arm; mild headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the right arm on 19Dec2020 08:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced sore arm, mild headache, and nausea after the first dose on an unspecified date with outcome of not recovered. The patient did not receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
34 2021-03-01 feeling hot, speech disorder, unresponsive to stimuli Woke in the middle of the night after receiving the Covid shot to use the bathroom. Checked tempera... Read more
Woke in the middle of the night after receiving the Covid shot to use the bathroom. Checked temperature and it was 99.8 got back into bed and as I got into bed experienced sudden severe dizziness/spins. I covered my face and told my husband that I was dizzy, began to lay down - and woke to him yelling my name. I fainted in bed. He said I was mumbling and making strange noises but was unresponsive for a few seconds. When I woke, I felt extremely hot and was drenched in sweat. I was also extremely confused and had a very hard time speaking/explaining to my husband where the Tylenol was, where the thermometer was, etc. it was very scary.
34 2021-03-02 muscle spasms, weakness Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle c... Read more
Elevated BP 166/99; Nausea; Heart palpitations hr 111; Heart palpitations hr 111; Sweating; Muscle cramps; Swollen lymph nodes; Dizzy; Body weakness; Fatigue; Pain moving across my neck/chest/back; Pain moving across my neck/chest/back; pain moving across my neck/chest/back; Trouble sleeping; Pressure in my chest; Splotchy skin; This is a spontaneous report from a contactable other health professional reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration, on the left arm, on 20Jan2021 at single dose for COVID-19 immunisation. Medical history included sinusitis, placenta accreta, infertility, caesarean section, seasonal allergy, sulfa allergy, and coriander allergy all from an unknown date. The patient did not have COVID-19 prior to vaccination. The patient is not pregnant. Concomitant medication included prednisone from an unspecified date. The patient previously took hydrocodone and experienced drug allergy. The patient previously received the first dose of BNT162B2 (lot number: EL1284) on 30Dec2020 for COVID-19 immunisation and experienced left arm completely numb and tingling for 4 weeks. No other vaccines were given in four weeks. On an unspecified date after the second shot, it was reported that the patient experienced elevated BP of 166/99, nausea, heart palpitations HR 111, sweating, muscle cramps, swollen lymph nodes, dizzy, body weakness, fatigue, pain moving across the neck/chest/back, trouble sleeping, and pressure in chest. On 30Jan2021, 10 days after the second vaccination, the patient experienced splotchy skin. The events resulted in doctor clinic visit and emergency room care. The patient was given an unspecified treatment for the events. The patient was tested for COVID-19 post vaccination via nasal swab on 26Jan2021 with a negative result. The vaccine was administered in the workplace clinic. The outcome of the events were reported as recovering.; Sender's Comments: A causal association between BNT162B2 and the reported elevated blood pressure cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
34 2021-03-02 cold sweat Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself o... Read more
Fever; chills; cold sweats; extremely achy body to the point where it was difficult to lift myself out of bed; extremely achy body to the point where it was difficult to lift myself out of bed; I also had extreme fatigue; I slept for almost 20 hours straight, and slept through work without waking up to call out; This is a spontaneous report from a contactable other healthcare professional reporting for herself. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1238), intramuscular from 28Jan2021 15:45 (03:45 PM), (at the age of 34-years-old) at single dose on left arm for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included bipolar 2 disorder (reported as "ipolar 2 disorder") and attention deficit hyperactivity disorder (ADHD). Patient has no allergies to medications, food and other products. Patient was not diagnosed with COVID-19 prior vaccination. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included lamotrigine (100 mg), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL; reported as "Adderall XR 15 mg") and quetiapine fumarate (50 mg). Patient did not received any other vaccines within 4 weeks prior vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient received first dose of COVID-19 vaccine on 07Jan2021 01:00 PM (lot number: EH9899), intramuscular on the left arm. On 29Jan2021 02:00 AM, the patient experienced fever, chills, cold sweats, extremely achy body to the point where it was difficult to lift herself out of bed. The patient also had extreme fatigue. Patient slept for almost 20 hours straight, and slept through work without waking up to call out. No treatment was received for the events. The events were assessed as non-serious. Outcome of the events was recovered in 2021. Body temperature on 29Jan2021 with unknown results. Since the vaccination, the patient has not been tested for COVID-19
34 2021-03-02 tremor High fever, high blood pressure and tremors.
34 2021-03-02 numbness Left arm numbness; BP 141/80 (pulse 67); f/u BP 134/74 (pulse 79).
34 2021-03-02 unresponsive to stimuli Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hy... Read more
Systemic: Dizziness / Light headiness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: Patient was given the 1st dose of the Pfizer COVID vaccine around 4:50pm PST without incident and she was directed to wait for 15 minutes in the store. the pharmacy technician monitoring patients noticed around 4:57pm that patient was pale and slumped over in her chair & alerted me. Immediately, patient fainted while seated, into arms. 911 was alerted & they came 10 mins afterwards. EMS found her BP to be low and recommended she go to the ER, but she refused.
34 2021-03-02 numbness Within 5 minutes of receiving the vaccine my throat became itchy, my sinuses began to swell, a press... Read more
Within 5 minutes of receiving the vaccine my throat became itchy, my sinuses began to swell, a pressure headache began and I became congested. After about 20 minutes my face and lips became numb, my cheeks turned red and hot to the touch, my face started to swell and it felt like my blood pressure dropped, I became dizzy. I took 50mg of Benadryl within 30 minutes of the initial onset of symptoms. All symptoms were gone within an hour of taking the benadryl. Over the next couple hours I experienced discomfort/soreness at the injection site and that tattoo on the same arm as the injection site became raised, hot and itchy. As of 3/3/2021 the only symptom remaining is the soreness at the injection site.
34 2021-03-02 tingling, numbness left arm completely numb; tingling; This is a spontaneous report from a contactable other health pro... Read more
left arm completely numb; tingling; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL1284 and expiry date unknown, via unspecified route of administration at the left arm on 30Dec2020 12:30 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sinusitis, placenta precreta, infertility, C-section, sulfa allergy, seasonal allergy. The patient's concomitant medications were not reported. The patient previously took hydrocodone, coriander oil; both experienced allergies. The patient had no other vaccine in four weeks. On 31Dec2020 06:00, the patient experienced left arm completely numb and tingling for 4 weeks. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment due to the events. The patient underwent lab tests and procedures which included nasal swab (Covid-19): negative on 26Jan2021. The outcome of the events was recovering.
34 2021-03-03 numbness, tingling Immediately following the injection, patients left hand went numb and tingling. Five hours after in... Read more
Immediately following the injection, patients left hand went numb and tingling. Five hours after injection, pinky and ring finger remain numb, with a tingling sensation in the rest of the hand.
34 2021-03-03 tingling, numbness Numbness and tingling to right side of face began 20 minutes after vaccine. The next day had tinglin... Read more
Numbness and tingling to right side of face began 20 minutes after vaccine. The next day had tingling in muscles of right arm and leg.
34 2021-03-03 numbness, bell's palsy, face paralysis On 2/4 patient recieved 1st dose of COVID vaccination and experienced headache and arm pain. On 2/23... Read more
On 2/4 patient recieved 1st dose of COVID vaccination and experienced headache and arm pain. On 2/23 patient received 2nd dose of COVID vaccination at 12:47 p.m. Noticed headache at base of head and took Ibuprofen for relief. On 2/26 at 1:30 pm patient noticed that her right eye was not closing well. Had to force eye closed. On 2/27 early in the morning patient's eyebrows were not moving and it was still hard to close right eye. Stated that the right side of her face was 'not working'. Presented Emergency Department around 8:30 a.m. with complaints of facial numbness. Full workup led to diagnosis of Bell's Palsy. Initiated Acyclovir and Prednisone and discharged to home.
34 2021-03-03 tingling, numbness Pt in COVID vaccine observation area and reports tingling bilateral extremities, lips and tongue. Pt... Read more
Pt in COVID vaccine observation area and reports tingling bilateral extremities, lips and tongue. Pt reports sensation of tongue swelling. Benadryl 25 mg/10ml given. Progressive tingling/numbness reported with mild dyspnea with mild dizziness. No itching reported. Vitals taken and stable. Emergency response contacted; arrived and completed EKG.
34 2021-03-03 weakness, pain in extremity, numbness Rcvd first COVID shot in Left deltoid on 12/27. After shot, arm very sore, and progressed over the l... Read more
Rcvd first COVID shot in Left deltoid on 12/27. After shot, arm very sore, and progressed over the last 8 weeks to reduced ROM, weakness, pain, and intermittent numbness. Contacted employee health and their MD stated the following: "Here is the information I received from, the Director of Infectious Diseases . She suggested that you follow up with your pcp to start. The syndrome is called Parsonage-Turner. Management and prognosis ? There is no specific treatment for neuralgic amyotrophy. Management is conservative. Physical therapy may be helpful to preserve range of motion but will not hasten recovery. Glucocorticoids have been advocated by some [34], but no clinical studies have demonstrated efficacy. In the first weeks, analgesic drugs, including narcotics, may be required to manage patients with severe pain. Recovery occurs slowly over one to three years, and some patients have persistent disability." I have contacted my PCP who has ordered a PT consult (scheduling next week), also seeing an acupuncturist for treatment.
34 2021-03-03 flushing, feeling hot patient experienced some lightheadedness and sensation of warm flushing sensation radiating up from ... Read more
patient experienced some lightheadedness and sensation of warm flushing sensation radiating up from her lower chest. Sensation would come and go. Symptoms lasted about 30 minutes.
34 2021-03-04 flushing First vaccine I could feel the vaccine go into my body and down into my legs. It was a very strange ... Read more
First vaccine I could feel the vaccine go into my body and down into my legs. It was a very strange sensation. I felt very fatigued 30 min after the vaccine but ignored it because it was not normal to have symptoms after the first vaccine. That night i did feel a litlle bit of swelling in my lips that continued into the next day but it was not severe. The muscle aches, joint pain and allodynia the 2nd day were so severe I don't really remember any other symptoms i may have had. I took Benadryl and Tylenol and slept for 2 days straight. After the 1st vaccine I did have shortness of breath for about 3 days post. Then I received the 2nd vaccine, I did not feel it go in this time. About 30 min after the second vaccine I felt very fatigued. About an hour later I started to feel slight swelling in my lips that increased and around 2 1/2 hours my eyes and lips were noticeably swollen and I was flushed. My husband noticed my ears and cheeks were bright red. I felt my heart racing and took my pulse it was around 120. I felt dizzy and like there was a lump in my throat. I requested an appointment via video call from the emergency line. I didn't feel like I was having trouble breathing and stayed calm, my pulse went down to 100 after about 20 min. while waiting for my video call. I spoke to the doctor and they recommended going to the ER. I asked since the pulse went down and it felt like I was slowly reacting, if I could try taking Benadryl and see how I felt. She said that was ok but if I felt any difficulty breathing to go to the ER right away. I took 50 mg of Benadryl and felt better and rested. The next morning lips and eyes were swollen again but a little worse. Difficulty swallowing persisted as well as severe muscle pain, joint pain, and allodynia. The symptoms were worse with 2nd vaccine. Noticed shortness of breath just walking up and down steps. These symptoms lasted a little bit longer. 4 days after the vaccine I noticed the lip swelling was not getting better so I called my PCP. He recommended taking the next 2 days off , rest with benadryl and tylenol. I listened and felt good enough to go into work. It is now 4 weeks since i had the vaccine and i am still experiencing some symptoms that seem to be in relation to after i eat. That includes lip swelling, tightness in the muscles around my throat (feel as if they are strained), stomach burning, indigestion, heartburn. Called PCP again who recommended I see an allergist/immunologist.
34 2021-03-06 numbness Five mins after vaccination, I felt tingling in my face and mouth. 15 mins after, I had numbness & t... Read more
Five mins after vaccination, I felt tingling in my face and mouth. 15 mins after, I had numbness & tingling in mouth and throat. Lips were slightly puffy. I reported to pharmacist on duty.
34 2021-03-07 pain in extremity Arm soreness, enlarged/ tender right posterior cervical chain lymph node and preauricular lymph node
34 2021-03-07 migraine Due 9/5/2021. From 15 hours of injection (at 5am) and lasting for 11 hours: migraine-like headache, ... Read more
Due 9/5/2021. From 15 hours of injection (at 5am) and lasting for 11 hours: migraine-like headache, chills, vomiting every 20 minutes. For 8 hours subsequent: headache, severe nausea but no vomiting
34 2021-03-08 night sweats Pain at injection site. Slight chills. Night sweats with sleep terrors. Slight lymphadenopathy. Slig... Read more
Pain at injection site. Slight chills. Night sweats with sleep terrors. Slight lymphadenopathy. Slight dizziness.
34 2021-03-08 migraine, muscle spasms Swollen lymph node under armpit (left side), Fever, chills, migraine, muscle spasms, joint pain, hea... Read more
Swollen lymph node under armpit (left side), Fever, chills, migraine, muscle spasms, joint pain, headache, nausea, exhaustion
34 2021-03-09 feeling cold 12hours after injection felt like cold; malaise; bigger rash than first dose; 1 inch induration; Thi... Read more
12hours after injection felt like cold; malaise; bigger rash than first dose; 1 inch induration; This is a spontaneous report from a non-contactable consumer or other non hcp. A 34-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no:EL3246), on Left arm via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot no: EH9899) on Left arm on16Dec2020 for covid-19 immunisation and experienced Rash at injection site, Induration and headache. It was reported that 12hours after injection (Jan2021) of second dose felt like cold, malaise, bigger rash than first dose, 1 inch induration, felt better after 48 hours with Tylenol. There was no COVID prior vaccination and no COVID tested post vaccination. Patient was not pregnant while vaccination. There was no known allergies. Outcome of the events was recovering. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
34 2021-03-09 hypersensitivity of all senses Developed Shingles shortly after: Skin sensitivity began 3/1/21, severe back pain following 2 days l... Read more
Developed Shingles shortly after: Skin sensitivity began 3/1/21, severe back pain following 2 days later, and rash appeared 3/6/21
34 2021-03-10 pain in extremity 1/11/2021 vaccination. I had chills, felt feverish, sore arm. I took the rest of the afternoon off f... Read more
1/11/2021 vaccination. I had chills, felt feverish, sore arm. I took the rest of the afternoon off from work. That evening had trouble sleep. Felt like stomach was 'burning'. Nausea. Stomach cramping. Had these symptoms for 24-36 hours. I went to urgent care. They gave me Zofran. to help with nausea and a acid reflux medicine. Symptoms were gone by that evening.
34 2021-03-10 seizure Seizures starting 1/25/21, transverse myelitis diagnosed 3/1/21 with symptoms of transverse myelitis... Read more
Seizures starting 1/25/21, transverse myelitis diagnosed 3/1/21 with symptoms of transverse myelitis starting 2/5/21. Now with diagnosis of multiple sclerosis but with atypical initial presentation
34 2021-03-10 involuntary muscle movements Started the next morning at 11am. Noticed I had started sweating. Took a shower and came out of the ... Read more
Started the next morning at 11am. Noticed I had started sweating. Took a shower and came out of the shower chattering with the chills. Soon started a high fever of 103.6. Also had body aches, headache, joint pain, fatigue, nausea, left lymph nodes in left arm pit are visible swollen and painful . The pain was so severe that I could not stop moving my legs. On a scale of 1-10, my overall pain level was at a 7. If I had not just had the COVID vaccine, I would have gone to the emergency room with how bad the symptoms were. The next morning all of the symptoms had subsided except for the swollen lymph nodes in my left arm pit. They are still visibly swollen, aching, and painful to the touch. They are so swollen they are restricting movement of my arm.
34 2021-03-10 pain in extremity still experiencing aching in my arm throughout the day since vaccine. Very uncomfortable at times.
34 2021-03-10 flushing, tremor tingling mouth/lips/tongue, flushing, shaky, "feels like a panic attack". Evaluated by EMS-Refused t... Read more
tingling mouth/lips/tongue, flushing, shaky, "feels like a panic attack". Evaluated by EMS-Refused to transport.
34 2021-03-11 muscle spasms Noticed small petechiae rash on right arm, it spread across upper chest area, rash is still present... Read more
Noticed small petechiae rash on right arm, it spread across upper chest area, rash is still present 2 weeks after vaccination. GI symptoms also were noted, 2 weeks of abdominal tenderness, cramping, diarrhea, color change in stools (a lighter yellow color), undigested food also present in stools.
34 2021-03-11 feeling hot, tingling, flushing Patient complaining of nausea and feeling warm. Patient was given water and ate part of a bagel with... Read more
Patient complaining of nausea and feeling warm. Patient was given water and ate part of a bagel with minimal improvement. Vitals taken BP 133/79 ; O2 99% RA P92, patient then began experiencing worsening nausea, tingling bilateral fingers and appearing more flushed. Patient brough to ED for evaluation
34 2021-03-11 pain in extremity dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); fa... Read more
dizzy; blood pressure, it was "high", around 129/88; shortness of breath; urge to vomit (nausea); faint; body aches; headache; her arm hurt; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 11Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of Pfizer's vaccine on Thursday, morning (11Feb2021), at the time her arm hurt. She had body aches the entire Friday (12Feb2021) and headache; she stayed in bed all day and the next day, she took Tylenol. On Saturday (13Feb2021), she had shortness of breath and the urge to vomit (nausea), she was about to faint. She was also dizzy and checked her blood pressure, it was "high", around 129/88, but she can't recall the values exactly. She doesn't know if she should get the second dose because she's scared. The patient wanted to know if these are symptoms from the vaccine or could it have been a reaction or allergy. She is scheduled for the second dose on 04Mar2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
34 2021-03-12 hot flush Sore throat, hot flashes, facial swelling, hand swelling
34 2021-03-12 pain in extremity Very sore arm, red, swollen, fatigue
34 2021-03-12 weakness Woke up at night to go to bathroom, then quickly started feeling like I was about to pass out, very ... Read more
Woke up at night to go to bathroom, then quickly started feeling like I was about to pass out, very weak, had to sit down on the floor to try and wait it out, had trouble seeing, was able to get up finally and find way back to bedroom by touch. With lights on vision was patchy. Was given water & a granola bar and was able to recover within 5 min. Slept fine after that
34 2021-03-13 cold extremities, feeling hot, tingling 20 mins after receiving the injection in my L arm, my L wrist and L ring finger felt very cold. It'... Read more
20 mins after receiving the injection in my L arm, my L wrist and L ring finger felt very cold. It's been a week now and I continue to experience pins and needles in my ring finger, pinky finger and palm. Sometimes my entire hand. Also feel warm sensation, L arm tightening and as of yesterday a continuous pulsing sensation in my palm.
34 2021-03-14 numbness 1st injection was given in Quad like my PCP had told them they need to do because of my reactions. ... Read more
1st injection was given in Quad like my PCP had told them they need to do because of my reactions. 2nd injection a RN lead at the clinic told me that I had to get it in my arm or it was not effective, I explained my previous reactions to injections and she stated only to be done in the arm. Last day for 2nd vaccination so I got it. Within the 30 min I told her I had numbness of my top teeth and roof of mouth, let me go back to work after the 30 min. 90 min later I was having red splotches all up and down my arms, 2.5 hours later my throat was starting to each and redness was up and down both arms and chest. ED admission, Pepcid and Benadryl had zero effect, was given a dose of Epi intramuscular in the quad which after 3 min took effect and after 5-7 min all symptoms started clearing up, throat itching and swelling resolved.
34 2021-03-14 tingling After administering vaccine, pt stated tingling in fingers, lightheadedness, slight high heart rate.... Read more
After administering vaccine, pt stated tingling in fingers, lightheadedness, slight high heart rate. BP was taken (162/90). called 911 pt was then cared for by EMS, BP normalized and pt went home
34 2021-03-14 pain in extremity Arm pain and muscle weakness for 2 days
34 2021-03-14 numbness, tingling Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-... Read more
Numbness; itchy throat; tingling in face; trouble swallowing; hives on face and back; This 34- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot En5318), via an unspecified route of administration, on 05Feb2021 at 01:30 PM (at the age of 34-years-old) as a single dose for COVID-19 immunization, in left arm. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 at 10.45 (lot EL1484, expiry 30Apr2021), for COVID-19 immunization and experienced the onset of headache, intense arm pain at the injection site and mild joint pain. The patient's concomitant medications included The medical history included: Asthma, GERD, and obesity. Allergy to Sulfa. Historical Vaccine included first dose of BNT162B2 on 15Jan2021 (lot E63248), for COVID-19 immunization in left arm. The patient's concomitant medications included ALBUTEROL [SALBUTAMOL]. She has had no other vaccines in the past 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 13:45, she reported experiencing Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back. Patient received treatment of 3 doses of Benadryl. The outcome of the events Numbness, tingling in face, trouble swallowing, itchy throat, hives on face and back was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
34 2021-03-14 flushing Patient felt flush 10 minutes after vaccine. Onsite EMS was called vitals BP 118/81 HR 91 100% O2. ... Read more
Patient felt flush 10 minutes after vaccine. Onsite EMS was called vitals BP 118/81 HR 91 100% O2. Benedryl was given monitored for 30 minutes. Patient was treated and released against medical advice.
34 2021-03-14 weakness, tremor Rash appeared on chest, itchy. Within 24 hrs it began to blister. Rash is still present 5 days late... Read more
Rash appeared on chest, itchy. Within 24 hrs it began to blister. Rash is still present 5 days later. Seeping, blister. Chills/sweating. I will go from uncontrollably shaking to a fever. This cycle repeats every 5-6 hrs. This has been on-going for 5 days now. I am unable to care for my infant as I am too weak to walk without feeling like I will pass out. Extreme body aches, my bones and joints are painful to move.
34 2021-03-15 discomfort, tingling 34 female with no previous medical history received 2nd dose of Pfizer vaccine in left deltoid. The ... Read more
34 female with no previous medical history received 2nd dose of Pfizer vaccine in left deltoid. The injection itself was unusually painful and after 10 minutes developed "pins and needles" surrounding naval, and then over the course of 4 days (present) the parasthesias/dysesthesia progressed to include bilateral upper and lower extremities. Today, 4 days post injection, started to notice perioral involvement. It is intermittent, migratory and unpleasant if not painful. Most severe symptoms experienced in right calf, right heel and left finger tips. Exacerbated by use/motion/pressure. Has not attempted any therapeutics to avoid masking progression of symptoms. Primary care physician made aware of.
34 2021-03-15 pain in extremity At the time of vaccine, was 34 weeks pregnant. After my first dose vaccine, I developed a UTI but I... Read more
At the time of vaccine, was 34 weeks pregnant. After my first dose vaccine, I developed a UTI but I did not have an infection. I then went to Urgent care where an ultrasound was performed showing I had a kidney stone not an infection. I do not know if it is related to the Pfizer vaccine. I also had my second dose vaccine, 03-09-2021 in the morning. I only experienced left arm soreness and no other symptoms to report. (Lot#: EN6205)
34 2021-03-16 pain in extremity Dizziness immediately after vaccine that improved within a few hours. Pain at injection site lasting... Read more
Dizziness immediately after vaccine that improved within a few hours. Pain at injection site lasting 2 days. Joint pain in fingers and hips lasting one week. Body aches starting 3/9 (no fever), still present daily. 5 days late for menstruation, 2 negative pregnancy tests.
34 2021-03-16 flushing Flushness and tachycardia at about 15min after vaccination
34 2021-03-16 pain in extremity I had burning pain radiating down my right butt cheek, hip and leg that started on 01/04/2021. A ra... Read more
I had burning pain radiating down my right butt cheek, hip and leg that started on 01/04/2021. A rash errupted on 01/09/2021 that stayed on my hip. I was prescribed Valtrex on 01/10/2021 for one week that haulted the progression of the rash.
34 2021-03-16 flushing Received vaccine on 3/3/21 at 11:15 AM. Was observed at the clinic for 15 minutes after the dose wa... Read more
Received vaccine on 3/3/21 at 11:15 AM. Was observed at the clinic for 15 minutes after the dose was given. She left the clinic reporting that she felt fine. She states that as she was driving home, that she was not feeling well, and decided to return to the clinic. She returned at 11:45. She reported that her jaw felt tight. She appeared to have flushing in her cheeks. She denied rash or itching, but there appeared to be a few blotchy areas on her upper chest. VS taken, BP ws 122/82, pulse 84, resp rate 16. O2 sat was 98%. She was observed by the nurse and no change in symptoms or vital signs. EMS personnel were on site and after consulting with EMS, administered Benadryl 50 mg IM into R upper arm. She was observed for 30 minutes after Benadryl administered, and symptoms disappeared after the observation period. Recommended that she follow up with her health care provider immediately. She was released from the observation site in good/improved condition.
34 2021-03-16 muscle spasms constant muscle spasm in the arm that was injected
34 2021-03-17 tingling Approximately 36 hours post vaccine dose #1, lower back pain began. About 3 hours later a pine and ... Read more
Approximately 36 hours post vaccine dose #1, lower back pain began. About 3 hours later a pine and needles sensation began in hands and feet and continued throughout the night and remain consistent at present time.
34 2021-03-17 pain in extremity Chills approximately two hours later. Lasted 2 days. Extreme fatigue two hours later. Lasted 2 days... Read more
Chills approximately two hours later. Lasted 2 days. Extreme fatigue two hours later. Lasted 2 days. Arm soreness approximately 4 hours later, lasted 4 days. Reaction to bandaid used - irritated skin in shape of bandaid that still exists faintly. Extreme irritability for 3 days, could be unrelated but I could feel myself being irritable over things I normally wouldn?t be. It was the awareness that tipped me off to it being unusual than normal.
34 2021-03-17 hot flush Coughing up excessive amounts of foamy phlegm tinged with blood, blowing out thick nasal secretions ... Read more
Coughing up excessive amounts of foamy phlegm tinged with blood, blowing out thick nasal secretions tinged with blood, full body muscle aches, joint pain, fatigue and tiredness, hot flashes and cold chills.
34 2021-03-18 tingling 3-18-21 3:09PM 'TIPS OF 4 FINGERS ON RT HAND TINGLE'. NO MOTER OR SENSORY DEFICIT. GOOD CAP REFILL... Read more
3-18-21 3:09PM 'TIPS OF 4 FINGERS ON RT HAND TINGLE'. NO MOTER OR SENSORY DEFICIT. GOOD CAP REFILL. A/O, PINK, W/D, RESP REG WITH EASE. NO ACUTE OR OBVIOUS DISTRESS. 3:11PM AMBULATORY TO EXIT - GAIT BRISK AND STEADY. 3-19-21 9AM: 'TINGLING LASTED SEVERAL HOURS AND TONGUE WAS ALSO TINGLING - BUT NOW IT'S GONE'.
34 2021-03-18 tingling Guest vaccinated at 1307, reported bilateral hand tingling to post vaccination observation staff at ... Read more
Guest vaccinated at 1307, reported bilateral hand tingling to post vaccination observation staff at 1326. Guest reported history of anxiety, vital signs taken at tingling onset were as follows: Blood Pressure 120/85, Heart rate 68, Respirations 20, O2 98% on room air. Guest reported not having eaten since 1030 and was given a granola bar. Aid arrived to assess guest per aid call but guest declined additional assessment as they reported improvement of tingling. Vital signs retaken at 1344 were as follows: Blood Pressure 110/80, Heart rate 81, Respirations 18, O2 98% on room air. Guest left post observation to go home at 1345. Was told to seek care if tingling returns or other symptoms of concern develop or worsen.
34 2021-03-18 pain in extremity Sore arm, redness, 10 days after initial first vaccine
34 2021-03-18 tingling, numbness Sudden facial discomfort on left side of face (pressure, numbness, tingling) and unexpected crying; ... Read more
Sudden facial discomfort on left side of face (pressure, numbness, tingling) and unexpected crying; 24 hours later mostly subsided but still decreased sensation in left side of face and feeling of pressure/tightness in left side of face.
34 2021-03-18 numbness and pain in extremities, facial pain, numbness, nerve pain, pain in extremity Symptoms initially started with exacerbation of my ulnar neuropathy (pain, numbness of the left 4th ... Read more
Symptoms initially started with exacerbation of my ulnar neuropathy (pain, numbness of the left 4th & 5th digits) as well as chest pain. The chest pain was midline and severe enough the evening of 1/12/21 that I sought care in the ED for evaluation. Since that time, I continue to have intermittent but daily episodes of left arm and chest pain as well as intermittent left face, neck, and head pains.
34 2021-03-19 flushing Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flus... Read more
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: PT as given the vaccine and waited 15min. during the waiting period she reported she didn't feel too good. her BP was taken every 5min BP was 115/71. 911 was called but she said she was feeling better and wasn't transported with the ambulance
34 2021-03-20 migraine Headache; taste was more impacted/ food didn't taste right/ too bitter/taste horrible; very bad migr... Read more
Headache; taste was more impacted/ food didn't taste right/ too bitter/taste horrible; very bad migraines; This is a spontaneous report from a contactable other health professional (patient). A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot/batch number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 07:30AM at single dose for COVID-19 immunization in hospital. Medical history included tested positive for COVID-19 on 09Sep2020. She had loss of taste and smell; next day horrible diarrhea; third day she had a headache for two days; then on day four or five she got a slight fever. The whole time starting on day three her heart was racing and she couldn't sleep. States her rapid heart rate was resolved about two weeks before the vaccine. She is still recovering her sense of taste. Mentions she saw a cardiologist and had an echocardiogram that was normal in 2020. She has continued to experience the episodes of resting tachycardia but not so often now. Maybe once every two weeks. Concomitant medications were none. No vaccines were administered on same date of the Pfizer suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34-year-old on 22Dec2020 at 10:00AM in the left arm for COVID-19 immunization. She had a headache and rapid heart rate that night and was up all night. It seemed like some of her COVID symptoms came back that first night. Added her arm hurt but she felt like that was related to the administration of the shot. Adds that is not how to give a shot. Adds her COVID symptoms had all gone away and then they came back but only for that first night after the first dose. Physical therapist reported that she received part two of the vaccine two weeks ago and ever since then she has had very bad migraines in Jan2021. She felt like she had recovered from the previous vaccine then she noticed her taste was more impacted on 15Jan2021. Her taste and smell was coming back from her COVID infection but after the second dose it seems like food didn't taste right. Mentions she loves Cilantro but now she can't eat it or anything citrus because it seems too bitter and Coke products taste horrible. Now she has a headache that started again on 16Jan2021. Adds normally she doesn't get headaches. She has tried rehydrating, tried drinking water and gatorade but the only thing that is helping is taking ibuprofen or Tylenol. She is rotating taking these products every other day and it is helping. Headaches come back when the medication has worn off. Patient does not require a visit to physician or ER for events. The outcome of events migraines, taste was more impacted was not recovered; unknown for another event. Information about lot/batch number has been requested.
34 2021-03-20 pain in extremity The next morning after vaccine felt heavy, by 12 had a Fever, acting lethargic laughing for no reaso... Read more
The next morning after vaccine felt heavy, by 12 had a Fever, acting lethargic laughing for no reason then crying felt like I was high that ended within an hour. Took no meds yet, once the lethargy ended got up and went about my day just feeling fatigued. As the day progressed by 5pm higher fever, headache, chills, body aches, arm soreness, armpit pain left side, left sided sudden sharp head pain on and off. Took 2 Advil 400mg which helped with the fever and some of the pain. Woke up Today Sunday and fever is gone and not fatigued, just left sided headache worse left armpit pain, left arm pain and left hand hurting, still having body aches taking Advil 400mg.
34 2021-03-21 involuntary muscle movements, tremor Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her... Read more
Within 10 minutes of injection, patient started to say her eyes were moving by themselves behind her eye sockets and she was feeling alot of "snapping" in her body. Her blood pressure and pulse were higher than normal and she could not keep her eyes open well. She was observed by nurses for approx 30 minutes and those symptoms seemed to subside although she was not steady walking. Midway into our 30 minute drive home it all started again, this time she said she felt heaviness in her chest but was pointing to her throat. I immediately drove her directly to the ER. Was monitored for 4 hours and was release to go home, be observed and follow up with Neurologist when possible. Throughout the night, she continued to say she was shaking alot on the inside and her eyes were still moving involuntarily. 3/20/19 at 8:30 am I called her Neurologist to inform her patients symptoms were continuing. I waited 8 hours and called back only to have her tell her service I was to call patients Primary Physician. Which I did. Dr. was on call and quickly prescribed medication to help calm patients symptoms. She prescribed Valium 2mg q 6 hours. 3/21/19: Patient is still experiencing shakiness, involuntary eye movement and fatigue. She does not have arm pain at injection site.
34 2021-03-23 feeling hot I passed out about 20 min. after the shot. I felt fine up until then. When I was walking to wash my ... Read more
I passed out about 20 min. after the shot. I felt fine up until then. When I was walking to wash my hands, i felt intense heat, vision blacked out and I passed out for about 30 seconds. II was dizzy with delayed vision for the rest of the day.
34 2021-03-23 tingling Im having a lot tingling in finger on the side the in got in injection and back side pain
34 2021-03-24 pain in extremity Itchy face hours after vaccination took Benadryl, Less then 12 hours after vaccination woke up with ... Read more
Itchy face hours after vaccination took Benadryl, Less then 12 hours after vaccination woke up with ongoing body aches and pain, soreness at vaccinated arm
34 2021-03-24 numbness, tremor Within a minute I felt very numb on my face and it spread to my neck. At the vaccination site they a... Read more
Within a minute I felt very numb on my face and it spread to my neck. At the vaccination site they asked me to stay hald an hour instead of the 30 min. I could not think clearly. I went home and felt that my ear drum felt numb as well. Went to my PCP and she said it seems I was having an allergic reaction and she recommended Pepcid and Benadryl for 3 days. The next morning I noticed I slept for 16 hours. and I was very confused, I could not keep my legs underneath me, I went to ER and my BP was 153/33, my pulse was 120. They kept me there I am not sure for how long, they did some labs and gave me some IVs and told me to go home and rest. Next day I woke up and I was throwing up, shaking, I thought I was going to die and I returned to the ER. They gave me some nausea meds. I returned to my PCP and she put me under BP meds she believes all was caused due to anxiety. I am still taking BP meds.
34 2021-03-24 numbness generalized numbness sensation, "tension with swallowing", feels "loopy" and "hazy"
34 2021-03-24 bell's palsy hurting from her hand to her chest; stress; nausea and threw up that night; nausea and threw up that... Read more
hurting from her hand to her chest; stress; nausea and threw up that night; nausea and threw up that night; Bell's palsy; arm on the side she got her shot was hurting; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 34 years of age), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma wherein she doesn't take medication, it was usually when she was cold; she had this diagnosis since her childhood. She was diabetic and was diagnosed when she was 16 years old (2002). Concomitant medication included insulin human injection, isophane (HUMULIN N) and insulin human (HUMULIN R), both for diabetes mellitus. Historical vaccine include PFIZER BIONTECH COVID 19 VACCINE first dose on 06Jan2021 for COVID-19 immunisation. She got the second dose and her arm on the side she got her shot was hurting from her hand to her chest for about 10 days. Then she got diagnosed with Bell's Palsy. The left side of her face has been twitching and droopy and not right. She got the second dose on 26Jan2021. Three days later was when she started experiencing the pain on left arm (29Jan2021). The shot was given in the left arm. It took 10 days to heal. Then after that was when she started to feel her face. She tried to call the doctor and they couldn't see her until 08Mar2021 to get diagnosed. She had been on medication for two days. She started one medication on Monday. There had been no improvement yet. One of the medication was Acyclovir 800mg tablet. She was taking it five times per day. She started it on 09Mar2021. The other medication she takes three at the time for the first six days. Then two at a time. It was a steroid. She started it on the 08Mar2021. She added that she was a diabetic and being on the steroid had her blood sugars high now. They said it was stress and not eating right. Investigations included blood work and checked her thyroid, both with unknown result. Then when she got in to the doctor she was diagnosed because it had been going on for five weeks. The arm pain started a couple of days after the vaccination (29Jan2021). It was after 10 days when she developed Bell's Palsy (Feb2021). The day that she got it she had nausea and threw up that night (Feb2021). She had gone to the emergency room for the arm pain as she was in bad pain and didn't go to work for 2 days. The ER told her it could take 10 days. She doesn't remember the exact date. It was sometime the first week of Feb2021. The outcome of vaccination site pain was recovered on 08Feb2021, chest pain was recovered on an unknown date; while unknown for other events. Therapeutic measures were taken as a result of Bell's palsy and vaccination site pain. Information on the lot/ batch number has been requested.
34 2021-03-25 pain in extremity 1. Soreness in left arm from neck to fingers, started around shoulder within 5 minutes of injection,... Read more
1. Soreness in left arm from neck to fingers, started around shoulder within 5 minutes of injection, continued to worsen over the day and into next day. 2. Slight sleepiness and minor headache on and off through day 1 and 2. Not sure how long either will last, can report back if needed.
34 2021-03-25 difficulty speaking Hoarse/rough voice, sore throat, stomach cramps, puffy face
34 2021-03-25 pain in extremity Moderate-severe arm pain, nausea and loss of appetite since day of vaccine, resulting in loss of 7 l... Read more
Moderate-severe arm pain, nausea and loss of appetite since day of vaccine, resulting in loss of 7 lbs in 10 days so far
34 2021-03-25 feeling hot Pfizer COVID-19 Vaccine EUA Patient upon receiving vaccine 2 mins began feel nauseated and hot-... Read more
Pfizer COVID-19 Vaccine EUA Patient upon receiving vaccine 2 mins began feel nauseated and hot- provided ice pack wheelchair and got her to the provider where she was placed on gurney.vitals were taken please see chart. Epi pen was given when patient's lips started to turn red cough and stridor noted please see the notes. Ambulance was call and patient was taken to the hospital see chart. At approximately 0903 peri oral erythema was noted and patient reported chest tightness. Stridor was noted. SpO2 remained stable at 97-98% on RA. EpiPen administered, 911 contacted for transport to ED. 0909 patient reports improved chest tightness, peri-oral erythema improving stridor. EMS transported patient to ED for further evaluation and treatment. ED - does not have chart access. 3/25: ED 3/23/21 Anaphylaxis after receiving Covid vaccine: chest tight, hot, and dizzy. Patient received epi at clinic and epi and benadryl in ambulance. Patient advised not to get 2nd dose. Patient states she picked up epi pens that were prescribed. She reports better. She is tired and has headache, her arm is red and bruised but it looks better. Patient states she will not be getting second dose.
34 2021-03-25 pain in extremity Red mark and lump under skin at injection site, sore ar,
34 2021-03-25 tremor sweaty palms, tremor, chest tightness, patient observed for 30 minutes and was transferred to medica... Read more
sweaty palms, tremor, chest tightness, patient observed for 30 minutes and was transferred to medical tent
34 2021-03-26 cold sweat, feeling hot Hot, clammy, light-headed. 31 weeks pregnant. Vitals wnl.
34 2021-03-26 pain in extremity March 25 11 pm started off with chills and body aches just on legs. March 26 2 am woke up with body... Read more
March 25 11 pm started off with chills and body aches just on legs. March 26 2 am woke up with body aches everywhere and hurting a lot. 8 am woke up with chills, body aches all over, nausea, headache and fever. All of theses symptoms lasted through out the day with the chills and headache going away and coming back. Took Advil, drank water and slept as much as I could to relieve symptoms. Tried to eat but couldn?t eat much due to the nausea. 10/10:30pm went to sleep with all symptoms returning. March 27 9:30 am woke up drenched in sweat and bed drenched in sweat and symptoms gone as if nothing happened. A little tired and worn out.
34 2021-03-26 feeling hot The left side of my face, neck and ear feel like they?re on fire, like I have a hot towel on just th... Read more
The left side of my face, neck and ear feel like they?re on fire, like I have a hot towel on just that side of my face. Same side as the shot was administered
34 2021-04-01 pain in extremity, muscle spasms Her heart rate in the vaccinated arm had a mark for arrhythmia; inflammation in the vaccinated arm; ... Read more
Her heart rate in the vaccinated arm had a mark for arrhythmia; inflammation in the vaccinated arm; some aching in the arm but I thought perhaps the stiffness is going to be, the onset of stiffness; If I put my arm bended towards my chest that's when I would feel sort of a pop or some type of spasm and I drop my arm just like shake it off that would stop the static; Some aching in the arm; She thought she felt muscle spasms in the vaccinated arm; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration on an unspecified date (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the 1st dose of the Pfizer COVID vaccine on Tuesday (unspecified date). She thought she felt muscle spasms in the vaccinated arm, it felt like it was matching her heart rate. Her heart rate in the vaccinated arm had a mark for arrhythmia. She spoke to a family member who is a medical student, he thought it was caused by pressure on the vessel or pressure on the area. She reported having a rare form of microscopic endometriosis. She also read in a magazine that there were 36 cases of severe reactions after receiving the COVID vaccine. Not sure if it was the Pfizer COVID vaccine, but in one case, a female had heavy vaginal bleeding and her obstetrician found that she had 0 platelets although the week before her platelet count was normal. On 19Mar2021, when probed for the side effects experienced, consumer stated, "Yesterday there was some aching in the arm but I thought perhaps the stiffness is going to be, the onset of stiffness is going to start but it didn't start as stiffness it just started progression to muscle out what I thought, muscle spasm. If I put my arm bended towards my chest that's when I would feel sort of a pop or some type of spasm and I drop my arm just like shake it off that would stop the static. When I work at my desk I keep my arm folded and today this morning is when I started to feel that the spasm in my fore arm sort of matched my heart rate a little bit and I thought do I feel my heart rate in my arm I thought that was impossible but apparently you can. I have a blood pressure check machine just to make sure I don't have high blood pressure which I have never had but I just in case you just want to check your 'vital signs'. I put that on, it also checks 'report' and your heart rate. I put it on my right arm which was the non-vaccinated arm because I didn't want to irritate inflammation in the vaccinated arm. When I put it my right arm my 'signs' they were perfectly fine and it was 118 over 66 and pulse rate 85 but I thought, you know I really need to check the arm that I felt the, that was vaccinated but I actually felt the heart beating through the arm 'is due to' muscle spasm so I put the device on that arm that was vaccinated, my left arm and when the results stopped it was completed, it was 107 over 68, 81 Pulse but then it had the notation that I had arrhythmia, I thought that here must be the heart , I don't know if it was skipping and so I thought it is a perhaps a blood clot matter but I keeping think what Pfizer had blood clot side effects so that's where I started to check and when I started to check on maybe compression or maybe inflammation I didn't want to assume blood clot so I checked for inflammation and compression. My sister's husband is a doctor, he said it sounds like Thoracic outlet syndrome and that compression but then there is like the 'veins' one which is the blood clot, then I thought man that does sound like what I have but the fact that it was involved with blood clot but let me check to see if Pfizer did have a blood issue or a blood clot matter, that's when I thought those rare side effects. I have Endometriosis (History) but I have rare type of Endometriosis that's called microscopic (not spelled) and so it travels throughout head to toe of my body and always triggers some sort of inflammatory problem that mimic other type of condition, either trigger finger arthritis and then I don't get also sensation and then it's ruled out and then I don't have it back but it mimics something that's different and that's what I am little concerned because if the vaccine attacks right there." For treatment, consumer stated, "I did immediately because I have heavy blood flow with Endometriosis, it's little bit frightening that the vaccine could be taking out my platelets and if I start bleeding I may just end up hemorrhaging and I went to online because the fastest thing to do on weekend, it's doing online when I did quick diagnostic to do the complete blood count to check my platelet numbers are okay so I just ran to the store that has a blood diagnostic and they were closing so I explained to them my concern about maybe having ITP and they could be attacking my platelets and if they could just you know stumbles it later and draw the blood they did so I am waiting that may take a day to receive the results." The patient underwent lab tests and procedures which included blood pressure measurement: 118 over 66 and 107 over 68, full blood count: result unknown, heart rate: 85 and 81, SARS-COV-2 test: unknown result and weight: i think i am now 190 on unspecified dates. The outcome of the events was unknown.
34 2021-04-05 pain in extremity DVT blood clot in leg. Not able to seek care due to high deductible health insurance. Swelling, pain... Read more
DVT blood clot in leg. Not able to seek care due to high deductible health insurance. Swelling, pain, discoloration, bruising in lower leg below soleus muscle and deep pain in calf. Using compression, ice, elevation, massage and aspirin regimen.
34 2021-04-06 breast pain sore right breast; chills; body aches; fever of 102.6; more soreness in right breast and a red mark;... Read more
sore right breast; chills; body aches; fever of 102.6; more soreness in right breast and a red mark; diagnosed with mastitis; This is a spontaneous report from a contactable consumer (patient reported for self). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported), dose 1, via an unspecified route of administration, administered in right arm on 01Mar2021 12:00 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with Covid-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine and did not receive any other medications within 2 weeks of vaccination. The Wednesday after the vaccine, on 03Mar2021 05:30 (also reported as about 36 hours later), patient woke up with a sore right breast. As the day progressed, patient had the chills, body aches, and a fever of 102.6. Patient also noticed more soreness in right breast and a red mark. Patient spoke to OB and was diagnosed with mastitis. The patient was tested for covid post vaccination reported as results of tests and procedures for investigation of the patient on 12Mar2021 as nasal swab: negative. Therapeutic measures were taken as a result of the events reported which included antibiotic. The events were reported as recovered in Mar2021. Information on the lot/batch number has been requested.
34 2021-04-07 tingling Neuro - reporting stocking/glove decreased sensation in hands and feet - to wrists in hands and feel... Read more
Neuro - reporting stocking/glove decreased sensation in hands and feet - to wrists in hands and feeling off still in forearms mand into upper arms and then from feet to knees with decreased sensation to touch, improved gait and not requiring husband to help transfer to exam table and no longer needing to use walker, positive romberg testitng and unable to balance on one leg without intense wobbling and nearly falling. Was dx from ER with dorsal cord syndrome from MRI C spine.
34 2021-04-07 pain in extremity headache; swollen lymphnodes in both armpits; woke up with mastitis in left breast; chills; 102 feve... Read more
headache; swollen lymphnodes in both armpits; woke up with mastitis in left breast; chills; 102 fever; Migraine occular headache (seeing zig zag lines in vision); trouble breathing--one dry cough after breathing deeply; fast heartbeat; developed a sore left arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in left arm on 19Mar2021 at 16:30 (age at vaccination 34- year-old) at single dose for COVID-19 immunization. Medical history included drug hypersensitivity to penicillin, sulfa drugs, levoquin, some fish oil supplement. The patient's concomitant medications were not reported. Vaccination history included: first dose of bnt162b2 for covid-19 immunization on 26Feb2021 at 16.30 (lot: EN6202) in right arm. On 20Mar2021, patient experienced woke up with sore left arm and body aches. Patient took ibuprofen and felt better. On 21Mar2021, patient woke up with mastitis in left breast, chills, and 102 fever, migraine ocular headache (seeing zig zag lines in vision), trouble breathing--one dry cough after breathing deeply and fast heartbeat. On 22Mar2021, patient had still a headache. She went to doctor for mastitis. A mammogram and ultrasound showed swollen lymphonodes in both armpits (first shot was on right arm). On 23Mar2021, patient had still headache. Patient received antibiotics as treatment for adverse events. Outcome of events was recovering. Additional information has been requested.
34 2021-04-09 pain in extremity, weakness Fainted while sitting; Too much pain in hand; chills; Weakness; This is a spontaneous report from a ... Read more
Fainted while sitting; Too much pain in hand; chills; Weakness; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received first dose of BNT162B2(Batch/Lot Number: Unknown), via an unspecified route of administration on 24Mar2021 18:15 at single dose in the left arm for COVID-19 immunization. Medical history included Known allergies: NSAID on an unknown date. The patient's concomitant medications were not reported. The patient previously took ibuprofen and experienced allergy. On 25Mar2021 03:00, the patient experienced fainted while sitting, too much pain in hand, chills and weakness. Therapeutic measures were taken as a result of all the events which included Tylenol. The adverse event result in doctor or other healthcare professional office/clinic visit. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive any other medications within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered. The following information on the lot/batch number has been requested.
34 2021-04-12 numbness and pain in extremities Worsening neuropathy symptoms in arms and legs
34 2021-04-14 pain in extremity, weakness The patient was reportedly in her USOH until she received the first dose of the Pfizer vaccine on 1/... Read more
The patient was reportedly in her USOH until she received the first dose of the Pfizer vaccine on 1/4. She woke up the following morning with a terrible headache and photophobia, later in the day developing myalgias and generalized weakness, followed by possible fever (did not take home temp). She describes the headache as a throbbing holocranial ache that is worse if she bends down She states the headache never really went away fully over the ensuing days, and she did begin to notice blurred vision in her right eye; she eventually presented to Medical Center on 1/9, where she was tested for COVID-19 and found to be negative - her symptoms were attributed to a vaccine reaction and she was sent home. She continued to have a terrible headache and blurred vision, and so returned to Medical Center on 1/12. She then presented to another Hospital she was admitted for frequent falls in the context of elevated blood pressure. Workup there included a head CT, which was unremarkable. She was discharged with home PT. On the day of presentation, she fell at physical therapy. Now with pain from R knee down. No numbness in the leg. States leg twisted when she fell. No head strike or LOC. States pain with attempted ambulation. This resulted in her presentation to the ED at a Medical Center on 1/27/21. On evaluation, she endorsed a headache, holocranial, throbbing, 5-6/10 (has been 10/10). Denies frank positional component. Not worse at any certain time of day. +Blurred vision, worse on the R. +photophobia, not phonophobia. Also complains of pulsatile tinnitus happening almost daily, R-sided, worse when bending down. Denies nausea or vomiting. Denies neck pain or stiffness. Exam was notable for significant peripheral vision loss in R>L eye and bilateral papilledema. She was seen by ophthalmology with documentation of formal visual field testing (reports included). MRV with filling defects in straight, sagittal, and R transverse sinuses; MRI without FLARE changes, reassuring for no obstruction and/or infarct.
34 2021-04-17 tingling Verterbal artery dissection that caused a stroke Very sharp neck pain, tingling on left side, dizz... Read more
Verterbal artery dissection that caused a stroke Very sharp neck pain, tingling on left side, dizziness, nausea (this went on for about 20 minutes prior to getting to the hospital)
34 2021-04-20 feeling cold felt feverish; Slept most of the day and night; few scattered hives; flu like symptoms; Flu like sym... Read more
felt feverish; Slept most of the day and night; few scattered hives; flu like symptoms; Flu like symptoms-woke up freezing; Flu like symptoms-headache; Flu like symptoms- neck pain; Flu like symptoms- body aches; Flu like symptoms- restless; nausea; vomiting; fatigue; diagnosed with vestibular neuritis secondary to the vaccine; This is a spontaneous report from a contactable physician (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 13:00 (Lot Number: EL3246) as single dose for covid-19 immunisation at age 34 years old. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. No concomitant medications. No other vaccine in four weeks and no other medications in two weeks. The patient previously received the first dose of BNT162B2 on 18Dec2020 (lot no: EJ1685) for COVID-19 immunization at 34 years old. After receiving the second dose of Pfizer vaccine on 08Jan2021, within 13 hours (09Jan2021 02:00) the patient was ill with flu like symptoms (woke up freezing, headache, neck pain, body aches, restless). Later that morning (09Jan2021), the patient had nausea, vomiting and fatigue. After 36 hours (09Jan2021), profound fatigue, intermittently dizzy, felt feverish but did not confirm; body aches had resolved. On 10Jan2021 01:00, slept most of the day and night, had a few scattered hives in the evening. On day 3 (11Jan2021), since this day the patient has had constant vertigo. She was hospitalized from 15Jan2021 to 16Jan2021, had extensive testing and saw different specialists, and was diagnosed with vestibular neuritis secondary to the vaccine. She never had CoVID before, healthy otherwise, and had negative CoVID antibody testing prior to receiving the vaccine. She was off work for 6 weeks, able to go back for 10 shifts but had worsening of vertigo symptoms and was unable to work x 3 weeks and ongoing; still working with vestibular rehab, still having daily significant vertigo. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Treatment received included medication and vestibular therapy. The patient underwent covid test (nasal swab) on 16Jan2021 with negative result. The patient recovered from body aches on an unspecified date in Jan2021; while not recovered from the rest of the events.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
34 2021-04-20 difficulty speaking throat and tongue started swelling again and were very itchy; throat and tongue started swelling aga... Read more
throat and tongue started swelling again and were very itchy; throat and tongue started swelling again and were very itchy; difficulty breathing; swallowing saliva; wheezing; noticeably lower than usual with a HR of ~60, BP of 100/70; feeling extreme itchiness and swelling in my tongue; itchiness in her tongue/throat and tongue started were very itchy/feeling extreme itchiness and swelling in her tongue; slight headache/ Headache got worse; felt fatigued; voice sounded weird/my throat was extremely hoarse; constantly cough; upset diarrhea; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 31Mar2021 16:45 at age of 34-year-old (Batch/Lot Number: ER8732) at single dose for COVID-19 immunization. Medical history included Von Willebrands Type 1, and a family history of auto-immune issues like myasthenia gravis, lupus and Chronic inflammatory demyelinating polyradiculoneuropathy. Patient had known allergies to coconut, latex. Concomitant medications included norethindrone acetate and ethinyl estradiol. There was no other vaccine in four weeks. On 01Apr2021, the patient woke up at 08:00 with slight headache and felt fatigued but most noticeably her voice sounded weird and her throat was extremely hoarse while talking in work meeting and she had to constantly cough to clear it. Headache got worse in the afternoon and she had upset diarrhea. Around 19:45 she started feeling extreme itchiness and swelling in her tongue. This didn't improve, so she took 25mg diphenhydramine hydrochloride (BENADRYL) at 20:20, at which time her vitals were normal, but noticeably lower than usual with a heart rate of 60, blood pressure of 100/70, O2 sat 99% and normal temperature. She also took another 1000 mg paracetamol (TYLENOL) at 21:30 and went to bed. 02Apr2021, 07: 30 woke up and her throat and tongue started swelling again and were very itchy. She then began had difficulty breathing and swallowing saliva. She also could not swallow a banana easily, stopped eating it. She also had some wheezing that would only go away with a cough. She took 25mg more of diphenhydramine hydrochloride and went to urgent care immediately because breathing was becoming increasingly difficult. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Treatment for the events included diphenhydramine hydrochloride injection and prednisone. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient recovered from the events in Apr2021.
34 2021-04-22 numbness, weakness The morning after receiving the vaccine, patient woke up with with numbness and weakness on right si... Read more
The morning after receiving the vaccine, patient woke up with with numbness and weakness on right side of body. The numbness and weakness has persisted to the present day (4-22-21).
34 2021-04-30 pain in extremity small red spot on right eye; Pain in left arm; This is a spontaneous report from a contactable consu... Read more
small red spot on right eye; Pain in left arm; This is a spontaneous report from a contactable consumer, reporting for herself. A 34-year-old non-pregnant female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER87Z7), via an unspecified route of administration in the left arm on 29Mar2021 at 13:45 at a single dose for covid-19 immunisation. Medical history included polycystic ovary syndrome (PCOS), fibromyalgia, rheumatoid arthritis, Hoshimoto's, and hypothyroidism. There were no known allergies. Concomitant medications included unspecified thyroid prescription, pain reliever, vitamins and supplements (as reported), given in two weeks. There were no other vaccinations given in prior four weeks. On 29Mar2021, the patient experienced small red spot on right eye and pain in left arm for two days, which were non-serious. There was no treatment given in response to the events. There was no covid prior to or post vaccination. The clinical outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
34 2021-05-04 pain in extremity unusual and pronounced panic attacks and depression; unusual and pronounced panic attacks and depres... Read more
unusual and pronounced panic attacks and depression; unusual and pronounced panic attacks and depression; fatigue; fever; sweats; pain in my arm and neck; pain in my arm and neck; swollen lymph nodes; I nearly passed out from an anxiety attack; I nearly passed out from an anxiety attack; This is a spontaneous report from a contactable consumer reporting for herself. A 34-year-old female consumer reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in arm left on 09Apr2021 01:15PM (at the age of 34-year-old) for COVID-19 immunisation. Relevant medical history included COVID prior vaccination. Past drug history included known allergy to cefaclor (CECLOR) and morphine. Concomitant medications were not reported. The patient nearly passed out from an anxiety attach 15 minutes after the vaccine was administered, on 09Apr2021 01:30PM: this had never happened before. For a week after, she experienced fatigue, fever, sweats, pain in arm and neck, and swollen lymph nodes. She had also experienced unusual and pronounced panic attacks and depression since receiving the vaccine and would be seeking medical attention for those issues. Events resulted in physician or other healthcare professional office/clinic visit. No treatment was received. The patient had not tested for COVID post vaccination. Outcome of the events was unknown. Information on the lot/batch number has been requested.
34 2021-05-07 seizure, pain in extremity After 15 minutes of sitting I passed out; slight seizure; headache; diarrhea; severe lethargy; arm s... Read more
After 15 minutes of sitting I passed out; slight seizure; headache; diarrhea; severe lethargy; arm soreness; This is a spontaneous report from a contactable consumer. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0164), via an unspecified route of administration, administered in Arm Right, at the age of 34 years, on 15Apr2021 12:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included basedow's disease, gastrooesophageal reflux disease and allergy to metals from an unknown date and unknown if ongoing. Concomitant medications included methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone and experienced drug hypersensitivity and gluten and experienced food allergy. The patient stated, "After 15 minutes of sitting I passed out and had a slight seizure, then passed out and seized a second time. I had headache and diarrhea for two days following with severe lethargy and arm soreness" on 15Apr2021 01:00 PM. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Apr2021. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.
34 2021-05-12 feeling hot Mild facial erythema flushing; chest tightness; SOB; sore throat; heart rate went up to 127 and bloo... Read more
Mild facial erythema flushing; chest tightness; SOB; sore throat; heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine; severe allergic reaction within 2 minutes; heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine; it was difficult to swallow/trouble swallowing; I started to get hot; my heart started racing; inflamed tonsils; fever; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient) reported for a 34-year-old non-pregnant female patient received BNT162B2 (Solution for injection), dose 1 via an unspecified route of administration, administration in left arm on 18Mar2021 11:45 (at the age of 34-year-old) (Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. The patient had allergies to Sulfa antibiotics, Lumbar disc herniation, keratosis pilaris, acne. Occasionally the patient drinks alcohol. Concomitant medication included ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE) spironolactone, ethinylestradiol, norethisterone acetate (AUROVELA), acetominophen and ibuprofen.. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a reaction a severe allergic reaction to the COVID 19 vaccine on 18Mar2021 at 11:45 . It was reported within 2 minutes of receiving vaccine the patient started to get hot, heart started racing, a facial redness, face got bright red and swollen, throat started to swell, and it was difficult to swallow. The patient heart rate went up to 127 and blood pressure up to 170 within a few minutes after getting vaccine. The patient heart rate and blood pressure were high. The patient also experienced inflamed tonsils. On 18Mar2021 at 11:52 the patient experienced also: sore throat, shortness of breath and chest tightness, at 12:00 the patient had mild facial erythema flushing and at an unknown time fever up to 99.5°F. All these with outcome of unknown. The patient was not in anaphylactic shock, but she was initially given diphenhydramine (BENADRYL) to treat the symptoms, but it had no effect. She was admitted to emergency room and was given epinephrine and prednisone and things started to get better. The next day symptoms returned, and patient went to urgent care the next morning. There the patient received another prescription for prednisone for 5 days. After that finished her symptoms returned and was given another round of prednisone for 6 days. The patient was still having slight symptoms that she was treating with fexofenadine (ALLEGRA) twice per day per advice of allergist. The patient was met with an allergist and was slightly concerned and thought it was unusual that this would continue past symptoms of 2 weeks. It was reported that the patient was experiencing slight symptoms, nothing crazy, but was wondering what communication from Pfizer was if someone did have an allergic reaction that most people were treated in emergency room. On an unknown date, the patient had allergy tests and no information found on allergy tests. It was reported that the patient antibody testing was not currently recommended to assess for immunity. The patient was discharged with instructions to get an epi pen in case anything got crazy, and her husband drove her home. It was stated as soon as it was her turn the system disconnected. The patient stated the only reason she waited after 4 hours was because she was 5th in line, and it took 2 hours 50 minutes to get to be her turn. The patient was on hold for four hours and she got hung up on, but she was not sure if the system was down, but she got an email and, in the case, it had her interactions. Among the Vaccine recipients, mild-to-moderate pain at the injection site within 7 days after an injection was the most reported local reaction, with less than 1% of participants. In general, local side effects; the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. A cross all age groups reporting severe pain. Since the vaccination the patient was not tested for COVID-19. The outcome of the events was recovering. The patient was suggested not to get the second dose of COVID-19 vaccination of any type. No follow-up attempts are needed. No further information is expected. Follow-up (27Apr2021): This is a follow-up spontaneous report from a contactable Pharmacist. New information included: patient medical history, concomitant medications, new non serious adverse event (sore throat, shortness of breath and chest tightness, mild facial erythema flushing and fever up to 99.5°F.); Sender's Comments: A contributory role of BNT162B2 to the reported events cannot be excluded based on the temporal relationship The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2020-12-31 seizure, feeling of body temperature change After receiving the vaccine I began to feel lightheaded and short of breath. I felt tachycardiac and... Read more
After receiving the vaccine I began to feel lightheaded and short of breath. I felt tachycardiac and felt like passing out. I got transferred to the er where I received the epipen along with oxygen and antiseizure meds for my seizure. I was then transferred to Medical Center for further care where I was later discharged.
35 2020-12-31 tingling, feeling cold, numbness No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills w... Read more
No immediate events. But about 24 hours after vaccination I felt extreme tiredness and some chills which I read is normal but I noticed tingling in my legs. And a cold sensation. No weakness and it resolved in about an hour. Then today 1/1/2021 numbness and tingling/pins and needles in my feet and legs . It lasted a few hours and mostly resolved. I was not sure if there was a possibility of guillian barre occurring post this .
35 2020-12-31 tingling, numbness Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, th... Read more
Within the first 15 minutes of receiving the vaccine I was was extremely tired. As time went on, this seemed to subside. Tiredness has appeared to come and go over the last few days. Every morning I have woken up with tingling in my left hand, as though there are pins and needles in my left hand. My left arm feels weaker and feels some numbness when more pressure is placed on it. I have a bruise that appeared above my left wrist. I have reached out, as this is my employer and I have not heard back. Assuming they were closed due to New Year?s Day.
35 2021-01-01 pain in extremity On December 31, 2020 at around 530PM I felt a discomfort on my left jaw that lasted for couple hours... Read more
On December 31, 2020 at around 530PM I felt a discomfort on my left jaw that lasted for couple hours, and at around 9PM I felt a stabbing pain on my whole left arm, I took Acetaminophen 500 mg 2 tabs without relief. The pain lasted 'til dawn, fell asleep and woke up and pain was gone.
35 2021-01-02 numbness, face paralysis, feeling cold, pain in extremity, cold extremities 12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in ... Read more
12/23/20: within 2 minutes of receiving the vaccine I felt pulsing in my left wrist and weakness in my left hand, within 30 minutes my left ear felt like it needed to pop, I had the normal/expected side effects for the first 1-2 days (very sore arm, headache, achy, fatigue, mild joint pain) 12/24/20: weakness/numbness/cold feeling in my left lower leg and foot, fullness in left ear continued 12/27/20: same sx as 12/24, plus weakness/numbness in left forearm, pinky and ring finger 12/28/20: same sx as above, plus fullness in R earned weakness/numbness in right forearm, pinky, and ring finger 12/30/20: same sx as above, plus weakness/numbness on the left side of my face, no drooping 12/31/20: same sx as above, now with weakness/numbness/cold sensations on both sides of face (although only one side at a time), in both legs, both arms down into pinky and ring fingers (weakness noticed when typing and writing). Both ears still with fullness feeling (only one side at a time). I can still walk/run, these symptoms are still present as of today 1/3/21.
35 2021-01-03 feeling hot, cold extremities ? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her th... Read more
? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to EOHD since we were so busy. ? Around 4pm in the afternoon after we closed EOHD, I went back to the ER. She was recovering and doing fine. Her ER nurse did have a question about receiving the 2nd dose, and I provided the same answer that Dr. provided to other Dr. about taking an Allegra 30 minutes before the second dose.
35 2021-01-03 hot flush, feeling jittery I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facili... Read more
I am an APRN, and received the vaccine not quite one week ago. I waited 15 minutes within the facility and then left. Sat in my car working for about 8-10 minutes when a sudden rush of heat ran through my body. I felt lightheaded, my tongue was prickly, and I felt like I was going to pass out. I was able to get back into the facility to let them know of the sudden symptoms. At that time I felt like my heart was racing and was diaphoretic. They continued to watch me for another 15-20 minutes, they did have an epi pen but it was not given. I was feeling slightly better and then left again. I waited in my car approximately 20 minutes before deciding it would be safe to drive away. After driving for about 10 minutes I had another rush of heat, lightheadedness, and then I started having shortness of breath. At this time it would have been about 1 hour, maybe longer, since receiving the vaccine. I was not close to an emergency medical facility at that time, and did not feel like my throat was swelling so thought it would be best to try to drive to the nearest ER. I knew I had an epi pen from my work that I could use if needed. I contacted another nurse practitioner who I work with who stayed on the phone with me until I was able to get to a safe place. At that time the symptoms had improved, not resolved. It had been able 20 minutes during this episode. In all, I continued to feel jittery for about 3-4 more hours. Since my symptoms did improve I did not go to the ER. I contacted my health department, Louisville health dept, the following day and reported symptoms to the medical director.
35 2021-01-03 pain in extremity Left arm soreness, Headache 30 mins after, Fever 100.9 T 5am and 9am, monitoring until now
35 2021-01-03 facial paralysis, tingling, numbness, face paralysis Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck. Diagnosed ... Read more
Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck. Diagnosed with Bells Palsy on 01/04/2021
35 2021-01-04 numbness, feeling hot, tingling, weakness 10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, ... Read more
10 minutes after receiving vaccination, patient reported rapid heart rate, fatigue, felt weak, hot, and palpitations. Patient reported tachycardia with heart rate 160-170's. Transient numbness to hands and perioral region. Presented to ED, was monitored with resolution of symptoms. On 1/4/21 patient presented to ED with tachycardia with HR up to 160s, Episode was severe, causing lightheadedness, "throat squeezing", with bilat UE paresthesias. Episode lasted 20 minutes. Patient evaluated in ED and discharged with outpatient follow up with cardiology and endocrinologist.
35 2021-01-04 pain in extremity Bleeding bilaterally of both sides of lower gums between cheeks and inside part of lower lip; kind o... Read more
Bleeding bilaterally of both sides of lower gums between cheeks and inside part of lower lip; kind of pooling of blood in bottom of mouth; went through several tissues; Mild arm pain; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the left deltoid on 24Dec2020 at a single dose for COVID-19 immunization. Medical history included anxiety. Concomitant medication included sertraline for anxiety. The patient received the first dose of the COVID-19 vaccination at the time of report and wanted to report of a probable side effect that she had about an hour and a half after she got the vaccination. About an hour and a half after she received the vaccination, she started to experience bleeding from gum both sides, bilaterally of both sides of lower gums between cheeks and then also from the inside part of lower lip that lasted for about 3 to 4 minutes. It wasn't necessarily profuse bleeding but it was significant enough to cause pooling, kind of pooling of blood in the bottom of my mouth. And she went through several tissues and then it just spontaneously resolved on its own and haven't had any bleeding since. The patient had them 24 hours but didn't have any further bleeding episodes from anywhere. Since that time, the patient haven't noticed any other symptoms other than some mild arm pain. The bleeding has stopped, it stopped after about 3 to 4 minutes and arm pain kind of persisted but not worsened, not terribly bothersome. No treatment was given for the events. The patient wanted to understand if this is a side effect that's being reported by anybody and also whether a recommendation if she should still get this. Outcome of the event gum bleeding was recovered in Dec2020; event mild arm pain was not recovered. The reporter assessed the events as related to COVID-19 vaccination.
35 2021-01-04 pain in extremity Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spont... Read more
Dizziness; Metallic taste upon injection; Sore arm; Headache; Muscle aches; Fatigue; This is a spontaneous report from a contactable healthcare professional. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on the left arm on 30Dec2020 14:00 at a single dose for COVID-19 immunisation. Medical history included hypertension (List of any other medications the patient received within 2 weeks of vaccination: Hypertension medication). On 30Dec2020 14:00, the patient experienced dizziness, metallic taste upon injection, sore arm, headache, muscle aches and fatigue. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was not recovered. Information on the lot/batch number has been requested.
35 2021-01-04 feeling hot, flushing Feeling of warmth, flushing, pruritic, eyelid swelling
35 2021-01-04 feeling hot Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting ... Read more
Headache; Fatigue; Muscle and joint pain; joint pain; Chills; heat surges; Sore throat; Not wanting to eat; Sore; Heart bothered me a little today; This is a spontaneous report from a contactable other Health Professional (Other HCP) (patient). A 35-year-old female Patient (no pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Ek9231) on 29Dec2020 10:30 AM, Intramuscularly, (vaccine location: Left arm) at single dose (first dose) for COVID-19 immunization. Medical history included Mitral valve prolapse (Mvp) and covid (patient had covid prior vaccination). Concomitant medication included naproxen a week before. Patient was allergic to Azithromycin. Patient received no other vaccine in four weeks. Patient experienced Headache, Fatigue, Muscle and joint pain, Chills and heat surges, Sore throat, Not wanting to eat, Sore, Heart bothered me a little today (29Dec2020 11:15). Patient did not receive any treatment. Patient did not have had covid tested post vaccination. The outcome of the events was unknown. This case was assessed non-serious by reporter. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
35 2021-01-04 tenderness, burning sensation I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermato... Read more
I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination.; feeling like prodromal shingles pain though she never personally had shingles; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 35-year-old female patient received first dose of BNT162B2, intramuscular (right arm), on 18Dec2020 at 11:00, at a single dose, for COVID-19 vaccination. Medical history included allergies to penicillin. The patient's concomitant medications were not reported. On 20Dec2020, the patient had mild tenderness and would describe as a burning sensation around the T1-T3 dermatome area, on the same side of her injection, beginning approximately 1-2 days post vaccination. She was feeling like prodromal shingles pain though she never had shingles. Patient is currently on 10th day post vaccination and continues to have this sensation and mild tenderness but have yet to develop any shingles rash. The patient did not receive treatment for events "I have had mild tenderness and what I would describe as a burning sensation around the T1-T3 dermatome area, on the same side as my injection, beginning approximately 1-2 days post vaccination." Outcome of the event pain was unknown, while for the remaining events was recovering. Information about lot/batch number has been requested.
35 2021-01-04 tingling Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the followin... Read more
Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the following morning, within 72 hours severe abdominal pain, nausea, vomiting, and diarrhea that lasted 5 days, fatigue, and low grade fever (no higher than 100.8)
35 2021-01-05 muscle spasms AS REPORTED BY PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning... Read more
AS REPORTED BY PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.
35 2021-01-05 muscle spasms DESCRIPTION THAT FOLLOWS IS FROM PATIENT: Monday 12-28 evening I begun to get chills and body aches,... Read more
DESCRIPTION THAT FOLLOWS IS FROM PATIENT: Monday 12-28 evening I begun to get chills and body aches, the next morning when waking up I felt like a truck hit me. Starting Tuesday morning, for three days, I got calf/feet cramps that were non-stop. I did call my doctor and got lab work done on 12-31. This lab work showed some kidney values that were off. Starting Sunday my legs and feet swelled up. I had a routine MS appointment on Monday and they stated since there is no data for folks with MS and the vaccine that they cannot rule out the vaccine is playing a role in some of this along with the IVIG. I did follow up with my primary care doctor on Tuesday and they re did lab work as well as did a ultrasound to rule out blood clots. She did state she felt like it was the perfect storm between the COVID vaccine and then the Immunoglobins that I am on. She suggested I download the app for CDC and report those items as well. The doctors are still suggesting I get the 2nd shot just have to do some things prior to the second shot.
35 2021-01-05 burning sensation Hives, burning sensation in her arms, anxiety. Noted she felt like she was hyperventilating.
35 2021-01-05 night sweats I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen a... Read more
I woke up with my eyes ever swollen and red (only my eyelids); I woke up with my eyes ever swollen and red (only my eyelids); they were still red and painful; My eyes were slightly puffy the next morning but nothing alarming; Night sweats that were worst the night of the vaccination; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 29Dec2020 17:00 at single dose in the left arm for COVID-19 immunization. Medical history included none. No known allergies. No other vaccine in four weeks. Concomitant medication included fluoxetine hydrochloride (PROZAC). Prior to vaccination, the patient was diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. The patient experienced night sweats that were worst the night of the vaccination. Her eyes were slightly puffy the next morning (30Dec2020) but nothing alarming, however, Thursday morning (31Dec2020 06:00) she woke up with her eyes ever swollen and red (only her eyelids). Thursday evening she'd been able to get the swelling down but they were still red and painful (after diphenhydramine hydrochloride (BENADRYL)). The events were non-serious. Employer and provider of vaccine had no protocol in place and said to treat it like any other reaction and go to ER if it worsened. The events were not resolved.
35 2021-01-05 pain in extremity, feeling hot, tingling Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later note... Read more
Noted had history of various allergies. Received vaccine at 6:06 pm and about 10 minutes later noted headache. BP 150/70; p 86. Then neck pain, bilateral leg soreness, and hip pain; R foot tingling, felt warm, itching, no rash noted. Treated with 25mg benadryl at 0624 pm; BP 130/82. And went to ED for evaluation via wheelchair/personnel.
35 2021-01-05 tingling Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), art... Read more
Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; This is a spontaneous report from a Non-contactable Physician (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 23Dec2020 at first single dose at arm left for covid-19 immunisation. The patient received the vaccine at hospital. Medical history included migraine, dermatitis atopic. The patient's concomitant medications were not reported. The patient experienced Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache on 24Dec2020. No treatment for events. The outcome of events was recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
35 2021-01-05 pain in extremity arm pain, shooting up to neck; arm pain, shooting up to neck; This is a spontaneous report from a no... Read more
arm pain, shooting up to neck; arm pain, shooting up to neck; This is a spontaneous report from a non-contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 23Dec2020 at single dose for Covid-19 immunization in a hospital facility. Medical history included Covid-19 diagnosed prior to vaccination. Concomitant medications included "OCP" (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 23Dec2020, the patient experienced arm pain, shooting up to neck. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events arm pain, shooting up to neck was recovered. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about batch number cannot be obtained.
35 2021-01-05 feeling hot, flushing within 5 minutes of receiving vaccine became hot and flushed, diaphoretic, nauseated, lightheaded, a... Read more
within 5 minutes of receiving vaccine became hot and flushed, diaphoretic, nauseated, lightheaded, and felt faint
35 2021-01-06 nerve pain, pain in extremity 1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lo... Read more
1. Noticing a sharp headache for about 10 seconds either in the occipital lobe region or temporal lobe region on the right side of my head every now and then. It has happened about 8 times since vaccine administration. The first time being about 25-30 minutes after vaccination. 2. I have also noticed a sharp pain in the back of my right thigh/upper buttock region that feels either like a nerve or muscle pain. It usually is most noticeable when I first stand up from a sitting position or laying position. If I don't put as much pressure on the heel of my right foot, it isn't as bad and ibuprofen has helped the pain subside, but it has been constant. This was first noticed about 4-5 hours after vaccination received.
35 2021-01-06 pain in extremity Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tigh... Read more
Myalgia, Fever, Diarrhea, Tachycardia, chest tightness, SOB, 12/29 After vaccination felt chest tightness, shortness of breath, tingling in her throat, heart racing. She stayed and was monitored for an hour. When she got home she took Benadryl which helped her sleep. She continues to have mild shortness-of-breath today. Her left arm is sore and she has body aches. Her temp is 100.6 today. 12/30 1712: While speaking on the phone with her she is speaking in full sentences without apparent dyspnea. 12/31 had bad night - high fever 101.5 at 0100 overnight last night. This morning feels tired, lethargic, and no appetite. She still has body aches. No fever this morning. 1/4 - employee reports she is doing much better today. She says she had a rough weekend but is much better today. She able to get back to her running usually runs 25 miles/week.
35 2021-01-06 numbness, sensory loss Numbness in right arm. Loss of feeling in fingers x 3 days. Following up with PCP.
35 2021-01-06 flushing Three minutes after receiving the first dose of the Pfizer\BioNTech COVID19 vaccine today (time 11:3... Read more
Three minutes after receiving the first dose of the Pfizer\BioNTech COVID19 vaccine today (time 11:34 am), this vaccine study participant developed swelling of both cheeks and "was able to bite on both cheeks" as well as vague flushing of the cheeks. She did not immediately report these symptoms but returned to the site of her injection (research study site) and reported the cheek swelling and facial flushing to our study nurse. She denied lip/tongue/airway swelling, difficulty breathing, nausea or vomiting, diarrhea, cough, wheezing, shortness of breath, rapid breathing, fever, headache, paresthesias, rapid heart rate, chest pain, or other symptoms at that time. I am a sub-I for Pfizer\BioNTech vaccine study and authorized an immediate dose of Benadryl 50 mg orally which she received. I examined her at 12:40 pm and she had a reassuring physical exam as follows: Constitutional: Appearance: Normal appearance; well-hydrated and alert; no retractions, tachypnea, nasal flaring, or audible wheezing/breath sounds. No pallor. HEENT: Head: Normocephalic and atraumatic. Nose: Nose normal without visible discharge. Mouth: Mucous membranes are moist. Cheeks: Minimal edema of both cheeks is present; no visible erythema on exam. Eyes: Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equally round and symmetric. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm, HR 80-90. Pulses: Normal pulses in left wrist 2+/2+; warm hands. Pulmonary: Effort: Pulmonary effort is normal; RR 12-14. Breath sounds: Normal breath sounds. Abdominal: General: Abdomen is flat. Neurological: Mental Status: She is alert; speech and comprehension are normal. The patient still felt unusual by 2:00 pm and was referred to our Emergency Room for further evaluation. In our ER, she had the following vital signs and exam findings: BP 140/87 | Pulse 73 | Temp 98.1 °F (36.7 °C) | Resp 16 | SpO2 100% Gen: well appearing, no apparent distress, speaking in full sentences, no dysphonia Head: normocephalic, atraumatic, no hematoma Eyes: pupils equal reactive to light, extraocular movements intact ENT: hearing grossly normal, oral mucosa moist without edema/angioedema Resp: speaking in full sentences, clear to auscultation bilaterally, no rubs/crackles/wheeze, normal effort Abd: normoactive bowel sounds, nontender nondistended, no rebound/guarding, no organomegaly, faint/resolving urticaria abd x2 Ext: no deformities, no joint swelling, no edema, faint patchy erythema bilateral upper arms Neuro: alert, nonfocal Psych: AAOX3, normal affect/mood   I walked to our emergency room and reexamined her, and the only new finding were some pink small nonraised popular lesions on her abdomen and proximal arms, but she had no urticaria. Her lungs remained CTA and she was otherwise as before. The emergency room only gave famotidine 20 mg to her and discharged her with an EpiPen to use at home (they specifically felt she did not need it in the ER), but gave her oral cetirizine 10 mg to take daily for the next few days. I asked her how she felt upon discharge from the ER and she felt fine/normal.
35 2021-01-06 weakness, pain in extremity Woke up with chills, headache, weak, felt like fainting, arm pain. Called off work. Fever of 100.4.
35 2021-01-06 numbness, facial paralysis, face paralysis had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbne... Read more
had a reaction of bells palsy with mild symptoms 5 minutes of receiving covid vaccine; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better; This is a spontaneous report from a contactable Other Health Professional reported that a 35-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient experienced a reaction of bells palsy with mild symptoms 5 minutes of receiving Covid vaccine. "facial numbness right sided ear discomfort, difficulty closing right eye, only right side numbness and weakness of her face. It has gotten a lot better, patient was vaccinated 10 days ago on 21Dec2020. Patient was treated with 60mg of Prednisone for 5 days which was started today." Question is regarding the 2nd dose of Covid vaccine, whether or not she should have it. The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. .; Sender's Comments: There is a positive chronological association between vaccine administration and onset of the events. Causality cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-06 facial paralysis it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small ar... Read more
it hits a nerve; perceived it along the face still and the arm; Bell's Palsy; numbness in a small area of her tongue; right eye was irritated a little dry; right eye was irritated a little dry; right sided ear pain; fluid in the ear but no infection; This is a spontaneous report from a contactable health care professional (nurse practitioner). A 35-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on the right side on 21Dec2020 for Covid-19 immunization. Medical history included intermittent hives. Concomitant drug included ongoing cetirizine hydrochloride (ZYRTEC) 5 mg for intermittent hives. The reporting nurse practitioner saw a patient on 31Dec2020 who was vaccinated on 21Dec2020 and had a Bell's Palsy reaction (reported as not serious). She did some research and saw no more incidents in the general population but she wanted to report this. She also wanted to get more information on if the patient should proceed with dose number 2 of the vaccine. The patient developed the Bell's Palsy within 5 minutes after getting the vaccine. She thought it was because she was anxious to get the vaccine, so she brushed it off. The Bell's Palsy was still occurring but per the patient it had improved. On exam she did not have any weakness, facial droop or dumbness with sharp or dull testing. The patient perceived it along the face still and the arm. The reporting nurse practitioner said that the arm was probably not Bell's Palsy, but more related to getting the vaccine in the arm and it hits a nerve. Patient stated that her smile was also unequal and it was difficult for her to close her right eye, although now (as of 31Dec2020) she can. Her right eye was irritated a little dry. Regarding treatment, the patient was started on steroids on 31Dec2020. She did not start her on an anti-viral as she did not want it to impact her immunity to the vaccine. The patient also complained of right sided ear pain. She was unsure if that was related to the Bell's Palsy, but it was also on the right side. There was fluid in the ear but no infection. The pain was still ongoing. The patient also mentioned numbness in a small area of her tongue when she first got the vaccine. This was still ongoing. Outcome of Bell's Palsy was resolving. Outcome of the event numbness in a small area of her tongue, right sided ear pain was not resolved. Outcome of the other events was unknown. The reporting nurse practitioner stated that this was not serious as this was a mild case and was thankfully resolving. The reporting nurse practitioner comment that nothing of history was relevant besides for the last several months (as of 31Dec2020) the patient had been taking 5mg of cetirizine hydrochloride for intermittent hives. She wondered if she had not been taking it how she would have reacted or if the reaction would have been more severe. Information on the lot/Batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of Bell's Palsy cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-06 feeling cold severe back pain, headache, injection site reaction, fatigue, chills
35 2021-01-07 tingling, numbness, pain in extremity ABOUT 1 HOUR AFTER THE INJECTION WAS GIVEN I BEGAN TO EXPERIENCE NUMBNESS AND TINGLING ON THE 3RD FI... Read more
ABOUT 1 HOUR AFTER THE INJECTION WAS GIVEN I BEGAN TO EXPERIENCE NUMBNESS AND TINGLING ON THE 3RD FINGER OF MY RIGHT ARM, THE ARM THE INJECTION WAS GIVEN IN. LATER THAT AFTERNOON IT HAD SPREAD TO MY RIGHT WRIST AND BY THE TIME I WOKE UP THE NEXT DAY, MY WHOLE ARM WAS NUMB/TINGLY/PAINFUL AND THERE WAS A SWOLLEN LYMPH NODE IN MY UNDERARM ON THE ARM THE VACCINE WAS GIVEN IN. THE NUMBNESS/TINGLING/PAIN FINALLY WENT AWAY 2-3 DAYS LATER.
35 2021-01-07 pain in extremity BODY ACHE (LEFT UPPER ARM) POST COVID VAC. SHOT
35 2021-01-07 pain in extremity COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am... Read more
COVID-19 vaccination administered IM in left deltoid around 6am. Patient called pharmacy around 10am and complained that the injection was delivered too high and she was experiencing pain at the site. Vaccine placed high on L shoulder, just below acromion process, at or above humeral head. Seemingly placed between acromion process and humeral head, near or in soft tissue/bursa. Site pain is inflammatory in nature and does not seem to affect muscles, but instead is contained within joint itself.
35 2021-01-07 tingling Dizziness, NauseaVomiting, While being monitored, pt ran to the bathroom and then was observed holdi... Read more
Dizziness, NauseaVomiting, While being monitored, pt ran to the bathroom and then was observed holding onto wall/divider, "felt like might fall down" "tingling in left arm and leg", sweating. BP 100/80 PR 80, 115/87 PR 77, reports has drank 30-40 oz of water in the morning prior Narrative: Rapid Response called
35 2021-01-07 numbness, pain in extremity Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, st... Read more
Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; Headache, right hand numbing and tingling, stiff neck; This is a spontaneous report from a non-contactable other healthcare professional. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On an unspecified date, the patient experienced headache, right hand numbing and tingling, and stiff neck. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient underwent post vaccination nasal swab with an unknown result. No follow up attempts are possible. Information about lot/batch number cannot be obtained.
35 2021-01-07 difficulty speaking, throat numbness Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly... Read more
Heart palpitations; elevated heart rate and bp; elevated heart rate and bp; initially burning/tingly injection site; initially burning/tingly injection site; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then back of throat/tongue/lips were tingly and numb feeling; then throat got hoarse; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration in the right arm, on 03Jan2021 at 14:30 (at the age of 35-years-old) at a single dose for COVID-19 immunization. Medical history included asthma (no medication used), irritable bowel syndrome (IBS) and reflux, headaches, and COVID-19 (prior to vaccination). The patient was not pregnant at the time of vaccination. The patient did not have any allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included pantoprazole sodium sesquihydrate (PROTONIX), venlafaxine (MANUFACTURER UNKNOWN) taken for headaches, curcuma longa (TURMERIC; MANUFACTURER UNKNOWN), and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse on 03Jan2021 at 14:30. The events were reported as non-serious. The events required a visit to the emergency room. The patient underwent lab tests and procedures which included: BP: elevated and heart rate: elevated, both on 03Jan2021. Therapeutic measures were taken as a result of the events, which included treatment with diphenhydramine hydrochloride (BENADRYL), methylprednisolone sodium succinate (SOLU-MEDROL), and famotidine (PEPCID). The clinical outcome of heart palpitations, elevated heart rate and blood pressure (BP), initially burning/tingly injection site, then back of throat/tongue/lips were tingly and numb feeling, then throat got hoarse was recovering.
35 2021-01-07 pain in extremity I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm w... Read more
I started a little dizzy after the vaccine but could have been my cycle. Later that evening my arm was soar and swollen. I didn't take anything, a little difficult to sleep. The next day it started wearing off, I did ice the area.
35 2021-01-07 pain in extremity Injection site soreness, fever 101F, chills/rigors, severe nausea
35 2021-01-07 numbness Intermittent numbness in hands
35 2021-01-07 tingling, weakness Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fl... Read more
Left hand weakness and tingling, dizziness, injection site throbbing 10 min post vax Observation, fluids, food Sxs largely resolved after 30 mins of close monitoring, returned to shift feeling a little lightheaded NKA
35 2021-01-07 numbness, tingling Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness... Read more
Noticed a tingling sensation in her left arm radiating down to her fingertips on 12/31/2020. Redness at the injection site and hives on the left arm where injection was given. Patient went to ER on 01/01/2021 due to numbness and tingling. Received Benadryl at the ER.
35 2021-01-07 flushing Pt states she started feeling flushed, started getting hives around neck, and tightness of the right... Read more
Pt states she started feeling flushed, started getting hives around neck, and tightness of the right leg
35 2021-01-07 tingling, numbness Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tin... Read more
Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; Tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows; This is a spontaneous report from a contactable Other Health Professional (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 05Jan2021 02:30 at single dose for COVID-19 immunization. The patient had no relevant medical history and concurrent conditions. Known allergies: No (Allergies to medications, food, or other products: No). Other medical history: None. Concomitant medication received within 2 weeks of vaccination included biotin, meclizine (MECLOZINE), multivitamin. The patient experienced tingling and numbness that radiated to the left side of the neck, ears, nose, lips and eyebrows on 05Jan2021 12:30 with outcome of recovered in Jan2021. The patient underwent lab tests and procedures which included COVID test post vaccination: Nasal Swab (Prc) on 27Dec2020 with result negative. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient had not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Ibuprofen received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about Lot/Batch has been requested.
35 2021-01-07 tenderness acute mild edema to affected forearm with light bruising of unknown origin without known injury; acu... Read more
acute mild edema to affected forearm with light bruising of unknown origin without known injury; acute mild edema to affected forearm with light bruising of unknown origin without known injury; unknown origin without known injury, tenderness to touch; Tennis elbow of opposite vaccine extremity around same time as vaccine, just after; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the right arm on 10Dec2020 in a hospital at a single dose for COVID vaccination. Medical history included anxiety and chronic migraines with aura. The patient has no known allergies. The patient was not pregnant at the time of vaccination, did not receive any other vaccine in four weeks, was not diagnosed with COVID prior to the vaccination, and was not tested for COVID post-vaccination. Concomitant medications included desvenlafaxine succinate (PRISTIQ), bupropion hydrochloride (WELLBUTRIN), and cyclobenzaprine. In Dec2020, the patient had tennis elbow of opposite vaccine extremity around the same time as the vaccine, just after. On 01Jan2021 at 04:00 AM, the patient experienced acute mild edema to affected forearm with light bruising of unknown origin without known injury, tenderness to touch. The patient did not receive any treatment for the events. It was reported that the events resulted in a doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect). Information on the lot/batch number has been requested.
35 2021-01-08 cold extremities, feeling hot ? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her th... Read more
? After her shot in the afternoon, she sat outside for 15 minutes. She came back in and said her throat is warm and scratchy, and her left hand felt cold. ? I escorted her over to the ER and she was checked in. I then went right back to HD since we were so busy. ? Around 4pm in the afternoon after we closed HD, I went back to the ER. She was recovering and doing fine. Her ER nurse and patient did have a question about receiving the 2nd dose, and I provided the same answer that Dr provided to Dr about taking an Allegra 30 minutes before the second dose. ED Note: Patient presents with symptoms concerning for angioedema or anaphylaxis after immunization with Covid vaccine. Patient described a sensation of warmth and also later tingling in her throat which was treated aggressively with medication for this problem so as to prevent airway closure or further worsening symptoms. Patient was treated with IV fluid hydration along with H1 and H2 blockers, IV steroids and also subcutaneous epinephrine. On my reevaluation, her symptoms completely resolved with treatment. She was without other concerning findings on examination or by history and was without further angioedema or anaphylaxis after period of observation. She was discharged with prescription medication in good condition and asked to return should she have any further problems. Immpression: Angioedema, allergic reaction to vaccine, throat tingling, throat warmth MEDS in ED: Sodium Chloride 0.9% (Sodium Chloride 0.9% Bolus) 1,000 mL once IV Bolus, Reason for Infusion = Abnormal fluid losses diphenhydrAMINE (Benadryl) 25 mg = 0.5 mL once IV push methylPREDNISolone (SOLUMedrol) 125 mg = 2 mL once IV push famotidine (Pepcid) 20 mg = 2 mL once IV push EPINEPHrine 0.3 mg = 0.3 mL once intraMUSCULAR
35 2021-01-08 feeling hot Immediately after immunization, Pt reported feeling "light-headed, strange, having an out of body ex... Read more
Immediately after immunization, Pt reported feeling "light-headed, strange, having an out of body experience". Increased heart rate (134/m). A&O x 3. Warm, dry. Adult Emergency called and team responded within 2 mins. Pt states symptoms improving rapidly. Transported to ED w/o delay.
35 2021-01-08 feeling hot Severe rash around neck area. Warmth in the area of the rash
35 2021-01-09 feeling cold 25min after injection while driving home, I got a cold sensation in the back of my head, trouble bre... Read more
25min after injection while driving home, I got a cold sensation in the back of my head, trouble breathing, racing heart, and lightheadedness. pulled over, paramedics called. no treatment, symptoms passed after 30min. (cold sensations, racing heart, and trouble breathing brief, lightheadedness ~30min)
35 2021-01-09 muscle spasms, muscle twitching About 40 minutes after my vaccine, I felt sudden onset progressive weakness of my entire left arm wi... Read more
About 40 minutes after my vaccine, I felt sudden onset progressive weakness of my entire left arm with spasms/fasciculations of my forearm and hand (while driving from hospital where I work as a physician to where I live). I pulled over, felt a bit dazed and was unable to use my left hand purposefully to call 911 on my cell phone, but was able to call 911 on my Watch using my right (dominant) hand. While talking to the dispatcher, my symptoms resolved (total duration a few minutes) so I requested that they not send an ambulance but instead felt well enough to drive to my hospital ED. I discussed my case with the triage RN and ED attending who felt my symptoms were related to the vaccine, with no further work up needed, given then my symptoms resolved. My vitals were stable in triage. No chest pain or shortness of breath, with normal neurological function and sensation of my left arm. Note: I was not officially checked in or seen as a patient. Sudden onset weakness and spasms of left arm (side of vaccine administration) about 40 minutes after vaccine
35 2021-01-09 migraine Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of brea... Read more
Fever tMax 103.9, myalgias, golf ball-sized axillary lymph node, migraine, nausea, shortness of breath.
35 2021-01-09 pain in extremity Nauseous, dizzy, sore arm, runny nose for an hour.
35 2021-01-09 cold sweat, pain in extremity On 1/9/21 I slept fitfully, woke up in a cold sweat but had a normal temp of 38.4. I had a headache,... Read more
On 1/9/21 I slept fitfully, woke up in a cold sweat but had a normal temp of 38.4. I had a headache, body aches, and nausea also. This was approx 16 hours post dose. I took 600mg of ibuprofen and felt more able to do normal home activities but still tired with a sore arm. 4.5 hours post ibuprofen dose I again had muscle aches, headache, fatigue, and nausea. I also had chills and joint pain. I napped for an hour, took another 600mg ibuprofen, and then napped for another 2.5 hours. After that I felt better at 27 hours post dose but still achy and fatigued. These symptoms had mostly resolved by 31 hours post dose.
35 2021-01-09 feeling hot Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, ... Read more
Severe headache, muscle aches, joint pain, especially prominent in upper back neck, nausea, chills, feeling hot, fever onset at 0200 1/10/2021 (100.8-100.9), I have taken Tylenol 650mg q 6 hrs. Ibuprofen 800mg once 1/9/21 at 2200.
35 2021-01-09 flushing Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild ... Read more
Swelling, redness, moderate itching at injection site Mild numbness, burning, raw feeling with mild feeling of swelling of tongue and lips, coughing, tightness in chest, flushed cheeks, Red rash under left arm pit, temp of 100.4. Body aches.
35 2021-01-10 flushing After vaccine became flushed across face and chest with racing pulse. Vitals taken, A&O x4; Answered... Read more
After vaccine became flushed across face and chest with racing pulse. Vitals taken, A&O x4; Answered questions appropriately. Pulse palpable and regular and fast. Given graham crackers and bottled water. Vital signs retaken along with blood glucose. VS- 114/101 HR 94 138/93 HR 91 Glucose 91 Declined offered escort to ED. A&O x4; speech clear, resp evan. No signs of surface reaction at left arm site. Suggested follow up with PCP. Explained VAERS to patient.
35 2021-01-10 weakness Feeling of fatigue, full body muscle ache, low energy
35 2021-01-10 night sweats I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the ... Read more
I received my second vaccine on Friday 1/8. I felt fine until that evening and then experienced the typical side effects that I had read about. Chills, Severe Headache, All over body, joint, and skin pain. Then developed Fever around 102. Saturday headache was mild, very fatigued, skin felt sunburnt/pain, no fever, was still achy. Temp highest was 99.4 that evening. Noticed palpable clavicular lymph nodes that were very tender. Then noted an axillary one that was about marble sized and tender as well. Sunday about the same- was able to get up and do housework but felt fatigued easily. No temp. Sunday evening developed tenderness in neck area and possible lymph node swelling and decreased ROM. Axillary lymph node is larger than a marble currently. Also at times if I change positions I have a very brief moderate headache. I did wake up in the middle of the night drench with sweat which is very abnormal for me. Neck is the biggest complaint as of now. I called my PCP with the above complaints who referred me to employee health.
35 2021-01-10 burning sensation, tension headache Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; H... Read more
Swollen lymph nodes; blood pressure was 90/50; Chills; body aches; Fatigue; Joint pain; Bone pain; Headache; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Swelling, pain, redness and soreness at the injection site; Tachycardia / heart rate was 144-152; painful to breath and she was grunting; also said that the injection site itched a little bit.; Fever; First dose on 17Dec2020, second does on 04Jan2021; This is a spontaneous report from a contactable nurse reporting for herself. A 35-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) ( (lot number was unknown) intramuscularly on 17Dec2020 at 0.3ml, and the second single dose (lot number EJ1685) intramuscularly on 04Jan2021 07:45 at 0.3ml, for COVID-19 prophylaxis. Medical history included ongoing diabetes. Her diabetes was diagnosed about 6 months ago (reported on 06Jan2021) and was well controlled. Her glucose was at 140 at the ER (emergency room) even after drinking a drink that had sugar in it. The patient's concomitant medications were not reported. The patient received the second dose on 04Jan2021 at 07:45 and experienced a severe reaction hours after she received it, and she ended up having to go the ER and that they were baffled about what happened. She reported her symptoms were: fatigue, joint pain mainly in her knees, bone pain that did not feel like muscle pain, headache, swollen lymph nodes in the left axilla, and swelling, redness, pain, and soreness in the left arm at the injection site and also said that the injection site itched a little bit. Her symptoms started about 9-10 at night on 04Jan2021. She said that she felt like with the second dose she noticed the soreness and pain and redness at injection site after about 2 hours after receiving the second dose, which was sooner than with the first injection. The fever started with the chills and body aches. The chills and body aches started at 22:00 on 04Jan2021. She took acetaminophen and melatonin to try and sleep it off. Fever was after that at around midnight 04Jan2021 and she was burning in fever and her temperature was 104. She stated she started taking layers off and got out from under her covers. She had a sweater on when she took her temperature and her axillary temperature was 105. She said that she got into a hot shower because that was the only thing that provided comfort to her chills. She had not had any chills in about the last 12 hours though (as reported on 06Jan2021). She said that the body aches were so severe that she just sat in her bed and cried. She had tachycardia and she was grunting in pain. She was rotating ibuprofen and acetaminophen and then her fever was not as high. She stated that if her fever came back it was lower each time, and if she did not take the medications though, the bone pain was excruciating. She said that with the bone pain it was like no-one can hold her hand or hug her. Fatigue started at around midnight 04Jan2021. Her headache was at midnight. She felt like she had a headband on and was radiating down the back of her neck. She noticed the lymph nodes were swollen after she went to the ER at around 07:00-08:00 05Jan2021. She was walking with pillow under her arm, and if she moved or lifted her arm it hurt. She went to the ER at 01:00 05Jan2021. Her blood pressure was 90/50, her heart rate was 144-152 at rest, temperature was 102.8, O2 saturation was 95-96. She said that it was painful to breath and she was grunting, but did not have any breathing issues. The nurse thought she was septic and notified the doctor. The nurse and the doctor did not think it was the vaccine and thought that she was COVID-19 positive. But after they tested her, she was negative for flu and COVID and they were baffled. They were unclear on what happened and did not think it was from the vaccine. They bolused her 1 liter of Normal Saline and gave her a dose of Fentanyl that minimally helped with the bone pain. She was also given 30mg of ketorolac (TORADOL) IV (intravenous) and that significantly improved her pain. She was there a total of 3 hours. She was admitted to the back area of the ER. She said that they drew labs and everything was within normal limits. Her CRP (C-reactive protein) was 30 and her lactate was at 1.5. She said that they told her that she was most likely having an immune response to the vaccine. Her heart rate and blood pressure came to a more normal range and everything returned to baseline. Her heart rate was 109. She was told to rotate paracetamol (TYLENOL) and ibuprofen for at least the next 24 hours and hydrate. The events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were serious due to hospitalization from 05Jan2021 to 05Jan2021. The patient was recovering from fever, chills, joint pain, headache, heart rate and blood pressure, not recovered from fatigue, bone pain, swollen lymph nodes and swelling, pain, redness and soreness at the injection site. The event swollen lymph nodes worsened. The outcome of "injection site itched a little bit" was unknown. The reporter considered the events fever, chills, fatigue, joint pain, bone pain, headache, swollen lymph nodes, and swelling, pain, redness and soreness at the injection site were all related to the vaccine; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pyrexia, chills, fatigue, pain, arthralgia, bone pain, headache, lymphadenopathy, vaccination site erythema, vaccination site swelling, vaccination site pain, blood pressure decreased, tachycardia, grunting and vaccination site pruritus cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-01-11 discomfort, weakness After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes ... Read more
After vaccination I felt diaphoretic and dizzy. After waiting in the monitoring area for 45 minutes I drank some water and felt like my bilateral upper thighs were difficult to lift when I tried to walk to my car. I went home and was tachycardic 120-130bpm that continued throughout the night to the point I couldn't sleep my heart was pounding so hard and fast. I was extremely thirsty and dehydrated all night. I continued to have tachycardia for several days despite hydrating. My thighs also continued to feel week for several weeks. I developed a 100.7 F temperature and had flu like symptoms the following days.
35 2021-01-11 tingling Headache, tiredness, muscle pain and tingling down the left arm, feeling unwell, feels swollen but d... Read more
Headache, tiredness, muscle pain and tingling down the left arm, feeling unwell, feels swollen but doesn?t appear to be
35 2021-01-11 numbness I started noticing swelling and altered sensation in my right lower arm about 10 minutes after injec... Read more
I started noticing swelling and altered sensation in my right lower arm about 10 minutes after injection. The swelling subsided but numbness lingered. Then around 10am I started feeling numbness in my right neck, jaw and ear. Numbness improved after taking half tab of benadryl.
35 2021-01-11 tingling, numbness, facial paralysis Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of to... Read more
Left Bell's palsy/left side of face, inability to raise left eyebrow; numbness and paresthesia of tongue; numbness and paresthesia of tongue; pain in left upper arm between elbow and shoulder; tachycardia; elevated blood pressure; This is a spontaneous report from a contactable physician. A 35-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscular at arm left on 31Dec2020 at single dose for covid-19 immunization. The vaccine was administered at other (as reported). Medical history included asthma (Allergy induced asthma). Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC) from Dec2020 at 10mg daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Dec2020, the patient experienced Left Bell's palsy, numbness and paresthesia of tongue, left side of face, inability to raise left eyebrow, pain in left upper arm between elbow and shoulder, tachycardia, elevated blood pressure. The adverse events result in emergency room/department or urgent care. The patient received treatment for the adverse events which included Prednisone 20mg daily, Valacyclovir 1000mg twice a day. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Bell's palsy and other reported events due to temporal relationship. However, the Bell's palsy may possibly represent a concurrent medical condition. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including viral serologies, and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-01-11 migraine, muscle spasms Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/b... Read more
Migraine day of vaccine Fever of 101.4 to 102.7 day 2 after vaccine Skin feeling like it?s burning/blistering day 2after vaccine Severe body aches and cramps day 2 after vaccine
35 2021-01-11 migraine On day four after the first, 99.5 temp, up to 100.8. Fever, head ache, joint pain. Second vaccinatio... Read more
On day four after the first, 99.5 temp, up to 100.8. Fever, head ache, joint pain. Second vaccination, fever 102, headache, and joint pain. Chills. Migratory migraine. Second vaccine Jan 8th.
35 2021-01-11 pain in extremity Severe sore arm for 2 days after vaccine. Rash/hives for 3 days after vaccine
35 2021-01-11 weakness Weakness, chills, nausea and excruciating stubbing pain in L shoulder with even minor movement
35 2021-01-11 hot flush aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot fl... Read more
aproximately 5 min after receiving the vaccine, client started c/o light headeness,dizziness, hot flashes,and a numb lip, cold and shivering. they started o2 at 4liters via nasal canula and gave her 2 Benadryl 25mg oral tabs. At 10:40 she said she felt better, not dizzy, lip not numb, and wasn't feeling cold. She said she would contact her pcp and let him know. She felt good enough to drive off.
35 2021-01-11 tingling, migraine nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itchi... Read more
nausea, tingling light headed ness. 24 after injection- Rash started on lower extremities. no itching. migraine. nausea, dizziness. positive D Dimer. Shortness of breath Treatment: IV fluids, Reglan. IV Tylenol. Covid test- negative. Na 121.
35 2021-01-11 tingling, numbness right arm numbness/tingling chest tightness dry heaving passed out lips and tongue tingling th... Read more
right arm numbness/tingling chest tightness dry heaving passed out lips and tongue tingling then swelled. 50mg IM Benadryl administered, vitals monitored, RR called and I was transported to the ER and given more medications.
35 2021-01-11 hypersensitivity of all senses severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain... Read more
severe myalgia 10/10 entire body affected; Hyperesthesia; violent chills/rigors; injection site pain (worse than prior dose); This is a spontaneous report from a contactable physician (patient herself). A 35-year-old female patient received second dose of PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left arm) on 05Jan2021 at 11:45 a.m., at a single dose, for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD) and allergic rhinitis. Concomitant medications included loratadine (CLARITIN), methylphenidate hydrochloride (CONCERTA), fluticasone propionate (FLONASE), and montelukast sodium (SINGULAIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 17Dec2020 for COVID-19 immunization and experienced injection site pain; and isoniazid and experienced rash. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 06Jan2021, at 12:00 a.m., the patient experienced severe myalgia 10/10 entire body affected, hyperesthesia, violent chills/rigors, and injection site pain (worse than prior dose), peaked approximately 12 hours after dose. Patient has no fever. It was reported that first dose side effect of moderate 6/10 injection site pain in Dec2020, responded well to naproxen. The patient did not receive treatment for the events. Patient did not seek medical care, because she and her husband are both intensive care unit (ICU) physicians. Outcome of the events was recovering. The patient has not been tested for COVID-19 since vaccination.
35 2021-01-12 flushing About 10 minutes after the vaccine was given, patient experienced flushing, tachycardia. No SOB nor ... Read more
About 10 minutes after the vaccine was given, patient experienced flushing, tachycardia. No SOB nor difficulty breathing. Tingling to mouth and slight swelling. Rapid response called. Monitored for 2 hours. Post dose redness resolved. Tingling sensation remained.
35 2021-01-12 feeling hot H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her... Read more
H/A, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, heart bothering her, feels warm, tired, heat surge, loss of appetite, SOB, Had COVID May 2020.
35 2021-01-12 breast pain I am nursing & on my left breast I developed menzies on 12/21/2020 & on 12/26/2020 I was seen by my ... Read more
I am nursing & on my left breast I developed menzies on 12/21/2020 & on 12/26/2020 I was seen by my doctor.
35 2021-01-12 breast pain Soreness on right breast, there is one specific area that feels like a lump and it is painful to tou... Read more
Soreness on right breast, there is one specific area that feels like a lump and it is painful to touch. This lump is on the lower part of my breast tissue towards the right side. I noticed the pain and soreness on 1/12/21. when I woke up.
35 2021-01-12 pain in extremity arm sore, sore throat,nasal congestion, chest hurt when taking deep breath,sob ,headache, pulse 100,... Read more
arm sore, sore throat,nasal congestion, chest hurt when taking deep breath,sob ,headache, pulse 100, advised to see PCP
35 2021-01-12 feeling hot h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, ... Read more
h/a, sore throat, muscle pain, chills, joint pain, pain at inj. site, nauseated, feels warm, tired, warm surges.
35 2021-01-13 migraine About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to ... Read more
About 11:30 while at working all of the sudden my peripheral vision became black, my bp raised to 180/120 and I was sent to the ER (Hospital) for monitoring. After some time it leveled out and I was released home to rest. That night and the next day I had a migrane, felt sluggish and really couldnt do anything. I took tylenol and motrin to help with the pain.
35 2021-01-13 cold sweat Approximately 10 minutes after receiving the vaccine the patient became clammy and light headed. VS ... Read more
Approximately 10 minutes after receiving the vaccine the patient became clammy and light headed. VS were stable and patient stayed an extra 30 minutes until she started feeling better. With follow up call, patient stated that she has headache, nausea and fatigue
35 2021-01-13 weakness Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous ... Read more
Chills; low-grade fever (100.9 at highest); muscle aches; weakness; diarrhea; This is a spontaneous report from a contactable other Health Care Professional (HCP). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number and expiration date unknown), intramuscularly, on 05Jan2021 (at the age of 35-years old) at an unspecified dose in the left arm for COVID-19 vaccination. Medical history included Thalassaemia from an unknown date and COVID-19 on an unknown date. The patient's historical vaccines included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730) on 17Dec2020 (at the age of 35-years-old) at unspecified dose in the left arm for COVID vaccination.The patient has no allergies to medications, food, or other products. The patient was administered the vaccine in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient had been diagnosed with COVID-19 on an unknown date. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccinations. On 05Jan2021 at 23:30 the patient experienced chills, low-grade fever (100.9), muscle aches, weakness and diarrhea. The patient did not receive any treatment for the events. The clinical outcome of the events was reported as recovered on an unspecified date in Jan2021. It was also reported that since the vaccination the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
35 2021-01-13 migraine Fatigued about 8 pm last night Woke up groggy 10 am - migraine started 11 am - shortness of breath... Read more
Fatigued about 8 pm last night Woke up groggy 10 am - migraine started 11 am - shortness of breath and fatigued (out of it really bad) Noon - heaviness in the chest 12:45 (current time) Aches in my shoulders, Migraine in my right temple area, short of breath, chest burning, head feels heavy to my neck. Similar symptoms to when I had Covid in the end of October.
35 2021-01-13 migraine Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Head... Read more
Shortness of breathe; Rapid heart rate; migraines; Fever; Chills; Body aches; Muscle tightness; Headaches; This is a spontaneous report from a contactable Other Health Professional (patient). A 35 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose (lot EK5230) via Intramuscular on 16Dec2020 11:30 in the left arm at single dose, second dose via Intramuscular on 06Jan2021 11:00 in the left arm at single dose for COVID-19 prophylaxis. Medical history and concomitant medications were none. Caller did not experience any side effects after the first dose. After the second dose, caller experienced, fever, chills, body aches, muscle tightness and headache. Today the caller also experienced shortness of breathe and a rapid heart rate. Fever; She said that she noticed her fever at 0130 07Jan2021. He fever started at 100.3 at 0130 and at 0400 it was 100.8. She took it at 1000 and it was 101. She has not taken her temperature since. Chills: She woke her up at 0130 07Jan2021 she said that she sleeps with a electric heated blanket and she woke up cold. Body aches: She noticed that she had the body aches and pain at 0130 07Jan2021. She said that she has not been able to sleep because the pain has been so bad. Muscle tightness: She said that it hurts to stand up and walk. She stated that she had to get a Covid test this morning so she had to move. She noticed the muscle tightness at 0130 07Jan2021 along with the body aches. Headaches: caller said that she noticed her headache around 0130 07Jan2021. She said that it is a dull achy headache. She stated that she get migraines and thought it was because of her fever. Shortness Of Breath: She said that she noticed she was short of breath around 1230 07Jan2021. She stated that it is hard to breath right now and feels like someone is standing on her chest. Rapid heart rate: Her watch at 1230 07Jan2021 said that she had a 116 heart rate and that was at rest. Outcome of event Chills was recovering, while outcome of other events was not recovered.
35 2021-01-13 flushing The evening I got the shot I felt my muscles starting to ache. The next morning when I woke up I wa... Read more
The evening I got the shot I felt my muscles starting to ache. The next morning when I woke up I was achy, but still went to work. Around 11:00 am on 1/13/21 I started to feel flushed and the chills. Took my temp and it was 100.3 F. I was achy all over and had a headache too.
35 2021-01-13 feeling hot Voiced s/s of itching @ 1232pm. Voices s/s to L side of face. Slight redness noted bilateral cheek... Read more
Voiced s/s of itching @ 1232pm. Voices s/s to L side of face. Slight redness noted bilateral cheeks and L ear. Continued to c/o s/s @ 1238 no relief. Benadryl 25mg given @ 1238. Redness still remains to area, heat also noted to L ear. Remains in observation @ 1238. Remains to have slight redness to areas. Denies any other s/s of distress. Left observation @ 1308. Voices allergies of Peanuts,Tree Nuts, Latex, Melons, and Bananas. Does have chronic illness's of Asthma, and Seasonal Allergies.
35 2021-01-13 migraine, pain in extremity Woke up with a very sore arm. About 10 am Migraine started 11 am Tired "feeling out of it" Noon -... Read more
Woke up with a very sore arm. About 10 am Migraine started 11 am Tired "feeling out of it" Noon - Short of breath Currently 12:30 Muscle soreness in shoulders, migraine worse, heavy chest
35 2021-01-14 pain in extremity 1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; ... Read more
1st vaccine- mild headache and mild arm soreness; 1st vaccine- mild headache and mild arm soreness; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), via unknown route of administration, on 18Dec2020 (at the age of 35 years old) as a single dose in the right arm via unknown route of administration for COVID-19 immunization at hospital facility. Relevant medical history was unknown. It was unknown if patient has any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unknown date, after the first dose, the patient experienced mild headache and mild arm soreness. No treatment was received for the events mild headache and mild arm soreness. The outcome of the events mild headache and mild arm soreness was unknown. The patient was not pregnant at time of vaccination. Since the vaccination, the patient had not been tested for COVID-19.
35 2021-01-14 feeling cold Chills, fever, headache, nausea, diarrhea, myalgia, palpitations (same side effects were present aft... Read more
Chills, fever, headache, nausea, diarrhea, myalgia, palpitations (same side effects were present after the first dose (12/22) except for diarrhea, a rash developed one week after the first vaccine)
35 2021-01-14 tenderness Complaints of fever, tachycardia after vaccination,myalgias, chest ache, axillary adenopathy and ten... Read more
Complaints of fever, tachycardia after vaccination,myalgias, chest ache, axillary adenopathy and tenderness.
35 2021-01-14 weakness, pain in extremity Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Inje... Read more
Heart palpitations Weakness Sore throat Low grade fever Lymph node swelling Arms soreness Injection site redness and swelling
35 2021-01-14 numbness Left sided scalp and facial numbness 5 minutes after vaccine. Left sided arm numbness 10 minutes aft... Read more
Left sided scalp and facial numbness 5 minutes after vaccine. Left sided arm numbness 10 minutes after. Seen in ED at Hospital with normal saline iv, Benadryl iv and solumedrol iv. Head ct completed which was negative. No improvement in symptoms. Discharged home. 1/9 woke up with left sided body numbness. Seen at Hospital MRI brain completed, 1/10 numbness and pain to left side of body. Start medrol dose pack. 1/11 saw PCP. 1/14 MRI brain with iv contrast. 1/15 completed medrol dose pack, continued symptoms
35 2021-01-14 numbness Patient felt numbness on her left cheek and developed hives on her forehead within 4 hours or recei... Read more
Patient felt numbness on her left cheek and developed hives on her forehead within 4 hours or receiving the Pfizer covid-19 vaccine. Resolved within 24 hours without treatment.
35 2021-01-14 pain in extremity STARTING TO NOT FEEL WELL AFTER WALKING OUT OF THE BUILDING WITH A UPSET STOMACH, THEN THROUGH OUT T... Read more
STARTING TO NOT FEEL WELL AFTER WALKING OUT OF THE BUILDING WITH A UPSET STOMACH, THEN THROUGH OUT THE DAY I STARTED TO GET A HEADACHE AND MY ARM WAS STARTING TO HURT ALSO, THE NEXT DAY I WOKE UP WITH MY BODY HURTING AND FEELING SICK TO MY STOMACH. IT TOOK ANOTHER DAY FOR ME TO FEEL BACK TO MYSELF.
35 2021-01-14 pain in extremity Sore arm, body aches, chills, headache. By 48 hours most of the symptoms had faded to very minor. Ex... Read more
Sore arm, body aches, chills, headache. By 48 hours most of the symptoms had faded to very minor. Exhausted within hours of the shot.
35 2021-01-14 tingling This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bn... Read more
This is a spontaneous report from a contactable Physician. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at the first single dose for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. Immediately after receiving the first dose of the vaccine, the patient reported having dizziness and tingling throughout her body, she could not feel her hands, the patient was not anxious. After that, her heart began to pound and it was difficult for her to breathe, after a minute she felt her heartbeat begin to normalize. After 30 minutes she began to normalize, but she went to the emergency room and began to feel nausea, her body hurt and her heart rate was 140 bpm, the episode lasted 30 seconds. The outcome of events was unknown. Information on the Batch/Lot number has been requested.
35 2021-01-14 cold sweat vaccinated 01/13/2021, at 0830. Her co-worker called down this afternoon and reported that sometime... Read more
vaccinated 01/13/2021, at 0830. Her co-worker called down this afternoon and reported that sometime between 11:30 am and noon, Patient started having cold sweats, nausea, low grade temp, and body aches. She did vomit once, but had just eaten lunch.
35 2021-01-15 weakness Developed fever Sunday night into Monday along with severe body aches, joints pain and weakness. too... Read more
Developed fever Sunday night into Monday along with severe body aches, joints pain and weakness. took Tylenol 500mg every 6 hours. on Tuesday symptoms continued. Wednesday felt little better with no fever but body ache and joint pain continued. Was out from work for 3 days. Weakness and joint pain is still there (today is Saturday). will continue to monitor
35 2021-01-15 muscle spasms I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days... Read more
I was 5 weeks pregnant when I got my first dose of the Pfizer covid-19 vaccine. I miscarried 4 days later. I do not know if the vaccine contributed to my miscarriage but wanted to contribute to the existing data. I had no other side effects or symptoms other than soreness at the injection site. There were no complications with the miscarriage.
35 2021-01-17 pain in extremity Pain in all fingertips with red sunburn-like appearance, white on some tips, generalized joint pain,... Read more
Pain in all fingertips with red sunburn-like appearance, white on some tips, generalized joint pain, shingles-like rash on back. Increased gabapentin to 300 mg daily for 7 days; keep hands warm and do warm water soaks to ease pain, labs drawn, will f/u in one week if s/s have not improved.
35 2021-01-17 flushing Patient's reaction(s) noted during COVID vaccine observation period: Pt states that 5 minutes after ... Read more
Patient's reaction(s) noted during COVID vaccine observation period: Pt states that 5 minutes after receiving covid vaccine she started to feel flush, sweaty, throat tingling. Vital signs taken: 1135: 134/80, HR 133, 97%O2 on RA. Pt sitting up in chair, drinking ice water, 1142: 133/61, HR 125, 97%O2 on RA, sitting in chair comfortable. Actions Taken: called ED clinician for evaluation per patient request. ED here at 11:56 to transport patient via wheelchair for evaluation. Pt in stable condition. Disposition: sent to ED for evaluation, received dose of diphenhydramine in ED with additional observation and then discharged.
35 2021-01-17 night sweats Received 2nd dose of Covid vaccine on Wednesday January 13th at 1040am, soon after had headache but ... Read more
Received 2nd dose of Covid vaccine on Wednesday January 13th at 1040am, soon after had headache but was able to work. Thursday morning at 0330 severe body aches, chills, headache. Symptoms lessened with Tylenol but would come back through Friday the 15th. Had to call out of work Friday the 15th. Saturday the 16th Woke in a sweat and aches/chills have since stopped. Still experiencing headaches
35 2021-01-17 migraine Severe chills, severe migraine, severe body aches, fever reaching 104.3 . 48 hours later GI issues a... Read more
Severe chills, severe migraine, severe body aches, fever reaching 104.3 . 48 hours later GI issues and slight sore throat.
35 2021-01-17 feeling hot Started feeling hot, redness all over body and itching that lasted 24 hours. Bilateral neck itching... Read more
Started feeling hot, redness all over body and itching that lasted 24 hours. Bilateral neck itching/redness and hives remain. Still occurring 1 week after vaccine. Worse at night.
35 2021-01-18 flushing After second dose of vaccine, about 10 minutes or less of vaccination, I had flushed redness in my a... Read more
After second dose of vaccine, about 10 minutes or less of vaccination, I had flushed redness in my arm, itching, and hives from my neck on the left side, down to my wrist. The symptoms resolved on their own within 10 minutes.
35 2021-01-18 numbness Dizziness and face numbness from nose to chin
35 2021-01-18 pain in extremity, tenderness, weakness Immediately > Sore to touch and felt swollen Within 1 hr > very tired 10pm: Body aches, temperature ... Read more
Immediately > Sore to touch and felt swollen Within 1 hr > very tired 10pm: Body aches, temperature of 99.9F, arm so sore I could not touch it, sweating, stomach muscle pain Saturday 1/16/21 @ 1am > 103F temperature, every part of body hurt (even my cheeks could not be touched), joints very sore, difficult to walk, very tired, sweating, dizziness Remainder of day until 10pm > Very tired, lethargic, fever not below 100 with medication, very sore muscles and joints throughout entire body, slight cough, difficult to sit or walk due to pain, sweating, muscle weakness, dizziness 10pm> temperature 99.9 without medication, muscle and joint pain not as severe, sweating, feet still very sore, tired, muscle weakness Sunday 1/17/21 @ 9am > temperature 98.8F without medication, a little tired, moderate joint pain in hips feet, slight cough, dizziness, sweating (symptoms continued) 9pm> temperature 98.3F, mild joint stiffness in hips, mild pain in feet, moderate nausea Monday 1/18/21 8am > temperature 97.9F Mild pain where toes and foot connect, mild nausea, slightly tired 5pm> temperature 98.3F, very painful stomach muscle spasm while leaned over for approximately 30 seconds to 1 minute on both sides 1/19/21 8am > temperature 97.6F, mildly tired, mild stomach muscle spasms while sitting and standing 7:40pm temperature 98.3, mild stomach muscle spasms while sitting and standing
35 2021-01-18 feeling cold cold sensation in back of head; trouble breathing; lightheadedness; racing heart; anxiety; This is a... Read more
cold sensation in back of head; trouble breathing; lightheadedness; racing heart; anxiety; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date: unknown), via an unspecified route of administration on 09Jan2021 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Infertility, IVF, known allergies: Penicillin. Patient is not pregnant. There were no concomitant medications. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. While driving home the patient experienced cold sensation in back of head, trouble breathing, lightheadedness, and racing heart. Paramedics called. Patient was better after 30minutes. They thought it was anxiety. They were asking if it was safe to get 2nd vaccine. The patient did not receive any treatment. Patient experienced the events on 09Jan2021 10:30. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: racing heart on 09Jan2021. Outcome of the events was recovered on an unspecified date.
35 2021-01-18 pain in extremity sore arm; Off label use; Drug use in unapproved population; This is a spontaneous report from a cont... Read more
sore arm; Off label use; Drug use in unapproved population; This is a spontaneous report from a contactable a nurse reporting for herself and for her baby. This is the mother case. This 35-year-old female patient who was breastfeeding her 7-month-old infant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient had sore arm with outcome of unknown. Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025730 baby case
35 2021-01-19 pain in extremity 1)arm soreness that lasted for a couple of days 2)bad headache that started 2 days after the vaccine... Read more
1)arm soreness that lasted for a couple of days 2)bad headache that started 2 days after the vaccine and require Motrin
35 2021-01-19 face paralysis, feeling cold, pain in extremity Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I sta... Read more
Around 30 minutes after vaccine, I started to feel dizzy and light headed As the day went on, I started to get a headache and get very tired. Then around 5 I started to feel intense: Headache Chills/cold Dizzy/light headed/almost fell over several times Muscle weakness, could not carry anything or lift Muscles in face felt like they were melting down/stroke sensation Exhaustion Sore/achy everywhere Tender left arm where shot was Could not think/memory was gone/could not put together a sentence Tightness chest/hard to breath Could not keep eyes open Had to lay down and sleep with long pants long sweater, jacket and 3 blankets I woke up the next morning and some of my symptoms were gone except I still felt tired and had some achy ness, pain and left arm hurt and had shooting pain in joints Shooting severe pain in each joint, laster for 3 days, most severe in joints where I received vaccine but also in wrists, shoulder, elbows, hips, knees, ankles At day 5 my left arm is still sore including muscles around injection site
35 2021-01-19 pain in extremity Day one, diarrhea, sore arm, headache, fatigue . Day 2 sore arm, fatigue day 3 fatigue day 4 headac... Read more
Day one, diarrhea, sore arm, headache, fatigue . Day 2 sore arm, fatigue day 3 fatigue day 4 headache day 5 headache day 6 swollen neck lymph nodes as well as armpits and body aches
35 2021-01-19 pain in extremity, tenderness Deep muscle pain, right arm for over 24 hours, resolved with Aleve 440 mg x 2. Right axillary/breas... Read more
Deep muscle pain, right arm for over 24 hours, resolved with Aleve 440 mg x 2. Right axillary/breast tenderness beginning 36 hours after injection. Mental sluggishness beginning about 12 hours after injection, resolved with sleep.
35 2021-01-19 weakness, tremor, feeling hot Developed fever of 101.3 at it's highest (yesterday evening). Accompanied by sweats (soaked through ... Read more
Developed fever of 101.3 at it's highest (yesterday evening). Accompanied by sweats (soaked through clothes/bed sheets), chills/trembles, fatigue, general aches and weakness, acute soreness at the muscle. Following morning woke up still with 100F temp, last took tylenol at 8am, fever has since remained down/normal (it is now 3pm). Still with some sweats/feeling hot, though temp is staying normal.
35 2021-01-19 weakness Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the show... Read more
Felt okay upon awakening at 06:30am. Got a shower before work. Shortly after getting out of the shower I became weak, ears started blocking, and started to have tunnel vision. Progressively got worse and was able to sit with head between legs. Took about 1 minute before I didn't feel like I was going to pass out. Shaky and weak after. Pulse 78 and oxygen level ok. Completed virtual visit and no further medical treatment advised unless symptoms got worse, but advised it was likely a vaccine reaction. Shortly after a bad headache and body aches developed (expected side effects).
35 2021-01-19 muscle spasms Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and... Read more
Fever, then 1/19/21 at 10:00am metallic taste in mouth followed by severe fatigue and body aches and back spasms
35 2021-01-19 night sweats Onset of chills and fever to 101.5 about 11 hours after injection. Responded well to OTC Acetaminoph... Read more
Onset of chills and fever to 101.5 about 11 hours after injection. Responded well to OTC Acetaminophen. 18 hours later, chills, fatigue and temperature returned, responded to Acetaminophen. Persistent night sweats for 5 consecutive nights.
35 2021-01-19 tingling, numbness Patient reported within 5 minutes of injection arm was tingling and numb and felt it was beginning t... Read more
Patient reported within 5 minutes of injection arm was tingling and numb and felt it was beginning to swell. Patient was given dose of oral benadryl and monitored for additional 15 minutes. Patient started to complain of stomach pain and heaviness in chest. Was sent to ER where she complained of difficulty swallowing, increased heaviness in chest, and arm tingling. Patient reported ER gave her a dose of a steroid. She was released to pharmacy with prescriptions for EpiPen and steroids.
35 2021-01-19 pain in extremity Sore arm and headache.
35 2021-01-20 feeling hot 10 min after vaccination patient complained of dizziness, feeling very warm. reminded her of the au... Read more
10 min after vaccination patient complained of dizziness, feeling very warm. reminded her of the aurora before migraine comes on. V.S. HR 75, Pulse ox, 99% BP 102/76, 0800 cool cloth applied to back of neck and and we put her head down. 0810 dizziness better seeing spots, 0810 Dizziness better spots persisted, 0825 same monitored and patient drinking water ate some crackers. 0830 V.S BP 114/80 HR 71 Pulse ox, 99% . 0835 bent over to pick up phone off the floor developed dizziness again cold, warm blanket applied monitored. 0850 feeling queezy and dizziness persistent 0900 sent to the ED per W/C. 2 sm. bottles of water taken in.
35 2021-01-20 feeling cold Headache, chills, left arm pit swollen and painful lymph nodes, muscle pain, and tiredness.
35 2021-01-20 weakness Headache, weakness, tachycardia (140), hypertensive (165/110)
35 2021-01-20 pain in extremity I started to feel rundown/fatigued in the evening on the day I got the vaccine and my arm was very s... Read more
I started to feel rundown/fatigued in the evening on the day I got the vaccine and my arm was very sore. I woke up very early the next morning with a fever of 101-102, body aches, severe headache, nausea, chills, severe fatigue, dizziness, difficulty concentrating, I would get tunnel vision, my eyes ached and felt very strained, sinus congestion and pressure. My fever spiked at 103.6 that evening and then stayed below 100 after that. For the following 7 days I still had the severe fatigue, nausea, headaches, chills, dizziness, difficult concentrating, tunnel vision that was especially bad when I had to drive, eye aches, sinus congestion and pressure, and my head felt very strange. The best way to describe it is that I felt like someone had drugged me. The only time I would leave my house was to take my daughter to school and when I would drive my head would feel super tight, my eye ache would intensify and they would feel super strained, I would get the tunnel vision and I would have trouble making it to the school and back home. Then I would go back to sleep for several hours, get up and drink some fluids and go back to bed. On day 7 or 8 I was able to stay up for periods of time and either watch movies or just lay in bed. I went back to work on 1/20 and am doing desk work. I am doing a lot better but still have daily headaches, moderate fatigue that is worse in the morning, mild intermittent nausea, my head still feels weird like I've been taking some kind of pain med or mild sedative, and I'm easily exhausted. I have trouble going grocery shopping because I get exhausted. I had a rapid COVID test done on 1/06/20 due to a headache and temp of 99.6-100.2, it was negative and we thought the temp was due to the Trokendi as that is a side effect of it. I also had a PCR done on 1/12 that came back negative.
35 2021-01-20 feeling of body temperature change Muscle pain Chills Headache Dizziness Heart palpitations Unsure of blood pressure or fever Hot and c... Read more
Muscle pain Chills Headache Dizziness Heart palpitations Unsure of blood pressure or fever Hot and cold Injection site pain
35 2021-01-20 numbness Tingling tongue, facial numbness on right side, lump in throat on right side
35 2021-01-20 weakness had a temperature of 102 broke a fever; couldn't get out of bed/weak; chills; bad body ache; couldn'... Read more
had a temperature of 102 broke a fever; couldn't get out of bed/weak; chills; bad body ache; couldn't sleep the whole night; This is a spontaneous report from a contactable other HCP repot for self. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 15:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of BNT162B2 at 35-year-old on 15Dec2020 and experienced sore arms, no other symptoms. After the 2nd dose patient was ok until got home around 9pm roughly 6 hours later, patient had chills and bad body ache. She couldn't sleep the whole night. In the morning (on 09Jan2021) she had a temperature of 102 broke a fever, couldn't get out of bed until the morning 24 hours later, she was really weak. Patient don't have any comorbidities, she was generally a healthy 35 year old person, no other health issues. Now patient feel like back to normal. The outcome of events was recovered. Information on the lot/batch number has been requested.
35 2021-01-21 feeling hot "Feeling hot temp 97.7. 10:53 BP 173/97 HR 139 11:05 BP 134/70 HR 94 - asymptomatic Educated pt to ... Read more
"Feeling hot temp 97.7. 10:53 BP 173/97 HR 139 11:05 BP 134/70 HR 94 - asymptomatic Educated pt to notify manager of any additional symptoms Pt returned at 1108 w/ cc palpitations, hot, shaky and difficulty swallowing. Assessed and sent to ED. BP 159/104. In the ED, symptoms resolved and pt discharged at 13:29. "
35 2021-01-21 weakness 101 fever lasting 24 hours, not alleviated with meds, total body aches and chills, significant weakn... Read more
101 fever lasting 24 hours, not alleviated with meds, total body aches and chills, significant weakness and fatigue. Fever broke after 24 hours with continued weakness, body sweats the next day. Day 3 started with headache and ended with severe GI disturbances.
35 2021-01-21 bell's palsy Bell's palsy. on prednisone 60 mg daily. improving
35 2021-01-21 weakness, flushing Body aches leading into flushing and nausea. Then vasovagal event. Unconscious for an unknown period... Read more
Body aches leading into flushing and nausea. Then vasovagal event. Unconscious for an unknown period of time. Symptoms occurred at approximately 02:30am, no treatment sought at time of event. Dizziness and weakness continued for about another hour. No further episodes of fainting. Body aches and fatigue continued into the next day for approximately 24 hours in total, pain managed with Motrin. All symptoms then resolved.
35 2021-01-21 feeling hot Headache developed before 7pm. Chills soon after for the remainder of the night. Woke up the next mo... Read more
Headache developed before 7pm. Chills soon after for the remainder of the night. Woke up the next morning feeling like hit by a bus with so many muscle aches. Also was warm/hot most of the day. Didn't feel good in general. Headache came and went most of the day. The next morning still felt 'off', but not horrible like the previous day.
35 2021-01-21 tremor, feeling cold I became very chilled around 8:30pm, so I assumed I was running a fever (I did with my first vaccine... Read more
I became very chilled around 8:30pm, so I assumed I was running a fever (I did with my first vaccine). I checked and it was only 99.5. So I went to bed and by 9:00pm I was very cold and shaking/shivering all over. I could not control the shivering. After about 45mins, I checked my temperature again and it was only 100.6. So at this point I took 600mg Ibuprofen. I continued to shivering uncontrollably for at least another hour. Finally I fell asleep and my fever broke.
35 2021-01-21 numbness, weakness, sensory loss Patient reported all energy and strength was wiped out of her. She slowly regained over a few days.... Read more
Patient reported all energy and strength was wiped out of her. She slowly regained over a few days. She has numbness and loss of sensation in whole left side of body, limp and sluggish. Went to ER 01/18/20 and they thought was overload of immune system. They suggested her to report. Symptoms did not subside until 01/22/21, gradually the feeling came back, with rest. She was off work the last week to rest up.
35 2021-01-21 sensory loss, weakness, nerve pain, numbness and pain in extremities Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/... Read more
Second vaccine 1/8/21: 10 hours post vaccine there was a 103 degree fever for 30 hours with sharp 9/10 muscle pain and partial awareness to time place and location. Fatigue and pain and nauseas and weakness continued up until day 5. At day 5 8pm: loss of sensation in feet and legs, unable to ambulate, day 6: hospitalized for 7 days. Currently in inpatient acute rehab to re learn how to walk. Sharp painful neuropathy ongoing.
35 2021-01-21 facial paralysis, numbness The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home,... Read more
The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home, she noticed some numbness of her right face as well as drooping on her eyelids. The patient came back to the hospital where she received her vaccine and checked into the ED. Physician's differential included Bell's Palsy vs CVA/TIA. The patient was discharged with prednisone 20mg daily for 7 days.
35 2021-01-23 tremor Fever of 104.6 for many hours, shaking, sore head
35 2021-01-23 pain in extremity The day of the vaccine (01/22) I had very mild soreness in my left arm. That night my submandibular ... Read more
The day of the vaccine (01/22) I had very mild soreness in my left arm. That night my submandibular lymph nodes were swollen. The following day (01/23) I felt tired throughout the day. I went to work and when I got home my whole body began to ache (especially my legs) and my lymph nodes were swollen again. This morning (01/24) I woke up physically feeling warm but I was heat seeking and had a fever of 100.8F and was dizzy. Currently my temperature is 98.6 and aside from a mild headache and a very sore left arm/axillary area I feel better.
35 2021-01-23 feeling hot patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" .... Read more
patient walked into the post vaccination site. was sitting in chair states, "I am hot and thirsty" . Patient then went limp in chair. when called by name she woke up then lost consciousness. Patient was placed in a W/C brought into med room to lay down. pt awake and breathing VS taken. drinking water. Vs continued to be monitored . Patient states, " I am really lightheaded and do not feel well'. Rapid response called, patient taken to ER. on a gurney with 2 nurses. Husband was notified, and updated.
35 2021-01-24 night sweats Chills, body aches, fatigue, night sweats
35 2021-01-24 tremor Dizziness, chills and tremors.
35 2021-01-24 numbness Numbness and swelling of the face, throat and hands. No difficulty breathing or swallowing, Denies p... Read more
Numbness and swelling of the face, throat and hands. No difficulty breathing or swallowing, Denies pain. Pt reports that symptoms are similar to covid illness in November.
35 2021-01-24 numbness, weakness Right facial numbness from cheek to jaw line. Weakness to jaw. Symptoms lasted 9 hrs and then reoc... Read more
Right facial numbness from cheek to jaw line. Weakness to jaw. Symptoms lasted 9 hrs and then reoccurred 9 days later.
35 2021-01-24 night sweats Rigors, chills, body aches, fatigue, night sweats, golf ball sized mass at injection site- tender an... Read more
Rigors, chills, body aches, fatigue, night sweats, golf ball sized mass at injection site- tender and painful to touch.
35 2021-01-24 feeling hot Swelling, redness to about 1.5 inches by 1 inch. Warm to touch. Sometimes itches
35 2021-01-24 weakness Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized... Read more
Swollen Tongue or Throat Nausea/Vomiting Headache Fatigue Dizziness Muscle aches Weakness Localized pain and swelling at injection site
35 2021-01-24 numbness, tingling, feeling hot Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my lef... Read more
Within 10 minutes I was numb with a hot, tingly sensation from my left knee up to my neck and my left wrist up my arm to my neck. Then I felt like I had been hit in the head with a bat, but the pain migrated from side to side in my head. It was a very strange feeling. The hot, tingly numbness lasted about 45 minutes to an hour, the headache began to subside after 2 hours. The next day I had a little raised redness and the injection site and a bad headache, but was otherwise fine. At the vaccination site they strongly advised I go to the ER, which I did. I have no history of vaccine reaction.
35 2021-01-25 migraine 1st dose- migraine for 4 days, stomach issues (diarrhea, no appetite, upset), for 4 days, did not fe... Read more
1st dose- migraine for 4 days, stomach issues (diarrhea, no appetite, upset), for 4 days, did not feel like myself all weekend. 2nd dose- migraine for 1 day, same stomach issues for 2 days.
35 2021-01-25 tingling, numbness, cold extremities, discomfort After 24 hours of receiving vaccine, I started getting numbness in my left arm (arm that received in... Read more
After 24 hours of receiving vaccine, I started getting numbness in my left arm (arm that received injection). Numbness felt like it was beginning from my elbow and going down to my fingertips. My left hand was noticeably colder than my right hand. 48 hours after injection, I started getting numbness in my left leg. Starting from my knee, down to my toes. My left foot was noticeably colder than my right foot. Both my elbow and knee feel swollen even though they don't look swollen. I tend to lay on my right side at night so I don't think I slept on it wrong. I get the numbness and tingling feeling randomly regardless of standing, sitting or laying down. It doesn't hurt but feels very uncomfortable. 48 hours after injection I felt nauseated, and felt like I had muscle weakness in both arms. I was extremely tired. I did have to take a child to the ER on the same day I received the vaccine (for a gastrointestinal virus that lead to dehydration). My 14 month old ended up with the same virus (uncontrolled nausea) two days later. I may have been fighting that virus even though I never threw up. No fever or redness at injection site. The numbness and tingling on my left side (including random spasms in my ribs) has continued for 96 hours since vaccine.
35 2021-01-25 breast pain After a week , have 3 large nodules in right breast. Did not have this before . It is upper chest , ... Read more
After a week , have 3 large nodules in right breast. Did not have this before . It is upper chest , in the breast and axillary. Have been taking ibuprofen and it has gone down slightly - still hard masses , and burning at times .
35 2021-01-25 feeling hot, hot flush day 5 of the second shot I woke up extremely hot, felt like my skin And everything around me was bu... Read more
day 5 of the second shot I woke up extremely hot, felt like my skin And everything around me was burning/overheating; I also had mild hot flashes after the second vaccine and headaches; I also had mild hot flashes after the second vaccine and headaches; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685) intramuscular at left arm on 06Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included Asthma, hypothyroidism, ADD. Concomitant medications were not reported. Patient had known allergies to erythromycin and seasonal allergies. it was unknown if covid prior vaccination. There were other medications in two weeks. Patient used took first dose of BNT162B2 (lot number: Ej1685) on 17Dec2020 at left arm at single dose for COVID-19 immunization and experienced extreme episode of overheating (at night) the first time, got up and almost passed out. It was reported day 5 after both shots patient had an extreme episode of overheating (at night) the first time she got up and almost passed out. day 5 of the second shot she woke up extremely hot, felt like her skin and everything around her was burning, it was inescapable, she had to open a window and wait it out, lasted about 30 minutes. she also had mild hot flashes after the second vaccine and headaches. adverse event start date was 10Jan2021. No covid tested post vaccination. no treatment received for the events. Patient was recovering from the events.
35 2021-01-26 flushing, pain in extremity Immediate onset of tachycardia and flushing, resolved after 5 minutes. 30-min delayed onset of metal... Read more
Immediate onset of tachycardia and flushing, resolved after 5 minutes. 30-min delayed onset of metallic taste in the mouth, resolved after 2 hours. 8-hours delayed onset of 8/10 arm pain and 8/10 fatigue, arm pain resolved after 4 days, fatigue improved after 3 days but has bet to resolve. 24-hours delayed onset of circular erythema around the injection site, approximately 6' in diameter, resolved after 9 days.
35 2021-01-26 tingling, numbness Patient reported numbness and tingling following 2nd dose of vaccine. (also reported with 1st) Pati... Read more
Patient reported numbness and tingling following 2nd dose of vaccine. (also reported with 1st) Patient presented to the Emergency Department: 4 days following vaccination (1.24.21) with CHEST PAIN (Pt receive the 2nd dose of Covid Vaccine on Wednesday and since then she has had numbness/tingling and chest pressure. Hasn't been able to sleep and just feels funny. PT has HX of MS). Chest pressure started last night and is 5/10 in severity not reproducible on exam and not pleuritic. Vital signs stable at time of presentation. She is in moderate distress related to chest pressure. On exam she has diminished sensation on her entire right side of her body as well as numbness and tingling in her left hand. Discharge with instructions to follow-up with neurologist regarding numbness and tingling and to obtain MRA as planned
35 2021-01-26 feeling cold Shortly after the Pfizer covid 19 vaccine was administered the patient complained of a severe headac... Read more
Shortly after the Pfizer covid 19 vaccine was administered the patient complained of a severe headache. Her BP was checked and was 206/110 using a wrist monitor... 142/96 using a manual BP apparatus and stethoscope after 30 mins... pt felt chills and was cold. Complained of nausea 5 mins before EMT arrived.
35 2021-01-26 weakness, cold extremities Weakness and cold sensation in left arm and hand lasting from time of waking up until evening. 10-12... Read more
Weakness and cold sensation in left arm and hand lasting from time of waking up until evening. 10-12hours.
35 2021-01-26 pain in extremity some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to peopl... Read more
some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people; Soreness in my arm; Headache; This is a spontaneous report from a contactable consumer reported for self. This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. And right after the vaccine the patient was okay. Into the next day (07Jan2021) the patient had soreness in her arm, and headache which was known as a common side effect of the vaccination. But as of Monday, had been experiencing some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people. Because she was almost gag in. Every time she talked she felt like she was going to throw up just if she was upright she felt like she had to throw up. So, she reached out to her employee health services and they asked her to reach out to you guys. She just wanted to add that she didn't experience this portion right away, it took some days for her to feel this. No treatments received for the event nausea. Outcome of the event nausea was not recovered. Outcome of other events was unknown. information on the lot/batch number has been requested.
35 2021-01-26 pain in extremity upper left arm feels sore and tighter; upper left arm feels sore and tighter, it feels like there's ... Read more
upper left arm feels sore and tighter; upper left arm feels sore and tighter, it feels like there's a small lump present there; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Pregnant at the time of vaccination: Yes; Sore arm for 2 days after receiving vaccine/upper left arm feels sore; exposed to 2 COVID positive coworkers in the pharmacy; This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown (reported as "misplaced/discarded")), intramuscular (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included allergies: iodine and, postural orthostatic tachycardia. Concomitant medications included ergocalciferol (VITAMIN D); docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3); probiotics NOS and; prenatal multivitamin. The patient was pregnant at the time of vaccination (last menstrual date: 05Dec2020, gestational period: 3 weeks, delivery date: 11Sep2021). The patient experienced sore arm for 2 days after receiving vaccine on 31Dec2020 (no treatment was received for this adverse event); no other side effects experienced. Then the patient was exposed to 2 COVID positive coworkers in the pharmacy on 31Dec2020, 02Jan2021, 03Jan2021, 04Jan2021, and 06Jan2021 (no treatment was received for this adverse event). The patient was informed about the exposure on 11Jan2021 and on the same day she had a PCR COVID test via nasal swab submitted. The test result came back on 12Jan2021 and it was negative. Today (13Jan2021 14:00), the patient stated that her upper left arm feels sore and tighter, it feels like there's a small lump present there (no treatment was received for these adverse events). The patient had no Covid prior to vaccination and had no other vaccine in four weeks. The outcome of the events was unknown. Information about the lot/batch number has been requested.
35 2021-01-27 feeling hot, flushing 1st shot- flushed/hot feeling a couple minutes after, only lasting minutes; 1st shot- flushed/hot fe... Read more
1st shot- flushed/hot feeling a couple minutes after, only lasting minutes; 1st shot- flushed/hot feeling a couple minutes after, only lasting minutes; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), intramuscular on 18Dec2020 12:00 PM at single dose on the right arm for COVID-19 immunization. The patient is not pregnant. Medical history included Bell's palsy in 2017. No known allergies. The patient's concomitant medications were not reported. Facility type vaccine was hospital. No COVID prior vaccination. The patient reported that on the first shot on 18Dec2020, she experienced flushed/hot feeling a couple minutes after, only lasting minutes. Outcome of the events was recovered on 18Dec2020. Patient was not tested for COVID post vaccination. Information about batch/lot number has been requested.
35 2021-01-27 muscle spasms DEVELOPED CHILLS AND BODY ACHES EVENING OF VACCINATION. GOT VERY RESTLESS AND PAIN OVER BODY DURING ... Read more
DEVELOPED CHILLS AND BODY ACHES EVENING OF VACCINATION. GOT VERY RESTLESS AND PAIN OVER BODY DURING NIGHT. DEVELOPED MUSCLE CRAMPS IN UPPER LEGS, CALF, AND ARMS THAT CONTINUES OFF AND ON. WENT TO THE CARDIOLOGIST FOR CHECK UP BECAUSE SHE DEVELOPED WATER RETENTION AFTER 1ST DOSE OF COVID VACCINE AND STARTED DEVELOPING SAME AFTER 2ND DOSE. CARDIOLOGIST NOTED, SOME FLUID AT THE BOTTOM OF HER LUNGS. SWELLING BEGINNING TO AFFECT LOWER LEGS AGAIN. BEING FOLLOWED BY MEDICAL TEAM.
35 2021-01-27 feeling hot, throat numbness, flushing Flushed; Hot feeling; Numb back of tongue or throat; Numb back of tongue or throat; This is a sponta... Read more
Flushed; Hot feeling; Numb back of tongue or throat; Numb back of tongue or throat; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL0142), intramuscular in left arm, on 08Jan2021 at 12:00, at a single dose, for COVID-19 immunization. The patient's medical history included Bell's palsy from 2017. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 18Dec2020 at 12 PM for COVID-19 immunization (intramuscular in right arm) and experienced flushed and hot feeling. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a hospital facility. On 08Jan2021 (12:30 PM), the patient experienced flushed or hot feeling 30 minutes after the second dose, followed by numb back of tongue or throat (best described like swallowing a good amount of throat numbing spray) that lasted about 2 hours. No treatment was administered for the events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on 08Jan2021 (14:30).
35 2021-01-27 muscle spasms, muscle spasms Similar events to the first vaccine. I got chills and bad body aches Monday evening. Got really rest... Read more
Similar events to the first vaccine. I got chills and bad body aches Monday evening. Got really restless and in pain overnight. Begun getting deep muscle cramps in my upper legs, calf?s and arms, still continuing off and on, little out of breath off and on. Went to the cardiologist for a check because of the water retention from the first vaccine and beginning again after second and he noted I had a little fluid at the bottom of my lungs. Swelling beginning to affect the lower legs again. Labs continued to being checked and continued doctor appointments.
35 2021-01-27 pain in extremity body ache; chills; fever; arm pain and the pain level was 8 from scale 1-10 with 10 being worst; Thi... Read more
body ache; chills; fever; arm pain and the pain level was 8 from scale 1-10 with 10 being worst; This is a spontaneous report from a contactable pharmacist (patient). This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3247) via an unspecified route of administration in the left arm on 13Jan2021 at 16:45 at single dose for COVID-19 immunisation. Vaccination facility type was workplace clinic. Relevant medical history was not reported. The patient was not pregnant. Concomitant medications were none: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and she did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number El1284) on 23Dec2020 at 16:45 in the left arm. On 13Jan2021, after taking the shot, the patient experienced terrible body ache, chills, fever and arm pain and the pain level was 8 from scale 1-10 with 10 being worst. Everything lasted 36-48 hours and the patient had to take 5 doses of paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient recovered with lasting effects from the events on an unspecified date in Jan2021.
35 2021-01-28 discomfort 1420: patient approached vaccinator and c/o heart racing and temporal HA 1421 patient HR117 pO2 100%... Read more
1420: patient approached vaccinator and c/o heart racing and temporal HA 1421 patient HR117 pO2 100%. c/o pain moving to top of heat seated in chair 1442: HR114 BO 116/86 pO2 100% HA pain level 5-6 and described as "heavy" 1443 HR 99, drank sips of water and no new complaints 1445: HR 104, pO2 100% 1450 HR 95 head still the same no change or new symptoms 1451 HR 89-90 no change in symptoms 1455 c/o mouth dry but sips of water without c/o 1500 HR 92, pO2 99% no new symptoms head pain slightly improved 1515 States head pain is resolved States feels ready to leave clinic. 1530 left clinic without c/o. escorted ambulatory to meet friends for ride home.
35 2021-01-28 migraine 830am vaccinated, 12pm mild-mod headache and fatigue (sore arm at inj site), persisted, 10pm worse ... Read more
830am vaccinated, 12pm mild-mod headache and fatigue (sore arm at inj site), persisted, 10pm worse headache, fatigue, mild body aches started at shoulders and upper back and neck, able to fall asleep by 11pm, woke up at 1am in severe pain, migraine, head pressure, joint pain of every joint in my body, hands were swollen, felt like my joints were pulsating, very painful to bend or move any of my joints, muscle aches so bad any tiny movement hurt, even lying still hurt my back because of the pressure onto my back, even my spine felt tender, stiff neck I could barely look down or up but i could turn head left and right, stomach ache and nausea, my arm that was given vaccine was severely in pain and tender to touch and swollen at area of inj. There was light headed sensation w/ movement and position, pressure in my head felt like my head was going to explode and my eyes were burning. Because so severe, I took 1000mg tylenol, lathered by entire body in eucalyptus oil and peppermint on my hands, I was able to fall asleep at 3am but it was restless sleep I kept waking up because any movement I made in bed I'd have severe pain. 6am I felt moderately better all symptoms 50% improved, applied eucalyptus oil on again, started work at 730am I could barely function at work I have brain fog, just thinking focusing eyes concentrating makes migraine worse, +photopphobia, phonophobia, just typing is very hard to do because it hurts my joints, the vertigo worsened and the slightest looking down to the keyboard while typing causes lightheaded sensation. No improvement and it's now almost 1pm. I didn't take any pain medication or apply any essential oils.
35 2021-01-28 pain in extremity Client report receiving COVID vaccination on 01/28 at 11:40, adverse reaction on left index /pointer... Read more
Client report receiving COVID vaccination on 01/28 at 11:40, adverse reaction on left index /pointer finger having moderate swelling. Has pain with bending it, and it is warm to the touch. Has not contacted a medical provider or had any treatment. Per client her mother is a nurse and told her to continue to monitor her finger. At this time, client believes the swelling is worse but not to the need to see a medical provider.
35 2021-01-28 tremor Fever (100.5 F), significant muscle and joint pain, lethargy, difficulty concentrating and thinking,... Read more
Fever (100.5 F), significant muscle and joint pain, lethargy, difficulty concentrating and thinking, chills/shaking. Symptoms started 16 hours post second vaccine and lasted ~30 hours.
35 2021-01-28 pain in extremity Initially severe pain in left arm. Within 24 hours post vaccine hives on thigh and elbow of arm that... Read more
Initially severe pain in left arm. Within 24 hours post vaccine hives on thigh and elbow of arm that received vaccine. By Friday hives had spread to stomach, chest, face and both arms
35 2021-01-28 feeling hot, flushing Patient reported feeling abrupt onset at about 5 minutes after injection of a sensation of 1/2 of he... Read more
Patient reported feeling abrupt onset at about 5 minutes after injection of a sensation of 1/2 of her head feeling hot like she was in a hot shower and a flushed feeling. No other sx that would suggest anaphylaxis. 40 minutes in while still experiencing above affected side ear was flushed. Given 50mg of benadryl at that time and all symptoms resolved by 65minutes
35 2021-01-28 numbness, nerve pain, muscle spasms The post-injection inflammation made my spinal arthritis go nuts, causing muscle spasms, severe nerv... Read more
The post-injection inflammation made my spinal arthritis go nuts, causing muscle spasms, severe nerve pain, and numbness in my hands. Prescription anti-inflammatory helped.
35 2021-01-30 feeling hot, tingling, burning sensation About 28 hours after receiving the injection, my smartwatch alerted me that I had an abnormal heart ... Read more
About 28 hours after receiving the injection, my smartwatch alerted me that I had an abnormal heart rate. Through the next hour, my heart rate increased to 105 bpm. My resting baseline is 60 bpm (I'm a self-proclaimed health nut and monitor my heart rate, nutrients, etc daily.). My heart rate was elevated for several hours while I was resting and it kept me from falling asleep. My face felt like it was burning but there was no rash. At times my face felt like it was not attached to my body. My nose swelled shut but I did not have difficulty breathing through my mouth. My entire body felt hot inside but I was having chills and sweating. Even covering myself in a thin bedsheet was uncomfortably hot. I have had an intense headache since my heart rate elevated until now, and my face continues to feel tingly as well as my arms and hands at times. The best I can describe it is like the time I took amoxicillin and found out I was allergic. The only difference was I got a rash all over my body with the amoxicillin.
35 2021-01-30 numbness, migraine, speech disorder Started with mild headache. Turned into severe migraine with stroke like symptoms (numbness in hand... Read more
Started with mild headache. Turned into severe migraine with stroke like symptoms (numbness in hands and face, loss of vision in one eye, seeing waves, dizziness, difficulty speaking). Vomiting, neck pain. PRN medications did not help. Went to ED at Hospital for 4 hours. MD ordered troponin level, metabolic panel, CBC, COVID test, and head CT. ECG. Given multiple rounds of toradol, Ativan, Benadryl, Reglan, fioricet. Sent home with fioricet. Continue to have daily headaches and neck pain.
35 2021-01-30 tenderness Symptoms began 1 day after 2nd dose was given. Lymph nodes swollen in axillary area (not painful), s... Read more
Symptoms began 1 day after 2nd dose was given. Lymph nodes swollen in axillary area (not painful), supraclavicular area (none painful), and cervical area (very tender) also shoulder joint pain all symptoms on the side the shot was given after the second dose. Currently 6 days post vaccination and all tenderness is gone lymph nodes smaller however still swollen.
35 2021-01-30 slurring hemiplegic migraine, blurry vision, slurred speech, high bp 140/103, l
35 2021-01-31 feeling cold At approximately 11:45 a.m. on the date of the injection my hands became freezing cold. This lasted ... Read more
At approximately 11:45 a.m. on the date of the injection my hands became freezing cold. This lasted for approximately 16 hours. My skin has since been very sensitive to touch, this includes skin on my face, arms, hands, and chest. I am very sensitive to temperature changes, especially cold. My nervous systems feels very sensitive, especially my hands. Touching cold items (refrigerator, outside, etc.) makes me shiver. I have also been experiencing a covid fog. I do not feel like myself and am not experiencing joy. I cry daily for no reason.
35 2021-01-31 pain in extremity Pt is 14 weeks pregnant. She had a sore arm immediately. about 12 hours after the injection she star... Read more
Pt is 14 weeks pregnant. She had a sore arm immediately. about 12 hours after the injection she started with a fever, shaking chills, rigors, severe muscle and bone pain, treated with Tylenol. Headache started the next day.
35 2021-01-31 flushing Received first dose of Pfizer covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the ob... Read more
Received first dose of Pfizer covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observation room for 5 minutes when she developed itching on hands and then noticed hands were red, spread to arms, then chest and neck started itching. Took vitals, blood pressure was high, she attributes to anxiety, acknowledges that she was nervous about getting vaccine. Then within 10 minutes from vaccination started getting hives and throat started feeling swollen and difficult to swallow. They gave her epipen - after receiving epi she was able to swallow within 5 minutes, hives and rash were gone but still somewhat itchy. Was sent to ER - was given steroids - symptoms resolved. Today she is feeling normal. She has never had a reaction like this before. Only known allergy is to cats. Never had allergic reaction or previous immunizations or medications. Started Wellbutrin 2 weeks ago but has been on this med before, not new. This is a 35-year-old female presents for an allergic reaction after receiving her 1st coronavirus vaccination. She was given IM epinephrine EN route. On my exam she appears in no acute distress. Blood pressures are stable. She is not tachycardic. She has normal O2 saturations. She states she still having some itchiness to the arms and behind her ears. She states her throat still feels little scratchy but is not having go difficult time breathing. Denies associated chest tightness or shortness of breath. Denies any abdominal pain, nausea vomiting. Denies any prior allergic reactions to other vaccines are medications. Her face does appear to be a bit flushed. She was given IV Solu-Medrol, IV Benadryl and IV Pepcid. She was observed for 2 hours and has significant improvement of her symptoms. Given a she was discharged home with instructions to use Benadryl as needed for any other allergic symptoms. She is instructed to return for increasing shortness of breath or throat tightness. She is agreeable this plan and discharged home.
35 2021-01-31 flushing Received first dose of covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observati... Read more
Received first dose of covid vaccine yesterday, 1/28. Dose given at 1:48pm. She was in the observation room for 5 minutes when she developed itching on hands and then noticed hands were red, spread to arms, then chest and neck started itching. Took vitals, blood pressure was high, she attributes to anxiety, acknowledges that she was nervous about getting vaccine. Then within 10 minutes from vaccination started getting hives and throat started feeling swollen and difficult to swallow. They gave her epipen - after receiving epi she was able to swallow within 5 minutes, hives and rash were gone but still somewhat itchy. Was sent to ER - was given steroids - symptoms resolved. 35-year-old female presents to the ER for evaluation allergic reaction. Symptoms started approximately 30 minutes after receiving her 1st COVID vaccination. She states she became very flushed and itchy and began having some throat discomfort. She was given a IM injection of epinephrine and sent to the ER by EMS for further evaluation. She states she still having some itchiness to the arms and behind her ears. She states her throat still feels little scratchy but is not having go difficult time breathing. Denies associated chest tightness or shortness of breath. Denies any abdominal pain, nausea vomiting. Denies any prior allergic reactions to other vaccines are medications. 35-year-old female presents for an allergic reaction after receiving her 1st coronavirus vaccination. She was given IM epinephrine EN route. On my exam she appears in no acute distress. Blood pressures are stable. She is not tachycardic. She has normal O2 saturations. Her face does appear to be a bit flushed. She was given 125 mg of IV Solu-Medrol, 50 mg IV Benadryl and 20 mg IV Pepcid. She was observed for 2 hours and has significant improvement of her symptoms. Given a she was discharged home with instructions to use Benadryl as needed for any other allergic symptoms. She is instructed to return for increasing shortness of breath or throat tightness. She is agreeable this plan and discharged home.
35 2021-01-31 feeling cold Within a minute of the injection, I began to feel a cold sensation that traveled across my shoulder ... Read more
Within a minute of the injection, I began to feel a cold sensation that traveled across my shoulder blades beginning at my left shoulder blade. The healthcare worker came back with my vaccination card within a couple minutes. I left her know about it. I had began to feel, but the sensation then spread to the back of my head and down to my lower back. I felt a little uneasy and had the thought that I probably couldn't drive. Before the 15 minute observation period was over, I felt better but still had the cool sensation in the back of my head.
35 2021-02-01 pain in extremity 1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down ... Read more
1/30/21 0800 chills, muscle pain, swollen axillary lymph nodes with pain radiating to neck and down arm 0830 nausea, vomiting 0900 fever, tylenol and ibuprofen 1300 afebrile 1/30/21 - current (2/1/21) increased fatigue, muscle aches, loss of appetite, swollen axillary lymph nodes have persisted
35 2021-02-01 breast pain Around 4PM on the 14th I started with chills. 2 hours later I took my temp and it was 102.8F ad I ha... Read more
Around 4PM on the 14th I started with chills. 2 hours later I took my temp and it was 102.8F ad I had really bad fever, chills, muscle aches, nausea and then the right breast pain started again (around 3AM). I noticed the redness on the same location as it happened with the 1st dose. I had a clogged duct this time as well. On the right breast. The symptoms with the second dose were much worse/stronger than the 1st dose. I consulted with urgent care over the phone and was prescribed Keflex. Symptoms subsided in about 3 days.
35 2021-02-01 pain in extremity, weakness Around 7pm the evening of receiving my shot, I was extremely tired. When I went to bed around 9 pm, ... Read more
Around 7pm the evening of receiving my shot, I was extremely tired. When I went to bed around 9 pm, I got chills that lasted at 15 minutes. I finally fell asleep and my husband said I got more chills. I woke up Sunday morning (1-31) and had a fever of 100.5. I took Ib Profen I was extremely tired and my arm hurt. My appetite has been suppressed since 1-30. I was also extremely worn out on 2-1. My energy has finally returned.
35 2021-02-01 tingling Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection ... Read more
Patient given first dose of Pfizer Covid vaccine. Upon administration felt burning at the injection site. patient then stated she felt tingling in her hands, feet, and mouth. Patient also stated that she felt her heart racing. BP 172/103, HR 149, SPO2 100% on room air. Denies SOB and difficulty breathing. Pt was transferred to ED. In ED was given oral prednisone and diphenhydramine. Assessment for possible drug reaction, not thought to be anaphylaxis, with mild anxiety contributing. Patient monitored and discharged in stable condition.
35 2021-02-01 burning sensation Rash that started in armpit and went across chest and back. Worse on left side. Rash is blotchy ,... Read more
Rash that started in armpit and went across chest and back. Worse on left side. Rash is blotchy , itchy, and burns. Also had diarrhea. Symptoms started on 1/29/2021 and have started to improved.
35 2021-02-01 breast pain, pain in extremity So, for the 1st dose it started early morning of 12/24 maybe even on the 23rd I had a kind of chills... Read more
So, for the 1st dose it started early morning of 12/24 maybe even on the 23rd I had a kind of chills, a pain sensation in my arm, temp on 12/24/20 was 100.3F I also developed a pain on my right breast - developed mastitis. I started antibiotics (Dycoclocilin)that afternoon after contacting my PCP. I am a breastfeeding mother. There was redness on the right breast and pain. Some muscle aches. Fatigue. It lasted about 3 days or so.
35 2021-02-01 throat numbness, difficulty speaking Symptoms: tingly arm at injection site, numb and tingly and sore/swollen throat, tongue, lips. Dizzy... Read more
Symptoms: tingly arm at injection site, numb and tingly and sore/swollen throat, tongue, lips. Dizzy, high bp and tachycardia, heart palpitations. All within 15 minutes. Then at the ER deep cough, hoarse and difficulty speaking.
35 2021-02-01 pain in extremity arm soreness for 36hrs; oral temp of 99.7 deg F.; malaise; chills; nausea; indigestion leading to sm... Read more
arm soreness for 36hrs; oral temp of 99.7 deg F.; malaise; chills; nausea; indigestion leading to small amounts bile rising into mouth when burping; indigestion leading to small amounts bile rising into mouth when burping; short of breath on usual activities; headache; sore throat; frequent dry cough; This is a spontaneous report from a non-contactable nurse (patient). A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the hospital, via intramuscular route on 15Jan2021 at a single dose for COVID-19 immunization. Medical history includes allergy to sulfa. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. The patient had a COVID PCR nasal swab in 15Apr2020, 29Sep2020 and in 04Dec2020 all with a negative result. The patient had a COVID antibodies blood test on 09Dec2020 with a negative result. The patient had a COVID test saliva on 23Dec2020 with a negative result. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) via intramuscular route on 28Dec2020 for COVID-19 immunization. The patient did not have other vaccines in four weeks. The patient experienced arm soreness for 36hrs, obtained oral temp of 99.7 deg F, malaise, chills, nausea, indigestion leading to small amounts bile rising into mouth when burping, short of breath on usual activities, headache, sore throat and frequent dry cough all on 16Jan2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
35 2021-02-02 feeling hot, cold sweat 11:23am Pt C/O feeling hot and clammy and nausea, skin pink, warm and clammy, denies SOB, and chest ... Read more
11:23am Pt C/O feeling hot and clammy and nausea, skin pink, warm and clammy, denies SOB, and chest tightness, no hives or itching present, A & Ox3 resps reg. No distress noted. This is her 1st shot of Covid 19 vaccine. Right arm BP 80/38 P-104 PO 99% sweatshirt taken off, chair reclined, knees bent up. Charge nurse RN summoned. 11/25am BP 75/37 P71, PO 99%, consulted RN about giving Benadryl and she since she did not have hives, and is A& Ox3 to hold off. RN has access to med dispenser. Pt states she takes Ativan for anxiety at night na Lamictal for mood stability. 11:26a,m BP changed to right arm due to pain to injection site, site asymptomatic. BP 70/31 P 70 PO 99%, ice packs to neck and forehead. No Benadryl per RN. 11:28 BP 101/60 P 98 PO 100% continue ice packs. 11:30am BP 95/59 P 92 PO 100%. 11:36am BP 97/59 P 82 PO 100% decreased nausea states she is feeing more normal. 11:39 BP 93/61 P 80 PO 100% continues to be A&O x3 states she feels fine. 11:42 am BP 103/67 p 84. 11:45am BP 110/77 P 88. 11:51am BP 96/66 P 88 sitting up right with feet down, given water and crackers. 12:04 pm BP 105/64 P 83 PO 100% continue to feel better. 12:10 pm BP 98/67 P 86 states she still feels weak. 12:20pm BP 104/60 P 86 . 12:23pm BP 93/63 P 85 while standing. 12:34pm BP 95/55 P 91 She states she feels back to normal and ready to go. Skin cool, dry and less pink. Instructed if she begins to feel light headed while walking to stop and lay down with feet bent up, and if driving to pull over, call emergency services and lay down. Pt states she understands. 12:35 Pt walked out without difficulty.
35 2021-02-02 pain in extremity 2 hours after vaccine I developed headache, burning/hot feeling in eyes and fatigue. That night I ha... Read more
2 hours after vaccine I developed headache, burning/hot feeling in eyes and fatigue. That night I had chills, fever, full body joint pain, nausea, heavy head feeling, muscle pain and left arm pain at injection site. The next day I had severe painful swollen lymph nodes to left clavicle and under left arm. Second night I had ongoing fever, chills, muscle pain, fatigue and overall feeling under the weather. 7 days after I had right leg pain from thigh to ankle. Till today I still have generalized fatigue and swollen lymph nodes (although they are smaller that before)
35 2021-02-02 face paralysis, tingling, facial pain, facial paralysis Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensati... Read more
Bell's palsy / pain in the left side of her face / pain irradiated to ear and jaw / tingling sensation in left side of the forehead / facial weakness; This is a spontaneous report from a contactable Physician reported for self. This 35-Year-old-female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 15Jan2021 08:20 on Arm left at single dose for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No known allergies. None concomitant medication included. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Dec2020 08:20 AM at the age of 35 year old via IM Injection Upper Left Arm for covid-19 immunisation, no reactions with first dose and flu vaccine, Expiry Date: Oct2020 for immunization and no reactions. The patient experienced Bell's palsy on 19Jan2021 and received prednisone 60 mg for 7 days. The same day of the vaccination (15Jan2021), she started to experience pain in the left side of her face, aggravated by 18Jan2021, her pain irradiated to ear and jaw. On Saturday 16 post vaccinated, she experienced also tingling sensation in left side of the forehead on 16Jan2021. She experienced facial weakness on 19Jan2021. And in 19Jan Monday evening Bells Palsy was confirmed. Lab data included Physical exams: weakness in the left side of forehead. No Covid tested post vaccination. Outcome of the event Bell's palsy was recovering. Outcome of other events was unknown. There was a reasonable possibility that the event Bell's palsy was related to BNT162B2. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
35 2021-02-02 feeling hot Estimated due date: 07/17/2021. I woke up in the middle of the night feeling very hot and sweaty. I ... Read more
Estimated due date: 07/17/2021. I woke up in the middle of the night feeling very hot and sweaty. I woke up later in the morning with a pretty bad headache. Consulted my OB-GYN who said it was ok to take a Tylenol. It helped ease it a little better in the afternoon. Next day when I woke up I was fine.
35 2021-02-02 numbness Numbness to right side of tongue, spread to lips to entire right side of the face, pain in the right... Read more
Numbness to right side of tongue, spread to lips to entire right side of the face, pain in the right and right jaw, right eye itching and dry, Neuro exam, given high dose predizone,
35 2021-02-02 flushing This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female p... Read more
This is a spontaneous report from a contactable pharmacist (patient herself). A 35-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0142), via an unspecified route of administration on 14Jan2021 14:30 in left arm at single dose for covid-19 immunization. Medical history included known allergies: seasonal allergies-pollen/dust and other medical history was none. No other vaccine was received in four weeks. Concomitant medication in two weeks included cetirizine, quercetin, ascorbic acid, sodium ascorbate (LIPOSOMAL VITAMIN C). Facility type vaccine was public health clinic/veterans administration facility. 7 minutes post injection, patient had hives/severe itching about 1x1 inch patch above left elbow. 40 minutes post injection, patient experienced swelling of left arm and both calves and facial flushing, mild rash on day 3- 4 on both arms. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient had no COVID prior vaccination and was not tested COVID post vaccination. Patient received the treatment of oral diphenhydramine hydrochloride (BENADRYL) 50 MG; famoditine IV (intravenous) for events. Outcome of events were recovered with sequel in Jan2021.
35 2021-02-02 numbness Wednesday evening Right arm felt heavy 3 hours after vaccination, right had went numb that night. N... Read more
Wednesday evening Right arm felt heavy 3 hours after vaccination, right had went numb that night. Next day on Thursday, Left hand went numb and had swelling in both hands. On Friday. Right arm was numb from hand to elbow and left hand continued to be numb. Went to the emergency room and was given high dose steroids and sent home on prednisone.
35 2021-02-03 feeling hot, muscle spasms 30 minutes after injection - muscle spasms in both arms from wrists to elbows 45 minutes after injec... Read more
30 minutes after injection - muscle spasms in both arms from wrists to elbows 45 minutes after injection - itching, warmth, rash, hives on face, neck, chest, arms, and legs 1 hour after injection - eyes watering and inner ears itching and stinging; itching all over body 4 to 5 hours after injection - tongue swelling and tingling
35 2021-02-03 migraine, tingling, numbness About 45 min after getting the second dose of the covid-19 vaccine I began to feel tingling and numb... Read more
About 45 min after getting the second dose of the covid-19 vaccine I began to feel tingling and numbness in my fingers, hand, and arm. Then shortly after that I developed a migraine headache.
35 2021-02-03 pain in extremity Moderate arm soreness, insomnia and body aches during the night.
35 2021-02-04 tingling, feeling hot, feeling of body temperature change, numbness, tremor Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes ... Read more
Began shaking and face tingling 6 minutes after shot, started to feel slightly better. 10 minutes after shot, neck became red, red welts appeared on bilateral upper arms. took 25mg of po benadryl at my desk. 25 minutes after shot felt hot, dizzy, arms and legs tingling, breathless, limbs went numb, rushed to ER via wheelchair. Treated in er for anaphylaxis. Arms and legs felt covered in "icy hot," tachycardia for several hours, numerous times felt impending doom. hospitalized overnight on cardiac monitor. ER gave steroids, benadryl, pepcid, 2L ivf. ativan given later in evening for nervousness.
35 2021-02-04 pain in extremity Nausea, vomiting, headache, arm soreness
35 2021-02-04 feeling hot, weakness, flushing Patient complained of feeling hot and flushed with sweating and weakness in the evening and night af... Read more
Patient complained of feeling hot and flushed with sweating and weakness in the evening and night after receiving the vaccine earlier in the day at 1311. Also stated having a sore throat and slight shortness of breath. She stated feeling better after lying down and resting.
35 2021-02-04 tenderness Received Pfizer COVID vaccine on Wed night 1/31/21 at 5:50pm. I had no prior recent illnesses prior ... Read more
Received Pfizer COVID vaccine on Wed night 1/31/21 at 5:50pm. I had no prior recent illnesses prior to getting the shot. About 24 hours later, developed fevers/chills, body aches, headaches, and fatigue, and a notable pain in the front of neck -- felt like tender thyroid. Temp was 100.3F on Thursday night 1/14. Took ibuprofen and went to bed. Next day felt fine, went to work, but symptoms returned on Friday night without fever. Symptoms persisted through the weekend without fever until Sunday AM 1/17/21 at 3:40am, I woke up with a temp of 101.7F. Went to get tested for COVID on Sunday 1/17/21 and Tuesday 1/19/21. Both times were negative (both rapid and PCR). Remained febrile on Monday and Tuesday AM. Went to urgent care on Monday 1/18/21 and was negative for flu, but provider observed the thyroid was tender. TSH was checked on 1/18/21 and was abnormal, 0.027 and FT4 was 3.20. Had virtual appt with PCP on 1/19/21, and she ordered more blood tests to evaluate the hyperthyroidism. On 1/21, repeat TSH was 0.014, and FT4 and T3 were both high. Inflammatory markers were elevated, liver function tests were mildly elevated, but thyroid antibodies were all negative. Over the course of the week after getting the shot, I experienced tachycardia, palpitations, fatigue, and shortness of breath and dyspnea on exertion with simple tasks like walking up a flight of stairs or getting up from the couch to walk to the kitchen. PCP ordered an echocardiogram to evaluate the dyspnea on exertion, but it was normal. I had radioactive iodine uptake thyroid scan performed on 2/3 and 2/4, and it was notable for markedly low 24-hour uptake, consistent with Hashimoto's thyroiditis, or other types of thyroiditis. As of 2/5/21, I am feeling significantly better from the past 3 weeks, and the hyperthyroid symptoms have improved and flu-like symptoms have resolved. Due to possible relation to the vaccine, I have delayed the 21-day booster shot to 23 days, and plan to get it this afternoon 2/5/21.
35 2021-02-04 pain in extremity Sore arm; insomnia; headache (mild to moderate); This is a spontaneous report from a contactable con... Read more
Sore arm; insomnia; headache (mild to moderate); This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no. EL3247, expiry date not reported), via an unspecified route of administration on 20Jan2021 01:45 at a single dose on her left arm for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium (LEVOXYL) for hypothyroidism which she received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with covid-19. The patient was not pregnant at time of vaccination and has not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has no known allergies to medications, food, or other products. On 20Jan2021 08:00 PM, patient experienced sore arm, insomnia, headache (mild to moderate). No treatment was received for the reported adverse events. The outcome of events was recovering. The facility where the most recent COVID-19 vaccine was administered was in workplace clinic. Since the vaccination, the patient has not been tested for COVID-19.
35 2021-02-04 weakness Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Wea... Read more
Very Fatigued; Fevers; Chills; Headache; Pressure in head; Muscle aches; soreness in whole body; Weakness; Stomach ache with diarrhea; Stomach ache with diarrhea; Injection site pain; Armpit pain & swelling; Armpit pain & swelling; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3246) solution for injection intramuscular in the left arm on 18Jan2021 at 03:30 (at the age of 35-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included chronic spontaneous urticaria. Concomitant medications included omalizumab (XOLAIR), lisdexamfetamine mesylate (VYVANSE), famotidine (PEPCID AC), fexofenadine hydrochloride (ALLEGRA), valacyclovir, fish oil, probiotic, medical marijuana. The patient had no known allergies. Historical vaccine included BNT162B2 (Pfizer, Lot EJ1685) in Dec2020 at 06:15 intramuscular in left arm for COVID-19 vaccination for 1st dose with no adverse event. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Jan2021 at 11:00, the patient experienced very fatigued, fevers, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. No treatment was provided for the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling. The outcome of the events fatigued, fever, chills, headache, pressure in head, muscle aches & soreness in whole body, weakness, stomachache with diarrhea, injection site pain, armpit pain & swelling was recovered in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.
35 2021-02-07 tingling 1258 C/O LEFT SIDE SURFACE NUMBNESS BELOW INJECTION SITE , UNABLE TO FEEL LIGHT TOUCH VSS 133/89; SA... Read more
1258 C/O LEFT SIDE SURFACE NUMBNESS BELOW INJECTION SITE , UNABLE TO FEEL LIGHT TOUCH VSS 133/89; SAT 98% HR 801310: C/O LEFT ARM HEAVINESS AND A "THICK" SENSATION; FROM DELTOID TO UPPER BICEPS1326: HEAVINESS AND TIGHTNESS DECREASING ;1338: HEAVINESS ALMOST RESOLVED.
35 2021-02-07 tingling 1354-vaccine received; 1400-felt a squeezing in chest; blackness in the outside of vision; tingling ... Read more
1354-vaccine received; 1400-felt a squeezing in chest; blackness in the outside of vision; tingling hands; nausea1420-symptoms resolved
35 2021-02-07 tingling 9:15 a.m. while waiting in 15 minutes observation c/o Tingling to upper and lower extremities VS Hr=... Read more
9:15 a.m. while waiting in 15 minutes observation c/o Tingling to upper and lower extremities VS Hr=59, o2 sat 99-100% x2 151/86 9:20 checked on and states that tingling is resolved. VS Hr=67, o2 sat 99-100%, BP 147/89 9:25 a.m. no new symptoms, states she is feeling fine 9:35 a.m. Patient stated symptoms resolved and left site, accompanied by co-worker.
35 2021-02-07 flushing tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm... Read more
tachycardia HR into 140s; numbness and tingling around lips; numbness and tingling around lips; warm flushing; This is a spontaneous report from a contactable nurse (patient). This 35-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) intramuscular, in left arm, on 22Jan2021 at 08:00, for COVID-19 immunization. No other vaccine was given on the same day or in 4 weeks. The patient received the first dose of BNT162B2 vaccine on 04Jan2021 at 03:00 PM, lot number EK9231, intramuscular, in left arm. Medical history included Crohn's disease. The patient had no COVID before vaccination. Concomitant medication included azathioprine (IMURAN) at 150 mg, daily. On 22Jan2021 the patient experienced warm flushing within 5 minutes of vaccination and at 08:15 tachycardia (HR into 140s), numbness and tingling around lips. The events required Emergency room/department or urgent care and treatment with diphenhydramine (BENADRYL) 25 mg IV. COVID was not tested after vaccination. The events were resolving.; Sender's Comments: Based on a compatible temporal association, causality between events tachycardia (HR into 140s), numbness and tingling around lips and warm flushing and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-02-07 tremor tachycardia, chills, SOB, shaking, high BP, difficulty swallowing, Medications give benydral 100mg... Read more
tachycardia, chills, SOB, shaking, high BP, difficulty swallowing, Medications give benydral 100mg po, claritin 10 mg, pepcid 20mg,. Staff member symptoms resolved after medication and eating.
35 2021-02-08 feeling hot 20 minutes after receiving the vaccine I started to feel swelling in my throat and a hot, tingling f... Read more
20 minutes after receiving the vaccine I started to feel swelling in my throat and a hot, tingling feeling on the inside surfaces of my mouth and tongue, my arm was also very itchy and had a lump approximately the size of half a golf ball at the injection site. I developed a severe headache as well. 23 minutes after the vaccine, I took 25 mg of Benedryl PO, 38 minutes after the vaccine, I took an additional 25 mg of Benedryl PO and 10 mg Zyrtec PO because my symptoms had not yet resolved. Approximately 1.5 hours after the vaccine administration my symptoms resolved, except for the headache and the lump on my arm.
35 2021-02-08 hot flush, flushing Approx. 5 hours after vaccine administered, bad headache and fatigue. Injection site and all upper a... Read more
Approx. 5 hours after vaccine administered, bad headache and fatigue. Injection site and all upper arm became very sore to the touch Approx. 6 hours after vaccine, face became very flushed, hot and inflamed. Lips began to slightly swell - both upper arms became red and hot, skin flushed - headache and fatigue persisted - fever of 99.9 Benadryl taken 8 hours after vaccine, which helped with hot feeling in face and hands, lip swelling went away
35 2021-02-08 migraine, seizure Fever of up to 102.5 F, convulsions (with absolutely no control over my muscles), migraine, chills, ... Read more
Fever of up to 102.5 F, convulsions (with absolutely no control over my muscles), migraine, chills, extreme fatigue, stomach cramps and nausea.
35 2021-02-09 tingling Difficulty swallowing and lip swelling, given Benadryl, Zyrtec and Prednisone at 8:05. Swelling went... Read more
Difficulty swallowing and lip swelling, given Benadryl, Zyrtec and Prednisone at 8:05. Swelling went down by 10 am. Has some tingling in hands and feet through out that day, but stopped after 24 hrs. Had some pain in left armpit on Sunday and Monday. No more symptoms today.
35 2021-02-09 night sweats Night sweat; This is a spontaneous report from a contactable consumer (patient). A 35-year-old femal... Read more
Night sweat; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EH9899, Expiry Date 31Mar2021), via an unspecified route of administration on 31Dec2020 at 0.3 mL, single dose for COVID-19 immunisation. Patient age at vaccination was 35 years. Medical history included ongoing Factor V Leiden (it's a blood clotting supporter) and asthma. The patient's concomitant medications were not reported. The patient reported since she got her first vaccine on 31Dec2020 she had had night sweat every single night to the point she had to get her clothes off and change. The event had not resolved.
35 2021-02-09 weakness, pain in extremity exhaustion; feel like I had a cold coming; I was running a fever of 101.2/My fevers ranged from 100.... Read more
exhaustion; feel like I had a cold coming; I was running a fever of 101.2/My fevers ranged from 100.1 to 103.2/fevers/have a low grade fever; had body aches; headache; no energy; my arm was extremely sore; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 20Jan2021 at 09:15 at single dose for COVID-19 immunization. The patient medical history included chronic constipation, depression and known allergies to latex, apples and adhesive, all from an unknown date and unknown if ongoing. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT), trazodone, cetirizine hydrochloride (ZYRTEC), cholecalciferol (VITAMIN D). The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left on 30Dec2020. The patient reported that: "on 21Jan2021 I started to feel like I had a cold coming when I woke in the morning. As the day went on, I began to feel worse. I was running a fever of 101.2, had body aches, headache, no energy, and my arm was extremely sore. This continued 22Jan2021. My fevers ranged from 100.1 to 103.2. On the 23Jan2021 I continued to have a headache, fevers and no energy. On 24Jan2021 I continued to have a low-grade fever, no energy, and headache. I was only able to work 5 hours due to exhaustion". Therapeutic measures were taken as results of events and included treatment with TYLENOL 1000 mg and ibuprofen 600 mg every 6 hours. The patient underwent lab test and procedures which included SARS-COV-2 tests (nasal swab and rapid test) both negative on 22Jan2021. The patient outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
35 2021-02-11 pain in extremity 2 days after both vaccines, I started my period 2 days after each vaccine. I currently have an IUD a... Read more
2 days after both vaccines, I started my period 2 days after each vaccine. I currently have an IUD and have not had a period in years. Other side effects were typical sore arm and muscle aches.
35 2021-02-11 pain in extremity I?m not sure exactly what?s going on but my left arm is extremely sore. It?s to the point where I ca... Read more
I?m not sure exactly what?s going on but my left arm is extremely sore. It?s to the point where I can?t put it all the way down. It?s a throbbing pain that shoots to my elbow. It started the day after my vaccine.
35 2021-02-15 pain in extremity Severe extremity pain down limb of injection site. Pain was not muscular, but ache and level of int... Read more
Severe extremity pain down limb of injection site. Pain was not muscular, but ache and level of intensity was most similar to my experiences with broken bones. Pain did not appear similar to neurological symptoms (no numbness or tingling). AE was noted after both vaccine doses, with an marked increase in severity after second dose. No symptoms immediately after dose or within same day (very minor irritation at injection site). Next day, severe pain developed down entire left arm. Pain started slowly, increased over ~2 hours, and lasted for ~24 hours. Pain was isolated down arm from shoulder to fingertips, with most of the pain felt slightly above and around the elbow, in wrist, and in fingers. During episode, the pain was so severe that the weight of any clothing was unbearable (pain was most similar to my past experiences with broken bones). Additionally, I was unable to rest my arm or hand on anything (the pressure from resting my arm on a pillow was too severe). Range of motion was limited, and I could not extend my fingers without pain.
35 2021-02-15 weakness The night that i received the shot it almost felt like i had a jolt of caffeine, i had a rough night... Read more
The night that i received the shot it almost felt like i had a jolt of caffeine, i had a rough night's sleep which i kept waking up in. I woke up Thursday 02/11 morning not feeling well at all, it felt like i had been hit by a train. I had a fever that has got up to as high as 101.3 (my normal temperature is 96 or low 97's so this is very unusual for me even when i get sick) fevers lasted until Saturday 02/13/21 in the morning, at which point I had been taking Tylenol and ibuprofen consistently so i stopped taking my temperature (If i were to stop taking those medications i feel i would maybe still have a temperature). I was so sore it hurt to move and walk, today (Tue 02/16) it doesn't hurt to walk finally. My arm pits hurt very bad and still slightly hurt. I have been very tired and weak as well. My eyes have hurt or felt different and appear glossy throughout all of this and still do.
35 2021-02-16 weakness Extremely fatigued unable to perform daily activities. Worst was next day after vaccine (Thursday) t... Read more
Extremely fatigued unable to perform daily activities. Worst was next day after vaccine (Thursday) through the 5th day (Monday). Starting Monday afternoon thru Wednesday afternoon (Now) extreme sweating, like the soaked clothes kind. Still extremely weak and fatigued
35 2021-02-16 flushing Pfizer COVID-19 Vaccine When given vaccine, had initial burning in deltoid. Right after flushing a... Read more
Pfizer COVID-19 Vaccine When given vaccine, had initial burning in deltoid. Right after flushing and sweating palms, along with nausea. Lasted 5 minutes. Next day fatigue, nausea, and sweats/chills. 3rd day same. 1/27/21: Pt received 2nd dose of COVID vaccine with no issue.
35 2021-02-16 breast pain Top and right side of right breast began itching within 6 hours of the vaccine, with increased sens... Read more
Top and right side of right breast began itching within 6 hours of the vaccine, with increased sensitivity from nipple to ribs. The itching continues now, 6 days later, but 4 days after vaccine (2 days ago), the itching was compounded with pain (same area as itching) and lumps (some at the base of right breast, others even into right armpit). They are not visibly red nor are they warm to the touch, but I can feel them under the skin, unlike the same area on the left breast.
35 2021-02-17 migraine This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient re... Read more
This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration (right arm) first dose on 29Jan2021 16:00 at single dose for covid-19 immunization. The patient's medical history included LBP (herniated disc and sciatica), GERD, IBS, PTSD, and allergies: Sulfa drugs. The patient was not pregnant at time of vaccination. The patient's concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), esomeprazole magnesium (NEXIUM), fluoxetine hydrochloride (PROZAC), cetirizine hydrochloride (ZYRTEC), and "Multi-vitamin". The patient previously took Ceclor and experienced allergies. On 29Jan2021 17:45, the patient noticed a slight headache, which I do not get often, and thought I might be slightly dehydrated, so the patient increased my water intake and drank 8 ounces of Gatorade. The headache got worse and when she was preparing to leave work, the patient was so much pain on the right, front side of my head lights, "noise", and walking hurt. The patient never had a migraine before, but I think this is what it was. The patient went home and took 2 Tylenol tablets, and went to bed. The patient woke up and in the morning with slight headache and took 2 more Tylenol tablets, and the headache subsided and did not return. The outcome of the events was recovered. The reporter assess the events as non-serious. Information on the lot/batch number has been requested.
35 2021-02-18 pain in extremity, tremor Pain and swelling in hands. Shaking and dizziness
35 2021-02-18 numbness and pain in extremities first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; first dose on 22Jan2021 at 09:45 AM/ ... Read more
first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; first dose on 22Jan2021 at 09:45 AM/ second dose on 05Feb2021; mild, intermittent neuropathy in left foot; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: Ej1686) via intramuscular on left arm on 22Jan2021 at 09:45 AM, and second dose of BNT162B2 (lot number: Em9810) via unspecified route of administration on left arm on 05Feb2021, both at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. The patient experienced mild, intermittent neuropathy in left foot. She experienced it first time on 29Jan2021 about a week after the first injection. Neuropathy got worse a day after the second dose. No treatment received for the event. No Covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks and no other medications in two weeks. The outcome of the event was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to reported peripheral neuropathy cannot totally be excluded.
35 2021-02-19 facial paralysis 2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeli... Read more
2 weeks after second dose of vaccine received I noticed my left eye lazy and loss of taste and feeling on left side of my tongue . As the day progressed I noticed my left side of face felt different number , my mouth was not opening wide on left side . I did a telemedicine call with a Dr that referee me to Er where I was diagnosed with Bell Palsy.
35 2021-02-21 tingling, numbness 3 days after first vaccine shot my thumb became a little numb and tingly and it eventually spread to... Read more
3 days after first vaccine shot my thumb became a little numb and tingly and it eventually spread to the 2nd and 3rd finger however no other side affects. When I went fir 2nd shot I asked pharmacist administering shot abs he said last time they may have hit a nerve I had no other side affects so I got second dose. Approximately 3/4 days after second dose on February right fingers became more numb and on 2/15 numbness started in left hand as well. Then on 2/19 started experiencing numbness weakness and tingling in both feet which progressively got worse so I went to the ER on 2/21. Blood work all came back normal and was sent home still having symptoms and told to see neurologist however still awaiting appt
35 2021-02-21 numbness Numbness on 1/2 of the face, left and drove home - resolved by the time she was home.
35 2021-02-22 feeling hot Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also mor... Read more
Beginning around 4pm on 2/22/21 I began feeling hot, but did not have a fever (98.8). I was also more tired than usual. Later that evening my injection site was sore, itchy, and raised, like a hive. On 2/23/21 I woke up at about 7:30AM and the injection site was the same as before, but I also had a sore/stiff neck and headache at the base of my skull. The reactions have not warranted a trip to the doctor, but I remember hearing somewhere that the CDC was interested to know about any side effects that may be related to the vaccine.
35 2021-02-22 night sweats Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine... Read more
Muscle and severe joint pain, lumbar, thoracic, and cervical spine pain (every vertebrae in my spine hurt like my car accident was yesterday), severe headache with horrible eye pain, nausea, injection site pain and arm weakness, sweating at night, diarrhea, sharp chest pains (like when I had covid), soft tissue between ribs hurt, gerd (reflux, over full feeling, gas, heartburn, sour stomach, pain when eating), extreme exhaustion, inability to do daily activities or go to work for one week
35 2021-02-23 facial paralysis Increased BP, Confusion, Facial Droop
35 2021-02-23 pain in extremity sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from ... Read more
sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (right arm), on 11Feb2021 10:00, at single dose, for covid-19 immunization. Medical history included celiac disease. Concomitant medication included bupropion. The patient experienced sore arm and headache overnight on 11Feb2021 18:00. The patient recovered from the events on 12Feb2021. The patient took ibuprofen (ADVIL) as treatment for the events (self-prescribed). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
35 2021-02-24 bell's palsy Bells Palsy
35 2021-02-24 feeling hot, pain in extremity Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a n... Read more
Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on her right arm, via an unspecified route of administration on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included thyroid condition and environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and levothyroxine. The patient experienced Chills, Arm Soreness, Malaise, slight sore throat, warm body feeling; all for 05Feb2021 10:00AM. No treatment was received for the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
35 2021-02-24 facial paralysis, tingling, bell's palsy, numbness Developed Bell's Palsy - started on 2/21/21 w/ ear pain and stiff neck, progressed to numbness and t... Read more
Developed Bell's Palsy - started on 2/21/21 w/ ear pain and stiff neck, progressed to numbness and tingling in face and lips on 2/22/21, then hearing loss and left sided facial paralysis. Went to ED, r/o stroke, neck/facial trauma. Given course of prednisone and acyclovir. No improvement noted to date.
35 2021-02-24 electric shock sensation Painful brain zaps - about 4 in the middle of the night.
35 2021-02-24 flushing When given vaccine, had initial burning in deltoid. Right after flushing and sweating palms, along w... Read more
When given vaccine, had initial burning in deltoid. Right after flushing and sweating palms, along with nausea. Lasted 5 minutes. Next day fatigue, nausea, and sweats/chills. 3rd day same. 1/27/21: Pt received 2nd dose of COVID vaccine with no issue.
35 2021-02-25 feeling cold 10pm began convulsive shivering, headache, nausea, diarrhea, back pain, swollen lymphnodes, freezing... Read more
10pm began convulsive shivering, headache, nausea, diarrhea, back pain, swollen lymphnodes, freezing cold extremities. 2am- 2/26 shivering and cold extremities ended. The rest of the symptoms persisted. Including exhaustion. 730pm- 2/26 pain/tightness in chest and fever 101 as new symptoms . Other symptoms besides shivering remain.
35 2021-02-25 cold sweat, weakness, tremor Injection site pain, stiffness, weakness in the right shoulder from 8 pm until 8 am following day. ... Read more
Injection site pain, stiffness, weakness in the right shoulder from 8 pm until 8 am following day. On 2/20/21 (2 days later), had sudden episode of body aching, weakness, tachycardia, extreme fatigue, nausea that lasts 1-2 hours . on 2/22/21 again had episode suddenly of shaking, aching, nausea, stomach pain, fatigue, chills, no fever, clammy skin that lasted 1-2 hours
35 2021-02-25 facial pain, facial paralysis, migraine, muscle twitching Major Trigeminal Neuralgia flare, starting day 4, peaking day 6. Severe pain in right side of face, ... Read more
Major Trigeminal Neuralgia flare, starting day 4, peaking day 6. Severe pain in right side of face, facial droop/non-responsiveness. Other existing neurological issues exacerbated and breaking through current maintenance regimen -migraine, major dizziness, vertigo, involuntary twitching, & muscle weakness. Day 7 is better than day 6, but incrementally over the course of the day.
35 2021-02-25 breast pain Started with pain in left breast a couple days after vaccine given, then developed the Shingles rash... Read more
Started with pain in left breast a couple days after vaccine given, then developed the Shingles rash a week after vaccine was given.
35 2021-02-25 pain in extremity Started with pain in my arms then led to chest pains on the upper left region of my chest. Pain was... Read more
Started with pain in my arms then led to chest pains on the upper left region of my chest. Pain was extensive for about 48hours and still persist but only mildly.
35 2021-02-25 feeling hot, difficulty speaking Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand... Read more
Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand begin itching which moved to the left hand. I was taken to the ER and was administed benedryl. I was transported to the hospital via ambulance because my mouth and throat was extremely dry and my voice got hardened. During the ride I regurgiatated because my stomach got queezy and was administered Zofran. My right hand turned completely white and I was administered another med to help turn my hand back right. My baby was checked and she was fine and was released after about 3 hrs. At that time I was 31 week gestation. Until about 3 days ago my body was still very very itchy all over which seemed to worsen when I was sleep.
35 2021-02-26 grand mal seizure ??I had a SEIZURE?? -only symptoms I had right before it happened were: 1-headache and 2-Dizziness ... Read more
??I had a SEIZURE?? -only symptoms I had right before it happened were: 1-headache and 2-Dizziness -lasted almost 4 minutes, it was tonic clinic -911 was called and I went by ambulance to ER
35 2021-02-27 migraine Felt fatigued and rundown two hours post-vaccine, The following day, I felt body aches and headaches... Read more
Felt fatigued and rundown two hours post-vaccine, The following day, I felt body aches and headaches. 5 days later, Wednesday evening, I developed a migraine that persisted for 24 hours. From about Wednesday night at 8pm till Thursday night at 10pm- after receiving medication and intervention from the local ER, I had a migraine at about a 6-8/10 on the pain scale. After 10 different medications administered, the migraine let up enough that I was able to be released home.
35 2021-02-28 feeling hot I got a really sweet 8 inch diameter hive on the injected arm. It is hot and very itchy. It's not wh... Read more
I got a really sweet 8 inch diameter hive on the injected arm. It is hot and very itchy. It's not where the injection was actually at, which is weird.
35 2021-02-28 nerve pain Less than 24 hours after receiving the 2nd COVID vaccination, I had neck pain that rivaled neck pain... Read more
Less than 24 hours after receiving the 2nd COVID vaccination, I had neck pain that rivaled neck pain year ago after having neck surgery. Some of the nerve pain has come and gone over the years, but this pain has lasted for 5 days and began less than 24 hours after receiving the COVID shot. The pain affects mostly trapezius and levator scapulae (underlying?) muscles on both left and right sides. It feels worse than the muscles aches of having the flu, but only in the neck area. I used Salonpas patches, took ibuprofen and rested.
35 2021-02-28 pain in extremity sore arm, fatigue. Both only lasting 3 days.
35 2021-03-01 weakness About 5 minutes after first dose, patient complained of feeling weak, tired, and lightheaded. Staff ... Read more
About 5 minutes after first dose, patient complained of feeling weak, tired, and lightheaded. Staff noticed she looked pale. She was transferred to a wheelchair, became unresponsive and slumped, and had decorticate posturing for about 15 seconds. Patient awoke and was immediately oriented. Patient was taken from clinic to ED via wheelchair. Of note, patient stated she has a history of syncope, which is worse when needles are involved, and has had similar episodes with phlebotomy in the past. Discharged home in stable condition.
35 2021-03-02 cold sweat Chills, cold, anxiety, clammy
35 2021-03-02 pain in extremity Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercisin... Read more
Couldn't take a full breath. Most intense standing or laying down, lesser when seated/when exercising like I can't take a big enough breathe; Centralized chest pain on sternum.; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak; Arm soreness; Nauseous all week; loss of appetite; Sore to touch; heavy chested; medical history included Hashimoto's; medical history included Hashimoto's; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318; expiration date not provided), via an unspecified route of administration on 25Jan2021 19:00 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history included Hashimoto's, asthma, and food allergy all from unknown dates and unknown if ongoing. The patient has no COVID prior vaccination. The patient was not COVID tested post vaccination. Patient is not pregnant. Concomitant medications included levothyroxine sodium, liothyronine sodium, progesteron, and sertraline. Adverse events on 26Jan2021 at 07:00 were reported as follows: Centralized chest pain on sternum. Felt extremely heavy, not like a regular flu. More like as asthma attack that was waiting to peak (patient reported that she has asthma). Sore to touch. Couldn't take a full breath, most intense standing or laying down, lesser when seated. Lasted just over 48 hours. Patient also stated, 'Still feel heavy chested when exercising like I can't take a big enough breathe'. Patient also reported arm soreness, nauseous all week, loss of appetite. Also on period. The patient has not received treatment for the events. Outcome of the events was reported as 'Recovered with lasting effects'.
35 2021-03-02 pain in extremity Long periods of chills Fever of 102.7 Headache Arm pain Fatigue
35 2021-03-02 pain in extremity had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walkin... Read more
had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-03-03 pain in extremity The following day, she complained of headache, fatigue, dizziness, and lightheadedness for 3 days. O... Read more
The following day, she complained of headache, fatigue, dizziness, and lightheadedness for 3 days. On 2/19/2021 she experienced hives on her abdomen and back that were itchy. No medicine was taken. On the 2/20/2021, she complained of further headache, fatigue, dizziness. She also had shortness of breath. The next day, she presented to the urgent care. She was given an intravenous fluid bolus for dehydration. She was given a "migraine cocktail." She was told that her D-dimer was positive. She had a CT scan that showed sinusitis and her chest was clear. The following day, she complained of progressively worsened ascending pain in her left arm. She had red patches of a rash in her left arm as well. One week later, she went back to the urgent care. An ultrasound was performed and a blood clot was found at. She is now taking Eliquis daily.
35 2021-03-04 pain in extremity I got the shot at 6:30pm. Drove, went to the grocery store, came home, did chores. Around 9:45 start... Read more
I got the shot at 6:30pm. Drove, went to the grocery store, came home, did chores. Around 9:45 started preparing for the next day (getting coffee pot ready, etc.) up until this moment I had no side effects except pain in my arm. Then at 9:45PM I began feeling light headed, ringing in my ears and fell unconscious. I woke up on my kitchen floor in a small pool of blood and disoriented. I do believe this reaction is related to the vaccine. I DO NOT have a history of fainting. I ate food and drank plenty of water throughout the day and after my vaccine injection. Everything about my day was typical except for the vaccination and losing consciousness.
35 2021-03-04 cold sweat, pain in extremity Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and s... Read more
Pale; Sweaty; her left arm was extremely sore; elevated heart rate/heart rate was in the 120s, and she usually has a heart rate in the 80s; shortness of breath; approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; the COVID-19 Vaccine injection site became red, warm, and itchy; Blood pressure increased; Clammy/cold sweat; muscle tenderness/all the muscles in her left arm were tender/aching; bruising near the injection site; she had bruising (more than usual) throughout the rest of her body; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender; anxiety; This is a spontaneous report from a contactable consumer (patient/Registered Medical Assistant). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL0142), via an unspecified route of administration on 12Jan2021 14:30 (2:30 PM) at single dose on left deltoid for COVID-19 immunization. Vaccination facility type is hospital. No history of previous immunization and no additional vaccines administered on same date of Pfizer suspect, also reported as "Prior Vaccinations (within 4 weeks): None". Medical history included ongoing Vitamin D deficiency for quite a few years. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) from Oct2020 and ongoing at 50000 IU gel cap, once weekly for Vitamin D deficiency. Patient is scheduled to receive the second dose of Pfizer vaccine on 02Feb2021 but reported side effects from her first shot including bruising near the injection site, shortness of breath, muscle tenderness and elevated heart rate (main concern). Upon contacting her HCP, she mentioned that this may be a side effect of her anxiety medications and asked "Should she take the second dose?". Approximately 22hours (13Jan2021) after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID-19 Vaccine injection site. COVID-19 vaccine injection site became red, warm, and itchy, also experienced blood pressure increased, shortness of breath and Clammy, all on 13Jan2021. The patient was pale on 13Dec2020. Patient noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) that the lymph nodes in her left axillary (or armpit area) were swollen, and super tender (onset reported as "Jan2021"). Patient became sweaty on 14Jan2021. It was further reported that patient received her first COVID-19 Vaccine dose on 12Jan2021 2:30PM . She said after receiving the first COVID-19 Vaccine, she has had multiple symptoms. Patient is now due for her second COVID-19 Vaccine dose today 02Feb2021. Patient did not know if she should get the second COVID-19 Vaccine dose, and if her side effects were from the first COVID-19 Vaccine. Patient works in a doctor's office where there is a medical doctor, nurse practitioner, and several other registered medical assistants. Approximately 12 hours later after vaccine, at 2:30AM (13Jan2021), her left arm was extremely sore. She said she went to work on Wednesday, 13Jan2021, and her left arm was still really sore, but she was fine, otherwise. She said approximately 22 hours after receiving her first COVID-19 Vaccine, her left arm started swelling slightly down from the COVID- 19 Vaccine injection site. She said her COVID-19 Vaccine was given a lot higher than she thinks the vaccine should have been given. She said the COVID-19 Vaccine injection site became red, warm, and itchy. Her heart rate and blood pressure shot up, and she had pretty bad shortness of breath. Patient said that the medical doctor and nurse practitioner (where she works) told her she gave herself a panic attack. She said that the medical doctor, who she works for, told her to go home, and to contact her primary care doctor if she doesn't feel better. Patient left work and went home. Patient clarified her heart rate was in the 120s, and she usually has a heart rate in the 80s. She said she was pale and clammy, too. Patient stated that she went to bed when she got home from work on 13Jan2021, and woke up the next morning (Thursday, 14Jan2021), and got ready for work. She said as she was getting dressed for work, she felt her pulse rate go up, and she became sweaty, and clammy. She said she called her work, and her boss (medical doctor) told her to take some Tylenol and rest, and to call her primary care doctor if she was not feeling better. Patient said that her primary care doctor said she was having anxiety, and started her on medicine. She said the medicine helped, but her heart rate was still 112-115. She said she noticed on Thursday evening (14Jan2021) through Friday morning (15Jan2021) the lymph nodes in her left axillary (or armpit area) were swollen, and super tender. She said all the muscles in her left arm were tender, as well. She said her left arm muscles were still aching. She said she had bruising on her left arm, and noticed she had bruising (more than usual) throughout the rest of her body. She said she has no idea if the bruising is a coincidence, or if the bruising is related to receiving the COVID-19 Vaccine. Patient mentioned that her left axillary lymph nodes were swollen for a good week and a half, but the swelling improved and was gone now. She said her heart rate was still elevated at 106-110 when she last checked her heart rate an hour and half ago. She said her heart rate was elevated, even though she was sitting down doing tele-work, and she has been taking anxiety medicine. She said she was still having breathing discomfort, clarifying she could not take a big enough breath. Patient will take a big breath, and will be good for a while, but then she needs to take another big breath. She said her doctor has checked her lungs, and her lungs were clear. She said she has to take multiple, deep breaths throughout the day. Patient's last blood work was in Oct2020. She said everything was good with her blood work. She said her hormones were good, but she had a Vitamin D deficiency. For treatment, patient stated that her primary care doctor prescribed Buspar 7.5mg, twice a day. She said the Buspar 7.5mg was dispensed in a pharmacy bottle and did not have the NCD, Lot, and Expiration Date. She said it will be 3 weeks from tomorrow (03Feb2021) she has been taking the Buspar 7.5mg and reported everyone seems to think she has anxiety, or she was crazy. Events did not require emergency room visit but patient visited physician office. There were no relevant tests. Outcome of muscles in her left arm were tender/aching, was not recovered, for axillary lymph nodes swelling and tender was recovered in 2021, for heart rate was elevated, Shortness of breath/breathing discomfort was recovering while for other events was unknown.
35 2021-03-04 weakness Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 9... Read more
Patient c/o weakness and feeling dizzy, EMT notified at 12:20, EMT assessed patient, VSS 157/93 HR 97 RR 26 O2 98% BGM 129 at 1430. At 1440 146/95 HR 93 RR 18 O2 95%. EMT did not administer any medications, EKG Normal sinus. Fire department recommended patient to hospital as she was alone and driving herself. Fire department escorted patient to hospital via ambulance as a precaution at 1456.
35 2021-03-04 flushing, tremor Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / ... Read more
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: GAVE 50MG BENADRYL AND MONITORED PT FOR ANOTHER 25 MINUTES. SHE FELT WELL ENOUGH TO GO HOME WITH HER HUSBAND WITH INSTRUCTIONS TO CALL EMS IF NEEDED. PER PT AT FOLLOW-UP PHONE CALL AT 1950, SHE FELT BACK TO NORMAL WITHIN THE HOUR AFTER LEAVING PHARMACY.
35 2021-03-04 tenderness Woke up this morning with some swelling on my left eye lid. Also very tender to the touch. It seems ... Read more
Woke up this morning with some swelling on my left eye lid. Also very tender to the touch. It seems slightly more tender now at the end of the day and a little more swollen than when I woke up
35 2021-03-05 pain in extremity Arm extremely sore, fever, fatigue
35 2021-03-06 hot flush 1324 - Vaccine received 1354 - Observation time ended, but developed "itching" to bilateral ears (re... Read more
1324 - Vaccine received 1354 - Observation time ended, but developed "itching" to bilateral ears (reported to assessment tent at 1355). History of same plus "heat flushing" to face after 1st dose, which autoresolved without any meds within a few hours the first time. 1400 - HR 85, RR 18, BP 153/109, SpO2 100 1405 - Administered 25 mg PO Benadryl per MD verbal orders. 1410 - D/ced home w/ verbal instructions per MD.
35 2021-03-06 tremor Patient reports that she was diagnosed with COVID-19 this summer and since that time has been experi... Read more
Patient reports that she was diagnosed with COVID-19 this summer and since that time has been experiencing 'long haulers' with headache, fever, body aches and pain, coughing, nasal congestion, extreme fatigue and mental fogginess. These symptoms have been ongoing since patient had her COVID infection but did seem to be improving when she had her 2nd dose of the COVID-19 Pfizer vaccination after which the patient experienced an exacerbation of these symptoms. Pt developed fever to 102 degrees, chills, myalgias, nausea, severe low back pain, shakiness. Was evaluated in the emergency department and discharged home
35 2021-03-06 pain in extremity hives, significant itching, body aches, pain in arm
35 2021-03-07 tingling, hot flush Immediate reaction to the vaccine, about 2 minutes following the vaccine, I felt my heart rate accel... Read more
Immediate reaction to the vaccine, about 2 minutes following the vaccine, I felt my heart rate accelerate and also felt flush feeling. The heart rate went up to 140-150. Also felt little tingling on both my finger tips. Waited about 30 minutes at site, the heart rate will go down to 120 but then it will go back up again. Felt little lightheaded. Decided to go to ER to check and be monitored. Felt a little prickling feeling at tongue, mouth area.
35 2021-03-07 bell's palsy, facial paralysis Patient awoke morning after the vaccine with symptoms consistent with Bell's Palsy on right side o... Read more
Patient awoke morning after the vaccine with symptoms consistent with Bell's Palsy on right side of face: drooping mouth, drooping eyebrow, eye unable to close, no wrinkles on forehead.
35 2021-03-07 muscle spasms, pain in extremity Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and c... Read more
Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe back muscle spasm 1 day after injection; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL1284), via an unspecified route of administration on left arm on 29Dec2020 at 11:30 (at the age of 35years) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe back muscle spasm 1 day after injection (30Dec2020). Severe right leg (thigh knee and calf) pain 7 days after vaccine (05Jan2021). There were no treatment given for the events. The events were considered non-serious by the patient as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The adverse events result in doctor or other healthcare professional office/clinic visit. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The COVID-19 test (nasal swab) on 12Jan2021 was negative. The outcome of the events was recovered for pain in extremity and arthralgia in 2021 and for muscle spasms on an unspecified date.
35 2021-03-07 tingling, feeling jittery, facial pain, pain in extremity o Complaint The patient is a 35 year(s) old Female complaining of allergic reaction, reactive to COV... Read more
o Complaint The patient is a 35 year(s) old Female complaining of allergic reaction, reactive to COVID vaccine. o Chief Complaint Quote Per triage note: Patient states she received her first COVID vaccine injection and started to feel pain/tingling down right arm/face and neck. Patient was given one IM epi at site. Patient states she now feels jittery only. o Time Seen 02-17-2021 13:54 o Historian patient o Objective Statement 35-year-old female presents the emergency department for an allergic reaction. Patient received her first dose of the Covid vaccination in her right deltoid and shortly after receiving the vaccination she began having tingling in the right arm extending down the right hand and up to the right neck and face. She was given epinephrine and sent to the emergency department. On arrival to the emergency department, she says the tingling in her arm has improved but she now feels "jittery ". She denies any headache, visual change, throat tightness, chest pain, difficulty breathing, abdominal pain, nausea, vomiting, rash. Says she had an anaphylactic reaction to bee stings in the past and is also allergic to Motrin. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough, chest tightness and shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. NECK: Supple, non-tender; no meningismus LUNGS: Lungs CTA, breathing even and unlabored. Normal air movement. HEART: Regular rate and rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1620: Repeat evaluation, patient resting comfortably in the room. Her vital signs remained stable. She was given steroids, Pepcid and Benadryl and has been monitored in the ED with no incident. She having any numbness or tingling in her right arm. She is still not having any shortness of breath or throat tightening. We will discharge the patient home. Patient will be given a prescription for an EpiPen. Did tell the patient to follow-up with primary care physician to discuss whether or not she should receive the second dose. Patient given warnings indications to return the ED. Patient understands and agrees the plan.
35 2021-03-08 numbness, muscle spasms 36 hours post injection, swelling in lymph node under right jaw began. Swelling for more than 12 ho... Read more
36 hours post injection, swelling in lymph node under right jaw began. Swelling for more than 12 hours, ibuprofen taken. Swelling so severe affected ear, sinus and jaw on right side and swallowing became difficult. Oral prednisone taken, swelling greatly reduced in the next 8-10 hours. Day 4 post injection mild swelling residing, right side of face tingling sensation to the point of vomiting. Diarrhea, cramping, vomiting, loss of fine gross motor movements in fingers and hands, tics throughout the body. Saw primary care and received a short acting steroid injection and taking gabopentin. 6 hours after injection and medication with no change noted.
35 2021-03-08 migraine About 4-5 days later I began feeling a little nauseous. By day 6-7 I had excessive diarrhea. By day... Read more
About 4-5 days later I began feeling a little nauseous. By day 6-7 I had excessive diarrhea. By day 9-10 I have had to leave work because I can?t go more than an hour without having to run to the restroom, and now there is also sharp bowel pain which radiates to my back. My nausea is extreme and I?m barely eating. My fatigue is such that I can barely keep my eyes open- not sure if it is related to the diarrhea and lack of eating out the vaccine, and my migraine which I usually get once a week have been more like every other day for the past week.
35 2021-03-08 pain in extremity After receiving the second dose of Pfizer covid 19 vaccine on Monday, February 8, I did experience ... Read more
After receiving the second dose of Pfizer covid 19 vaccine on Monday, February 8, I did experience muscle aches, low grade fever and headache 24 hrs after the shot. Those symptoms lasted for about 3-4 days. Then on Sunday morning February 14 I work up with sciatic pain on my left leg. Then on Monday February 15 my right eye was red after I woke up that morning. Gradually during the week my eye continued to be red, blurry, and eventually cloudy Friday morning February 19. Found an eye doctor who could see me that morning. He diagnose me having Iritis and prescribed me durezol eye drops. I had to put one drop every 2hr until it gradually got better. I'm still under his care.
35 2021-03-08 tingling pt reports lip and tongue tingling. no chest tightness, SOB, or wheezing. Benadryl 25mg IM. pt feels... Read more
pt reports lip and tongue tingling. no chest tightness, SOB, or wheezing. Benadryl 25mg IM. pt feels improved no facial symptoms. reports now mild tingling in fingers. she would like to go home
35 2021-03-09 bell's palsy Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthca... Read more
Bell's Palsy (left side of face paralysis); This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received the 2nd dose (at the age of 35-year-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL8982), via an unspecified route of administration on the left arm on 05Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient had no known allergies and medical history reported as none. There were no concomitant medications. The patient was not pregnant (including the time of vaccination). The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot# EL1283), via an unspecified route of administration on the left arm on 15Jan2021 09:30 (at the age of 35-year-old) for COVID-19 immunization. The patient developed Bell's Palsy (left side of face paralysis) on Friday afternoon 19Feb2021 (2 weeks after second dose of the vaccine). The patient went to the doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care due to the event (which was considered as serious disability or permanent damage). The emergency room (ER) doctor prescribed valacyclovir and prednisone. Outcome of the event was not recovered.; Sender's Comments: Based on temporal relationship and known drug safety profiles, a possible contributory role of suspect drug cannot be excluded for the reported event Bell's Palsy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-03-09 breast pain Severe tender/sore breasts. No other symptoms. breasts didn?t start hurting until 2nd full day afte... Read more
Severe tender/sore breasts. No other symptoms. breasts didn?t start hurting until 2nd full day after vaccine dose.
35 2021-03-09 cold sweat s/p vaccine c/o shortness of breath, "clammy", lightheaded, near syncopol, pale
35 2021-03-10 night sweats Diarrhea, night sweats, fatigue
35 2021-03-10 discomfort Shortly after shot (5-10 minutes after) heart rate dropped from average 70-80 BPM down to low 60?s. ... Read more
Shortly after shot (5-10 minutes after) heart rate dropped from average 70-80 BPM down to low 60?s. Felt strange/panicky. Heart rate then spiked to 116. Heart felt fast/uncomfortable for a few minutes. Felt a bit dizzy/unsteady. I was in wk 17 of my first pregnancy at this time.
35 2021-03-10 weakness, tremor was going to pass out/Loss of consciousness; was going to pass out/Loss of consciousness/hx of passi... Read more
was going to pass out/Loss of consciousness; was going to pass out/Loss of consciousness/hx of passing out remote in distant past; started to feel very strange/No hearing or vision loss, just a general strange and uncomfortable feeling.; deep dreaming, then awoke feeling poorly; deep dreaming, then awoke feeling poorly; shaking; chills; BNT162B2 used in a Breastfeeding Mother; BNT162B2 used in a Breastfeeding Mother; This is a spontaneous report from a contactable physician (patient), this physician reported information for both mother and fetus/baby. This is the maternal report. Only this case is serious. A 35-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular into left arm on 05Feb2021 09:00 at single dose for COVID-19 immunization in workplace clinic. Medical history included hx of passing out remote in distant past. No allergies to medications, food, or other products. concomitant medications were none (no other medications the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. patient previously took the first dose of BNT162B2 on unspecified date at single dose for covid-19 immunization. About 17 hours after vaccine, at 3am (06Feb2021 03:00), while up feeding her infant and sitting in a chair in the dark, she started to feel very strange, kind of like she was going to pass out (hx of passing out remote in distant past). No hearing or vision loss, just a general strange and uncomfortable feeling. Tried to call for help. Lost consciousness for a few seconds and had deep dreaming, then awoke feeling poorly. Set child back to bed, went to bed myself, had shaking chills for maybe 30 minutes following. No sweats, no normal symptoms related to vasovagal syncope. Just a general uncomfortable strange sensation as the prodrome. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovered from the events on unspecified date. It was reported as non-serious report. Seriousness criteria results in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating and congenital anomaly/birth defect were all no. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information, the Company considers the reported event loss of consciousness recurrence is unrelated to BNT162B2 vaccine but more likely an inter-current medical condition in this subject with medical history of passing out remote in distant past. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021240721 mother/baby case
35 2021-03-11 pain in extremity Very sore arm Stuffy nose Slight headache Drowsiness Slight back ache Taking 2 Tylenol for the... Read more
Very sore arm Stuffy nose Slight headache Drowsiness Slight back ache Taking 2 Tylenol for the above.
35 2021-03-11 tremor, feeling cold, pain in extremity start with sore arm, then about 10 pm couldn't raise my arm above my shoulder, over night had severe... Read more
start with sore arm, then about 10 pm couldn't raise my arm above my shoulder, over night had severe shakes and cold, woke up at 845 throwing up, have been severely nauseated since and arm is still in pain, running a fever, very lethargic
35 2021-03-12 muscle spasms Slight sharp burning pain "behind" left eye begin a few hours after I had shot. That pain was interm... Read more
Slight sharp burning pain "behind" left eye begin a few hours after I had shot. That pain was intermittent for a few hours and dissipated by early evening of the day of the shot. My left lip and left side of throat had minor feeling of tingly burn when I was driving home 30 minutes after I had the shot. Stiff muscles on left side of neck. Intermittent mild muscle pinching along left side of body but went away by Friday night.
35 2021-03-13 migraine, pain in extremity Chills, achy, fever up to 102, migraine/headache, upset stomach (ate very little), nauseas Mostly sl... Read more
Chills, achy, fever up to 102, migraine/headache, upset stomach (ate very little), nauseas Mostly slept, took 3 ibuprofen after 9 hours and again 4 hours later, fever, upset stomach, and aches gone after 12 hours, chills and continued off and on overnight Original symptoms gone a little over 24 hours later. Arm pain has returned and is radiating up through collar bone.
35 2021-03-14 cold sweat, tenderness, pain in extremity, feeling hot Around 1030 PM on 3/12/2021 I woke up dry heaving. I then spent the night alternating between a cold... Read more
Around 1030 PM on 3/12/2021 I woke up dry heaving. I then spent the night alternating between a cold sweat and a hot sweat. When I woke up on the morning of 3/13/2021 my whole body hurt. I felt as if I had been run over by a truck. My left arm was very sore from the injection. My left underarm hurt. Across my upper back was sore and tender. My chest felt tight. I was nauseous all day. I took benedryl and Advil and slept most of the day. By 5:00 PM on 3/13/2021 I was feeling better but still hurting. By 3/14/2021 the pain had mostly gone away, but my left underarm is still sore and I am still very tired
35 2021-03-14 feeling hot Body very hot then chills. Temp up to 99.4
35 2021-03-14 tingling Fever, nausea, headache, fatigue, myalgias, forgetfulness for 2 days after. Fatigue lasted 1 week. T... Read more
Fever, nausea, headache, fatigue, myalgias, forgetfulness for 2 days after. Fatigue lasted 1 week. Then 2 weeks later back pain and tingling in hands and feet. Also now have large platelets on CBC which wasn?t present before.
35 2021-03-14 muscle spasms Pain at injection site as well as GI Issues such as intense cramping and diarrhea.
35 2021-03-15 burning sensation 3 days after the vaccine my left knee joint and area of achilles tendon started to hurt, inflammatio... Read more
3 days after the vaccine my left knee joint and area of achilles tendon started to hurt, inflammation and burning. Difficulty walking.
35 2021-03-15 muscle spasms 3/4 hours after receiving the vaccine my heart started racing causing a massive anxiety attack. I ha... Read more
3/4 hours after receiving the vaccine my heart started racing causing a massive anxiety attack. I had chills, nausea, lost of appetite, and muscular aches. I felt tired and fatigued. I got sweaty hands and experienced reduced amount of saliva in my mouth. Ten hours after the injection I also had diarrhea and cramps. Today is day 2 and I am still experiencing tiredness and anxiety. I didn't take anything, just waited for the side effects to pass.
35 2021-03-15 speech disorder, tremor At 3:47 pm (36 minutes after receiving shot) tongue swelled lips tingled, increased heart rate, and ... Read more
At 3:47 pm (36 minutes after receiving shot) tongue swelled lips tingled, increased heart rate, and extremities shook. Called 911 at 3:50 pm. Fire department came and blood pressure was high, heart rate was high, blood sugar was low. Fire fighter noticed hives on right shoulder (shot was administered in left arm) and they could see hives spreading across chest and neck. Hives covered upper torso but did not spread to abdomen or legs. Tongue swelled more making speech difficult. Breathing was easy, no constriction or wheezing heard through stethoscope. Vitals taken 2 or 3 more times, becoming more regular each time. Fire fighters provided Gatorade and discussed options. Fire department left at 4:10. I took Benadryl and Pepcid at 4:15. Tongue swelling decreased around 6 pm, but remained slightly swollen until 3/14/21. Hives visible and itchy until 3/15/21. Other symptoms included fatigue, dizziness, body aches. Triamcinolone was used topically on hives twice daily on 3/13/21 and 3/14/21.
35 2021-03-15 unresponsive to stimuli She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning o... Read more
She received the 2nd Dose on 3/9/2021. On 3/10/2021 She complained of a headache. On the morning of 3/11/2021 she complained of abdominal pain and had no appetite. We then found her unresponsive, called 911 and the medics pronounced her at around 1300.
35 2021-03-15 breast pain, pain in extremity Shot received @ 9:45 am, normal arm tenderness started around 8 pm and continued through to the next... Read more
Shot received @ 9:45 am, normal arm tenderness started around 8 pm and continued through to the next day. The next day around 3 pm I started having pain in my left arm pit and the underneath of my arm in the injection area, by 9pm that night (day after receiving shot) the pain in my arm pit was so bad it hurt to lift my arm or lay one it. the following day Friday the 12th the pain continued in my left armpit and underneath of my arm. It was extremely painful to touch. My Saturday March 13th the pain had started to shift to the lower part of my arm pit and into the side of my left breast. On Sunday the 14th the pain in my breast was gone and I finally felt like I could lift my arm and sleep on it, It was just tender to the touch. Now it is tender to touch in the center of my armpit and the underneath of my arm from arm pit to elbow.
35 2021-03-15 pain in extremity Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a sp... Read more
Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a spontaneous report from a contactable Other Health Professional. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 03Jan2021 at 09:30am (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. The patient had none medical history. The patients Concomitant medication included buprenorphine hydrochloride (SUBUTEX) taken for an unspecified indication, start and stop date were not reported. The patients past drug included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 administered in Arm Left arm on 23Dec2020 at 09:30am(Batch/Lot Number: EK5730) as single dose for covid-19 immunisation. The patient experienced sore big toes on both feet, bruising under toenails and poor circulation on both big toes on 15Jan2021 at 20:00. The outcome of the events was not recovered.
35 2021-03-16 pain in extremity patient had slight arm swelling and pain and developed headache after injection. she showed no dizzi... Read more
patient had slight arm swelling and pain and developed headache after injection. she showed no dizziness or fainting . patient stayed in pharmacy for 30 minutes and showed no other symptoms . I checked with her later in the day and she said she was fine.
35 2021-03-17 migraine On 1/19/21- visual migraine, severe fatigue, difficulty concentrating. These symptoms continued alon... Read more
On 1/19/21- visual migraine, severe fatigue, difficulty concentrating. These symptoms continued along with blurry vision, dizziness, waking at night to ?buzzing? in head, hypoglycemic symptoms. Multiple doctors visits over the past two months, blood tests, BP and heart rate assessments - only to assume it?s a reaction to the vaccine. Extreme diet change, elimination of the two prescribed meds and detox- feeling much better however still experiencing hypoglycemic symptoms throughout the day and sometimes at night.
35 2021-03-17 tingling, numbness, tremor Severe chills (teeth chattering and shaking), temperatures ranging from 101.5-103.0 throughout the d... Read more
Severe chills (teeth chattering and shaking), temperatures ranging from 101.5-103.0 throughout the day (2 am - current time 2:45 pm), severe fatigue and body aches (trouble standing and opening eyes), bluish fingernail beds with numbness and tingling to knocking knuckles. 2x taken excedrin which did break fever first time for temporary relief. Moving arms and fingers to encourage circulation.
35 2021-03-18 tingling, numbness Allergic response to Pfizer Covid Vaccine #1, resulting in immediate numbness and tingling in face a... Read more
Allergic response to Pfizer Covid Vaccine #1, resulting in immediate numbness and tingling in face and mouth, dry cough and tightness in throat. Hives present after 6 hours. Symptoms were controllable with benadryl for the first 6 hours, but became uncontrollable 6 hours after the vaccine. Patient went to Emergency Room to control symptoms.
35 2021-03-18 pain in extremity Arm soreness, headache, fatigue starting morning after injection, not responsive to NSAID?s
35 2021-03-18 pain in extremity Develop lightheadedness/dizziness, Rapid Respirations, Left arm and neck pain 30 minutes after recei... Read more
Develop lightheadedness/dizziness, Rapid Respirations, Left arm and neck pain 30 minutes after receiving 2nd dose. Had same but milder sx. After 1st she thought was related to anxiety. Had skipped Baclofen and Gabapentin this A.M.
35 2021-03-18 feeling jittery Feeling of jitters about 10 minutes after vaccine administration, history of anxiety. Patient refuse... Read more
Feeling of jitters about 10 minutes after vaccine administration, history of anxiety. Patient refused transport. vitals stable.
35 2021-03-18 tingling Significant nausea and vomiting, with body aches and tingling in fingers.
35 2021-03-18 pain in extremity, seizure Sore arm for first few days. Woke up on day 5 feeling off. Had an aura start in the left side of v... Read more
Sore arm for first few days. Woke up on day 5 feeling off. Had an aura start in the left side of vision and thought it was just a migraine. Took migraine medication and 45 minutes later had a seizure. This is the first in my life.
35 2021-03-18 pain in extremity Within about two minutes my head started feeling "off", my mouth started to go numb, my heart starte... Read more
Within about two minutes my head started feeling "off", my mouth started to go numb, my heart started to race, my face started itching/sweating and I could feel a headache coming on. I had a headache, chills, fatigue, increased body temperature (2+ degrees) and a sore arm for the rest of the day. I woke up this morning with a really sore arm. I could only lift my arm halfway up, due to the deep muscle pain.
35 2021-03-18 tingling, numbness left leg had muscle pain; foot was numb/tingling; right side of her face and upper body was tingling... Read more
left leg had muscle pain; foot was numb/tingling; right side of her face and upper body was tingling; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right on 13Feb2021 10:30 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included covid-19, seasonal allergy and allergy to some fruits. Patient was not pregnant at the time of vaccination. No prior vaccinations within 4 weeks. Concomitant medication(s) included zinc (ZINC), fish oil, cyanocobalamin (VIT B12) and vitamin d. The patient previously took metamucil and experienced allergy. On 13Feb2021 16:00, (evening), patient was laying on her right side in bed for maybe an hour and the right side of her face and upper body was tingling like it "fell asleep". On 16Feb2021, 3 days later she got to work at 3pm and her left leg had muscle pain and foot was numb/tingling. The tingling lasted about an hour. Muscle pain still persisted although not as bad. Treatment was not received for the events. Patient was diagnosed with COVID-19 prior to vaccination and has not been tested post-vaccination. Outcome of the event muscle pain was not recovered, for event foot was numb was recovered while for the remaining event was unknown. Information on the lot/batch number has been requested.
35 2021-03-19 migraine Cold/flu like symptoms. Sore throat, dry cough, migraine, severe fatigue
35 2021-03-19 numbness and pain in extremities, tingling Paresthesias, neuropathy
35 2021-03-20 discomfort, pain in extremity, involuntary muscle movements Day of vaccine: fatigue, sore arm at injection site, at 10pm: metallic taste Day after vaccine: Feve... Read more
Day of vaccine: fatigue, sore arm at injection site, at 10pm: metallic taste Day after vaccine: Fever 99.5 for ~2 hours, extreme clumsiness/lack of full control of appendages, muscle aches, and fatigue all day. Sore arm (injected arm), intermittent headaches. At 10pm: swollen lymph node (size of cherry tomato of injected arm). For the next 9 days: arm tingling, as if nerve(s) were pinched, when trying to extend or stretch straight (injected arm) Symptoms caused fair/tolerable discomfort, but not severe.
35 2021-03-20 migraine, pain in extremity Debilitating migraine, 48 hours- had to take off from work. Sore arm (48 hours). Chills (5 hours, 24... Read more
Debilitating migraine, 48 hours- had to take off from work. Sore arm (48 hours). Chills (5 hours, 24 hours after the injection.)
35 2021-03-20 pain in extremity, feeling hot Immediate pain in collar bone and hand. 2 minutes later feeling hot, dizzy and nauseated and about ... Read more
Immediate pain in collar bone and hand. 2 minutes later feeling hot, dizzy and nauseated and about to lose consciousness. Went to medical within facility and was monitored for 30 min until getting better. In addition, woke up with dizziness 48 hours later.
35 2021-03-20 numbness, burning sensation Itching/burning/tingling/numbness in left arm -- pinky and ring finger especially affected. Itchines... Read more
Itching/burning/tingling/numbness in left arm -- pinky and ring finger especially affected. Itchiness spread to neck, chest, other arm, and head. Dissipated after about 30 minutes.
35 2021-03-21 inability to speak, tingling Patient started to feel aware of tingling and racing heart. She states she then felt "out of it." Vi... Read more
Patient started to feel aware of tingling and racing heart. She states she then felt "out of it." Vital signs obtained= BP 114/86; heart rate 100; temperature 100; pulse oximeter 98% on room air. Repeat vital signs BP 116/84; heart rate 92; pulse oximeter 98% on room air. On initial exam patient was unable to verbalize. She was near syncopal. She denied respiratory symptoms. O2 sat normal. Skin dry with pallor noted. No respiratory symptoms. Pulse is weak but regular. Blood glucose by finger stick is 130. Patient was hydrated with oral fluids, Gatorade. After observation for 20 minutes the patient was much improved with complete resolution of her symptoms. Patient was released home with her husband who was driving. She was advised to hydrate with at least two bottles of sports drink prior to her next vaccination. Note: patient has twins and two young children to care for.
35 2021-03-21 pain in extremity, migraine Sore arm, pain in arm pit, lump in arm, migraine, fever, chills, groggy
35 2021-03-22 pain in extremity First day arm pain shoulder and a bit chest pain. Gun pain too. Next day still arm pain.
35 2021-03-22 weakness Second dose, ~ 15 minutes post vaccine...left the building . She experienced redness, warmth & weak... Read more
Second dose, ~ 15 minutes post vaccine...left the building . She experienced redness, warmth & weakness. She was given oral benadryl at her clinic and administered 0.3mg epi x 1 en route by EMS.
35 2021-03-23 tingling, burning sensation Beginning about 35-36 hours after vaccination I developed sudden tingling/burning sensation in the b... Read more
Beginning about 35-36 hours after vaccination I developed sudden tingling/burning sensation in the bottom of my left foot. Over the next 24 hours this was constant and also felt in my left lower lateral leg and shin area. After 24 hours it was improved, but still occuring intermittently. Also experiencing random patches of tingling/burning/itching at various spots on body (arm/back). Wanted to report this as I have spoken with several others who have reported this same phenomenon in random extremities after both pfizer and moderna but it doesn't seem to be a documented side effect that I can find anywhere.
35 2021-03-23 muscle spasms I started bleeding vaginally and having cramping on Tuesday morning. I got my 2nd COVID-19 vaccine o... Read more
I started bleeding vaginally and having cramping on Tuesday morning. I got my 2nd COVID-19 vaccine on Monday morning. I was 5 weeks 5 days pregnant when I started bleeding. I was diagnosed with subchorionic hematoma in the ER. I also experienced bleeding on Thursday and Friday of that week.
35 2021-03-24 discomfort Before going to bed the day of vaccine, I noticed my left shoulder/collarbone area was hurting and d... Read more
Before going to bed the day of vaccine, I noticed my left shoulder/collarbone area was hurting and did not sleep well that night even though I was tired. When I woke up the next day, I was in some discomfort around my collarbone and felts a small lump. I waited until Wednesday and did a virtual visit with a doctor and they said it is probably the lymph nodes. There has been no change in the size of the lump nor has it moved to a new spot.
35 2021-03-24 bell's palsy Bell's palsy facial paralysis right side of face was droopy with no control on eye, nasal, and mouth... Read more
Bell's palsy facial paralysis right side of face was droopy with no control on eye, nasal, and mouth; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Left Arm on 06Mar2021 18:15 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included COVID from Dec2020 to an unknown date. There were no concomitant medications. The patient previously took cefalexin (KEFLEX) and experienced known allergies to KEFLEX. The patient experienced Bell's palsy facial paralysis right side of face was droopy with no control on eye, nasal, and mouth on 07Mar2021 18:00 with outcome of not recovered. The event resulted in doctor or healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood labs: unknown results on an unknown date. Therapeutic measures were taken as a result of the event.
35 2021-03-24 muscle twitching, hot flush, numbness, tingling Day 1: Tingling in feet, strongly in left foot. Day 4: Constant hot flashes, dizziness, vertigo Sin... Read more
Day 1: Tingling in feet, strongly in left foot. Day 4: Constant hot flashes, dizziness, vertigo Since day 4, there have been hot flashes and dizziness, muscle weakness, diarrhea and tingling of hands, feet, and lips to varying degrees. Yesterday, day 12, my left side of my face started to tingle as well and felt some numbness. My pinky finger on my left hand started twitching. They have continued to tingle and twitch since.
35 2021-03-24 facial pain, bell's palsy, facial paralysis Gradual onset Bell?s Palsy. Left side facial paralysis (partial), intermittent ear and facial pain. ... Read more
Gradual onset Bell?s Palsy. Left side facial paralysis (partial), intermittent ear and facial pain. Onset at 39+6 days pregnant.
35 2021-03-24 pain in extremity, muscle spasms, flushing I immediately felt a strange sensation in my head, and the hearing in my left ear dulled as if I wer... Read more
I immediately felt a strange sensation in my head, and the hearing in my left ear dulled as if I were listening under the ocean. My left ear has a constant feeling of fullness. I have experienced tinnitus and a persistent need to "pop" my ears in my left ear since, as well as bouts of vertigo. I am very sensitive to sound in my left ear, and background noise is amplified and sounds "spotlighted." I have intermittently been experiencing pain in both of my calves since the injection, as well as joint pain in my hands. I have been experiencing a flushed feeling in the evening, though it is not accompanied by a fever. My muscles in my hands, feet, and legs have been cramping often, which is not a usual occurrence. I have experienced intense chest pain in what feels to be my heart. I have also experienced very vivid dreams.
35 2021-03-25 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
35 2021-03-25 tenderness Pt. developed reactive supraclavicular lymphadenopathy on 3/23/2021 following her first COVID 19 Pfi... Read more
Pt. developed reactive supraclavicular lymphadenopathy on 3/23/2021 following her first COVID 19 Pfizer vaccination on 3/21/2021 in the ipsilateral arm. Details: Sunday 3/21/21 she received her first dose of the Pfizer COVID 19 vaccine to her left deltoid and the following day on Monday felt tired and a sore left deltoid. On Tuesday her soreness in her left deltoid improved but she still felt exhausted and before going to bed noted a tender bump just above her left clavicle which was tender to touch. Pt. States that it feels like a "jelly bean" size and is mobile, tender and soft to touch. Pt. States that it is much smaller on 3/25/21 than when she first noted it on 3/23/21 and appears to be improving but got concerned. Pt. States that the deltoid soreness resolved but the lump above her left clavicle persisted but she also had a headache all day and still felt tired but also nauseated but denies any vomiting, abdominal pain, changes in bowels, fevers or chills, rashes. Pt. states that3/25/21 she is feeling much better and has more energy and her headache and nausea resolved and that the lump above her left clavicle is still there but smaller in size. Pt. with no hx of lymphadenopathy after any other vaccines in the past. No hx of severe or unusual adverse reactions following immunization in past. Denies any breast or armpit complaints, fever, chills, wt loss, left arm pain or arm swelling at or around the injection site, rashes, sore throat, nasal or sinus symptoms, cough, difficulty swallowing or breathing. Of note pt. states she was ill with COVID 19 like s/s back in April 2020 but at that time testing was not available unless your were hospitalized and her s/s were mild and she self treated at home with supportive care. Pt. States that she got an antibody test 3 months later and had + COVID 19 antibodies and was recently retested for antibodies on 2/27/2021 and they were still positive.
35 2021-03-25 feeling cold Severe dizziness leading to almost fainting, nausea, diarrhea, feeling like ice was flowing through ... Read more
Severe dizziness leading to almost fainting, nausea, diarrhea, feeling like ice was flowing through veins while severely sweating, rushing noise in ears, difficulty standing without feeling faint. Lasted for about 30 minutes before being able to fall back asleep.
35 2021-03-25 flushing Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-M... Read more
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
35 2021-03-26 flushing Flu like symptoms including fever, chills, fatigue, body aches started after 12 hours and lasted for... Read more
Flu like symptoms including fever, chills, fatigue, body aches started after 12 hours and lasted for 36 hours. Then hives and flushing on day 2-3, intermittently. Swollen lymph nodes in armpit, neck, groin, jaw and tooth pain. Continuous headaches, congestion, and worsening fatigue for weeks. At week 3, started having increased shortness of breath, nocturnal hypoxemia, cough, chest tightness, fatigue, increased heart rate with exertion. These symptoms worsened over the next three weeks.
35 2021-03-26 migraine, tension headache Next day began a fever of 101.3 to 102.5, felt hit by a truck. Sore throat, nausea, vomiting, body... Read more
Next day began a fever of 101.3 to 102.5, felt hit by a truck. Sore throat, nausea, vomiting, body aches, swollen joints, headache and migraine. Loss of appetite and loss of desire to hydrate. Lasted over 5 days. Took my routine pain meds, percocet, tylen rapid release gels alternating with generic excedein tension headache. Lots of hot baths, humidifier at night for my severe dry mouth.
35 2021-03-27 numbness It did not manifest in a normal way- I started coughing and needed my inhaler, proceeded to feel as ... Read more
It did not manifest in a normal way- I started coughing and needed my inhaler, proceeded to feel as if my legs were covered in fire ant bites and swollen, the skin all over my body itched to the point that I broke the skin, my face became bright red and hivey, and my throat began to tighten as if someone were choking me. The only reason I did not use my Epipen was the fact that I could still breathe through this, even if it was a bit labored. I should add that my reaction began 1.5 hours after I was vaccinated. I?ve been managing having life threatening allergies since I was a child, but this reaction resembled nothing I?ve ever experienced. After using 50 mg of Benadryl, my symptoms were manageable. The pain at the injection site lasted for five days and caused intermittent numbness to my pinky finger and up my neck.
35 2021-03-27 muscle spasms The day after receiving my Pfizer vaccine I experienced fever, chills, body aches and other flu like... Read more
The day after receiving my Pfizer vaccine I experienced fever, chills, body aches and other flu like systems. I have been in bed about a day and a half using Tylenol to manage headaches and fever, and advil for body aches and muscle cramps.
35 2021-03-30 pain in extremity Sore arm; headache; chills; low grade fever; fatigue; This is a spontaneous report from a contactabl... Read more
Sore arm; headache; chills; low grade fever; fatigue; This is a spontaneous report from a contactable consumer. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL3247), on 11Feb2021 10:45 AM at Left arm, as single dose for covid-19 immunisation. The patient had received first dose on 0Jan2021. the patients' medical history included hypothyroidism and no known allergies were reported. The concomitant medications included Levoxyl. on 11Feb2021, 05:00 PM, the patient experienced Sore arm, headache, chills, low grade fever, fatigue. the patient was treated with Acetaminophen, ibuprofen (OTC). the outcome of event was Recovering. No follow up attempts are possible. No further information is expected.
35 2021-03-30 facial paralysis developed left sided facial paralysis; some findings of inflammation on the 8th nerve; developed uni... Read more
developed left sided facial paralysis; some findings of inflammation on the 8th nerve; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus; ear discomfort; ear discomfort that worsened; progressed to mild hearing loss; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: EN5318), via an unspecified route of administration, administered in the left arm on 11Feb2021 08:15 at a single dose (at the age of 35-years-old) for COVID-19 immunisation; vaccinated in a hospital. Medical history was not reported. No known allergies. Concomitant medication included escitalopram. The patient had no other vaccine in four weeks. The patient did not have COVID prior to vaccination. Six days after the vaccine (17Feb2021), the patient developed unilateral left ear symptoms such as muffled hearing, mild pain, pressure, tinnitus, which then progressed to mild hearing loss. After about 7 days of ear discomfort that worsened (2 weeks exactly after first dose of vaccine), the patient developed left sided facial paralysis. The patient was seen by ENT, had a full workup including hearing test and head MRI with contrast. Came back normal aside for some findings of inflammation on the 8th nerve. The patient was placed on acyclovir 500mg 3x a day for 7 days and 60 mg of prednisone for 7 days with a 9 day taper. The facial paralysis completely recovered after 2-3 full weeks. The ear was mostly recovered with some residual tinnitus. The patient was not COVID tested post vaccination. The patient required a visit to the doctor and emergency room for the events. The patient recovered from left sided facial paralysis in Mar2021. The patient was recovering from the remaining events.; Sender's Comments: Considering plausible temporal association and lack of alternative explanations, the events left ear hearing loss, inflammation on the 8th nerve, and left sided facial paralysis are possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
35 2021-04-01 numbness, one side paralysis, pain in extremity, sensory loss It started with 103 for 48 hours with extreme pain in lower extremities after loss sensation in both... Read more
It started with 103 for 48 hours with extreme pain in lower extremities after loss sensation in both legs and arms. I went to ER on 1/14 stayed for 2 weeks and followed up with the Neurological. I went to the Clinic (they did a very good job identifying my diagnosis) diagnosed with post vaccine neurologic deficit in lower extremities and assist with me walking again, IVIG 5 days of infusion and physical therapy. I'm a physician was out of work for 6 weeks and still experiencing left side balance issues/weaknesses of both feet numbness of 4/2.
35 2021-04-01 numbness, facial paralysis tight facial drooping; numbness in right arm, neck and head; Right lower arm swelling; The initial c... Read more
tight facial drooping; numbness in right arm, neck and head; Right lower arm swelling; The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 12Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right deltoid on 28Dec2020 09:12 (lot number: EH9899; Expiration Date: Mar2021) as single dose at the age of 35 years old as COVID vaccine. The patient's medical history and concomitant medications were not reported. On 28Dec2020 09:20, the patient experienced right lower arm swelling, numbness in right arm, neck and head. Eventually had tight facial drooping. The patient went to emergency department. The events numbness and facial drooping resulted in visit to physician office and emergency room. The patient was not admitted in the hospital. No treatment was received for the adverse events. The patient underwent CTA neck and CTA head; both on 29Dec2020 with negative results. The patient recovered from the events on unspecified date.
35 2021-04-06 migraine The next day I had the normal symptoms that I had expected. I worked through the next two days with ... Read more
The next day I had the normal symptoms that I had expected. I worked through the next two days with headaches. On the fifth day I had a sudden onset of severe abdominal pain and a migraine like headache followed by the chills. These symptoms repeated two to four times daily for four days. I also had low grade abdominal cramping which is ongoing. I am unsure whether this is contractions or abdominal problems. I communicated with my Obstetrician and my GI doctor. My water broke at 21 weeks, but I did not lose the baby. I am currently 22 weeks pregnant and on bed rest. I was hospitalized for four days. On Monday the 29th I had a CRP of 85 and by Friday April 2nd it dropped to 35. On Monday my WBC was 14.1. I am unsure of the outcome right now.
35 2021-04-09 feeling hot, tingling pressure in her ears; right ear was burning; almost passed out; dizzy; hot; couldn't hear everything... Read more
pressure in her ears; right ear was burning; almost passed out; dizzy; hot; couldn't hear everything sounded really far away; had impaired thinking, couldn't think straight; no concentration for two days straight; had buzzing in her ears and heightened sounds; pins and needles sensation in her feet that went up to her legs/on day 9 the pins and needles sensation seems to be in her hands and arms as well; This is a spontaneous report received from a contactable consumer (patient). A 35-year-old female patient received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 18Mar2021 at age of 35-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated she received the first dose of the Pfizer COVID vaccine on 18MAR 2021. She stated ten minutes after the vaccine on 18Mar2021 she became dizzy, hot, almost passed out, couldn't hear everything sounded really far away. Patient stated this lasted for 20 minutes. Patient stated she also had impaired thinking, couldn't think straight and no concentration for two days straight. She stated she also had buzzing in her ears and heightened sounds for three days. She stated she had pins and needles sensation in her feet that went up to her legs. She stated on day 9 the pins and needles sensation seems to be in her hands and arms as well. Patient stated yesterday (26Mar2021) her right ear was burning and today (27Mar2021) she has pressure in her ears in addition to the pins and needles sensation. Events were reported as non-serious. Patient would like to know if her symptoms have been reported or are normal. She would like to know how long will her symptoms last and if they are permanent. She would like to know if she should receive the second dose of the vaccine. She would like to know what treatment she should have for her symptoms. She would like to know if there were any reports of autoimmune diseases being diagnosed after receiving the vaccine. She would like for someone to notify her if any information or data becomes available regarding the side effects she has mentioned that were not mentioned in the FactSheet. No information in PI regarding impaired thinking, loss of hearing, heightened hearing, pins and needles in extremities, and burning and pressure in ears. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to Pfizer-BioNTech COVID-19 Vaccine. Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. No information in PI regarding autoimmune disorders being diagnosed after receiving Pfizer COVID vaccine. Outcome of dizzy, hot, almost passed out, couldn't hear everything sounded really far away was recovered on 18Mar2021, of had impaired thinking, couldn't think straight, no concentration for two days straight, buzzing in her ears and heightened sounds for three days was recovered in Mar2021, of the other events was unknown. Information on the lot/batch number has been requested.
35 2021-04-11 tingling My right arm has been tingly on and off since about an hour after receiving the vaccine. My head sta... Read more
My right arm has been tingly on and off since about an hour after receiving the vaccine. My head started hurting at the base of my neck approximately 2 hours after the vaccine.
35 2021-04-13 numbness, pain in extremity Doctors believe my wife has developed Gillian-Barre Syndrome as a result of the covid vaccine. We ha... Read more
Doctors believe my wife has developed Gillian-Barre Syndrome as a result of the covid vaccine. We have visited the ER, 2 different Nuerologist, 2 different Internalist, a eye specialist (optometrist) and today the a spine Center. Healthy 35 year old pre vacine, post-first vaccine shot developed numbness and shooting pain in feet, it has spread to fingers, mouth and rectum. Eye prescriptions have changed drastically in last 3 weeks, extreme weight loss (down 20lbs), insomnia
35 2021-04-13 migraine Within one month after the first vaccination (2/8/21) migraine intensity increased significantly. Se... Read more
Within one month after the first vaccination (2/8/21) migraine intensity increased significantly. Second vaccine was on 3/22/21. Migraine became so unbearable that I was admitted to ED on 3/25/21.
35 2021-04-14 muscle spasms Bladder/UTI infection, diarrhea, muscle spasms, fever, headache
35 2021-04-14 numbness, tingling Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ARM NUMB ... Read more
Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: ARM NUMB AND TINGLING FROM SITE OF INJ TO FINGERTIPS-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
35 2021-04-14 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushe... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt sat in store for 30 minutes after injection (20 minutes after feeling faint). Was feeling well when she left.
35 2021-04-16 discomfort sinus infection; very uncomfortable; delayed reaction after 38-42 hours or after 48 hours; rash and ... Read more
sinus infection; very uncomfortable; delayed reaction after 38-42 hours or after 48 hours; rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives; rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives; This is a spontaneous report from a contactable nurse (patient herself) via medical information team. A 35-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left deltoid at age 35 years on 23Mar2021 16:30 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunization (prevention). Medical history included none. Family history of sister that had COVID and then got vaccine. She did not get a rash but is prone to allergies and things like that. Her sister has very sensitive skin and she does get rashes. Her sister got really sick but did not have the things she had. Her sister had COVID pretty bad for a week or 2. Once her sister was COVID negative, she got the first COVID vaccine and did ok. her sister got the second vaccine and got pretty sick like she had COVID again. Patient did not ever get COVID though. There were no concomitant medications. No vaccines administered on same date of the Pfizer suspect and no vaccines administered within 4 weeks. Patient historically took first dose of Pfizer COVID vaccine given on 28Feb2021 at age 35 years, Injected intramuscularly in left deltoid, Lot number: EN6205, expiration date unknown and just had a sore arm after injection, mild discomfort in arm. Patient would like to report an adverse reaction that may be related. Patient got the second vaccine on 23Mar2021 16:30 (Tuesday), and on Thursday afternoon (25Mar2021), she broke out in a rash like hives, pretty much all over her body. Rash and hives all over body was reported as worsened. There was no prescriber for vaccine. She just received it as a part of an initiative. This is a delayed reaction after 38-42 hours or after 48 hours. It was not near the vaccination site. It is all over her torso, legs, thighs and looks like hives. She said "hives in general if in an immuno response to BENADRYL or steroid cream". Patient stated event was medically significant. It is very uncomfortable. She doesn't normally get rashes and this was a new experience for her. Patient had labs done on an unspecified date for a physical and they were all within normal limits, such as her CBC, and CMP. She even got a C-Reactive protein and it was within normal limits. She has not left the house and has not changed detergents and has not done anything different that would cause this reaction. She wanted to know if there have been other delayed reactions like this. She also mentioned taking amoxicillin antibiotics (Lot SM8720051-A, Expiration Mar2022. Dose was 875/125 1 tablet by mouth twice daily) for a sinus infection on unspecified date, and was on the last day and does not know if it would be clinically significant. Outcome of the events 'rash and hives all over her body, not only on the injection site/all over her torso, legs, thighs and looks like hives' and 'delayed reaction after 38-42 hours or after 48 hours' was not recovered, for the other events, it was unknown. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Rash and hives all over body, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Reporter seriousness for Rash and hives all over body: Medically significant.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-04-18 paralysis Paralysis; Right lip swelling; This is spontaneous report from a contactable consumer (patient). A n... Read more
Paralysis; Right lip swelling; This is spontaneous report from a contactable consumer (patient). A non-pregnant 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 01Apr2021 at 05:15 PM (17:15), at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 04Mar2021 for COVID-19 immunization (left arm). The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in a pharmacy or drug store facility. On 02Apr2021, the patient experienced right lip swelling and paralysis. The events were considered non-serious. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
35 2021-04-20 bell's palsy Bell's Palsy with headache; Bell's Palsy with headache; This is a spontaneous case from a contactabl... Read more
Bell's Palsy with headache; Bell's Palsy with headache; This is a spontaneous case from a contactable consumer (patient). A 35-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6204, expiration date unknown), via an unspecified route of administration, administered in left arm on 17Mar2021 at 15:00 at the age of 35-year-old at a single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history included pcos (Polycystic ovarian syndrome), obese and bactrim allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient experienced bell's palsy with headache on 28Mar2021 at 23:30. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Received prednisone medication for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has been tested for COVID-19 after the vaccination. Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: covid test on 26Mar2021. Covid test result: negative. The patient was recovering from the events. Follow up attempts are needed. Information on batch/lot number was obtained.
35 2021-04-22 flushing Flush and feverish (low grade), racing heart. Headache onset at say 6 and continuing.
35 2021-04-22 burning sensation Severe allergic reaction with hives that started on my face and moved down to my neck and body also ... Read more
Severe allergic reaction with hives that started on my face and moved down to my neck and body also with a cough. Went to Er bc my face felt like it was on fire and they gave me meds and a steroid shot and I know have to take steroids for 3 days along with Benadryl every 6 hours as well.
35 2021-04-23 pain in extremity neck and arm soreness; neck and arm soreness; L supraclavicular lymph nod swelling; This is a sponta... Read more
neck and arm soreness; neck and arm soreness; L supraclavicular lymph nod swelling; This is a spontaneous report from a contactable other HCP (patient). A 35-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via unspecified route of administration in left arm on 27Jan2021, (at the age o f 35-years-old) as a single dose for COVID-19 immunisation. The patient medical history reported as non-chronic (not specified). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medication was reported as none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 09Feb2021, the patient Initially had neck and arm soreness 12 days post vaccine noted L supraclavicular lymph node swelling. The patient did not receive any treatment for the events. The outcome of the events was not resolved.
35 2021-04-24 tingling felt a little tingly; Sat down for 15 mins and could not stand up because I was too dizzy; was break... Read more
felt a little tingly; Sat down for 15 mins and could not stand up because I was too dizzy; was breaking out in hives on my face and chest; my throat started closing; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8734) at single dose on 06Apr2021 12:00 in left arm for COVID-19 immunisation. Medical history included fibromyalgia; asthma (controlled). Patient had known allergies to CT contrast and codeine (when taken with albuterol). Concomitant medications in two weeks included pregabalin (LYRICA), baclofen, nortriptyline, vitamin D3. There was no other vaccine in four weeks. Patient got the shot and felt a little tingly and sat down for 15 mins and could not stand up because she was too dizzy. Her daughter (also there receiving the shot) grabbed paramedics to check if this was common. The paramedics helped walk her to their triage room set up maybe 50 yards away. By the time they got there, patient was breaking out in hives on her face and chest. The paramedics started setting up an IV and that was when her throat started closing. Patient was given a shot of EPI while they finished the IV and gave her a bunch of other things in the IV. Patient got another shot of EPI in the ambulance on the way to the hospital and was put on an EPI drip while admitted. Patient stayed in the hospital while they tried several times to take her off EPI, but was not successful until the end of the third day (Thursday night) when she was sent home. Patient returned to hospital Monday and currently still under medical care at home. All adverse events start date was 06Apr2021 12:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The seriousness criteria was hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized 3 days for the events, treatment included medication intervention. There was no covid prior vaccination, covid was tested post vaccination. Novel corona virus test via nasal swab on 13Jun2020 and 22Jun2020 were both negative; COVID-19 RT PCR via nasal swab on 21Jan2021 was negative. The outcome of events was recovering.
35 2021-04-24 feeling hot tested positive for Covid last Sunday; tested positive for Covid last Sunday; Hot and Cold; Hot and ... Read more
tested positive for Covid last Sunday; tested positive for Covid last Sunday; Hot and Cold; Hot and Cold; nauseated/Nausea; fever; chills; headache; tired; feeling bad; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EP6955), on an unspecified route of administration on Arm Left on 19Mar2021 at 11:00 as single dose for COVID-19 immunisation. No additional vaccines were administered on the same date. The patient had a medical history included ongoing asthma (last time she had asthma was one month ago. Caller doesn't remember when she was first diagnosed by a doctor). The patient's concomitant medications included paracetamol (TYLENOL) and ibuprofen (MOTRIN); both are at three times a day (takes it every 8 hours). The patient was not received any vaccinations within 4 weeks. It was reported that, Patient felts tired after the vaccine. Caller states her first dose was 19Mar2021 and the next day 20Mar2021, she was tired and had a headache. Caller states she has chills on 27Mar2021 for two days only. Caller verifies it was chills she was experiencing, states she was hot and cold on 27Mar2021, unsure of what the word is in English for that. Tired and headache no more after the vaccine. Caller states nausea stopped around 03Apr2021 or 04Apr2021. Caller states she waited for her test to come back, her symptoms were bad on 27Mar2021, so she waited and stayed in her house. Caller states she tested positive for COVID, last Sunday, she waited for a long time for the test to come back. Caller verifies the date she was tested for COVID was 04Apr2021 and she found out the same day she was positive. Patent second dose will be scheduled tomorrow (09Apr2021). Caller states she would like to know if she can take the vaccine tomorrow or if she needs to wait. The patient was not visited to emergency room. Caller states she went to her physician's office after her first dose of the vaccine. Caller states she visited her family doctor because she was feeling bad by a telephone appointment yesterday with her. Caller states her doctor said she needed her weight, and she can take Tylenol. The outcome of the event tested positive for Covid last Sunday was reported as recovering, fever, chills, Hot and Cold was recovered on 28Mar2021, headache was recovered on 04Apr2021, tired was recovered on 05Apr2021, nausea was recovered on Apr2021, whereas outcome for feeling bad was unknown. Follow-up attempts are completed. No further information is expected.
35 2021-04-27 burning sensation Experiencing what is being described as ?Covid Arm?. Redness at injection site, hard lump, feverish ... Read more
Experiencing what is being described as ?Covid Arm?. Redness at injection site, hard lump, feverish to touch, painful. My arm feels like dead weight and there?s a white hot burning sensation in my shoulder joint. Nausea, dizziness and light headed feeling that comes and goes.
35 2021-04-27 tremor Nearly fainting; vertigo like symptoms; lightheaded; lethargic; blurred vision; shaky; heart palpita... Read more
Nearly fainting; vertigo like symptoms; lightheaded; lethargic; blurred vision; shaky; heart palpitations; limbs feel heavy; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ep 6955) via an unspecified route of administration, administered on the right arm on 26Mar2021 15:30 at a single dose for COVID-19 immunization. Medical history included anxiety, depression; and known allergies: penicillin and gluten. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and sertraline hydrochloride (ZOLOFT). The patient previously took amoxicillin and diflucan and experienced allergies. On 30Mar2021 22:00, the patient experienced nearly fainting, vertigo like symptoms, lightheaded, lethargic, blurred vision, shaky, heart palpitations and limbs feel heavy. The event resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for the events for 1 day. Treatment was received for the events which included medication, heart monitor, MRI, MRA, MRV, CT scan. COVID test post vaccination included nasal swab on 01Apr2021: negative. Patient was not pregnant. The facility where the vaccine was administered was in a school or student health clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
35 2021-04-28 pain in extremity Caller states she was not due for her monthly menstrual period for another week, so she found, passi... Read more
Caller states she was not due for her monthly menstrual period for another week, so she found, passing the clot, odd.; Blot clot/Very big blood clot, that passed out of body; Fever, of 102; Sore arm; This is a spontaneous report from a contactable Other HCP (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 29Mar2021 09:00 (Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included ongoing asthma , contraception. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for contraception from an unspecified start date and ongoing. The patient previously took bactrim and experienced drug hypersensitivity. The blood clot only was for one day on 31Mar2021, and it was one blood clot. The patient went to the bathroom and it was passed, one time. The patient was not due for her monthly menstrual period for another week, so she found, passing the clot, odd. The patient menstrual period did happen on time and it was normal. The patient was not due for her menstrual period for another week, and she takes birth control. The patient contacted her Gynocologist, and it was confirmed that she was not pregnant, and states her menstrual period happened on time. The clot did not happen again. The patient had Fever, of 102 on 30Mar2021, the temperature resolved in a day. The patient took Aleve, drank a lot of water and napped, reclarifies, and the temperature improved. The patient experienced sore arm on 30Mar2021. The outcome of event Clot blood was recovered on 31Mar2021; outcome of event Fever was recovered on 30Mar2021; outcome of event Sore arm was recovered on 01Apr2021, outcome of other event was unknown. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Thrombosis and Menstrual Disorder cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
35 2021-04-28 seizure had 5 small seizures; felt very dizzy; This is a spontaneous report from a contactable consumer (pat... Read more
had 5 small seizures; felt very dizzy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 09:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included pre-diabetes and depression. Patient was not pregnant. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. The patient previously took antibiotics and antidepressants and experienced allergies. 5 minutes after getting the vaccine, patient felt very dizzy. She had 5 small seizures on 14Apr2021 10:45 which resulted in emergency room/ urgent care. Treatment was received for the events. Outcome was recovering. Patient had covid prior to vaccination on an unspecified date and had not been tested post vaccination.
35 2021-04-30 flushing cold feeling in chest; About 35 minutes post 2nd vaccine, I had a severe panic attack; Flushing feel... Read more
cold feeling in chest; About 35 minutes post 2nd vaccine, I had a severe panic attack; Flushing feeling; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient (not pregnant, age at vaccination: 35-year-old) received the second dose of bnt162b2 (BNT162B2, lot EW0161), via an unspecified route of administration in the right arm, on 15Apr2021 as SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported. She had her first dose of bnt162b2 (lot EN6204) on 18Mar2021, administered in the left arm. The patient previously took aspirin (acetylsalicylic acid) and experienced drug allergy. Concomitant medications included atenolol, hctz, hydrocodone, cyclobenzaprine hydrochloride (FLEXERIL) and gabapentin; taken for an unspecified indication, start and stop date were not reported. On 15Apr2021 19:45, she had panic attack, flushing feeling, shortness of breath and cold feeling in chest. These did not occur with the 1st dose of vaccine. As treatment, she was given with 3mg Ativan PO (oral). The outcome of events was recovering. Information on the lot number was already obtained.
35 2021-05-10 numbness, tingling difficulty breathing; racing heart; Dizzy; nauseated; headache; heart attack; fingers started tingli... Read more
difficulty breathing; racing heart; Dizzy; nauseated; headache; heart attack; fingers started tingling and going numb; fingers started tingling and going numb; arms became heavy; lethargic; feeling exhausted; Arms are still weak; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 23Apr2021 09:00 (Batch/Lot Number: EW0169) as single dose for covid-19 immunisation. Medical history included scoliosis. The patient's concomitant medications were not reported. Patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CR8733), at age of 35 years old, administered in arm left on 02Apr2021 05:00 PM, for covid-19 immunisation. The patient experienced dizzy and nauseated with a headache at 3:00am 26Apr2021. At 7:00am patient woke up again with the same symptoms but strong nausea, difficulty breathing and racing heart. Her fingers started tingling and going numb once she was up (on 26Apr2021). Her arms became heavy and she started feeling lethargic (on 26Apr2021). Patient thought she was having a heart attack on 26Apr2021. Blood pressure was normal and pulse ox was normal. Most symptoms subsided by 11:00am. Arms are still weak at 7:47pm. Still feeling exhausted. Events resulted in doctor or other healthcare professional office/clinic visit. No other vaccine administered in four weeks. No other medications in two weeks. No treatment was received. No covid prior vaccination. No covid tested post vaccination. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcomes of events were recovering.
36 2021-01-03 nerve pain, burning sensation, numbness 12/24/2020 swollen right side lymph nodes under arm; felt "on fire" reduced burning sensation over t... Read more
12/24/2020 swollen right side lymph nodes under arm; felt "on fire" reduced burning sensation over time. Then 1/1/2021 patient got weakness in bilateral arms, felt "rubbery" ; left arm and neck lymph nodes swollen 1/3/2021 was seen in ER for full body numbness, prickly heat, like waves of it. Bilateral arm weakness; nerves feel "on fire". vomiting x 1 50 mg of Benadryl taken approximately 9 pm on 1/3/2021.
36 2021-01-03 weakness Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110 muscle ache, fatigue, ... Read more
Delayed Moderate. temp 100.6-100.1, , nausea,chills, elevated Heart rate 110 muscle ache, fatigue, weakness
36 2021-01-03 tenderness Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issu... Read more
Gold ball sized lump to left armpit near breast that was tender and warm to the touch. No prior issues with armpit or breast tissue. Needed to take Motrin/Tylenol for pain and swelling for two days after vaccination.
36 2021-01-03 pain in extremity, cold sweat, flushing Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was f... Read more
Injection received at 0815. At 0900 I started getting diaphoretic, clammy, nauseas and my face was flushed. At 0930, I developed hives on my neck, chest and arms. I immediately went back to the vaccination site (I was still in the hospital at work) and was administered 25mg oral Benadryl and monitored for 30 minutes. The hives resolved, but I still felt unwell. At 1600 I noticed a swelling in my right upper thigh about the size of my hand. It was about 2 inches inferior to my inguinal crease and was the width of my thigh. It was mildly painful to the touch. My injection site was red, inflamed and itchy. I continued taking 25-50mg Benadryl Q4 and took 100 mg at night due to itchiness on my eyes, face, neck, chest and arms. This is still present, although less each day, as of Monday 1/4/21 morning. I have felt feverish but have not had a recorded fever. I took some Ibuprofen for the pain in my arm at the injection site. The redness, swelling and itchiness has decreased each day at the injection site, but is also still present as of Monday 1/4/21 morning. I still feel unwell and have continued diarrhea throughout the weekend.
36 2021-01-04 flushing Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands... Read more
Angioedema of lips, throat, eyes, hands. Flushing of hands; Angioedema of lips, throat, eyes, hands. Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
36 2021-01-04 flushing At 8:20 AM she complained of tongue swelling, Facial Flushing, BP went up 174/112, Pulse 123, Used a... Read more
At 8:20 AM she complained of tongue swelling, Facial Flushing, BP went up 174/112, Pulse 123, Used albuterol inhaler, Benadryl 50 MG PO, Vitals Signs gradually returned to normal BP on discharge 122/87, Discharged to coworkers at 9AM.
36 2021-01-04 weakness Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, los... Read more
Begin with localized tenderness and pain at injection site. Progressed to joint pain in the arm, loss of strength, tenderness and inability to move arm.
36 2021-01-04 flushing, feeling jittery, cold extremities, tremor, feeling hot I have learned that it was syncope. I felt like time was moving quickly. I was jittery and felt like... Read more
I have learned that it was syncope. I felt like time was moving quickly. I was jittery and felt like my heart was beating quickly. I was taken to a separate area and felt warm and flush in my chest. They laid me down on the cot and said I looked pale. My hands were cold and within minutes I was shaking uncontrollably. I think it was an anxiety related to my research I've done at my job related to COVID. I don't think it was an allergic reaction, but I do have an appt on Thursday. I was monitored for about an hour. Symptoms went away but I wasn't totally ok until the next day besides soreness in next arm.
36 2021-01-04 pain in extremity I worked the night of 18th and 19th (night shift nurse) - night of 18th - arm very sore (dominant ... Read more
I worked the night of 18th and 19th (night shift nurse) - night of 18th - arm very sore (dominant arm where shot was taken) by end of night arm was sore; continued for several days. (Got my period either the night of 18th or morning of 19th). About 36 hours after vaccine; stood up to attend an alarm and felt very ill at patient's bedside and had to sit down: nauseous (felt similar to co-vid) - took Motrin an hour later; the day of 20th - slept all day; 21st - no appetite; mild headache - nauseous - period at same time of vaccine; 22nd - felt bleh; didn't eat much food - period going away but I was feeling worse; feel like I have the return of internal vibrations (can sit in my hands when I'm trying to do something for a patient that needs done quickly) back in July when I had Co-Vid (when I was out of work out of month - and had to see a cardiologist - two months until normal (neural and cardiac symptoms that went away with time) - so was returning of buzzing/etc. 23rd: could feel like I had internal vibrations sensations; nauseous - increased - got a refill from an old dental prescription - started Zofran; headache pressure (head pressure); a vertigo-ish feeling - felt like I just walked off a boat; at that point - called out of work - COVID hotline hospital call - did a rapid test that was negative (on 24th) and on 24th: had still all the same symptoms - nausea was worse and felt a bit more dizzy occasionally and called out of work again but could take care of myself (laid around) - " it felt like baby covid" 25th - work wanted me to get tested again; 26th - Panther Co-vid test - which was also negative. 27th and 28th - dizziness better; still taking Zofran one time /day (for nausea); was able to go to work on 29th - still had some nausea but didn't have to lie down all day anymore - still had internal vibrations - feels like I should be having a tremor but can't see it externally; 30th finally able to see primary care Dr and she ordered lab work: Dr wasn't certain it was an adverse effect vs. me feeling my own immune response to spike protein; Initial covid symptoms in July were similar to this; and she will see how things go; SED Rate was 1 so not concerning; CBC was fine and B12 was fine. Not much as changed since then: returned to work; can go about things in every day; stopped taking Zofran on 31st; I still had nausea but it was mild enough that I didn't need to take it and Dr said it would be best to stop due to it's on effects. Yesterday, was first day with no nausea (1/4/2021); still have internal vibrations sensation but it has gone down quite a bit - now more of a mild buzzing electric current sensation - like insides are buzzing super fast ; when I noticed when not occupied with other things which is how it faded out with original illness.
36 2021-01-04 pain in extremity, tingling Pt reports tingling and sweating to R side of the body (face, arm, and leg). Reports HA R side of b... Read more
Pt reports tingling and sweating to R side of the body (face, arm, and leg). Reports HA R side of body. As evening progressed, patient reports worsening HA and vomiting. Pt reports pain in R arm and swelling in armpit area. Reports s/s resolved the next day. Recommended f/u with PCP.
36 2021-01-04 weakness starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have b... Read more
starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have blood work done to see if I was experiencing anemia. Blood work complete on 12/31/2020. On 1/3/2021, I woke up with blood blisters all over the inside of my mouth and petechia on my trunk and bilateral upper and lower extremities. I called my primary physician to report the symptoms. He suggested to go to the ER if my symptoms worsened. Later that evening I started with a nose bleed and did go to the ER. Upon arrival to the ER, my platelet count was 9. I was admitted to the hospital and diagnosed with ITP.
36 2021-01-04 pain in extremity, feeling hot woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection si... Read more
woke up with a slight headache; she felt her whole arm was sore; slight soreness at the injection site; felt some warmness right after the vaccine, like she felt kind of high; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular at deltoid left on 23Dec2020 at single dose for COVID-19 immunization. The patient medical history included ongoing high blood pressure. Concomitant medication included hydrochlorothiazide/losartan (strength: 25mg/320mg, formulation: tablet), oral one dose form from an unknown date and ongoing, once a day for blood pressure high. The patient previously took flu vaccine for immunization and experienced soreness in her arm and generally felt tired throughout that week. The patient reported that on 23Dec2020 she felt some warmness right after the vaccine, like she felt kind of high (she doesn't know if it was just nerves with this being a new vaccine) and slight soreness at the injection site, on 23Dec2020 at 19:00 she felt her whole arm was sore and on 24Dec2020 she woke up with headache. The patient outcome of the events was unknown.
36 2021-01-05 pain in extremity, tingling 40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching s... Read more
40 seconds after shot: tingling in left arm and left hand with then wooziness. Tingling itching sensation and mind pain in left arm and hand continued for a few hours then spread into left leg which continued into the next day. Moderate left shoulder tenderness 6 hours after shot lasting 2 days. 6 days after shot severe lethargy, body aches and brain fog which is current on 01/06/21.
36 2021-01-05 hot flush, pain in extremity Employee received Pfizer COVID-19 vaccine on 12/23/2020. Waited 15 minutes after immunization and f... Read more
Employee received Pfizer COVID-19 vaccine on 12/23/2020. Waited 15 minutes after immunization and felt fine. Started to have a hot flash on the way home. Then her tongue felt sluggish but not swollen. She had a few minutes having difficulty swallowing but denies a sensation of throat swelling. Arm became sore and heavy but no redness. Drove back to the hospital with the onset of these symptoms and waited in the parking lot for 15 minutes to see if the symptoms were going to progress but they didn't. Stated she became very fatigues for a few hours but felt fine the next day except for a sore arm.
36 2021-01-05 muscle twitching Facial hives: resolved with PO Benadryl Right eye/cheek muscle twitching (ongoing for 1 week and c... Read more
Facial hives: resolved with PO Benadryl Right eye/cheek muscle twitching (ongoing for 1 week and continuously occurring).
36 2021-01-05 feeling hot, tingling, pain in extremity, facial paralysis I recieved my injection at 1:00pm. My arm became sore around 3:30pm as expected. I became very ti... Read more
I recieved my injection at 1:00pm. My arm became sore around 3:30pm as expected. I became very tired around 5pm. Around 6:30 I experience heat on the left side of my neck up to the back of my left ear. Also tingling, mild swelling, and drooping on left side of face that lasted a couple of hours. The next day I still experienced the heat feeling in left side of neck up to the back of left ear, fatigue, and soreness in arm. But by 3pm I felt fine and haven't had any problems since.
36 2021-01-05 migraine I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in ... Read more
I suffered an ocular migraine 5 days post vaccine. Never had one before. Very scary. Zigzag spot in both fields of visions for 10 minutes followed by kaleidoscope vision in the left field for 5 mins. No headache after.
36 2021-01-05 night sweats Nausea, headache, diarrhea, nightsweats, sore throat and swollen lymph notes causing difficulty swal... Read more
Nausea, headache, diarrhea, nightsweats, sore throat and swollen lymph notes causing difficulty swallowing x 2 days (took ibuprofen) Multiple fever blister outbreaks since receiving vaccine
36 2021-01-05 numbness, tingling, pain in extremity On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness i... Read more
On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness in my upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. It is now 3pm, about 21 hours since vaccination-fever has broken once (I took ibuprofen at 2pm) but returned but not as high, and severe headache with light sensitivity. The joint pain and numbness has faded but I am left with severe muscle soreness, like I was in a car accident. Oh and I lost taste sometime today. Also I had injection site pain for both doses, starting the morning after.
36 2021-01-05 burning sensation, weakness Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash fr... Read more
Per patient: "I recieved the covid vaccine on 12/29/2020. Ten minutes later I broke out in a rash from chest down it was a burning and itching and red spots. They took me to ER and gave me medicine. Within 40 mins I felt better so I left to go home. I have been feeling really tired and weak. I went home on the 4th with weakness and I did vomit 1 time. I felt sick to my stomach all day. I came back to work today still feeling nausiated."
36 2021-01-05 muscle twitching Pt developed Left eye twitching on 12/20/20 which continues to 1/4/21
36 2021-01-05 breast pain Swollen lymph nodes in arm pit and breast with pain
36 2021-01-05 pain in extremity Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint p... Read more
Usual sore arm and headache right after the vaccine, followed by body aches, fevers, chills, joint pains, sore throat, cough, swollen lymph nodes, and now a facial rash.
36 2021-01-06 tremor Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headac... Read more
Got vaccine at 1100am Starting at about 1100pm, I developed shaking chills, myalgia, Frontal Headache, nausea. I had redness and soreness at site of injection. Symptoms resolved within 24hrs with help from Tylenol.
36 2021-01-06 feeling hot Immediately after injection, I felt a warm feeling flow from the injection site and across my chest.... Read more
Immediately after injection, I felt a warm feeling flow from the injection site and across my chest. No shortness of breath or chest pain. Felt slightly light-headed. Drank water and ate some food to closely monitor. Very sore Left deltoid starting about 8 PM on 12/31/20 (same day as the vaccine administration). It was so sore that it woke me up a few times at night and 1/1/21 I had to take Ibuprofen 400 mg to alleviate the pain. Had a dull headache all day 1/1/21 and very tired. Slept that night from 9 pm - 8 am next day. No symptoms since 1/3/21.
36 2021-01-06 flushing, tingling Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from v... Read more
Lightheadedness, chest pain/pressure, flushed skin of chest, tingling BLE > BUE. Taken to ED from vax site. Improved but still with lightheadedness and rash of upper chest. Given IVF and benadryl injx. Observation x 3 hours.
36 2021-01-06 tingling, numbness Pt reports numbness/tingling in hand and fingers on the right. Pt received 2nd dose of COVID-19 in r... Read more
Pt reports numbness/tingling in hand and fingers on the right. Pt received 2nd dose of COVID-19 in right upper arm approximately 5 minutes prior to time of RRT. Observed pt from 1146 to 1205. Pt maintained stable vital signs throughout observation period, maintained a strong regular pulse ranging from 80 - 90 bpm. Maintained oxygen saturation on room air between 98-100%. At time of release, pt was still exhibiting numbness in fingers and palm of right hand. Good range of motion with right arm. Denies any symptoms other than the above stated. Provided pt of option to be seen in the emergency department, but pt declined, and stated that she would like to wait and if her symptoms persisted or worsened, she would come back to the ER.
36 2021-01-06 facial paralysis transient right sided facial droop lasting 2-3 seconds 4 days after COVID-19 shot #1 of 2
36 2021-01-07 pain in extremity - Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along w... Read more
- Almost immediate onset of nausea, sore throat, headache, and sensation of fast heart rate; along with feelings of mild illness (like a cold) and arm pain which is consistent with other vaccination response. - Waited at clinic for 30 minutes as directed due to previous history of anaphylaxis to injected meds (among others). Reported feeling poorly to nurse monitoring people waiting at 30 minute mark, who encouraged waiting longer but did no further assessment. Waited another 15 minutes with no resolution or improvement. Decided to leave and monitoring staff said they could not keep patients if they wanted to leave. - Approximately 15 minutes later (1hr after injection), took one 25mg Benadryl liquid gel as nausea/headache/fast heart rate were consistent with prior allergic reaction and not with prior vaccine response. Those symptoms resolved after 1-2 hours; the feeling of mild illness lingered for approx. 3 days more.
36 2021-01-07 flushing, numbness Approx 10-15 min post vaccine, pt began to c/o bilat foot numbness & flushing. NIBP 172/30, HR 90s. ... Read more
Approx 10-15 min post vaccine, pt began to c/o bilat foot numbness & flushing. NIBP 172/30, HR 90s. Benadryl 50 given IM. Pt discharged to ED, NIBP 157/111 HR 102.
36 2021-01-07 tingling, flushing, numbness Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/9... Read more
Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/90, HR 90s. No SOB, hypoxia. Benadryl 50 IM given @ 1756. Pt discharged from vaccine clinic to ED. NIBP 157/111, HR 102 @ time of discharge.
36 2021-01-07 migraine, flushing Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my th... Read more
Around 10:30pm I felt like my throat was closing and I was choking; Around 10:30pm I felt like my throat was closing and I was choking; I had chest pain, chest tightness; I had chest pain, chest tightness; Very SOB at rest; Throughout the day I was cough and my face started flushing so I tool Benadryl/severe facial flushing; On 23Dec I got nerve blocks for my migraines.; Throughout the day I was cough and my face started flushing so I tool Benadryl.; This is a spontaneous report from a contactable nurse who reported for herself. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK5730) dose number 1, via an unspecified route of administration on 19Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included von willebrand's disease, narcolepsy with cataplexy, IIH (Idiopathic intracranial hypertension), HTN (hypertension), GERD (gastrooesophageal reflux disease), migraines. Patient also had known allergies: PCN (penicillin), shellfish, IV contrast, cefdinir and bees. On 23Dec2020, patient got nerve blocks for her migraines. Throughout the day patient was cough and her face started flushing so she tooled diphenhydramine hydrochloride (BENADRYL). Around 22:30, patient felt like her throat was closing and she was choking. She had chest pain, chest tightness. EMS (emergency medical services) was called and patient was brought to the hospital. On 25Dec2020, patient felt like her throat was closing, like someone was sitting on her chest and chest tightness still with chest pain. Very SOB (shortness of breath) at rest. Patient went to the ER (emergency room) and received IV dexamethasone (DECADRON) and diphenhydramine hydrochloride. On 26Dec2020, patient had the same symptoms but with severe facial flushing and patient went back to the ER and was given IV dexamethasone. Patient was sent home on a maximum amount of medications. I had seen her primary care, ENT (ear nose throat centre), Allergy, ID (infectious disease), and pulmonology. Her CT (computerised tomogram) of chest on 25Dec2020 was negative along with her COVID test. Patient SOB on rest and exertion still. Onset date of the adverse events was reported as 23Dec2020, 22:30. Patient received treatment for the events included multiple medications and high dose prednisone. Lab data on 25Dec2020 included CT of chest: negative, influenza type A/B combo: negative, Covid 19: negative and nasal swab: negative. Action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. The clinical presentation of the events is suggestive of possible allergic reactions. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-07 numbness Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours; light headed; numbnes... Read more
Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours; light headed; numbness in left hand and fingers from arm swelling; numbness in left hand and fingers from arm swelling; nausea; chills; headache; body aches; joint pain; first dose on 16Dec2020 10:15, second dose on 04Jan2021 11:45; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, first dose on 16Dec2020 10:15, second dose on 04Jan2021 11:45 (lot number EJ1685), both on left arm at single dose for COVID-19 immunization. Medical history included known allergies Sulfa. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced Fever of 102.6 F for 6 hours, fever of 100.4 or greater for at least 24 hours, light headed, numbness in left hand and fingers from arm swelling, nausea, chills, headache, body aches and joint pain on 04Jan2021 14:30. Patient received Acetaminophen and ibuprofen for treatment. The outcome of the events was not recovered.
36 2021-01-07 breast pain In addition to my first report, I want to add: Pain and soreness in my left armpit/breast area since... Read more
In addition to my first report, I want to add: Pain and soreness in my left armpit/breast area since 12/25 that started mild and is moderately sore and painful. It seems to be getting worse.
36 2021-01-07 tingling, numbness Patient had numbness, itching, tingling in left face. Given Benadryl 25mg, Pepcid 40mg po. symptom... Read more
Patient had numbness, itching, tingling in left face. Given Benadryl 25mg, Pepcid 40mg po. symptoms responded rapidly. No complaints of GI, respiratory, cardiovascular symptoms. Observed almost an hour and a half.
36 2021-01-07 sensory loss Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by n... Read more
Patient presented to the emergency department with sensory loss and loss of reflexes, evaluated by neurology and diagnosed with Guillain- Barre Syndrome thought to be secondary to the Pfizer Covid Vaccine
36 2021-01-07 feeling hot Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ... Read more
Patient started having severe dizziness, with a racing pulse. Pt stated she felt very warm. Given ice pack and cold cloths. BP was slightly elevated. Pulse initially was about 112. Had patient lay down and she felt better. Thought to be vasovagal response. Starting at 01:30 on 1/7/21 she had a severe headaches, eyes watering, runny nose, dry throat. Injection site reaction
36 2021-01-07 tingling Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine... Read more
Tingling/Hot burning throat/tachycardia and chest tightness. Presented to ED. Given diphenhydramine. Observed and discharged.
36 2021-01-07 pain in extremity headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that... Read more
headache; arm soreness for 3 days; fever and back pain that began Thursday; fever and back pain that began Thursday; nausea; body aches for 2 weeks; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 30Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. Medical history was not reported. The patient's concomitant medications were not reported. On an unknown date the patient experienced headache, arm soreness, body aches for 2 weeks, fever, back pain and nausea. The patient reported feeling absolutely horrible, which felt like it is escalating sometimes per patient. The patient stated that it was initially just arm soreness for 3 days then all other symptoms including fever and back pain that began Thursday (date unknown), and now a headache, per the patient "before it was just soreness, body aches for 2 weeks, nausea". The patient is completing daily check-ins on the website name. She has a copy of the Fact Sheet for Recipients and Caregivers. The clinical outcome of the headache, arm soreness for 3 days, fever, back pain, nausea and body aches for 2 weeks was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
36 2021-01-07 numbness, tingling numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no... Read more
numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no drooping to face hives injection site pain
36 2021-01-07 pain in extremity sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by feve... Read more
sore arm immediately. then 10 hours after the shot, chills, headache, and back pain followed by fever up to 104.7, abdominal pain, nausea and vomiting, myalgia, and cough.
36 2021-01-07 nerve pain, muscle spasms vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; ... Read more
vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; vaccination burning, itching redness to eye lids; It appears I have eye shadow; peeling/dryness of skin around lips; peeling/dryness of skin around lips/It appears I have eye shadow but peeling is not visible; burning and itch of lip region; burning and itch of lip region; muscle spasm; Neuralgia; medium-severe headache; nausea; sensitive to light; mild confusion; lack of concentration; This is a spontaneous report from a contactable nurse (patient herself). A 36-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular in 28Dec2020 08:30 at a single dose in the left arm as COVID vaccine. Medical history included history of Grave's disease at age 19 which has resolved without medication for many years. The patient had no known allergies: no allergies to medications, food, or other products. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient had no other vaccine in four weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not taking any daily medications. On 28Dec2020 (day 1), patient had no significant symptoms. On 29Dec2020 (day 2), patient had medium-severe headache, nausea, sensitive to light, mild confusion and lack of concentration. On 30Dec2020 (day 3), patient had muscle spasm that wake from a sound sleep in biceps tendon region, and neuralgia in left upper and lower extremities. On 31Dec2020 (day 4), patient had peeling/dryness of skin around lips, burning and itch of lip region. On 01Jan2021 (day 5), patient had post vaccination burning, itching redness to eye lids. Patient realized patient should photo her journey. It appeared patient have eye shadow but peeling was not visible due to moisturizer and bacitracin "ito" try and sooth the pain. Patient can send at additional request since patient can't upload. The patient was not tested for COVID post vaccination. Therapeutic measures were taken as a result of the event "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible". No treatment received in response to the other events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The outcome of the events medium-severe headache, nausea, sensitive to light, mild confusion, lack of concentration, muscle spasm, neuralgia in left upper and lower extremities, dryness of skin around lips, "peeling/dryness of skin around lips/it appeared patient have eye shadow but peeling was not visible", burning and itch of lip region, post vaccination burning, itching redness to eye lids, and "it appeared patient have eye shadow" was not recovered. Information on the lot/ batch number has been requested.
36 2021-01-08 feeling cold, cold sweat !2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, swea... Read more
!2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, sweats, diaphoretic / pale clammy skin, fever, and joint pain. all the fore mentioned symptoms were not all at once, every half hour and not all once. some symptoms lingered longer than others.
36 2021-01-08 pain in extremity 1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: seve... Read more
1/7/21 at 0850: received vaccine 1200 - left arm soreness 2200 - headache began 1/8/21 at 0000: severe chills, worsening headache and neck pain, temperature started to rise, muscle and joint aches began 0500 - chills and aches continued, temperature max of 102.2 0800 - severe muscle aches, fever remained around 102, pulse 130's, SO2 99% 0900-2100 - rested the entire day, unable to move much because my body aches were so severe, when I did get up to go to the bathroom, I could barely walk because my hips and knees hurt so much, headache so severe that I began getting nauseous and dry heaving, I took 650mg acetaminophen and 25mg Benadryl around noon and used ice packs on my neck and the back of my head, ate very little, no appetite, drank water and ginger ale, temperature fluctuated between 101 and 102 all day, came down to 99.6 after acetaminophen, but came right back up to 101 as it wore off 2200 - took 975mg Tylenol and 25mg Benadryl and went to sleep, temperature 100.9 1/9/21 - 0900 - woke up after sleeping all night, temperature 98.2, body aches and headache gone, feel normal
36 2021-01-08 numbness, tingling 25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to loc... Read more
25 minutes after receiving vaccination ascending numbness of left half of tongue (ipsilateral to location of vaccination site) with associated moderate headache. No tongue swelling or weakness. No breathing difficulty. This was followed by left arm numbness and mild left leg numbness. Left-sided paresthesias /numbness resolved within 3 hours of vaccination. The severity was mild-moderate without there ever being complete loss of sensation. No vision problems or weakness.
36 2021-01-08 pain in extremity, tingling, numbness Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of ap... Read more
Fever and chills starting 5 hours after dose, joint pain, myalgia, anxiety, palpitations, loss of appetite, fatigue, abdominal pain, dizziness, near syncope, headache, insomnia, arm soreness, tingling and numbness in my face and mouth about 10 hours after dose and lasting about 30 min, taking ibuprofen one tablet q6 hours for fever and pain. 26 hours dose symptoms are improving
36 2021-01-09 bell's palsy, facial paralysis Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swell... Read more
Bell?s palsy the morning after the vaccination administration with left facial droop, left lip swelling
36 2021-01-09 pain in extremity Fever of 102 degrees, chills, headache, muscle aches, fatigue, sore arm. Sore arm mild night of inje... Read more
Fever of 102 degrees, chills, headache, muscle aches, fatigue, sore arm. Sore arm mild night of injection, severe and with back pain upon waking on 1/5. By noon of 1/5, had all symptoms listed above. Continued worsening until I took Motrin 400 mg at 6:00pm. Symptoms improved significantly within 30 minutes, fever resolved. Body aches and sore arm persisted at mild levels for a few days but resolved by 1/8.
36 2021-01-09 pain in extremity Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen fo... Read more
Headache, Vertigo, and nausea for one day 7am-3pm, sore arm all day for one day, I used Ibuprofen for the headache and slept off all the symptoms
36 2021-01-09 pain in extremity Lethargy, Headache, Sore arm, Body aches for 36 hours
36 2021-01-09 tingling Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getti... Read more
Syncope at approximately 5:20am this morning. I had been awake and active for about 30 minutes getting ready for work. As I was walking to my kitchen, I suddenly became very dizzy with blurred vision, tingling hands, nausea, ringing in my ears, and I felt like I was going to lose control of my bowels. I became very weak in the legs and I made it to the couch before I fell. Episode lasted approximately 2 minutes. As I laid down, my symptoms recovered. My husband gave me some juice and toast. After about 20 minutes, I got up and was able to walk without symptoms. I felt perfectly normal prior to this event. Last night, I ate a full dinner and drank about a liter of water. This event did not seem to be precipitated by hypoglycemia or dehydration. For the rest of this day, I have felt normal.
36 2021-01-09 tingling Two minutes after: facial and hand tingling, dizziness. Progressed to intense nausea, diaphoresis, t... Read more
Two minutes after: facial and hand tingling, dizziness. Progressed to intense nausea, diaphoresis, tachycardia, hypertension.
36 2021-01-10 numbness Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later th... Read more
Had palpitations while I was sleeping that woke me up. Had numbness to right and left arms. Later that morning around 1130 had palpitations, dizziness, lightheaded ness that would not go away even when sitting down. I felt numbness around my mouth took blood pressure and it was elevated 200 systolic and 100 systolic called EMS they assessed my blood pressure but it was normal systolic 130?s which is hi for me Norma blood pressure for me 90-100 systolic
36 2021-01-10 tingling Headache, body aches, chills, fatigue, dizziness, confusion, extremity tingling in first 24 hours. A... Read more
Headache, body aches, chills, fatigue, dizziness, confusion, extremity tingling in first 24 hours. At 26 hours post injection, severe left axillary lymphadenopathy noted with axillary pain.
36 2021-01-10 migraine I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 day... Read more
I would say the day after mild injection site pain, then at 10 days after mild fatigue and at 14 days after a migraine.
36 2021-01-10 tenderness Lump found above left collarbone. Painful, tender to touch. Have an appt with my PCP 1/13 to be ass... Read more
Lump found above left collarbone. Painful, tender to touch. Have an appt with my PCP 1/13 to be assessed.
36 2021-01-10 numbness, tingling Stiff neck like symptoms; including pain/aches in neck, radiating to back of ear/inner ear, dull thr... Read more
Stiff neck like symptoms; including pain/aches in neck, radiating to back of ear/inner ear, dull throbbing in jaw, pain in shoulder blade/back area towards left side--all of these symptoms progressively worsened and it is currently day 5 and still in a lot of pain, facial numbness/tingling for first two days on left side.
36 2021-01-10 weakness eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; ... Read more
eventually inability to move arm; pain; joint pain; tenderness at injection site; loss of strength; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EJ1685) intramuscular at arm left, on 19Dec2020 06:45 at single dose for covid-19 immunisation. Medical history included ongoing acne. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included isotretinoin (ACCUTANE). On 19Dec2020 11:30, approximate 5 hours after vaccine, the patient experienced pain, joint pain and tenderness at injection site, progressively loss of strength and eventually inability to move arm. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-10 tingling tingling to neck PO oral Benadryl 25 mg given
36 2021-01-10 pain in extremity, hot flush, flushing tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt st... Read more
tongue not swollen but felt sluggish/tongue felt strange, it was sluggish to swallow; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/Her tongue felt strange; tongue felt strange like hard to swallow/tongue felt strange, it was sluggish to swallow/felt hard to swallow; hot flash; flush feeling all over her face/flush all over her face/she felt flush; arm was sore; arm was sore and heavy; drowsiness; pain and redness at injection site; pain and redness at injection site; This is a spontaneous report from a contactable nurse reporting for herself. A 36-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiry date not provided) on 23Dec2020 09:15 intramuscularly in the left arm for COVID-19 immunisation (reported as preventive). There was no relevant medical history and no concomitant medications. The nurse (patient) received her first dose of the vaccine on 23Dec2020 at the hospital that she worked at. She was kept there for 15 min for monitoring and she felt fine. About 30 minutes post vaccination she got a hot flash, a flush over her face, she does not know if she was red but she felt flush. Her tongue felt strange, nothing swelled that she could tell, it felt hard to swallow, to make the motion to swallow it felt kind of sluggish. She felt weird swallowing which lasted for only a few minutes. She never struggled to breathe. She went back to park in the hospital parking lot since she was not sure if she was experiencing a anaphylactic reaction and then after a few minutes it went away. Her arm was sore and heavy feeling for that day. She had drowsiness for a couple of hours and pain and redness at the injection site for a couple of days that was not bothersome, it was mild. No relevant test. She wanted to know if she should get the second dose of the vaccine due to the symptoms she had after the first dose. The pain and redness at injection site was resolved on an unspecified date in Dec2020, while the other events were resolved on 23Dec2020. The reporting nurse considered the events hot flash, flush all over her face, arm was sore and heavy, drowsiness, pain and redness at injection site were non-serious, while the events "tongue felt strange, it was sluggish to swallow" were serious that she drove back to the hospital (no emergency room/phycian office visit). She considered the events were related to the vaccine.; Sender's Comments: A possible contributory effect of suspect BNT162Bw on the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-01-11 tingling, numbness Began having numbess to face, tingling to hands and legs and dizziness that started roughly 6 hours... Read more
Began having numbess to face, tingling to hands and legs and dizziness that started roughly 6 hours after injection; felt dizzy with movement and that her legs were going to give out.
36 2021-01-11 weakness Day 0: Patient developed fatigue, headache, weakness, muscle aches. Describes muscle weakness as m... Read more
Day 0: Patient developed fatigue, headache, weakness, muscle aches. Describes muscle weakness as mostly in her legs, feeling like they are going to give out. Grip strength normal. No difficulty breathing. Pain in neck and back similar to pain she experiences with ankylosing spondalitis. No numbness or tingling in hands and feet. Day 8: COVID test done - negative. No other tests run. Day 10: COVID PCR test done - also negative. No other tests run. Spoke with rheumatologist who believes it could be related to AS. Day 15: Still experiencing side effects - very fatigued. This is the first day she has been out of bed for more than a few hours at a time. Planned visit with PCP tomorrow.
36 2021-01-11 tingling Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined ... Read more
Day of shot: she reported "tingling fingers" and "mild fogginess - like I took Benadryl" - declined MD assessment (and states this resolved within hours. Day after shot (1/9), she states she noted redness/tenderness at site, fatigue, body aches, fever to 103 (responsive to tylenol; reduced to 99.4 after 8hrs). She presents to AOH 01/12/21 for assessment of L deltoid: 8x8.5cm injection site erythema/tenderness/very mild induration. States fever has resolved; neck/back aches continue; tenderness at site continues. Possible cellulitis? Advised to seek PCP counsel as soon as possible.
36 2021-01-11 pain in extremity Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the ... Read more
Headache, strong arm pain and redness at injection site, apart from these usual side-effects of the vaccine, she sees gray cloud-like vision, intermittently, usually gets worse during the afternoon.
36 2021-01-11 tingling, weakness, tenderness Inital onset of arm tenderness then heaviness in left arm. This was followed by increased weakness a... Read more
Inital onset of arm tenderness then heaviness in left arm. This was followed by increased weakness and tingling in entire left side. I found it difficult to ambulate and lift my arm at all. This was followed by malaise, weakness, and fatigue. The decreased strength and sensation on the left side of my body lasted for several hours, gradually fading around 4am. The weakness of the left side of the body improved over time and I was just left with fatigue and malaise.
36 2021-01-11 feeling hot Low grade fever, body aches, chills, nausea/motion sickness on Saturday. Sunday to Tuesday: nausea a... Read more
Low grade fever, body aches, chills, nausea/motion sickness on Saturday. Sunday to Tuesday: nausea and difficulty cooling down/sweating present
36 2021-01-11 tingling Patient states that she received her second vaccination and in the hours after she had flu-like symp... Read more
Patient states that she received her second vaccination and in the hours after she had flu-like symptoms. Then over the next few days, she started to notice tingling and a "prickly" sensation in various areas. This progressed to symmetric BLE weakness which started in her feet and had reached to just above her knees bilaterally time and she arrived. The weakness had progressed to her hips. She also noticed weakness in her arms and they are easily fatigued. She is able to walk but it takes much effort.
36 2021-01-11 tremor Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11. By 12am 1/12 unable ... Read more
Pfizer-biotentech covid 19 vaccine EUA Body aches fatigued started at 3pm1/11. By 12am 1/12 unable to sleep due to Such severe pain all over head to toe, chills/shaking , vomiting and sweats. As of now today 1/12 1pm still very achey and fatigued with waves of nausea.
36 2021-01-11 tingling, migraine, numbness Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and sore... Read more
Received the second dose on 1/8- Felt tired with muscle aches and minor headache. Felt pain and soreness around injection site. On 1/9- had a severe migraine was unable to get out of bed due to migraine and extreme light sensitivity. Experienced severe muscle aches and chills. 1/10- started experiencing facial swelling especially of the left side. Extreme left eye swelling. With headache. Went to ER. Was given Benadryl to reduce swelling fluids and Prilosec for throat irritation. 1/11-started experiencing left arm numbness and tingling radiating down to fingertips. Experience left side facial numbness and tingling. 1/12- symptoms have begun to improve.
36 2021-01-11 pain in extremity Right arm pain (injection site), nausea, chills
36 2021-01-11 weakness Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering... Read more
Sore throat; Headache; Felt out of sorts/ feeling unwell; Bizarre feeling/felt really bad; wondering if being on Stelera made the symptoms from the COVID Vaccine worse; extreme/ severe fatigue; lightheaded; soreness around injection/Sore arm; felt run down; chills; This is a spontaneous report from a contactable nurse (patient). This 36-years-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via unspecified route at left arm on 21Dec2020 14:00 at single dose for COVID-19 immunization; she also started to receive ustekinumab (STELERA injection), via subcutaneous from 2017 (last injection on 04Nov2020) at unspecified dose every 12 weeks for psoriasis. Medical history was none. Concomitant medications were not reported. No additional vaccines administered on same date of Pfizer vaccine. Historical vaccine included influenza vaccine on Nov2020 for immunization, which was 5 weeks prior to COVID vaccine. Vaccination facility type was hospital. At night of vaccination on 21Dec2020, patient felt run down, thought she had chills. She did not have fever. She woke up next day 22Dec2020 with sore arm/ soreness around injection, was otherwise fine. Day 2, 3, and 4 post vaccine was sick (23Dec2020). She had a sore throat, headache, and extreme/ severe fatigue on 23Dec2020. She was not feeling well/ felt out of sorts on 23Dec2020. She expected to wake up feeling unwell. On 23Dec2020 and 24Dec2020 she felt really bad. Could have been in bed all day. She still did not have fever. She was lightheaded and had a bizarre feeling on 23Dec2020. She woke up 26Dec2020 and felt completely fine. Patient was wondering if being on ustekinumab made the symptoms from the COVID Vaccine worse. Action taken for ustekinumab was unknown. Outcome of events was recovered on 26Dec2020.
36 2021-01-11 tingling, numbness Within 15 minutes of receiving the vaccine she developed jaw tingling. This resolved but when drivi... Read more
Within 15 minutes of receiving the vaccine she developed jaw tingling. This resolved but when driving home she developed jaw numbness which persisted over the next day. Eventually improved. Was recommended to proceed to the ED but she did not go.
36 2021-01-11 weakness, pain in extremity around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body... Read more
around 14 hours past vaccine woke up with chills, low grade fever (100.8), severe calf pain and body aches all over, and severe headache, around 3am had nausea to the point of needing zofran, chills continued until around 5am, body aches continued and was yelling, crying and tossing and turning, woke up at around 8am with 9/10 headache, light and sound sensitivity, alleviated some with coffee, extremely fatigued and weak (had trouble walking half a block), headache mostly gone by. 10am, fatigue continued throughout the day, NO appetite, intermittent chills. At bedtime ~9pm day 2 temperature 99.8. Slept through night. Sunday fatigue and excercise intolerance (typically exercise daily and am in good physical shape), had to sit down during walks with dog, Monday fatigue continued as did difficulty exercising long periods of time until afternoon, continued difficulty monitoring body temperature, getting cold really easily. Tuesday (today) continued weakness and exhausted but can't nap, no appetite. Never took anything except zofran 2x for nausea
36 2021-01-11 tingling, numbness began having numbness to face, tingling to hands and legs and dizziness with movement and that her l... Read more
began having numbness to face, tingling to hands and legs and dizziness with movement and that her legs were going to give out
36 2021-01-11 pain in extremity is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a cont... Read more
is pregnant: yes; Extremely sore arm; body aches; headache; This is a spontaneous report from a contactable other health professional (patient). This reporter reported information for both mother and fetus/baby. This is a maternal report. A 36-year-old female patient (pregnant) receive first dose of BNT162B2, via an unspecified route of administration on 04Jan2021 16:45 in right arm at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient experienced extremely sore arm, body aches, headache on 04Jan2021. The adverse event was not resulted in emergency room visit and physician office visit. The events were reported as non-serious. No treatment received for the adverse event. The mother reported she became pregnant while taking bnt162b2. Last menstrual date was 12Jun2020. The mother was 29 weeks pregnant at the onset of the event. The mother was due to deliver on 19Mar2021. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient wasn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Prenatal vitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Allergies to medications, food, or other products was no. The outcome of events was resolving. Information on the Lot/batch number has been requested.
36 2021-01-11 weakness it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized w... Read more
it was like having Covid again; it was like having Covid again; body aches; dry mouth; generalized weakness; temp was 38.1 Celsius; head feels weird; can't sleep; decreased appetite; pain at the injection site; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19 from Mar2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced body aches, dry mouth, can't sleep, generalized weakness, decreased appetite, and pain at the injection site, temp was 38.1 Celsius, head feels weird in Jan2021. The patient got her first dose and was looking online to see the symptoms. She said that she saw that during the trials, people were experiencing the symptoms she was experiencing after the second dose and she was concerned. She said that she wanted to make sure her symptoms are ok and to make sure that the symptoms are not just caused from the booster, but also from the first dose. The caller said that her mom told her that someone died from the Pfizer vaccine. No further details provided. The patient was having body aches, could not sleep, her mouth is really dry, her temp was 38.1 Celsius, her head feels weird, she has generalized weakness, pain at the injection site, and decreased appetite. She said that it was like having Covid again. She said that she had Covid back in Mar2020. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade. The outcome of all the events was unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the suspected COVID likely represents a pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 Nucleic acid/ PCR test is needed for full medical assessment.
36 2021-01-11 numbness left sided facial numbness left sided numbness on the hand; This is a spontaneous report from a cont... Read more
left sided facial numbness left sided numbness on the hand; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 07Jan2021 08:00 (lot number: EL1284) for the second dose and on 17Dec2020 08:00 (lot number: EH9899) for the first dose, both via intramuscular route in the left arm for COVID-19 immunization. Medical history included asthma and allergies to shellfish. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced left sided facial numbness and left sided numbness on the hand on 07Jan2021 08:30 with outcome of not recovered. The event was reported as non-serious with no treatment received.
36 2021-01-12 migraine Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness... Read more
Had Vaccine on 12/24. Since then she has had daily episodic full-body itchiness and rash or redness; light-headedness, migraines, irregular heartbeat. She has also noted episodic throat tightness and SOB in the 10 days since the vaccine. She has a history of anaphylaxis w/ morphine. She has an autoimmune condition currently being evaluated by rheumatology. Has Von Willibrands and Hx stroke due to BCP. Will need Allergy Consultation with MD prior to 2nd dose.
36 2021-01-12 pain in extremity I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body ... Read more
I have had a sore arm; I also have been having a low-grade fever the highest it has been 99.5; Body aches; Chills; This is a spontaneous report from a contactable nurse reporting for self. A 36-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EK923, via an unspecified route of administration on 05Jan2021 08:45 as a single dose (dose 1), left arm (age at vaccination: 36 years old), for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no other vaccine administered in the 4 weeks prior to the COVID vaccine. Medical history included multiple sclerosis and hypothyroidism . The patient was receiving unspecified concomitant medications ("10 meds").The patient previously took copaxone and experienced drug allergy. The patient reported having a sore arm, but also had been having a low-grade fever. The highest it had been was 99.5. The patient also had body aches and chills. These symptoms started couple hours after the injection (on 05Jan2021) and have been with the patient since then. The events were reported as non-serious. There was no hospitalization or treatment received for the events. The outcome of the events sore arm, low grade fever, body aches, and chills was not recovered. The patient had not been COVID-19 tested post vaccination.
36 2021-01-12 pain in extremity Intense bone/joint pain that occurred ~8 hours after vaccine. Started in hips/back, then moved to e... Read more
Intense bone/joint pain that occurred ~8 hours after vaccine. Started in hips/back, then moved to extremities. Patient unable to walk normally due to pain. Took 500 mg of acetaminophen at bedtime. Symptoms resolved the next morning except for slight right knee pain, which resolved by the afternoon. Patient feels that joints "crack" more frequently after vaccine.
36 2021-01-12 numbness, tingling Numbness in neck and face on left side lasting for 3-4 days; now intermittent tingling in face and n... Read more
Numbness in neck and face on left side lasting for 3-4 days; now intermittent tingling in face and neck on left side; no facial droop
36 2021-01-12 tingling, discomfort, numbness Numbness,tingling in both upper and lower extremity, especially left foot and hand which began sever... Read more
Numbness,tingling in both upper and lower extremity, especially left foot and hand which began several hours after vaccination. Day 6 post vaccine, numbness and tingling began in right hand. Associated symptoms include heaviness, mild weakness of extremities described above.
36 2021-01-12 feeling hot, unresponsive to stimuli Patient experienced a syncopal episode post vaccination, accompanied by feeling hot and tachycardic.... Read more
Patient experienced a syncopal episode post vaccination, accompanied by feeling hot and tachycardic. Prior to the syncope, she reported hyperventilating. She remained unresponsive for about 10 minutes and was brought to the ED. There she became responsive, and reported chest pain and had sinus tachycardia episodes. She also had lower extremity weakness. This has improved per the latest neurology notes. She also had a negative EEG. Unsure if this is an allergic reaction or if the syncope was due to hyperventilation. Patient is currently on day 3 of hospitalization.
36 2021-01-12 pain in extremity, numbness Severe pain and numbness in Left arm , forearm and hand. It lasted for one day.
36 2021-01-12 weakness, cold sweat, tingling Within minutes of receiving the vaccine, started c/c dizziness, tingling all over, feeling "splotchy... Read more
Within minutes of receiving the vaccine, started c/c dizziness, tingling all over, feeling "splotchy", weakness, seeing stars. Appeared pale and clammy. Eased to floor to lie flat. B/P=92/62. B?P after 5 min of being supine 102/64. Able to sit up after 10 minutes. Continued to rest for 30 minutes with slow consistent improvement in weakness and dizziness. Left clinic within one hour with improvement.
36 2021-01-12 tingling, numbness light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my uppe... Read more
light sensitivity; joint pain in my fingers while typing/worsening joint; muscle soreness in my upper back/worsening muscle pain everywhere; a headache; a slightly sore throat/worsening sore throat; a fever; chills; nausea; severe fatigue; tingling; numbness in all extremities at random locations; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), intramuscularly on 05Jan2021 at 18:30 on Left arm at single dose for COVID-19 immunization in hospital. None other vaccine received on same date. The patient medical history included Hypothyroid Generally healthy; Hx of depression and ADHD (Attention deficit hyperactivity disorder); and prior to vaccination, patient was diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE); ibuprofen; cetirizine hydrochloride (ZYRTEC). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly on 15Dec2020 at 18:30 on Left arm at single dose for COVID-19 immunization; and had known allergies with Sulfa and ciprofloxacin hydrochloride monohydrate (CIPRO) drugs, tramadol and oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET). The patient experienced on 06Jan2021 at approximately 9am hour, she noticed joint pain in her fingers while typing, muscle soreness in her upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. Then at 3pm, about 21 hours since vaccination-fever had broken once but returned quickly, and severe headache with light sensitivity. The joint pain and numbness had faded but she was left with severe muscle soreness, like she was in a car accident. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event Muscle soreness was not recovered, outcome of the other events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
36 2021-01-13 tingling, numbness, pain in extremity After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection ... Read more
After first vaccine i experienced fatigue, body aches, headache and nausea for 2 days and injection site pain for two weeks. After second Vaccine given at 9:55am. tingling of feet for about 20 mins, 30 mins after the vaccine. Two hours later fatigue, body aches, headache and nausea began. At 0030 1/12/2021 I woke up with severe chills and left chest pain, temp was 101.6 and heart rate was 160. I began to see black and chest pain was severe feeling like i was having a heart atack and was going to pass out so i called 911. I then began to get short of breath and got numbess on my legs, left arm and left side of neck. Chest pressure/pain radiated to left arm and neck. I was taken by the ambulance to hospital. Arrived around 0130. My heart rate sustained at 140s in the ER so I was admitted at 0530 am. My D Dimer was a bit elevated as well as my lactic so I was given a bolus of fluids plus maintenance. I had a CXR done, CTA chest(negative for PE), UA, Labs, entire cardiac workup including an ECHO during my admission. I also began to have loose stools and wrist joint pain. MY heart rate sustained at 125-147 for about 30 hours. Fevers on and off. After everthing was negative we determined this was secondary to the covid 19 vaccine. I was discharged 1/13/2021 at around 1:30 pm. My heart rate is still not at baseline which is 87-90. I'm 100-130 and still get very fatigued with a simple slow walking. Still having tachycardia, fevers, body aches, joint wrist pain, chest discomfort and headaches. My potassium was 3.0 at discharge so will be needing labs in a week. Also bruised a little different than I usually do with lab draws so keeping an eye on them and will be checking my platelets again in a week. Ive been taking tylenol for my fever and pain and ativan for any anxiety when my heart rate goes up. (treatment during hospital stay was normal saline bolus, nomal saline maintenance fluids at 150 cc/hr, tylenol, ativan, ice packs, rest)
36 2021-01-13 unresponsive to stimuli Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseou... Read more
Approximately 12 hours after receiving the booster dose, she awoke feeling extremely ill and nauseous, roused me to say so, and then immediately became unresponsive and pulseless. She was admitted to hospital for cardiac work up, and all diagnostic tests have found her heart to be normal in structure and function. Cardiology believes she experienced a vasovagal syncope with asystole. She remains hospitalized at this time for initiation of sotalol therapy; she was diagnosed with frequent PVCs approximately 1 year ago.
36 2021-01-13 tingling Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult wit... Read more
Employee had same reaction as Dose # 1 despite pre-medicating with Benadryl and having a consult with an Allergist. Dizziness, Lightheaded, Tongue and Facial Tingling
36 2021-01-13 pain in extremity Headache, arm pain, fever
36 2021-01-13 pain in extremity, feeling cold In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever... Read more
In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4; This is a spontaneous report from a contactable other HCP (patient). A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK9231), intramuscularly on 06Jan2021 14:45 at single dose in Left arm for COVID-19 immunisation. No Pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was Hospital. Medical history included Irritable bowel syndrome. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included fluticasone propionate, ethinylestradiol, norethisterone (WERA). The patient experienced In order of occurrence: left arm pain, headache, then neck and body pain. Feeling cold, but no fever until the evening 100.4 on 07Jan202105:30 AM. No treatment received for the adverse events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was unknown.
36 2021-01-13 flushing, pain in extremity My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at... Read more
My first dose of COVID vaccine I didn't have any symptoms (1st dose: 12/23/20). Received 2nd dose at 0800 on 1/12/21. First symptom was on 1/12 at 2000 when I had a headache and malaise so I went to bed early. Woke up at 0200 on 1/13 with nausea, body aches and chills. My temp felt fever-ish (100.4 via temporal scan). So I took Tylenol and Pepto to go back to sleep. Same symptoms carried throughout the morning of 1/13. By noon 1/13 = my L arm where the injection had occurred was swollen, painful and hard to move. That evening I had a presyncopal event where I felt flushed and nearly passed out. My L arm continued to hurt but the swelling moved down into my lymph nodes where lymphadenopathy continues to be a problem until now.
36 2021-01-13 cold sweat Patient reports mild body aches, cold sweats and fatigue. Also a mild sore throat and slight headach... Read more
Patient reports mild body aches, cold sweats and fatigue. Also a mild sore throat and slight headache
36 2021-01-13 numbness and pain in extremities Peripheral neuropathy
36 2021-01-13 feeling hot, pain in extremity Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1... Read more
Pfizer Vaccine First dose - 12/19/2020 Mild soreness to arm, fatigue Second dose - 1/8/2021 AM of 1/10/2021 had small patch of hives on ankle, took zyrtec resolved 1/11/2021 felt ok no symptoms 1/11 to 1/12 night "woke up and had massive allergic reaction everywhere - patches of redness on leg, arms, belly, back, face-sparing" -- took zyrtec and the reaction improved somewhat. Was in clinic so went up stairs and spoke to our dermatologist who thought this was likely reaction to vaccine. Prednisone RX given but has not taken. Takes 1-2 zyrtec daily. Spoke to me on the phone 1/12 at night, increased zyrtec to 4 pills daily, added pepcid and decided to speak today. Did not take atarax or benadryl bc she was on call. Improves with triamcinolone Presents today with worsening rash, she will upload pics in Epic. Areas of urticarial patches from yesterday now have left non blanching purple rash/bruising. More urticarial plaques today. No angioedema. Feels hot has not take temperature. No joint pain or swelling. No oral or vaginal mucosal involvement. No issues with respiration generally but maybe a little tight. >75% BSA involved Allergy history - chronic rhinitis, no known triggers or patterns No history of asthma, eczema, food allergy or drug allergies
36 2021-01-13 weakness Rigors, fever , body pain, chills, diaphoresis, fatigue, weakness .lymphadenopathy left axilla
36 2021-01-13 weakness Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and r... Read more
Severe headache in back of lower head/neck and frontal head, fever up to 101 degrees F, chills and rigors, muscle pain, extreme weakness and fatigue. Affected my ability to function. Took Tylenol. Took almost 48 hours to recover.
36 2021-01-13 feeling cold, pain in extremity, tremor, breast pain Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including b... Read more
Symptoms started approximately 16 hours after receiving the vaccine. Body aches all over including breast, under arms, legs, feet stomach. Horrible headache that did improve with tylenol and ibuprofen taken at the same time. Body shakes and can't control body temperature. Felt freezing cold but skin was very hot to the touch (according to my husband). Then, I started sweating and felt really hot and couldn't cool down. Felt nauseous but no vomiting. Could not sleep but felt very tired. Today is now 48 hours after vaccine and body aches are gone but I am still extremely fatigued.
36 2021-01-13 feeling cold, feeling hot The night after receiving the vaccine (approximately 17 hours post-dose), I got up to use the restro... Read more
The night after receiving the vaccine (approximately 17 hours post-dose), I got up to use the restroom. While washing my hands I became extremely dizzy, hot and nauseous. While bending over to open the toilet (so that I could vomit) I ended up passing out. I woke up on the floor of my bathroom (with my head against the wall), somewhat disoriented, shortly thereafter (exact timeframe that I was "down" is unknown). I tried to get up and get back to bed but became extremely dizzy and hot again - this time bringing myself back down to the floor. I laid there for an unknown amount of time before feeling like I could try to move again. Once I felt a little better I crawled back to bed and laid down. I believe I was out of bed for a total of 15-20 minutes. I had no further dizzy/hot/nauseous episodes after that, however for the remainder of that day I felt exhausted, had a mild headache and felt like I couldn't get warm. I did not take my temperature. At about the 48-hr mark post-vaccination I was feeling back to normal other than a slight headache.
36 2021-01-13 numbness Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sa... Read more
Vaccinated Thursday morning, later in the evening felt achy and had a fever. Headache for 2 days. Sat morning 1/9/21 woke up with left arm weakness and numbness which went up to her face. Had an MRI completed which showed a new small right paritial ischemic stroke.
36 2021-01-14 feeling cold After 12hrs of covid vaccine 2nd shot i feel dizzy and tired/fatigue then feeling cold,feverish and... Read more
After 12hrs of covid vaccine 2nd shot i feel dizzy and tired/fatigue then feeling cold,feverish and having body aches and headache.i just rest in bed and took advil that night and tylenol on the 2nd day.until now on and off feeling fatigue,body aches, headache and fever.
36 2021-01-14 pain in extremity Arm pain, extreme fatigue and body aches upon waking the morning after the 2nd vaccination 1/14/21. ... Read more
Arm pain, extreme fatigue and body aches upon waking the morning after the 2nd vaccination 1/14/21. Fatigue and body aches lasted the entire next day and resolved by the morning 1/15/21. No fever
36 2021-01-14 pain in extremity Left arm was sore on 01/13 Diarrhea started on 01/14, along with nausea
36 2021-01-14 weakness, night sweats, numbness My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I ten... Read more
My face went numb, that was the first symptom 10/15 min after immunization. I got tachycardia (I tend to have a rapid hart beat but this was pumping pretty good). I also had some GI distress (watery diarrhea) and that lasted for a while. Later I got really weak and shaky, fatigued, that night I woke up with night sweats, and chills, woke up completely drenched, I had to change the sheets and pajamas. 5 days after the vaccine I was really exhausted, the fatigue was awful. There was also an itching sensation but no hives.
36 2021-01-14 tingling On 1/13/21 I noticed some tingling in my feet and hands. This has continued and worsened - I have co... Read more
On 1/13/21 I noticed some tingling in my feet and hands. This has continued and worsened - I have constant "pins and needles" sensations in both feet and it is extending up to my knees. It's also in both hands and extending up my arms. Last night it was up to elbows, now it's going above my elbows. It doesn't go away. I was unable to sleep well because of the sensations. I'm also starting to feel tingling in my back and shoulders. I called my doctor and he said to fill out this form and report the ER if my symptoms don't improve over the weekend.
36 2021-01-14 weakness Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout m... Read more
Symptoms started around 2300 on 01/14/2021. I experienced SOB; sharp and shooting pain throughout my extremities; dull body aches; nausea induced vomiting; dizziness; weakness. I was unable to sleep throughout most of the night. I used tylenol and ibuprofen for my symptoms which didnt seem to alleviate any of the symptoms during the night. Woke up on 01/15/2021 with a rash on my face.
36 2021-01-15 pain in extremity Chills, headache, sore arm, tired
36 2021-01-16 pain in extremity Arm soreness, body aches, headache, fever of 99.6, fatigue
36 2021-01-16 pain in extremity At about 12 hours after the second dose I had chills, headache, fever of 101, fatigue and nausea. It... Read more
At about 12 hours after the second dose I had chills, headache, fever of 101, fatigue and nausea. It lasted for about 24 hours. My arm was also sore for about 72 hours after the shot. I did not have any reaction from the first dose except for a sore arm.
36 2021-01-16 burning sensation, tingling Patient developed feeling of "burning in mid-chest" and palpitations 15 minutes after COVID vaccine ... Read more
Patient developed feeling of "burning in mid-chest" and palpitations 15 minutes after COVID vaccine administered. She also experienced intermittent tingling in hands and feet. Patient was evaluated by EMS in the vaccine clinic. The chest symptoms were episodic, occurring every 5 minutes and lasting 1-2 minutes with each episode. Intermittent dizziness also occurred during the chest-discomfort symptoms. Vital signs were stable and oxygen saturation was 100% on room air. Patient denied SOB, stridor and no labored breathing. Patient was transported to the hospital emergency department for further evaluation/observation. After 2 hours of observation, patient's symptoms resolved spontaneously. She discharged from the emergency department to home with family.
36 2021-01-17 feeling hot 1 hour post injection patient returned with redness and borderline hives in her left arm, chest, nec... Read more
1 hour post injection patient returned with redness and borderline hives in her left arm, chest, neck and face. She complained of feeling very hot and with mental confusion. We administered 50 mg of diphenhydramine, and 15 minutes later sent her to the ED. At the ED they diagnosed her with a minor anaphylaxis reaction, gave her methylprednisolone and epinephrine.
36 2021-01-17 cold sweat, migraine 12-13 hours post second COVID vaccine shot (~2100) started to feel full body pains, lightheadedness ... Read more
12-13 hours post second COVID vaccine shot (~2100) started to feel full body pains, lightheadedness and nausea. Then throughout the night symptoms worsened with significant body chills despite multiple layers, severe body pain and migraine trigger. In the morning felt like full-blown flu with fever of > 100 F, sensitive skin painful to the touch, cold sweats, full body pains, heart palpitations (pounding heart beats and ave 100-120 bpm), and migraine level 8/10. Medication required to try to treat symptoms (metoclopramide, claritin, excedrin). Symptoms continued and did not start to lessen until approximately 30 hours post vaccine dose (18 hours post severe symptom initiation) and two doses of medication regimens. Arm around injection site also showed raised, red irritation local to the site, however, was not exacerbated throughout the symptom course. COVID call center recommended for me to see emergency care facility due to symptoms which I waited to see if symptoms worsened before deciding to not go to the urgent care center.
36 2021-01-17 throat numbness Elevated heart rate, dizzy, sweating, throat numb
36 2021-01-17 facial paralysis Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself). A 36-... Read more
Facial paralysis; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received bnt162b2 (COVID-19 Vaccine by Pfizer, lot EK9231, expiry date was not reported), via an unspecified route of administration on 08Jan2021 at SINGLE DOSE for Covid-19 immunisation (to prevent the COVID). Medical history was none. There were no concomitant medications. The patient experienced facial paralysis on the left side of her face upon waking up on 09Jan2021. The outcome of event was not recovered.
36 2021-01-17 pain in extremity Friday Jan 15th - arm pain. Saturday Jan 16th - fever of 99.5, chills, no appetite, dehyrdration, sw... Read more
Friday Jan 15th - arm pain. Saturday Jan 16th - fever of 99.5, chills, no appetite, dehyrdration, swelling and redness around injection site, progressed throughout day. Sunday Jan 17th - further swelling and arm pain, lymphnods in underarm area painful and swollen, bruising Monday Jan 18th - Swelling and redness size of palm, warm to touch, painful, itchy
36 2021-01-17 face paralysis, facial paralysis, tingling Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/d... Read more
Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/droop 4 days post vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination/Tingling to lower extremities; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EK9231), via an unspecified route of administration in the left arm on 04Jan2021 13:00 at single dose, for Covid-19 immunisation. The vaccine was given in a Nursing Home/Senior Living Facility. Medical history was none. No known drug allergies. No other vaccine in four weeks. No Covid-19 prior vaccination. Concomitant medication included naproxen sodium (ALEVE). The patient experienced tingling in injected arm and facial tingling in cheeks/lips same day of vaccination (04Jan2021). Tingling to lower extremities the day after vaccination (still continuing). Slight left sided facial weakness/droop 4 days post vaccination (04Jan2021). Tingling to left arm continuing on and off. No treatment reported. On 04Jan2021, she was negative to PCR covid test post vaccination. She went to the Emergency room/department or urgent care. The outcome of events was not recovered.
36 2021-01-17 difficulty speaking Throat tightening, visible rash, difficulty breathing, changes in phonation, hypotension approximat... Read more
Throat tightening, visible rash, difficulty breathing, changes in phonation, hypotension approximately 10 minutes after receiving vaccination. Given Epi 0.3mg IM X 2 doses, PO Benadryl and transported via ambulance to ED. Left facility with stable vital signs and improvement of symptoms.
36 2021-01-17 tenderness Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and n... Read more
Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and neck. Profound fatigue. methylprednisoLONE (Medrol, Pak,) 4 mg tablet and azithromycin (Zithromax Z-Pak) 250 MG tablet mono test negative After 5 days on medications nodes size reduced, tenderness, stiffness, fatigue remain, but overall improved.
36 2021-01-17 tenderness few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the... Read more
few enlarged and abnormal lymph nodes believed to be reactive in nature; patient was pregnant at the time of vaccination; large mass appeared in right axilla; mass was painful to touch; large mass appeared in right axilla; mass was painful to touch; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of bnt162b2 (COVID 19, brand: Pfizer) lot no: EJ1685, via an unspecified route of administration in right arm on 23Dec2020 07:15 at a single dose for COVID-19 immunization in a hospital. The patient had no relevant medical history and no known allergies. The patient was pregnant at the time of vaccination, last menstrual date was on 05Oct2020, delivery date will be on 12Jun2021, gestation period: 11. Concomitant medication includes daily multivitamin. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. On 30Dec2020 04:00 am, 7 days after vaccine (as reported), a large mass appeared in right axilla. The mass was painful to touch. Overnight mass more than doubled in size on 31Dec2020 the mass took up her entire arm pit, went to immediate care and was given antibiotics. The mass decreased in size but has not gone away. She followed up with primary care. She had bloodwork and ultrasound of axilla and right breast. Blood work was normal. Ultrasound showed a few enlarged and abnormal lymph nodes believed to be reactive in nature. Largest lymph node as of 08Dec2020 2.5 x 0.9 x 2.2 cm. The events were reported as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
36 2021-01-18 pain in extremity, numbness, tingling Bouts of profuse perspiration; Nausea; Slight headache; Extreme left arm soreness with some tingling... Read more
Bouts of profuse perspiration; Nausea; Slight headache; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Extreme left arm soreness with some tingling and numbness spreading to hand; Fever of 101.0 at 12 hours post vaccination; Body aches; Malaise; Chills; Dizziness; Loss of appetite; second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), via an unspecified route of administration at Left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization. Facility type vaccine was hospital. Medical history included hypothyroidism. No known allergies. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE) 50mcg. No other vaccine in four weeks. The patient previously received first dose of BNT162B2 (lot number=EJ1685) via an unspecified route of administration at arm right on 21Dec2020 07:15 at single dose for COVID-19 immunization. The patient experienced nausea, slight headache, extreme left arm soreness with some tingling and numbness spreading to hand, fever of 101.0 at 12 hours post vaccination, body aches, malaise, chills, dizziness, loss of appetite. Adverse events start time reported as 08Jan2021 19:00. 24 hours after 2nd dose, the patient had body aches and bouts of profuse perspiration on 09Jan2021 07:15. No treatment received for these events. No COVID prior and COVID was not tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.0 on 08Jan2021 at 19:15. The outcome of the events "second dose on 08Jan2021 07:15/first dose on 21Dec2020 07:15" was unknown, of other events was recovering.
36 2021-01-18 muscle spasms Fever; Chills; Body ache; Headache; She had allergic reactions in the area where she took the vaccin... Read more
Fever; Chills; Body ache; Headache; She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen; She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen; She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen; she had allergy reactions; Some spasm in my neck; This is a spontaneous report from a contactable nurse. A 36-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), intramuscular from 05Jan2021 to 05Jan2021 at a single dose for an unspecified indication. Medical history included Hypertension. Concomitant medication included lisinopril. It was reported by the patient that she had side effects of fever, chills, body ache, headache within 24 hours. I received my second dose. She had allergic reactions in the area where she took the vaccine and today it turned red, hard and really painful. It was swollen. She also reported that she had some spasm in my neck and that she had allergy reactions. The patient reported that she took Tylenol as treatment for the events. The outcome of the events was unknown.
36 2021-01-18 pain in extremity fever, headache, chills, muscle aches, soreness of arm, flu symptoms
36 2021-01-18 flushing headache at 12 hrs post vaccine. Then fever (max 101), chills, muscle aches, fatigue starting 16hrs ... Read more
headache at 12 hrs post vaccine. Then fever (max 101), chills, muscle aches, fatigue starting 16hrs after vaccine. All symptoms resolved by 30hrs post vaccine
36 2021-01-19 pain in extremity, cold sweat, migraine 1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAI... Read more
1/7/21: MODERATE BODY ACHES AND MILD JOINT PAIN. 1/8/21 MORNING: SEVERE BODY ACHE, CHILLS, JOINT PAIN, LOW GRADE FEVER (99.8) AND SEVERE HEADACHE. SWOLLEN FACE AND ARM PAIN. 1/8 NIGHT: HIGH GRADE FEVER (101.4). 1/10: HIGH GRADE FEVER (101.3 REACHING HIGHEST OF 102.9). SEVERE BODY ACHES, CLUSTER HEADACHE/MIGRAINE, JOINT PAIN. CILLS, COLD SEATS, LOSS OF APPETITIE, NAUSEA. SWOLLEN FACE AND ARM PAIN. 1/11 MORNING: LOW GRADE FEVER, MODERATE BODY ACHES, CHILLS AND COLD SWEATS, NAUSEA (STRONGER), LOSS OF APPETITE AND STOMACH ACHE, DIARRHEA, AND ARM PAIN. 1/11 AFTERNOON AND NIGHT: MODERATE STOMACH ACHE, NAUSEA. 1/12: STILL MILD NAUSEA AND LOSS OF APPETITE, ARM PAIN. TOOK IBUPROFEN, TYLENOL.
36 2021-01-19 pain in extremity Arm pain, body muscle aches, fever, fatigue. 48 hours
36 2021-01-19 weakness Developed symptoms the evening after vaccine administered. Sx included: nausea, vomiting, diarrhea, ... Read more
Developed symptoms the evening after vaccine administered. Sx included: nausea, vomiting, diarrhea, weakness, body aches, headache, decreased appetite. Symptoms significantly improved after 3-4 days
36 2021-01-19 flushing Symptoms include flushed/itchy face, red patches on face, numb tongue, no fever
36 2021-01-19 migraine The following day @1:30pm on 1/18/21 I started feeling achy like I had a fever, chills, pains in my ... Read more
The following day @1:30pm on 1/18/21 I started feeling achy like I had a fever, chills, pains in my body all through the night. This morning on 1/20/21 I had a horrible migraine that lasted till 3:30pm. All the symptoms went away by 4:30pm
36 2021-01-19 weakness fever, headache, weakness/ fatigue
36 2021-01-19 night sweats, involuntary muscle movements sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a cont... Read more
sinus arrhythmia; Night sweats; Heart rate low; Dyskinesia; This is a spontaneous report from a contactable nurse (patient). This 36-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at single dose in the left arm on 07Jan2021 10:00 for covid-19 immunisation. Medical history included hypotension, rheumatoid arthritis, asthma. Concomitant medication included clonazepam, methylprednisolone. On 07Jan2021 21:00, the patient experienced sinus arrhythmia, night sweats, heart rate low, dyskinesia, all with outcome of recovered with sequelae. Therapeutic measures were taken as a result of the events included Inderal 10mg. The events were assessed as congenital anomaly. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
36 2021-01-20 burning sensation, pain in extremity, muscle spasms, tingling 1/11@2200 soreness at injection site. 1/12@2045 aching in both feet, left ankle, joints of right fin... Read more
1/11@2200 soreness at injection site. 1/12@2045 aching in both feet, left ankle, joints of right fingers, mod back and thigh pain - all resolved with acetaminophen. 1/17@0100 severe lower back pain. 1/17@1300 pins and needles in bilateral feet that were progressively uncomfortable. 1/18-1/19 severe bilateral foot pain, burning, pins and needles. painful ambulation. Not relieved with any over the counter medications. nausea and retching noted that day. Mild dizziness. Pins and needles progressed up to thighs. 1/20 seen in Emergency Department, neurology consulted. Question of vs vaccine reaction. However discharged home. Symptoms started to decline on 1/21 with less pain and pins and needles. 1/21 minimal pins and needles but muscle cramps in right lower leg and foot more than left leg.
36 2021-01-20 weakness Insomnia Body aches sweats cant walk body aches fatigue headache fever nausea weakness
36 2021-01-20 breast pain, pain in extremity Left arm soreness achiness, left lateral breast soreness and pain, left axillary lymph node swelling... Read more
Left arm soreness achiness, left lateral breast soreness and pain, left axillary lymph node swelling to size of softball. Fatigue
36 2021-01-20 feeling of body temperature change, cold sweat Light headiness, achy, Nausea, Severe headache, BP dropped, Hot/Cold chills. Clammy/Pale. Pt was... Read more
Light headiness, achy, Nausea, Severe headache, BP dropped, Hot/Cold chills. Clammy/Pale. Pt was sent home unable to function due to light headiness and nausea. Unable to walk due to unsteadiness.
36 2021-01-20 numbness, tingling Numbness in right arm after 30 minutes, spread to face and head in the next couple hours, lastly tin... Read more
Numbness in right arm after 30 minutes, spread to face and head in the next couple hours, lastly tingling feet, seen in ER but dismissed quickly, the numbness was gone by the next morning
36 2021-01-20 tremor, muscle spasms, tingling patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very ... Read more
patient received BNT162B2/ breastfeeding; patient received BNT162B2/ breastfeeding; Right away very strong jaw tightness with lightheadedness/muscles feel so tight; Right away very strong jaw tightness with lightheadedness; the tight jaw with Very tight full deep ache all over body/whole body hurts/feeling more pain; Headache lasting over 59 hours; Very very fatigued/feeling more fatigue; Chills worse at night; her hands feel swollen and cramping but they do not look swollen; her hands feel swollen and cramping but they do not look swollen; On and off lip/face tingling; On and off lip/face tingling; she felt like her lymph nodes were swollen; shaking; This is a spontaneous report from a contactable nurse (reported for herself). This nurse reported information for both mother and baby. This is the maternal report. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ec1284), via an unspecified route of administration on 11Jan2021 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included low vitamin d and patient is currently breastfeeding. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has no allergies to medications, food or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid, calcium, colecalciferol, cyanocobalamin, folic acid, iron, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol, zinc (PRENATAL S), vitamin d [vitamin d nos] (VITAMIN D), and calcium. The patient was administered with first dose of bnt162b2 (Pfizer brand) on 21Dec2020 at 10:00 on her left arm (lot number: EJ1685) for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 10:15, the patient experienced right away, very strong jaw tightness with lightheadedness. The lightheadedness feeling improved 2 hours later, but the tight jaw with very tight full deep ache all over her body. She had headache lasting over 59 hours. Her whole body hurt. Her muscles felt so tight and she was "very very" fatigued. She had chills (worse at night). She was shaking both nights after 2nd vaccine. Her hands felt swollen and cramping, but they did not look swollen. She also had on and off lip/face tingling. She felt like her lymph nodes were swollen. She can't even do a load of laundry without feeling more pain and fatigue. It was unknown if treatment was given for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious. The patient was not hospitalized due to the events. The patient has not recovered from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021038485 baby case
36 2021-01-20 numbness, tingling treated as panic attack; having difficulty getting thoughts together; My arms were very numb and tin... Read more
treated as panic attack; having difficulty getting thoughts together; My arms were very numb and tingly; My arms were very numb and tingly; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown lot number), via an unspecified route of administration in left arm on 30Dec2020 at 09:30 at a single dose for COVID-19 immunization. Medical history included prior history of panic attacks, HPV, and known allergies to pets and pollen. Concomitant medications included naproxen sodium (ALEVE), cyclobenzaprine, and aspirin. The patient was vaccinated in a hospital on 30Dec2020 at 09:30. The early morning of 06Jan2021 at 03:15 AM, the patient woke up with very alarming symptoms. She woke up very suddenly and was having difficulty getting thoughts together, her arms were very numb and tingly. She has had panic attacks before, and this did not feel like anything she had experienced. The events resulted in emergency room (ER)/department or urgent care visit. In ER, the patient treated as panic attack, no testing done. The patient was treated for the events. The patient did not have COVID prior to vaccination and the patient was not tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient recovered from the events in Jan2021. No follow-up attempts are possible. No further information is expected.
36 2021-01-21 tingling I received the 2nd dose at 730am and by 1130pm the following symptoms occurred dizziness, sweating, ... Read more
I received the 2nd dose at 730am and by 1130pm the following symptoms occurred dizziness, sweating, tingling in the feet, hands, and face; headaches rapid heart beats and I have these symptoms for 5 days now.
36 2021-01-21 tingling, numbness I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injec... Read more
I received the Covid-19 vaccine on 01/20/2021 and had tingling/slight numbness in my left arm (injection arm). Later in the evening I had the same feeling in my left leg and in my cheeks, lips, tongue and teeth. I felt like I had been numbed at the dentist, but was coming out of the numbness. It was like when the numbness is mostly gone and you're left with that tingling sensation, and your face feels puffy. It was basically that feeling in my face, left leg, and left arm. Those sensations are mostly gone today (the second day following), but not quite.
36 2021-01-21 discomfort, tingling Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left ... Read more
Pt received first Covid Pfizer vaccine this evening and during 15 minute wait time experienced left arm swelling, tingling and discomfort. Pt alert, oriented and denies any respiratory symptoms. Gave Benadryl 25 mg po at 1758 and pt states "50 mg makes me tired and I live out of town". Gave second dose of Benadryl 25 mg po at 1800 when pt began feeling "like my tongue is swelling". Contacted Med ER team to assist with monitoring. Removed pt rings and bracelets on left wrist/hand as pt states "feel like my whole arm is swelling". BP: 122/78 Rt. Arm with apical HR: 60/min and regular. Injection site Left deltoid is not red but swelling noted and spreading. Area is normal temp to touch. Tried ice bag to injection site left deltoid which made it feel worse per pt. The ice made the arm area red. 1818 BP: 136/90. Med team arrived and decision made to transport pt to ED for observation. Pt assisted to wheelchair for transport. Report given to RN from ED. Pt remained alert and oriented throughout. Pt contacted her family herself to notify. Pt received Solumedrol and Famotidine in the ED. Pt was observed and discharged within an hour. Pt follow up with Employee Health provider 1/22/21. Pt continues to experience intermittent rash/hives on chest/neck relieved by Benadryl, Headache, and entire left side feeling tingling and "weird".
36 2021-01-21 numbness The patient developed numbness to left cheek and tightness in her chest 30 minutes after she receive... Read more
The patient developed numbness to left cheek and tightness in her chest 30 minutes after she received the vaccine. The patient was seen in the ED and given Benadryl and Pepcid. She never developed a rash or difficulty breathing. He O2 sat was 98% and ED provider told patient she more than likely had a panic attack.
36 2021-01-21 numbness The person developed some numbness to the left cheek of the face. We watched the individual and held... Read more
The person developed some numbness to the left cheek of the face. We watched the individual and held her for additional 30 minutes and then she states she had tightness in her chest. She was seen in the ED. No other symptoms developed at this time. She was given pepcid and benadryl in the ED. She was told she had a mild anxiety attack but she states the medications did help.
36 2021-01-22 tremor Approximately around 1030 pm started having body aches and shaking chills. Finally fel asleep and th... Read more
Approximately around 1030 pm started having body aches and shaking chills. Finally fel asleep and then woke up around 2am 1-21 and had a major head ache body aches checked temp it was 101.7. Took Tylenol woke back up 4 hours later had chills and body aches temp was 100.9 took more Tylenol every 3-4 hours had fever around 4pm I took some vitamin c and Tylenol did not have any fever after that. Woke up next morning 1-22 with arm pit slightly sore progressively got worse theouhtout day. Woke up 1-23 moderately sore to touch and move
36 2021-01-22 one side paralysis, migraine At aprox 36hrs post vaccine I developed a rapid onset of left arm and left sided body weakness. cont... Read more
At aprox 36hrs post vaccine I developed a rapid onset of left arm and left sided body weakness. continuing near syncope episodes. diagnosed as a complex mograine which lasted 5-6hrs. and lingering headache for about 8days
36 2021-01-22 migraine, feeling hot Warm sensation started from the neck up approximately 30 min after vaccination. Arm soar was began ... Read more
Warm sensation started from the neck up approximately 30 min after vaccination. Arm soar was began about two hours after vaccination, and was felt from the vaccination site to the wrist. This lasted throughout the night. Later in evening stomach cramps , nausea and and migraines began. They next day my shoulder bald and neck muscle were stiff and I was unable to move them. This lasted until day three where no symptoms were present.
36 2021-01-23 weakness Body chills, weak, tiredness, headache, joint pain, fever, muscle pain, injection site pain
36 2021-01-24 facial paralysis At 0930 1-21-2021 at the site of her injection on her left deltoid her arm began to itch. Between 1... Read more
At 0930 1-21-2021 at the site of her injection on her left deltoid her arm began to itch. Between 1100-1130 the left side of her jaw began to hurt. She rates that pain 4-7/10. Five minutes later the left side of her lips began to tingle and became numb. She looked in the mirror and saw her face drooping. The Occupational Health Call Center advised her to go the ED. The ED physician told her she did not have Bell's Palsy due to the fact that her eyebrow and cheek were not involved. She was give Toradol and later took Benadryl at home. The ED physician reported to her she had a severe reaction and to monitor for symptoms.
36 2021-01-24 pain in extremity, migraine Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitiv... Read more
Day of vaccine: headache, sore arm. Day 2: migraine, eyes sore to touch, burning, extremely sensitive to light, dizzy, extremely tired. Day 3: headache, nausea, vomiting, diarrhea, dizzy, resting heat rate above 100, exhaustion. Day 4: shaky, dizzy, nauseous, resting heat rate not below 100 for several hours, heart palpitations, heart beating very hard at times, exhaustion.
36 2021-01-24 cold sweat Fever, body aches, diarrhea, lethargic, cold sweats.
36 2021-01-24 hot flush Hot flash Shortness of breath Dizziness All within 2 minutes of injection, relieved on its own afte... Read more
Hot flash Shortness of breath Dizziness All within 2 minutes of injection, relieved on its own after resting for 15 minutes, remained extremely tired for the remainder of the day and the day following
36 2021-01-24 feeling cold Injection site pain, headache, nausea, chills, fatigue and fever
36 2021-01-24 tingling, numbness NUMBNESS AND TINGLING ON LEFT LEG. IT STARTED ON LEFT HIP AND WENT DOWN TO LEFT FOOT.
36 2021-01-25 hot flush 1530 - receive vaccine 1540-c/o itching at site and hot flashes. Site was red and raised. Sbp 118/... Read more
1530 - receive vaccine 1540-c/o itching at site and hot flashes. Site was red and raised. Sbp 118/75, hr 68, rr 20, sats 97. 25 mg of bendaryl given po. 1344 - hr 69. HR ranged from 68-70 1550-walked in hallway. 1550 - hot flashes ended. Injection site remained red and itchy 1600-pt dcd home
36 2021-01-25 flushing Flushing of neck and face, palpitations, increased heart rate
36 2021-01-25 weakness Throat/tongue swelling initially. Took benadryl. Next day, I was very weak, in/off heachache. Mild... Read more
Throat/tongue swelling initially. Took benadryl. Next day, I was very weak, in/off heachache. Mild temperature. Today is day 6 and I'm still very weak, get light headed at times
36 2021-01-25 pain in extremity warm to touch; Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on s... Read more
warm to touch; Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection; Severe burning with injection followed by mild soreness at arm; Severe burning with injection followed by mild soreness at arm; redness; moderate soreness; Itchy; This is a spontaneous report from a contactable Other HCP (patient). This 36-year-old female (not pregnant) patient received 2nd dose of BNT162B2 (Covid vaccine, lot number=EK4176 on 09Jan2021 09:30 AM on Left arm for covid-19 immunization. Medical history was migraines. Concomitant drug was sumatriptan succinate (IMITREX) for migraines, ethinylestradiol norgestimate (SPRINTEC). Historical Vaccine was 1st dose of BNT162B2 on 19Dec2020 08:15 AM (lot number=EK 5730, vaccine location=Left arm) and experienced moderate soreness at injection site only x2 days. It was reported that patient experienced Severe burning with injection followed by mild soreness at arm. Small red, raised, palpable lump warm to touch about the size of the dime by 6pm on same day as injection. 10Jan2021 - moderate soreness. Area remains bright red, raised, warm to touch increased in size to 1"x1" 24 hours after vaccine. 11Jan2021 - 48 hours post vaccine area further enlarged to 2"x2". Moderate soreness. Itchy. Warm to touch. Palpable area extending to edge of redness. 12Jan2021 - 72 hours. No soreness except when touching injection site. Redness less in color and size. No longer itchy. Palpable lump smaller. Quarter size. Treatment was Tylenol. Outcome of the event palpable lump, Redness was recovering, for itchy was recovered, for other events was Not recovered. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are needed. No further information is expected.
36 2021-01-26 facial paralysis 1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild... Read more
1/18/2021- injection right arm 1/19/2021- mild pain at injection sight. Body aches. 1/20/2021- mild pain and muscle stiffness at injection sight. Chills and body aches. 1/21/2021woke up with itching on left side of face a scalp. 1/22/2021 itching subsided 1/23/2021- left side face drooping started.
36 2021-01-26 tenderness, migraine, hypersensitivity of all senses 12 hrs post injection: stiff shoulders/neck/arm (at injection site) and headache 18 hrs: migraine, ... Read more
12 hrs post injection: stiff shoulders/neck/arm (at injection site) and headache 18 hrs: migraine, muscle pain, chills 24-36 hrs: fever (100-102 Fahrenheit), migraine, muscle pain/fatigue, joint pain, increased skin sensitivity/pain to the touch, chills/sweats, shortness of breath, nausea 37-48 hrs: fever broke, continued headache/muscle pain and fatigue, exhaustion at 51 hrs: headache, muscle stiffness, pain at injection site
36 2021-01-26 numbness, tingling Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, to... Read more
Facial swelling; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; Numbness and tingling of Mouth, tongue and face; This is a spontaneous report from a contactable other hcp (patient) reported that a 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El1284), via an unspecified route of administration on the left arm on 11Jan2021 13:00 at a single dose for Covid-19 immunization. Medical history included endometriosis, gastrooesophageal reflux disease (GERD) and liver lesion; all from an unknown date. Concomitant medications included fish oil (FISH OIL), omeprazole (PROTONIX [OMEPRAZOLE]) and sertraline hydrochloride (ZOLOFT); all were taken from an unspecified date for an unspecified indication. The patient previously took amantadine and experienced drug allergy. On 12Jan2021 03:00, the patient experienced facial swelling, and numbness and tingling of mouth, tongue and face. Therapeutic measures were taken as a result of facial swelling, numbness and tingling of mouth, tongue and face. The reported events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was not recovered.
36 2021-01-26 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Arm soreness the evening of injection and the following day. H... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Arm soreness the evening of injection and the following day. Headache the night of injection
36 2021-01-26 pain in extremity, muscle spasms Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started... Read more
Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started having neck pain on my left side until now and irradiate toarse my shoulder and arm p to my hand on left side also random days present dizziness when I lie down blurry vision. on January 19 had neck pain shoulder pain and headaches on left side too went to Dr. and his medical diagnosis was muscle spasm might be induce due to stress pre-scribe Diazepam 5 mg . start taking it on Wednesday January 20-2021 but Saturday January 23 my upper lip started getting swollen , IL STOP THE MEDICATION ON MONDAY JANUARY 27 LIPS got better but still filling burning sensation inside mucosa on left side of the lip. still mild swollen started taking Zyrtec my concern is second doses of Pfizer vaccine is this Friday 29 should I get it or wait ?? what I Have could be effects from first Dose??.
36 2021-01-27 seizure At checkout post observation period, recipient fell to floor from standing position, seizure observe... Read more
At checkout post observation period, recipient fell to floor from standing position, seizure observed, series of seizures observed, occurring every 1-3 min, 15-20 second duration, with increasing intensity. BP 144/80 P 87 R 20. O2 Via NC at 6 liters initiated. EMS arrived 1:07 pm. EMS left to transfer to hospital at 1:14 pm. Recipient responding appropriately to commands before and after each seizure. Reported by caregiver that recipient has history of recurrent seizures.
36 2021-01-27 numbness, tingling Developed axillary lymphadenopathy about 24-36 hours after second dose of Pfizer COVID-19 vaccine. L... Read more
Developed axillary lymphadenopathy about 24-36 hours after second dose of Pfizer COVID-19 vaccine. Lymphadenopathy was palpable and visible when arm raised. Significant enough to cause numbness and tingling in arm and hand. Lasted about 24-36 hours, resolved with no treatment. Patient also had chills, body aches, and fatigue associated with vaccine which began about 12 hours after the dose and lasted for about 24 hours. Lymphadenopathy developed after these other symptoms had resolved, also with no treatment.
36 2021-01-27 pain in extremity Headache; Fatigue; swollen lymph nodes; arm soreness; This is a spontaneous report from a contactabl... Read more
Headache; Fatigue; swollen lymph nodes; arm soreness; This is a spontaneous report from a contactable healthcare professional. A 36-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscular in the left arm on 08Jan2021 08:15 at a single dose for covid-19 immunisation. The patient's medical history was not reported. The patient is not pregnant. Concomitant medication included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN). The patient previously took tamiflu and experienced allergies. On 08Jan2021 10:00, the patient experienced headache, fatigue, swollen lymph nodes and arm soreness. The patient has not tested positive for COVID post vaccination. The patient did not received treatment for the events. The outcome of the events was not recovered. Information on the Lot/batch number has been requested.
36 2021-01-27 tingling, flushing Immediately after administration, flushed face, tingling in hands and feet, mild shortness of breath... Read more
Immediately after administration, flushed face, tingling in hands and feet, mild shortness of breath. Resolved after 15 minutes.
36 2021-01-27 numbness LEFT ARM NUMBNESS AND TINGLING THROAT FELT THICK BENADRYL 50MG IM GIVEN
36 2021-01-27 tingling, feeling hot PT stated her heart felt like it was racing, hot, tingly, and lightheaded. Moved PT to the floor and... Read more
PT stated her heart felt like it was racing, hot, tingly, and lightheaded. Moved PT to the floor and monitored vitals with initial BP of 180/80, HR 115, RR 12, SpO299% Continued to monitor PT as BP returned to normal and PT felt better.
36 2021-01-27 pain in extremity Sore arm, itchy arm, headache, sneezing, runny nose, fatigue. Started approximately two hours after ... Read more
Sore arm, itchy arm, headache, sneezing, runny nose, fatigue. Started approximately two hours after administration.
36 2021-01-27 tingling tingling in her arm; This is a spontaneous report from a non-contactable physician (patient). A 36-y... Read more
tingling in her arm; This is a spontaneous report from a non-contactable physician (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly in left arm on 26Dec2020 18:30 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant when receiving the vaccine. If COVID prior vaccination: No. If COVID tested post vaccination: No. Concomitant medication in two weeks included ibuprofen, lansoprazole, levocetirizine. The patient experienced tingling in her arm on 26Dec2020 with outcome of not recovered. After the injection the patient experienced tingling in her arm which she described as "the patient thought they hit a nerve. That's what it felt like." The tingling was "kind a constant very full light tingling most of the day/constant." No treatment received for the event. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No follow-up attempts are possible. No further information is expected.
36 2021-01-28 feeling hot 8 hours after vx on 1/13/21 felt very hot in night to early morning, heart was racing thru night and... Read more
8 hours after vx on 1/13/21 felt very hot in night to early morning, heart was racing thru night and checked that morning to be in 160bpm range and fever of 101.6, this resolved with ibuprofen medication OTC 2 tabs. Had chills and everything resolved by 36hrs. 2 weeks later strted feeling heart palpitations at night but heartbeat normal 85bpm. Then as of 01/28/21 4am felt palpitations stronger and heartbeat was in 160's and traveled down to 135 then 120 and would go up/down between 80's to 125 for 30 mins-1hour. Resolved at ER, ekg normal there and normal day before in clinic office.
36 2021-01-28 feeling hot, tingling Directly after, bright red/ hot ears, itchy face, tingling face and lips Some hives later Severe hea... Read more
Directly after, bright red/ hot ears, itchy face, tingling face and lips Some hives later Severe headache and nausea the next day
36 2021-01-28 pain in extremity, weakness Temp 100.6-100.1. Soreness>flu shot, nausea, Chills, elevated HR 110, muscle ache, fatigue, weaknes... Read more
Temp 100.6-100.1. Soreness>flu shot, nausea, Chills, elevated HR 110, muscle ache, fatigue, weakness
36 2021-01-28 muscle spasms This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-o... Read more
This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), intramuscular (left arm) on 08Jan2021 15:00 at single dose for Covid-19 immunization. The patient's medical history included skin cancer removal in September and Covid (reported as prior vaccination); no known allergies. Concomitant medications included spironolactone, ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE), desvenlafaxine succinate (PRISTIQ), escitalopram, sambucus nigra (ELDERBERRY), and apple cider vinegar (gummies), and daily vitamin (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant. The patient reported that she had flu symptoms all weekend after she got the vaccine. It included chills, fatigue, headache, dizziness and she had bad muscle cramps in calves. She then started having pain in lymph nodes under left arm a couple days ago. The adverse events start date was reported as 09Jan2021. There was no treatment received for the adverse events. The outcome of events was recovered with sequel (reported as recovered with lasting effects) on an unspecified date. The patient has not been tested for COVID-19 since the vaccination.
36 2021-01-28 tingling Tingling and pins and needles throughout the body (head, arms, neck, back) occurred immediately post... Read more
Tingling and pins and needles throughout the body (head, arms, neck, back) occurred immediately post vaccination, patient was given 25mg of benadryl after 30 minute wait period and still reported tingling after 15 minutes. 30 minutes after benadryl no more tingling was reported.
36 2021-01-28 feeling cold, feeling jittery feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedn... Read more
feels tired; heart rate became very fast, it went into like the 150's; feeling jittery; Lightheadedness; weakness of lower extremities; Nauseated; felt really cold; probably had a fever; really thirsty; very hot; she wasn't feeling well; This is spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular (deltoid left) on 14Jan2021 18:25 at 0.3 mL, single for Covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took Bactrim and experienced allergy. The patient reported she did develop some side effects, but the hospital she received the vaccine at didn't know if it was an allergic reaction or what. She reported that a minute or two minutes after receiving the COVID-19 vaccine (14Jan2021), her heart rate became very fast, it went into like the 150's. She started feeling jittery, lightheaded, and she had some weakness of her lower extremities. She also felt nauseated. She didn't have any shortness of breath; she thinks she was okay there. She clarified that she had her mask on and they told her to remove her mask and to breathe, breathe, breathe. She had a pulse oximeter on, and her levels were always at 98, 96. She was told to sit still, and she was given water. Her heart rate went down to 76. She was fine and then after 5 minutes, she had the same reaction again. Her heart rate this time was in the 120's. She was lightheaded, cold, jittery. She did the same thing again and waited another 5- 10 minute. She felt better but was still nauseated, lightheaded, and really, really cold. She was kept there for 45 minutes. After that, she still did not feel 100%. Currently, she still does not feel 100% well. She was okay, she thinks she was okay. She explains they wanted to send her to the ER (emergency room) but she declined. Her heart rate had improved, she wasn't feeling like she was going to pass out. She wasn't experiencing shortness of breath, she wasn't throwing up, she didn't have a rash, her throat wasn't closing up, so she went back to work. She further stated that she came back home. Her heart rate was a little faster, but it wasn't as high as it had been. She still felt a little bit of weakness. At night (14Jan2021), she probably had a fever, she doesn't know. She was really thirsty and very hot. Because she was not feeling well, she didn't get up and drink anything. This morning (15Jan2021), she feels a little better. If she is doing her normal activities, she does get tired. She feels like she is running and is like "okay I feel tired". She has a little bit of weakness in her lower extremities. She was given information for reporting side effects, but because she wasn't feeling well, she didn't do any of it. She checked her heart rate today (15Jan2021) and it's at 76. She added that when she moves a lot, she feels tired and she doesn't know why. She's normally a very active person. She is no longer jittery, but still feels lightheaded. She has a little bit of nausea. She felt hungry so she made a shake and it's not like she is going to throw up, but she is still feeling yucky. She still has a little weakness of her lower extremities. They feel light, she doesn't know how to explain it. She is just a little bit concerned because this is a new vaccine. The outcome of event heart rate increased was recovering; outcome of event feeling jittery was recovered on an unspecified date; while the outcome of other events was unknown. The patient confirmed he doesn't believe it to be life threatening. She doesn't know if this is a severe allergic reaction. She was reading on the side effects the COVID-19 vaccine can cause. Per reporter all events were related to suspect product.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162b2 to the event heart rate increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-28 weakness, night sweats night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactab... Read more
night sweats; myalgia; weakness; fatigue; fever Hours; This is a spontaneous report from a contactable physician. This 36- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via intramuscular route of administration, on 28Dec2020 at 01:00 pm (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the left arm. The medical history was not reported. Concomitant medications included Levothyroxine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020 at 11:00PM, she experienced a "Fever hours", night sweats, myalgias, weakness and fatigue. The patient did not receive treatment for the events. The clinical outcome of the events "Fever hours", night sweats, myalgias, weakness and fatigue were recovered without treatment. On 31Dec2020, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.
36 2021-01-28 speech disorder, weakness tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard fo... Read more
tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard for her to talk/was having a hard time talking, like she had to put effort into talking; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Mar2021, lot# EJ1685), intramuscularly in left arm on 31Dec2020 at 0.3 mL, single for COVID Prevention. Medical history included ongoing Hypertension/high blood pressure (Diagnosed about 2 years ago). Concomitant medication included ongoing ascorbic acid (VITAMIN C) and just some other vitamins but she does not think that is relevant. She had no other vaccines on the same day as the COVID vaccine. The patient experienced dizziness/felt dizzy, weakness/felt very weak, hard for her to talk/was having a hard time talking, like she had to put effort into talking, thought that she would pass out, all on 31Dec2020 with outcome of recovered on 31Dec2020, tired and sore on 02Jan2021 with outcome of recovered on 04Jan2021. The patient got the vaccine on 31Dec2020, and is scheduled to receive the 2nd dose next week and within a couple minutes after getting the vaccine, like less than 5 minutes later, she felt dizzy and very weak, and thought that she would pass out, and she was having a hard time talking, like she had to put effort into talking. After like an hour, she felt better. From then on, she had no side effects besides just being tired and sore, but she had no fever or anything like that. She does have hypertension in her history, but she hasn't been taking her pill because her BP has been stable. She felt like when she took the Pfizer Vaccine, some people can feel their BP shooting up, like it felt like a sensation in the back of head that her BP went up, but she did not think it was her BP because she has not needed to take her pill because her BP has been good. She did not take her BP, so she doesn't know what her BP was at the time. It was a pressure in the back of her like how she feels if her blood pressure is elevated. Investigation Assessment: No. Relatedness of drug to all the events was related per source of assessment: primary source reporter, method of assessment: global introspection.; Sender's Comments: Based on the compatible time association, the event depressed level of consciousness is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-01-29 pain in extremity, tingling I received the Pfizer COVID vaccine on Wednesday, January 20th at 1:15 PM. After I got the vaccine, ... Read more
I received the Pfizer COVID vaccine on Wednesday, January 20th at 1:15 PM. After I got the vaccine, I went in to the observation tent for observation. I sat down and immediately felt a tingle sensation in my fingers on my left hand and my arm hurt at the injection site on my left arm. After I left the observation and returned home, the rest of the day/night, my left arm hurt where I received the shot, I had a headache, my neck hurt, and I felt a little nauseous. The next day, January 21st, I felt a slight tingle sensation in both my hands and feet on my left and right side. January 22nd, the slight tingle sensation in both hands and feet on my left and right side continued, and I had a very bad headache. The slight tingle sensation has continued along with some muscle soreness in my arms and legs. The tingle sensation is intermittent throughout the day in my fingers and toes. I have no numbness and it is not painful. It is just a slight minor tingle sensation. I messaged my doctor on January 25th and was advised to monitor it and contact back if it doesn't go away. Present day January 30th, I still have slight tingling sensation in my fingers and toes on my left and right side, the muscle soreness has since subsided.
36 2021-01-29 tremor Shaky. No other symptoms. Symptoms resolved without treatment. Lasted <60 minutes.
36 2021-01-30 hot flush 1/22: dizziness, chills, hot flashes, diarrhea, nausea for 6 hours. Exhaustion rest of night 1/23: e... Read more
1/22: dizziness, chills, hot flashes, diarrhea, nausea for 6 hours. Exhaustion rest of night 1/23: exhaustion, anxiety 1/24: spotting- beginning of period (have not had a period since august 2020) tires, lack of appetite 1/25: period, hot flashes, tired, lack of appetite 1/26: felt better in terms of energy, had period 1/27,28: diarrhea each morning 1/28: swollen, painful lymph node under right arm 1/29: pain at injection site, small red bump, slightly swollen arm 1/30 1/31: diarrhea in the morning Continued lack of app since vaccine
36 2021-01-30 hot flush Severe body aches, bone pain, exhaustion, hot flashes
36 2021-01-31 tremor About 5 hours after vaccination I started to get dizzy, nauseous, lethargic, fever, uncontrollable c... Read more
About 5 hours after vaccination I started to get dizzy, nauseous, lethargic, fever, uncontrollable chills, tremors, day 2 I become very ill throwing up, complete body shakes blood pressure got up to 212/91 tremors got worse, I slept about 24 hours straight. Day 2 I also started to get swollen lymph nodes under my armpit right side side of vaccination my right breast is swollen and very tender as is my whole right arm and armpit. Still having severe pain.
36 2021-01-31 migraine Fever of 103.5; severe body aches; Migraine; Fatigue; Insomnia; This is a spontaneous report from a ... Read more
Fever of 103.5; severe body aches; Migraine; Fatigue; Insomnia; This is a spontaneous report from a contactable other health professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), via an unspecified route of administration on 29Dec2020 at 15:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history included GERD and allergy to latex. The patient was also diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has concomitant medications but were not specified. On 01Jan2021 at 02:00, the patient experienced fever of 103.5, severe body aches, migraine, fatigue, and insomnia. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
36 2021-01-31 pain in extremity, discomfort feeling like I was 500 lbs; I felt like an impending sense of doom; swollen lymph nodes in my neck; ... Read more
feeling like I was 500 lbs; I felt like an impending sense of doom; swollen lymph nodes in my neck; stiff neck; severe shivering; I needed assistance to walk safely to avoid falling; Intense pain in my left arm; dryness in my throat/severely dry throat; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration in right arm on 23Dec2020 17:15 at single dose for COVID-19 immunization. Medical history included acid reflux from an unknown date and unknown if ongoing. There were no concomitant medications. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received the first Pfizer vaccine on 23Dec2020 at approximately 5:15 PM. The patient felt fine until about 11 PM at night, the patient stated, "when I began experiencing intense pain in my left arm and dryness in my throat" on 23Dec2020. I took a Benadryl and went to bed. At approximately 1 AM (24Dec2020) I woke up feeling like I was 500 lbs (I am about 175 lbs). I also had swollen lymph nodes in my neck, a stiff neck, a severely dry throat, and severe shivering. I attempted to navigate to the bathroom and felt like I needed assistance to walk safely to avoid falling. I felt like an impending sense of doom, and called my mom who is a nurse. She told me to contact the Pfizer #, but nobody was answering the phone at that time. I then started looking up on the internet if anyone else had experience what I was feeling after the vaccine and if the feeling passed, as I was not sure if I should go to the ER. I ended up falling asleep." The outcome of the events was recovering. The patient took Benadryl for events "intense pain in my left arm and dryness in my throat" as treatment. No treatment was given to the patient from the remaining events. Information on the lot/batch number has been requested.
36 2021-02-01 pain in extremity Agitation, anger, sore arm, lump on arm, redness, extreme itchiness.
36 2021-02-01 flushing, pain in extremity Facial flushing that was more prominent on the left side of my face and left ear flushing and burnin... Read more
Facial flushing that was more prominent on the left side of my face and left ear flushing and burning, dizziness, nausea., and rapid pounding heart beat. This started 45 minutes after receiving the vaccine. About 1 1/2 hours symptoms still persisted so took 50mg of Benadryl and slept for 2 hours. Upon waking up facial flushing, dizziness, and pounding heart rate still present but was better. Continued to have left sided cluster headache and face flushing for 48 hours. Also was sore in my left arm down my left side to the bottom of my rib cage all the way up my left neck and sore into my left chest.
36 2021-02-01 pain in extremity, numbness I received the shot a little after 5pm. Afterwards my arm hurt, I was tired, and my head hurt - all... Read more
I received the shot a little after 5pm. Afterwards my arm hurt, I was tired, and my head hurt - all expected. However at 7pm I could feel something strange spreading across my face. My left side of my face became numb and swollen. I went to urgent care the next day and they said I had inflammation in my facial nerve and prescribed me prednisone. I'll be on the prednisone for another 8 days, tapering. My face and head have continued to be numb and swollen. Today for the first time, it feels a little better. Today is a week since I received the vaccine.
36 2021-02-01 pain in extremity, numbness Numbness and pain in left arm 45 mins after injection, headache Numbness in left arm and hand every... Read more
Numbness and pain in left arm 45 mins after injection, headache Numbness in left arm and hand everyday since injection Numbness in right arm, hand, foot day after injection and intermittent since then. Consistent Numbness in right side face, right arm, right leg and right foot on day 4 after injection , went to emergency department
36 2021-02-01 tingling Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive house... Read more
Tested positive for COVID 1/23/21. Was asymptomatic at the time and was tested due to positive household members. Developed symptoms (headache) 1/25/21. Developed sensation change (pins and needles) in left arm 1/31/21. Was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found.
36 2021-02-01 numbness Vaccine administered by RN on 2/02/2021 at 11:50am. Location was at Nursing Home. Coordinating fac... Read more
Vaccine administered by RN on 2/02/2021 at 11:50am. Location was at Nursing Home. Coordinating facility for vaccines is the Health District. Within five minutes after vaccine administration, the patient's co-worker informed the patient that she had some redness on her neck. Patient left dining hall where vaccines were being administered and upon return, RN with HD asked patient how she was feeling. The patient was noted to have a red neck and chest with some petechiae on neck and chest. Patient c/o headeache and numb right arm, same arm used for vaccine. At 12pm, 25mg PO of Diphenhydramine was given by RN. The patient c/o nausea and started to vomit. HR was assessed by RN at a radial rate of 106 BPM. Patient stated her head was hurting worse and continued to vomit. RN, called EMS. Cold compress given to patient and patient was assisted to restroom by RN. Upon exiting the restroom, patient started vomiting again and stated her throat was itching and tongue felt swollen. She stated she was allergic to vanilla and her throat felt the same as when she reacts to vanilla. RN, attempted to visually inspect the patient's throat/tongue/mouth and noted that back of the mouth was edematous and unable to visually see the throat. 12:11 pm, 0.3 mg of epinephrine administed by EPIPEN into right lateral thigh. EMS arrived at 12:15pm. Patient assessed by EMS and agreed to transport to Hospital for evaluation. EMS and RN assisted patient to stretcher for transport. Nursing Supervisor, with Health District notified by phone by RN.
36 2021-02-01 weakness Welts / redness on face 11:55pm 2-1 benadryl Weak 2 -1 Welts/ redness on face 8pm 2-2 benadryl Sore... Read more
Welts / redness on face 11:55pm 2-1 benadryl Weak 2 -1 Welts/ redness on face 8pm 2-2 benadryl Sore neck, stiff Weak
36 2021-02-01 tremor, feeling hot both legs became hot and shaky; both legs became hot and shaky; Elevated blood pressure for 3 days f... Read more
both legs became hot and shaky; both legs became hot and shaky; Elevated blood pressure for 3 days following vaccine; This is a spontaneous report from a contactable other HCP. A 36-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on arm left from 16Jan2021 10:30 to 16Jan2021 10:30 at SINGLE DOSE for covid-19 immunisation. Medical history included birth control implant. Concomitant medication included etonogestrel (NEXPLANON) for birth control implant. The patient previously took zithromax and experienced Known allergies: Zithromax. On 16Jan2021 10:30, within 2 minutes of vaccine, both legs became hot and shaky. Elevated blood pressure for 3 days following vaccine. Will continue to track bp (blood pressure). The patient underwent lab tests and procedures which Nasal Swab: unknown results (pending results) on 19Jan2021. Outcome of the events was recovering.
36 2021-02-01 tingling pt stated that she had an overall itchiness on both feet that were swollen and red like a neuropathy... Read more
pt stated that she had an overall itchiness on both feet that were swollen and red like a neuropathy effect. Pt states it is better now but still has some tingling and sensitivity on both feet. Pt has not contacted PCP at this time.
36 2021-02-01 discomfort soreness; fatigue; slight heaviness; This is a spontaneous report from a contactable other health pr... Read more
soreness; fatigue; slight heaviness; This is a spontaneous report from a contactable other health professional. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in the left arm, on 13Jan2021 17:15 at SINGLE DOSE for COVID-19 immunization. Medical history included Acid reflux. Patient received the first doe of BNT162B2 on 23Dec2021 for COVID-19 immunization There were no concomitant medications. On an unspecified date, the patient experienced soreness, fatigue and slight heaviness but still feel off today (16Jan2021). The outcome of events was recovering. Patient did not receive any treatment due to events. Information about lot/batch number has been requested.
36 2021-02-02 migraine At 7am started to get a migraine felt nausea threw up took a hot shower drank 7up and eating crack... Read more
At 7am started to get a migraine felt nausea threw up took a hot shower drank 7up and eating crackers
36 2021-02-02 tingling Chills, sweats, vertigo, joint pain (particularly in my knees) , muscle pain, extreme exhaustion, li... Read more
Chills, sweats, vertigo, joint pain (particularly in my knees) , muscle pain, extreme exhaustion, lightheadedness, swelling of my extremities, injection site soreness felt like my heart was beating irregularly, cotton mouth, decreased appetite, mental fog. These all started about 12 hours after vaccination and lasted for 2 whole days. Additionally, on Jan 31st, I experienced numerous occasions of "pins and needles" in my feet. This went away and came back over several hours of time throughout the day on Jan 31st. Exhaustion and mental fog have continued through 2/3, but all other symptoms have resolved.
36 2021-02-02 weakness On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, ... Read more
On Saturday had nausea, vomiting started, and progressively lead to dizziness, shortness of breath, chest tightness, diarrhea, feeling of something stuck in her throat globus sensation, weakness. She went to the ER on 1/18/21 they felt she had gastritis and gave her fluids, Zofran and COVID test which was negative, then they sent her home. It continued where she could not eat, could not sleep, felt like she was going to die. She ended up going back to the ER again on 1/23/21. They did a CT scan, EKG, gave her IV fluids, flu and an antimotility agent for the nausea. They did lab work to rule out other tests. Did stool culture, blood work. She got admitted over night, then she had endoscopy on 1/24/21 to rule out any issues with her throat since she felt like it was closing on her. They said her esophagus looked fine, took biopsies. All the tests that were done were negative, and sent her home on 1/24/21. Then on Monday, 1/25/21 went to see a ENT specialist who also did a scope to loop down her throat to se if anything was blocked and felt that it was inflammation due to vomiting. Advised to take Proton pump inhibitor to help with the acid reflux from the vomiting. The GI doctor called on 1/26/21 showed some H-pylori, but did not know why she had that. Was started on antibiotics for that. She saw her PCP on 1/28/21, who did work up for celiac disease, thyroid scan/studies and all tests were negative as well. Right now she is home and the plan is to wait it out and to see if she gets better over time. She still having today 2/3/21 diarrhea, no appetite, cannot sleep, occasional chills, no fever, headache, chest tightness, nausea but is taking Zofran, still having the globus sensation in her throat. States her "body is not well", weakness as well.
36 2021-02-02 tenderness pt may have allergic reaction to COVID injection, pt had second injection this past friday. rash to ... Read more
pt may have allergic reaction to COVID injection, pt had second injection this past friday. rash to arms, swelling/tenderness to lt arm. pt on routine allergy medicine at home.
36 2021-02-03 migraine, night sweats About an hour or two after the injection I started to get a medium grade headache. Then it progress... Read more
About an hour or two after the injection I started to get a medium grade headache. Then it progressed to a serve migraine, I was able to stay at work but went straight home after. I started taking Maxalt for my migraines and it didn't help any, I took this for two days. Mid day on the 31st I wasn't feeling to hot, laying around, couldn't shake the headache. The following day symptoms were the same but I was more ill, sick to my stomach, flu like symptoms I would say. I had chills and night sweats during the evening , this went on for two evenings. Monday the physical effects went away but the headache was still there and concerned me because it was on my left said. I called my Neurologist and let her now my symptoms, she stated it was most likely from the vaccine. She was surprised my medication I was taking did not work but advised me to take Tylenol and it went away completely. About a week and a day my head ace went away and I was ok.
36 2021-02-03 tingling Left shoulder/joint pain; left shoulder partial immobility; left hand/finger tingling; This is a spo... Read more
Left shoulder/joint pain; left shoulder partial immobility; left hand/finger tingling; This is a spontaneous report from a contactable Nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK417J, expiry date: unknown), via an unspecified route of administration from on 05Jan2021 10:30 at single dose (Left Deltoid) for COVID-19 immunization. The patient medical history was not reported. Patient is not pregnant. Patient had no covid prior vaccination, patient had no covid tested post vaccination, and no known allergies. Concomitant medication included paroxetine (PAROXETINE). The patient received first dose of bnt162b2 (lot number: PAA156051) on 12Dec2020 at Left Deltoid for COVID-19 immunization at 35 years-old. Vaccination facility type was Hospital. The patient experienced left shoulder/joint pain, left shoulder partial immobility, and left hand/finger tingling that has not gone away; all on 08Jan2021 08:00. The outcome of the events was not recovered. No treatment for events was given.
36 2021-02-03 weakness, feeling hot, electric shock sensation, discomfort On 2/2, my whole body was heavy and I felt tired. I had occasional brain zaps. I felt hot. On 2/3, I... Read more
On 2/2, my whole body was heavy and I felt tired. I had occasional brain zaps. I felt hot. On 2/3, I felt better during daytime, but then at night developed abdominal pain. I woke up in the middle of the night and had diarrhea throughout the night. I had a total of 3 episodes of explosive diarrhea. Nausea, dizziness, weakness, low grade temp. I went to urgent care on the morning of 2/4. I was told my symptoms are likely adverse effect of the vaccine.
36 2021-02-03 flushing Patient received her 2nd dose of covid-19 Pfzier vaccine drive thru @ 0819. Patient c/o severe heada... Read more
Patient received her 2nd dose of covid-19 Pfzier vaccine drive thru @ 0819. Patient c/o severe headache, dizziness, nausea, palpitations. 0821 BP164/100, denied shortness of breath, no respiratory distress noted. 0828 BP 160/98, O2 sat 98 %. HR 115, c/o nausea, severe headache, face flushed. 0831 BP 145/83 HR 99, o2 sat 100%, c/o severe headache, vomited x 1. 0832EMS activated. 0833BP 143/91 HR 95. 0835 Fire Department on site, 0838 BP 182/102 HR 125 O2 sat 98% (by the Fire Department) 0839 Patient c/o severe headache, nausea, vomited x 1 0841 Blood glucose 173 (by the Fire Department) 0848 EMS arrived 0850 BP 180/99 HR 105, patient c/o severe headache, nausea and dizziness. 0901 Patient transported to Hospital. Pt was alert and oriented x 3 @ all time, no respiratory distress noted.
36 2021-02-04 migraine Fever 103.5, whelp on injection site , migraine, muscle tightness in neck and back, soar throat, dr... Read more
Fever 103.5, whelp on injection site , migraine, muscle tightness in neck and back, soar throat, dry cough
36 2021-02-04 pain in extremity Sore arm; fatigue; This is a spontaneous report from a contactable consumer reported for herself. A ... Read more
Sore arm; fatigue; This is a spontaneous report from a contactable consumer reported for herself. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration on the left arm on 16Jan2021 07:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included sertraline hydrochloride (ZOLOFT), probiotics (PROBIOTICS), lecithin (LECITHIN) and multivitamin. The patient experienced sore arm and fatigue on 16Jan2021 18:00. No treatment was received for the events. The outcome of the events was recovered on an unspecified date.
36 2021-02-04 pain in extremity Swollen arm; sore arm; tiredness and some fatigue feeling in my upper back; tiredness and some fatig... Read more
Swollen arm; sore arm; tiredness and some fatigue feeling in my upper back; tiredness and some fatigue feeling in my upper back; This is a spontaneous report from a contactable consumer reported for self. This 36-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL9262) at single dose in right arm on 20Jan2021 at 03:15 PM for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced swollen arm, sore arm, tiredness and some fatigue feeling in her upper back on 21Jan2021. There was no treatment received for the adverse events. Serious was no: not results in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating and not congenital anomaly/birth defect. The outcome of events was resolving.
36 2021-02-04 feeling hot, flushing hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; diffi... Read more
hives started to appear on her body/hives on her neck; nauseous/ was going to throw up; dizzy; difficulty breathing (wheezing); difficulty breathing (wheezing); injection site soreness; She was hot, flush; difficulty swallowing; the tongue started swelling/Swollen tongue; Anaphylactic reaction/anaphylaxis; This is a spontaneous report from a contactable consumer reported for self. This 36-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 12:52 left arm at single dose (Lot: EL3247) for covid-19 immunisation. Medical history included ongoing Anaphylaxis to Walnuts, Oranges, and morphine, ongoing allergy to a steroid cream Kenalog, and a steroid powder which she broke out immediately and ongoing Colitis. Concomitant therapy was none. She received the first dose of the vaccine yesterday on 20Jan2021 12:52 and 10 minutes later (20Jan2021 13:02) the tongue started swelling/Swollen tongue so they gave her Benadryl to try to stop it but it didn't help enough, hives started to appear on her body so they gave her a dose of epinephrine in the right arm and put on an IV, because she was feeling nauseous and dizzy. She started to feel better and was transferred to the hospital, when she was in the hall of the hospital she started having difficulty breathing (wheezing) and difficulty swallowing so she received another dose of Epinephrine (EpiPen) and also Benadryl, Prednisone and Pepcid. She went home and was taking Prednisone (1 daily), Benadryl and salbutamol (twice daily). She went into anaphylaxis within 15 minutes of receiving it on 20Jan2021. She brought 2 Epi injections with her. They monitored at the hospital for a few hours. She knows exactly how it happened. She was sitting in the observation room. She had told them multiple times that she had allergies before. She came in with two Epi pens and Benadryl. She let them know that as well. She was very verbal that she has history of anaphylaxis. They gave it to her. They said they were going to monitor her for 30 minutes. Her tongue started to swell 10 minutes after. She was sent to the paramedic tent. She took liquid children's Benadryl to try to stop the reaction. It did not help. She clarified it just didn't work enough to delay it. She doesn't have UPC, but provided the following information from the bottle: PLD-H242C LB004314 Lot WJ00896 Expiration Feb2023. She then started getting hives on her neck. She was hot, flush, and dizzy. She felt like she was going to throw up. That passed. They then gave her Epi in the opposite arm, her right arm. She got the COVID vaccine in her left arm. Then, they got her ready to go to the hospital. The transfer was smooth. She was waiting for intake when she started to not be able to swallow. She complained quickly. The nurses ran to get Epi, but the paramedic grabbed the patient's Epi pen and injected it in her thigh. She was IVed up at the vaccine center before transfer. They gave her Benadryl, Pepcid, and methyl prednisone. The Epi pen they gave her was her own shot. They monitored her a few hours. Then sent her home with Pepcid, more Epi pens, and Prednisone for 4 days. She has had normal soreness in her arm at the injection site. It has been status quo, it feels like a tetanus shot. She still has swelling in tongue, but they told her that might take a day or two to go away. She is supposed to also take Benadryl for the next 2 days. She was given the vaccine at the (Place name). Events visit to Emergency Room. They did a CBC and she was in normal range for everything. Lab data included on 20Jan2021: CBC normal. Outcome of the event Swollen tongue was recovering. Outcome of the event Anaphylactic reaction/anaphylaxis was recovered. Outcome of the event injection site soreness was not recovered. Outcome of the events was unknown.
36 2021-02-05 flushing, hot flush 24 hrs after 2nd dose, (approx. 2pm next day): body flushing and lip tingling noted. 40 hrs after (... Read more
24 hrs after 2nd dose, (approx. 2pm next day): body flushing and lip tingling noted. 40 hrs after (approx 6am 2 days after 2nd dose): moderate, painful upper lip swelling present for 10-12 hours. Body flushing, hot flashes noted on and off throughout day. Resolved without treatment.
36 2021-02-05 pain in extremity Fever for about 8 hours, fatigue, sore arm
36 2021-02-06 feeling hot I was sitting down waiting my 15 minutes. About eight minutes in, I started to feel very hot and sha... Read more
I was sitting down waiting my 15 minutes. About eight minutes in, I started to feel very hot and shaky. I asked for some water and took some crackers. I was extremely nauseous. Then I felt my pulse pounding through my chest and so forceful I felt it in my tongue. I had my Fitbit watch on and looked at my pulse: it was 168 BPM. I called for help. The nurses took my Blood pressure and HR. My normal BP is low - usuall 110/68. When they took my vitals it was 180 BPM & 149/98. I was taken to the ER and monitored. My vitamins returned to normal within a few hours .
36 2021-02-07 feeling hot, numbness, weakness "Patient states that she received the first dose of the Pfizer COVID vaccination on 1/2/21. Approxim... Read more
"Patient states that she received the first dose of the Pfizer COVID vaccination on 1/2/21. Approximately 30 minutes later, she started having left arm numbness and shooting pain. This has not occurred with any previous vaccinations. Over the course of the next several hours, numbness spread to involve her left foot and she felt like her knee was swollen. The day after, she started having numbness in her right foot and some in her right hand/fingers. Her left sided symptoms seem to have improved, but her right sided numbness persisted/worsened. Felt subjectively warm and generally weak/tired. No similar episodes in the past and no prior episode of other focal neurologic deficits. " Sensory changes and paresthesias present daily and slowly improving for the following weeks.
36 2021-02-07 migraine, tenderness, tingling, pain in extremity She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to tou... Read more
She couldn't walk for 4 days; Migraine; Bone pain; skin hurt to the touch; Her skin even hurt to touch. She was sensitive all over.; Chest burning and hurting; Joint pain; extremely dizzy; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; arm was sore/soreness where they gave the vaccine on her arm all the sudden came back very suddenly; The lady that gave it was not gentle. She screamed.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number EL1284) via an unspecified route of administration on 03Jan2021 at a single dose for covid-19 immunization. The patient had headaches in the past. The patient's concomitant medications were none. The patient got vaccine on the 03Jan2021 and her arm was sore, but she felt like this was normal, just like it would feel after a flu shot. Throughout the next week, she was extremely stressed for work. By Friday, which would have been 6 days later. She was feeling really off wellness wise. She was very fatigued, and extremely dizzy on 07Jan2021. On Saturday night 09Jan2021, she felt very bad. She had a sore throat, she was coughing, her chest was burning and hurting. She had severe chills and aches. She thought maybe she needed more sleep because she works out 6 days a week. She felt like she was in over drive like she was killing herself. Sunday morning 10Jan2021, she felt bad. She has so much adrenaline. She was always on the go. She decided to take a nap before the gym Sunday, and she woke up with a huge migraine. She had headaches in the past, but never a migraine. Her head was hurting so bad it woke her up. It hurt all over. She also felt like she had taken a hammer to her joints and bones. Her joints and bones were hurting. She has never felt that before. Her muscles were so achy. Her skin even hurt to touch. She was sensitive all over. She had severe chills. The soreness where they gave the vaccine on her arm all the sudden came back very suddenly. It came back the same day as the other symptoms started. They mostly started on the 09Jan2021, and then on the 10Jan2021 they were worse while migraine and bone hurting were occurred on 10Jan2021. She assumed there were subtle symptoms leading up to the 09Jan2021, but she just didn't realize it. That was a Saturday and Sunday. The lady that gave it was not gentle. She screamed. The side effects lasted at least 5 days after the 10Jan2021. On the 10Jan2021, she did not feel well so she got tested for COVID because her boss told her to. They tested her Flu, COVID, and strep. She only tested positive for COVID on 10Jan2021. She felt like she wouldn't be able to drive. She couldn't walk for 4 days. She felt most of the symptoms had gone away around 5 days after the 10th except fatigue, feeling dizzy, and headaches here and there. She also had a little coughing here and there. That started 09Jan2021 and was ongoing but improved. She got the vaccine because the doctor at her practice really encouraged her to get it done. She also thought if she ever wanted to travel that she might need it. She thought in the long run she might benefit from having the vaccine. She felt peer pressured honestly to get it because she was sketched out to get it at all. She wants to know the rate of people testing positive for COVID after getting the vaccine. The outcome of the events sore arm, chest burning, joint and bone pain, skin even hurt to touch and sensitive was recovered on 15Jan2021, the outcome of the events screamed and couldn't walk was unknown and the outcome of the other events was recovering.
36 2021-02-09 tingling, numbness, throat numbness Face, mouth, neck, and throat tingling and then numb for an hour. No difficulty breathing and the nu... Read more
Face, mouth, neck, and throat tingling and then numb for an hour. No difficulty breathing and the numbness stopped on its own.
36 2021-02-09 numbness, weakness Headache; neck pain; numbness into extremities; extreme pain in left arm; Extreme muscle pain in nec... Read more
Headache; neck pain; numbness into extremities; extreme pain in left arm; Extreme muscle pain in neck caused me to go to ER; Significant bilateral shoulder pain; Weakness; This is a spontaneous report from a contactable consumer (patient). This 36-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 20Jan2021 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient is not pregnant at the time of report and at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose on 31Dec2020 on the left arm. On 20Jan2021 21:00, the patient's extreme muscle pain in neck caused her to go to the ER and tramadol and Norflex were administered. The patient had significant bilateral shoulder pain and weakness. The head and muscle pain in neck persisted. Events resulted in emergency room/department or urgent care. Treatment received were tramadol and Norflex. On 20Jan2021 22:00, the patient experienced headache, neck pain, numbness into extremities, and extreme pain in left arm. The events resulted in emergency room/department or urgent care. Tramadol was received as treatment but it worsened the symptoms. The tramadol was administered on the left arm at the hospital. Outcome of the events "extreme muscle pain in neck", "significant bilateral shoulder pain", and "weakness" was unknown and of the other events was not recovered. Information about lot/batch number has been requested.
36 2021-02-09 flushing, feeling hot Patient stated that she felt hot and short of breath. Patient was offered an ice pack and a pulse o... Read more
Patient stated that she felt hot and short of breath. Patient was offered an ice pack and a pulse oximeter was placed on finger for obtaining O2 sat. Patient stated she felt flushed and that tongue and throat were tingling. EMS was called. Attempted to transfer patient to a wheelchair to relocated patient to clinic emergency area. Patient passed out and onsite MD consulted. Epi pen administered at 1021 via R arm and vitals monitored until EMS arrived. O2 sat 99%. BP 180/86 and HR 126. EMS arrived on site at 1040
36 2021-02-09 pain in extremity, breast pain Swollen and tender axillary and pec lymph nodes; sore arm, R breast and R scapular area; sore arm, R... Read more
Swollen and tender axillary and pec lymph nodes; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; sore arm, R breast and R scapular area; R abdominal/flank pain; R abdominal/flank pain; mild fever; This is a spontaneous report from a contactable health professional, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the right arm on 20Jan2021 at 10:15 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and COVID-19 (diagnosed prior to vaccination), as of unknown dates. The patient had no known allergies. Concomitant medications included olmesartan, fish oil (OMEGA 3) and unspecified CLARITIN. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 21Jan2021 at 16:00, the patient experienced swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever. The patient was treated for the events with acetaminophen (TYLENOL) and ibuprofen (ADVIL). Since the vaccination, the patient was tested for COVID-19 via nasal swab on 20Jan2021 with a negative result. The clinical outcome of swollen and tender axillary and pec lymph nodes, sore arm, right breast and right scapular area, right abdominal/flank pain and mild fever was resolving. Information on the Batch/Lot number has been requested.
36 2021-02-09 muscle spasms, numbness never had high blood pressure, she is normally 105/60, and in the ER she was 170/101; chills; fever;... Read more
never had high blood pressure, she is normally 105/60, and in the ER she was 170/101; chills; fever; skin irritation, like achiness from wearing clothes; neck is very stiff; headache; general malaise; numbness in hand and arm; muscle pain; muscle spasms; exhausted; pain; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1283), via an unspecified route of administration in the left deltoid on 20Jan2021 16:30 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (lot EH9899) on unspecified date for COVID-19 immunisation. On 20Jan2021 the patient had headache with outcome of recovering, general malaise, muscle pain and muscle spasms in neck with outcome of not recovered, numbness in hand and arm with outcome of unknown. On 21Jan2021 the patient experienced chills with outcome of recovered in Jan2021 and fever with outcome of recovered on 21Jan2021, neck was very stiff, skin irritation, like achiness from wearing clothes with outcome of unknown. The patient experienced also exhausted, pain, on Jan2021 with outcome of unknown and high blood pressure (she was normally 105/60, and in the ER she was 170/101) on 23Jan2021 with outcome of unknown. Clinical course was as follows. The patient began to develop the following symptoms: headache, numbness in hand and arm, and muscle spasm in neck. The patient was working and had some patients the day following vaccination, and her headache got much worse, the muscle spasms and pain were worse, and all of a sudden she got skin irritation, like achiness from wearing clothes, and she realized she had a bit of a fever. Chills have gone away, she did not feel those. Muscle aches, especially the muscle spasms on her neck into the shoulder have not. Fever went away that day, she took Tylenol, and after she took it, she got home from work, and was better that evening from chills and fever, she has recovered completely from fever. She was in so much pain, she was feeling overall exhausted. She had headaches the day of the injection. She thought she had slept wrong, possibly the night before, so she didn't think of it, until symptoms worsened. She went to emergency room on 23Jan2021 due to severity of the muscle spasms in neck, so the doctor was worried about stenosis, or like impingement of spinal cord, but the CT scan on 23Jan2021 was negative for structural reasons, so she was prescribed a muscle relaxer and one for pain and inflammation. The patient was given Tramadol and Norophlex at the ER via injection in each arm. After receiving injections she reported that she developed a severe reaction in both arms, she cannot move her arms, it was extremely painful, like she had surgery on both sides and her neck was very stiff. Her arms were now weak, very painful, and she could not lift her arms. She has had Tramadol in the past, never had pain, but this was worse than labor. Her left arm felt like it would explode when he injected it, and now she can barely move both arms, she has not been able to move her arms, and the hospital doesn't know why, this is not a response from those medications. Headaches were the same intensity, but better from when she went to the ER. They were now a 7 out of 10 and in the ER were a 10 out of 10. When she got chills, she had an intense stiffness in her neck, muscle pain across shoulders to upper back, and it varies in intensity, she's been laying down the last day and a half, today was tolerable, but when she went to the ER on Saturday, it was so extreme she thought she had a nervous breakdown, it was a lot of pain, she didn't know if that contributed to her elevated blood pressure, or was something separate.
36 2021-02-10 feeling cold 1/6/21 - left underarm soreness, 1/7/21 - body aches, fatigue, headache, felt cold, took ibuprofen a... Read more
1/6/21 - left underarm soreness, 1/7/21 - body aches, fatigue, headache, felt cold, took ibuprofen and felt better, fever started, 1/8/21 - fever, malaise, body aches, rash started on arms and worsened until it covered entire body surface head to toe, went to urgent care for testing, flu and COVID negative, fever came down and tachycardia persisted when afebrile (160's finally coming down to 130ish when lying down deep breathing), urgent care physician wanted an EKG due to tachycardia, drinking plenty of water, not dehydrated, 1/9/21 - fever and entire body rash persisted, taking acetaminophen, ibuprofen, and diphenhydramine, 1/10 - rash improved and intense itching started, had to take 75mg diphenhydramine every 3 hours and stay in the bathtub to tolerate itching, still had fever on and off but was responsive to medication, 1/11/21 - intense itching continued, same therapy as previous day, 1/12/21 - itching improved, no fever, 1/13/21 - able to work remotely, 1/14/21 - able to work on site.
36 2021-02-10 cold sweat 103.5 degree Fahrenheit fever while taking Acetaminophen every 6 hrs; extreme fatigue bedridden; chi... Read more
103.5 degree Fahrenheit fever while taking Acetaminophen every 6 hrs; extreme fatigue bedridden; chills; cold sweats; bone pain/aching; administration date=11Jan2021, dose number=2/administration date=30Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). This 36-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 11Jan2021 11:15 AM at single dose for COVID-19 immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR). The patient previous received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 30Dec2020 09:15 AM at 36-year old for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 103.5 degree Fahrenheit fever while taking Tylenol every 6 hrs, extreme fatigue bedridden, chills and cold sweats, bone pain/aching on 12Jan2021 04:00 AM. No treatment was received for the adverse even. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequel. Seriousness criteria was reported as non-serious. Information on the lot/batch number has been requested.
36 2021-02-10 tingling At 15 minutes post vaccination right leg felt "heavy" followed by tingling of right side of face an... Read more
At 15 minutes post vaccination right leg felt "heavy" followed by tingling of right side of face and tongue. Mostly, but not completely resolved at 24 hours post vaccination.
36 2021-02-10 migraine Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salt... Read more
Mental foggyness/forgetful; Chills; Migraine; Dizziness; Fatigue; Loss of appetite; Food tasted salty/rotten; Diarrhea; Vomiting; intestinal discomfort; Cough with some shortness of breath (relieved with asthma inhaler); Cough with some shortness of breath (relieved with asthma inhaler); This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Solution for injection; lot number: EL3249, expiration date: unknown) via unspecified route of administration in the arm left on 22Jan2021 08:00 at single dose for COVID-19 immunisation. Medical history included asthma, multifocal myoclonus, IBS/lynch syndrome, hypothyroidism, Allergy: Dairy (milk allergy), allergies, alcohol allergy, Allergy: beef (meat allergy), and allergy: adhesives (dermatitis contact). Patient was taking unspecified concomitant medications. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: urgent care center (also reported as Doctor's office). The patient experienced mental foggyness/forgetful, chills, migraine, dizziness, fatigue, loss of appetite, food tasted salty/rotten, diarrhea, vomiting, intestinal discomfort, and cough with some shortness of breath (relieved with asthma inhaler); all on 23Jan2021 at 06:00. The events resulted to: Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken in response to all events (unspecified). Patient also had teleconference with doctor. Outcome of all events was recovering.
36 2021-02-10 migraine Patient developed spontaneous nosebleed, lasting 20 minutes, one day after injection. Patient repor... Read more
Patient developed spontaneous nosebleed, lasting 20 minutes, one day after injection. Patient reported 2nd spontaneous nose bleed lasting 10 minutes two weeks post injection. Patient has no known history of nosebleeds in the past, and no recent accidents, falls or other injuries to the head, neck or face. Patient experienced first ever migraine two weeks post injection.
36 2021-02-10 numbness Right arm was very sore; right hand felt numb; itchy on the right side of her back and her right arm... Read more
Right arm was very sore; right hand felt numb; itchy on the right side of her back and her right arm; Itchy on the right side of my back; Rash with bumps; This is a spontaneous report from a contactable healthcare professional (patient). This 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 22Jan2021 15:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified birth control pill. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 2, 23Jan2021 17:00, the patient's right arm was very sore, right hand felt numb, itchy on the right side of her back and her right arm. The patient started to develop rash with bumps. Rash went away as soon as she took Benadryl. On Day 3, she was back to normal, no soreness, no numbness and no itchiness. The events were reported as non-serious. Outcome of the events was recovered on 24Jan2021.
36 2021-02-10 feeling hot, flushing Throat swelling; tightening; difficulty breathing/swallowing and hot/flushing/sweating all over body... Read more
Throat swelling; tightening; difficulty breathing/swallowing and hot/flushing/sweating all over body. The ER gave me Epinephrine; Benadryl; Fluids.
36 2021-02-14 feeling hot Occurring within 5 minutes after injection Dizziness, fatigue, palpitations (HR>120), feeling hot. ... Read more
Occurring within 5 minutes after injection Dizziness, fatigue, palpitations (HR>120), feeling hot. Occurring 3 days after injection and ongoing since for past 9 days abnormal vaginal bleeding (spotting)
36 2021-02-14 numbness, tingling numbness and tingling in upper and lower extremities/bilateral upper and lower extremity changes, st... Read more
numbness and tingling in upper and lower extremities/bilateral upper and lower extremity changes, strength and dexterity changes; numbness and tingling in upper and lower extremities; dexterity issues/bilateral upper and lower extremity changes, strength and dexterity changes; intermittent dull occipital headaches; This is a spontaneous report from a contactable Nurse (patient) This 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose for covid-19 immunization .The patient medical history was not reported. The patient's concomitant medications were not reported. She received the first dose of the Pfizer vaccine on 7th Jan and after 2 weeks, she started experiencing numbness and tingling in upper and lower extremities and dexterity issues, caller stated its progressive issue to the point that its interfering with her daily actives.On 21Jan she recognized bilateral upper and lower extremity changes, strength and dexterity changes, intermittent dull occipital headaches. She Wanted to know if those symptoms are in line for reported symptoms with part one. Is scheduled for her second one today and was unable to get appointment with her doctor until tomorrow. Stated that she has reservations about having the second one.The events were reported as non serious.Outcome of the event was unkown
36 2021-02-15 tingling C/o tingling of right arm and palm. . Hx of being in car accident and right side effected. EMS eval... Read more
C/o tingling of right arm and palm. . Hx of being in car accident and right side effected. EMS evaluated. Given stretching exercises and felt better.
36 2021-02-15 difficulty speaking, weakness, cold sweat, tremor, tingling, flushing Several days after 1st Covid-19 vaccine I have incidents at least 2 times per day feeling shakiness,... Read more
Several days after 1st Covid-19 vaccine I have incidents at least 2 times per day feeling shakiness, feeling like blood sugar was low, feeling weak and dizzy and clammy This lasted for 2 weeks post the 1st vaccine. Also experienced headache for 10 days post vaccine. After dose 2, Flushing on face and chest. Tingling and heaviness on chest. Feeling short of breath and feeling tightness in throat Tingling of arms. BP was 141/101 (normally runs low). I was informed that I was having a panic attack and was released by the staff. Chest tightness, heaviness and difficulty breathing continued. On Saturday 2/13 I went to urgent care and was prescribed an inhaler and steroids for shortness of breath. I continue with feeling heaviness in my chest, difficulty with shortness of breath, and hoarseness in my voice/tightness in my throat especially with increased activity or talking.
36 2021-02-15 pain in extremity arm pain- lasted several days; muscle aches- lasted approximately 12 hours; chills- lasted approxima... Read more
arm pain- lasted several days; muscle aches- lasted approximately 12 hours; chills- lasted approximately 12 hours; fatigue- lasted approximately 12 hours; fever (101)- lasted approximately 12 hours
36 2021-02-16 unresponsive to stimuli, flushing became unresponsive after receiving her first dose of Pfizer Vaccine . Smelling salts were applied ... Read more
became unresponsive after receiving her first dose of Pfizer Vaccine . Smelling salts were applied and patient quickly became responsive. Patient was given 4 oz of apple juice which she tolerated well. Also complained of loss of hearing/smell and feeling flushed. Patient had no difficulty breathing and or rash. 911 was called and patient subsequently was sent to ER for further evaluation.
36 2021-02-16 tingling sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Teste... Read more
sensation change (pins and needles) in left arm; Tested positive for COVID 23Jan2021/headache; Tested positive for COVID 23Jan2021/headache; This is a spontaneous report from a contactable nurse. A 36-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1685), via intramuscular on 05Jan2021 13:00 at single dose in right arm for COVID-19 immunisation. Medical history included known allergies: coconut. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient was tested positive for COVID (test name was reported as COVID-19/SARS COV2, PCR (COVOO)) on 23Jan2021. Patient was asymptomatic at the time and was tested due to positive household members. Patient developed symptom (headache) on 25Jan2021. Patient developed sensation change (pins and needles) in left arm on 31Jan2021. Patient was seen in Emergency Room and kept overnight for observation. No obvious cause for symptoms was found. No treatment was received for the events. Outcome of the events was reported as resolving. This case was reported as serious with seriousness criteria: caused/prolonged hospitalization.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
36 2021-02-18 tremor Nausea, dizziness, vomiting, headache, fatigue, chills, shaky. This lasted about 24 hours.
36 2021-02-18 tingling, pain in extremity Onset of pain in upper arm and shoulder that evening, and the next day had "frozen shoulder" where I... Read more
Onset of pain in upper arm and shoulder that evening, and the next day had "frozen shoulder" where I had very limited range of motion in the shoulder. I also had some tingling in the right fingers the next day. The frozen shoulder resolved by day 3 and the pain in the upper arm resolved within 1 week. However, it has been almost 3 weeks and I still have quite a lot of pain in the shoulder. I was diagnosed with rotator cuff tendinopathy and they are not sure if this is due to improper injection technique (it was given a bit high on the deltoid muscle) or the vaccine itself.
36 2021-02-21 weakness Starting the night of vaccine - had a headache about 8PM in evening .I woke up feeling weird through... Read more
Starting the night of vaccine - had a headache about 8PM in evening .I woke up feeling weird throughout the morning: fatigue - didn't want to move at all but not moving wasn't comfortable; fever, chills, joint and muscle aches - mostly in my back (I couldn't get comfortable) - felt like I had been hit by semi truck. Very weak - if that was a 10th of what COVID felt like, I didn't want it! Those symptoms lasted about three to five days. By the5th day - I was mostly back to myself. I took Motrin - which helped slightly for headache.
36 2021-02-21 hypersensitivity of all senses, tingling after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touch... Read more
after receiving the vaccine, I have developed a skin intolerance to heat (hot water, hit items touching skin), heat causes itching and tingling and well as redness and swelling with hotter temperatures at longer durations. This has been occurring since after receiving the first vaccine, with increased severity after the second. The symptoms last from 20-2 hours after exposure and then resolve.
36 2021-02-21 burning sensation started out with a rash around injection site and is now full blown on left arm from top to wrist an... Read more
started out with a rash around injection site and is now full blown on left arm from top to wrist and under to arm pit area of arm. rash is a burning sensation and very itchy.
36 2021-02-21 tremor woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; ha... Read more
woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband). A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver. The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021. The outcome of events was recovering. The reporter assessed the events as not serious. Information on the lot/batch number has been requested.
36 2021-02-22 tingling About 10 minutes after getting the shot I suddenly felt like I was having an anxiety attack. My hea... Read more
About 10 minutes after getting the shot I suddenly felt like I was having an anxiety attack. My heart was racing and a tingling adrenaline feeling started in my head and spread down through my body. My throat felt strange, but I could still breathe. It started to subside after a couple of minutes but didn?t resolve completely for another hour or so. I also had a headache almost immediately. In the days following the vaccine I had such sore muscles it was hard to get out of chair or go upstairs. That lasted 3 days. About one week after the shot I started noticing my brain felt glitchy. At night I have not slept well since about one week after the vaccination and I frequently awaken feeling confused, stressed, and disoriented. This is not normal for me. Additionally, about 3 weeks after the vaccine I had another mild panic attack. I have not been troubled by panic attacks before getting the vaccine. As of today I am starting to feel less glitchy in my thinking. I am still not sleeping soundly and waking often, sometimes accompanied with confusion.
36 2021-02-22 cold sweat, feeling hot Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of b... Read more
Approx 10 minutes after receiving the vaccine client started c/o feeling hot inside and outside of body, sweating on neck, and light headed, clamminess to hands. Vitals monitored. no medications given.
36 2021-02-22 pain in extremity Headache, Tired, Fatigue, Leg and arm shooting pain
36 2021-02-22 pain in extremity Herpes simplex 1 outbreak of oral lesions 48 Hours after receiving vaccine Arm soreness and nausea ... Read more
Herpes simplex 1 outbreak of oral lesions 48 Hours after receiving vaccine Arm soreness and nausea 24 hours after receiving vaccine
36 2021-02-23 numbness, tingling 1/6 vaccination 1/7 typical immune system response; recovered in 12 hours. 1/8 Woke up and my left ... Read more
1/6 vaccination 1/7 typical immune system response; recovered in 12 hours. 1/8 Woke up and my left hand was weak, numb and tingling in glove distribution. The right hand started to have problems as evening came. The right hand resolved within 12 hours. The left hand symptoms persisted for 6 weeks. *unable to work for 6 weeks. **Still having symptoms in middle finger, pointer finger; left hand. 1/8 I went to urgent care; referred to ED. They did put me in the clinical observation unit, discharged the next day. I went to PCM 2 days later. Dr. didn't know what to think of symptoms. Had me try some steroids. Hospital referred me to neurology; He had me do another MRI (1st in the ER). EMG. He didn't find anything unusual except some nerve damage; carpal tunnel *Symptoms are still persisting. It has gotten better but the 2 fingers are still an issue.
36 2021-02-23 feeling hot 12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat ... Read more
12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat on hand and elbow on the left side; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 26Jan2021 at 07:30 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included caffeine/paracetamol (EXCEDRIN), paracetamol (TYLENOL) and ergocalciferol (VIT D). Past drug history included known allergies: cefaclor (CECLOR) and sulfamethoxazole/trimethoprim (SEPTRA). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Jan2021 at 19:30, 12 hours after vaccination, the patient experienced redness and heat on hand and elbow on the left side. Treatment included applied Burts Bees lotion on hand and elbow for the event redness and heat. The outcome of the event redness and heat was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
36 2021-02-23 weakness, burning sensation Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched ... Read more
Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.
36 2021-02-23 night sweats I woke up with a moderate headache at 7am. My entire body began to ache by 10am. Full body chills be... Read more
I woke up with a moderate headache at 7am. My entire body began to ache by 10am. Full body chills began at noon. I was lethargic with full body aches, headache and chills for the remainder of the day. I checked my temperature throughout the day, but I never had a fever. My symptoms prevented me from working that day, but I did not take pain medication and I was able to eat meals normally. At some point during the night, I woke up in a sweat. The following morning, Feb 12th, the symptoms were gone. The injection site was sore for a few days more.
36 2021-02-23 migraine woke during the night with chills, body aches, and migraines, hurts to walk
36 2021-02-24 tingling Felt lightheaded, tingling. Described feeling as if her ears were going to cave in and had "hearing ... Read more
Felt lightheaded, tingling. Described feeling as if her ears were going to cave in and had "hearing change". BP 70/90. HR 60. Medics on site. Evaluated. Once feeling better able to leave clinic on her own.
36 2021-02-24 numbness and pain in extremities On day 9 after my second vaccine, I experienced extreme fatigue, muscle aches and joint pain with ne... Read more
On day 9 after my second vaccine, I experienced extreme fatigue, muscle aches and joint pain with neuropathy in feet, hands that has continued until today day 14 I was tested for COVID 19 and was negative on day 12
36 2021-02-24 pain in extremity Sore arm within 8 hours of receiving vaccine shot. Currently 20 weeks, 4 days pregnant. No other sid... Read more
Sore arm within 8 hours of receiving vaccine shot. Currently 20 weeks, 4 days pregnant. No other side effects from dose 1.
36 2021-02-24 tingling Tingling radiating to fingertips.
36 2021-02-25 migraine, discomfort 1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hour... Read more
1st dose: 24 hrs after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explore; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; 1st dose: 24 hours after administration, I developed a searing migraine that lasted for approx 15 hours. No medications could touch the pain and it felt like my brain and eyeballs were going to explor; This is a spontaneous report from a contactable self-reporting other health professional. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686), intramuscularly on an unspecified date in Jan2021 at 13:00 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included anaphylactic reactions to penicillin and pistachios. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered to the patient in a hospital. The patient reported that twenty-four hours after administration she developed a searing migraine that lasted for approximately fifteen hours. She stated that "no medications could touch the pain" and it felt like her brain and eyeballs were going to explode. The patient specified that she did not receive any treatment for the events. The clinical outcomes of migraine, sensation of pressure and eye discomfort were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
36 2021-02-25 pain in extremity arm pain; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female pati... Read more
arm pain; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899 and expiry date: unknown), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first vaccine back and everything went great. She had that usual arm pain on Jan2021. There was no treatment for the event. Outcome of the event was unknown.
36 2021-02-28 burning sensation Burning right arm; fatigue; This is a spontaneous report from a contactable other healthcare profess... Read more
Burning right arm; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 15Jan2021, the patient experienced burning right arm and fatigue. Treatment was received for the adverse events which included MRI, NCS, Blood work. The events resulted to a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered. Information on the lot/batch number has been requested.
36 2021-02-28 pain in extremity, migraine, numbness Fever, stomach cramps, migraine, chills, nausea, vomitting, diarrhea, fatigue, muscle ache, arm pain... Read more
Fever, stomach cramps, migraine, chills, nausea, vomitting, diarrhea, fatigue, muscle ache, arm pain/redness/numbness
36 2021-03-01 muscle spasms **22 Weeks pregnant. Due date 7/1/21. 1st pregnancy** The day after the vaccine around 3pm I had cra... Read more
**22 Weeks pregnant. Due date 7/1/21. 1st pregnancy** The day after the vaccine around 3pm I had cramps and light spotting. The nurse on call advised me to go to the ER. I went to ER, they ran an ultra sound and all kinds of test, they said everything looked good they thought it was a Fibroid. They discharged me, and that night at 11:30pm I had a very big and fast bleed around a cup of blood and went back to the ER. That time I went to hospital because it was closer. Again they did an ultrasound and thought it was a Fibroid. I ended up seeing my OB GYN 2/8/21, she said she didn't think it was a Fibroid and sent me to get an ultrasound on 2/12/21. At that point after the bleed I had 4 days of spotting. When I went to the ultrasound they said I had a partial placenta abruption and my cervex has shortened. Since then everything has been fine.
36 2021-03-01 migraine By 3pm I was extremely lethargic. By 7pm I was starting to feel a bit "not myself" and had an optic ... Read more
By 3pm I was extremely lethargic. By 7pm I was starting to feel a bit "not myself" and had an optic migraine and by 10pm I was throwing up and had chills (no fever) and aches on all limbs. The vomiting and chills went away by 12am but the aches lasted all through the next day. The left arm/injection site also ached the rest of the week.
36 2021-03-01 migraine, tremor Fever 100-101, body aches, shaking, and migraine headache until Sunday 2/28/21. Continued with bod... Read more
Fever 100-101, body aches, shaking, and migraine headache until Sunday 2/28/21. Continued with body aches and headache until 2/29/2021.
36 2021-03-02 tingling, numbness Approximately 10 minutes after injecting the 2nd dose of COVID19(Pfizer-bioNTech) the patient made m... Read more
Approximately 10 minutes after injecting the 2nd dose of COVID19(Pfizer-bioNTech) the patient made me aware of numbness/tingling in her feet. She explained it like her feet falling asleep. Approximately 5 minutes later she said the sensation was radiating up her right leg. She said the symptoms subsided in her leg after approximately 10 minutes. She had no trouble standing or walking. At approximately 3:15pm she proceed to her shift. I was leaving the building at approximately 3:35pm and verified with her that the symptoms did not proceed any further and at this point of time she did not feel she needed emergency medical intervention
36 2021-03-02 sensory loss, numbness Lost feeling in face, tongue, mouth. Numbness in cheeks - 2 hours after vaccine Metallic taste immed... Read more
Lost feeling in face, tongue, mouth. Numbness in cheeks - 2 hours after vaccine Metallic taste immediate after vaccine. Treated with Benadryl. 27 weeks pregnant - Due May 31, 2021.
36 2021-03-03 flushing Was released from the testing site 5-10 minutes after second dose was administered. Approximately 15... Read more
Was released from the testing site 5-10 minutes after second dose was administered. Approximately 15-20 minutes after dose was administered I began feeling a reaction. The skin on my face, neck, and chest became red, flushed, warm, splotchy, and itchy. My tongue and throat began to feel swollen/tight. I was also lightheaded and dizzy. My husband was driving the car and we almost returned to the vaccination site, but after approximately 5 more minutes, the tightness in my throat subsided, so we continued to go home. The flushing and lightheaded-ness went away after approximately 20 minutes. This is similar to the reactions I had just before I discontinued taking copaxone (approx. 2 years ago). I did not feel this way after dose one of the Pfizer COVID vaccine.
36 2021-03-04 tremor, flushing, feeling hot About 20 min after I received the vaccine, I was driving home and all of a sudden I got extremely ho... Read more
About 20 min after I received the vaccine, I was driving home and all of a sudden I got extremely hot, flushed, very sweaty. I was sweating so much my hands were slipping on the steering wheel. I was shaking and felt faint, dizzy. I almost pulled over and and called an ambulance, I never felt this way before, there was this crazy rushing feeling through my whole body. I made it home and sat down, after some time I slowly started to feel better, about two hours later it completely went away.
36 2021-03-04 breast pain I had my first COVID vaccine on 1/16/21. I had my second one on 2/5/21. On 2/9/21 I started experien... Read more
I had my first COVID vaccine on 1/16/21. I had my second one on 2/5/21. On 2/9/21 I started experiencing a sharp pain in my left breast. On 2/10/21 I had sharp pain in between my shoulder blades. On 2/11/21 I noticed a small red rash-like spot in between my breast. I woke up on 2/12/21 in incredible pain on my back, so I lifted my shirt to look in the mirror and that is when I noticed a blister type rash from the middle of my back wrapping around the front of my body covering my left breast. I went to see the PA at my PCP's office. She diagnosed me with shingles. She placed me on an anti-viral medication for a week, and gabapentin (nerve medication) for a month. It has been 3 weeks today since I first began treatment and I have not fully recovered yet. My blisters dried up about a week ago, but ever since then I have been incredibly itchy, which has kept me up every night for over a week now. On 3/3/21 I called my PCP's office and they started me on Prednisone for 6 days. I am 2 days into treatment and I still have not had relief from the itching.
36 2021-03-04 tingling Systemic: Allergic: Itch (specify: facial area, extremities)-Mild. Systemic: Allergic: Itch Generali... Read more
Systemic: Allergic: Itch (specify: facial area, extremities)-Mild. Systemic: Allergic: Itch Generalized-Mild. Systemic: Chest Tightness/Heaviness/Pain-Medium. Systemic: Tingling (specify: facial area, extremities)-Medium.
36 2021-03-05 pain in extremity Night of shot I had severe arm pain and itchy skin. Next night I broke out in hives. Since vaccine I... Read more
Night of shot I had severe arm pain and itchy skin. Next night I broke out in hives. Since vaccine I?ve non stop itchy skin and hives that come and go. Mostly large rash on chest that looks like a sunburn/scratched skin. Very painful . Was told to take Zyrtec. No relief yet
36 2021-03-06 weakness Couple weeks later, have experienced generalized weakness, chills, low grade fever, generalized musc... Read more
Couple weeks later, have experienced generalized weakness, chills, low grade fever, generalized muscle aches, unsure if related
36 2021-03-06 migraine Migraine. Neck and shoulder soreness.
36 2021-03-06 tingling hives/rash across various body parts, including behind the knees/elbows, on the neck/arms/thigh/butt... Read more
hives/rash across various body parts, including behind the knees/elbows, on the neck/arms/thigh/buttock (since 2/12/2021, ongoing); swollen lips, tingling lower jaw (since 2/12/2021, for 2 weeks); body ache (since 1/27/2021 for one week); chills and headache (since 2/17/2021, ongoing).
36 2021-03-07 tingling Subjective Patient is a 36 y.o. female who was seen today for her first dose of the COVID 19 vaccin... Read more
Subjective Patient is a 36 y.o. female who was seen today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience warmth of left arm and chest. Red rash present on left forearm. Later she developed tingling of left arm. She denied difficulty breathing, difficulty swallowing, lightheadedness and dizziness. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms, respiratory distress and skin changes. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing, dizziness and headaches Warmth of left arm with tingling: Previous Reactions: Flu shot made her really sick in the past with respiratory issues. She has had a tetanus shot in the last 3 years though and she handled it well without any symptoms. Objective Vitals Vitals: 03/05/21 1202 03/05/21 1238 03/05/21 1305 BP: (!) 139/100 (!) 134/112 126/86 Pulse: 80 92 SpO2: 99% 99% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. No posterior oropharyngeal erythema. Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Radial pulses are 2+ on the right side and 2+ on the left side. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Musculoskeletal: Comments: Equal hand grip in bilateral arms. No weakness noted. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Findings: Rash (lower arm and near injection site) present. No erythema. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines, water and pepcid and Tylenol. Applied ice to left arm near injection site where warmth was noted. Redness of lower and upper arm resolved with time. Follow up response to treatment: good. Symptoms resolved upon discharge and BP improved. She still had some warmth of right arm after being observed for 1.5 hours. She did not have any rashes, swelling, burning or weakness of left arm. Discussed with patient continuing to ice left arm near injection site. If she experiences any redness, swelling, burning or worsening symptoms this weekend she is to seek medical care. Pt understands and agreed to plan. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) 3/5/2021 1:05 PM
36 2021-03-08 weakness A few hours after the vaccine i had a headache and took Aleve which did not help. The next day i had... Read more
A few hours after the vaccine i had a headache and took Aleve which did not help. The next day i had a fever of 99.1-99.7 most of the day including body aches, chills, and exhaustion. It let up around 7pm 3/7/21 and on 3/8/21 i felt a little weak but mostly back to normal. No symptoms left on 3/9/21
36 2021-03-08 pain in extremity About a half hour or 45 minutes after shot my vision was distorted in both eyes. It was almost as if... Read more
About a half hour or 45 minutes after shot my vision was distorted in both eyes. It was almost as if there was a ripple effect when looking at an object, combined with a rainbow like effect when lights were bright. I could look at a wall and it was as it it was reverberating. When looking at text on a screen I was able to see either side of the text but not the middle. This lasted about an hour and thankfully my vision returned to normal. I now have tiredness, a sore arm and slight headache.
36 2021-03-08 throat numbness, numbness Face got very hot, then mild numbness throughout cheeks, in eyes, tongue, and throat.
36 2021-03-08 hot flush, flushing Headache/Sharp stabbing pains in head as well as muscles; cough; cold chills; hot flashes; fever; mu... Read more
Headache/Sharp stabbing pains in head as well as muscles; cough; cold chills; hot flashes; fever; muscle and joint pain/Sharp stabbing pains in head as well as muscles; muscle and joint pain; fatigue; Loss of appetite; Brain fog; Some sinus pressure; flushed cheeks; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EL9265) via an unspecified route of administration on 04Feb2021 at 08:30 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. It was reported that the patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (other medications in two weeks) included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), zinc and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: 9L3246) via an unspecified route of administration on 07Jan2021 at 18:45 (at the age of 36-years-old) as a single dose in the left arm for COVID-19 immunization. On 04Feb2021 at 20:30 the patient experienced headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks. The patient did not require treatment for the events. The clinical outcome of the events headache, cough, cold chills, hot flashes, fever, muscle and joint pain, sharp stabbing pains in head as well as muscles, fatigue, loss of appetite, brain fog, some sinus pressure and flushed cheeks were recovering/resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
36 2021-03-08 tingling Reaction: tingling in fingers of vaccine arm and small local rash on forearm Outcomes: Benadryl 25 ... Read more
Reaction: tingling in fingers of vaccine arm and small local rash on forearm Outcomes: Benadryl 25 mg given at 17:10. Rash resolved and tingling subsided.
36 2021-03-09 tingling Approximately 25 minutes after my shot my whole body went tingly- from my head to my toes. I became... Read more
Approximately 25 minutes after my shot my whole body went tingly- from my head to my toes. I became light headed, dizzy, and my heart was beating rapidly. I drove myself to an ER because I thought I was having an allergic reaction. They kept me for a few hours but I did not receive any treatment. The other symptoms subsided, however I?m concerned that my left arm is still tingling.
36 2021-03-09 tenderness This morning I woke up swollen under my eyes right where I had filler done; The swelling and tendern... Read more
This morning I woke up swollen under my eyes right where I had filler done; The swelling and tenderness is the exact same swelling and tenderness experienced right after the filler was done; achy and tired; achy and tired; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration in the left arm on 05Feb2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunization. Medical history included Celiac disease, allergy to gluten, filler under eyes in Jul2020, and the patient is prone to inflammation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included GUARANA [PAULLINIA CUPANA] and a multivitamin, both from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date for COVID-19 immunization and experienced fatigue and feeling achy. The patient stated she did not have any kind of reaction to her first dose other than fatigue and feeling achy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021 the patient experienced feeling achy and tired, the patient had no other initial reactions after the injection. On 07Feb2021 at 06:30, the second day after the second immunization, the patient woke up swollen under her eyes right where she previously had filler done (last Jul2020, so per the patient, it wasn't recent). The patient stated the swelling and tenderness was the exact same swelling and tenderness that the patient experienced right after she had the filler done. The patient stated she should also note that she does have Celiac disease, which is an autoimmune disease and she is prone to inflammation, however the patient was not on immunosuppressant drugs and was otherwise very healthy. The patient did not receive any treatment for the events feeling achy and tired, swelling and tenderness under her eyes. The clinical outcome of the feeling achy and tired, swelling and tenderness was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
36 2021-03-10 weakness, migraine, feeling cold Bad sensitivity to light. Had to wear sunglasses indoors. Migraine headache for 7 straight days. Hea... Read more
Bad sensitivity to light. Had to wear sunglasses indoors. Migraine headache for 7 straight days. Head felt like it was in fishbowl, sounds muffled, hard to concentrate, or give answers, brain felt disconnected. Felt cold a lot but did not have fever, generally weak and tired. I?m starting to feel better but still have a couple times a day that this happens.
36 2021-03-10 feeling hot Became very ill once vaccine was completed, became hot, pounding headache, skin itchy and red splotc... Read more
Became very ill once vaccine was completed, became hot, pounding headache, skin itchy and red splotches , blood pressure was elevated and throat started getting tight
36 2021-03-12 flushing Abdominal pain, nausea, fever, seeking at injection site, pain at injection site, itching at injecti... Read more
Abdominal pain, nausea, fever, seeking at injection site, pain at injection site, itching at injection site, swelling at injection site, sweating, flushing, fatigue, malaise
36 2021-03-12 migraine Bad headache/migraine the next night with vomit and diarrhea. Took Excedrin. Felt groggy with mild ... Read more
Bad headache/migraine the next night with vomit and diarrhea. Took Excedrin. Felt groggy with mild headache the next two days.
36 2021-03-12 feeling jittery Pfizer-BioNTech COVID-19 Vaccine EUA: six days after vaccination patient reports persistent fatigue,... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: six days after vaccination patient reports persistent fatigue, light headedness, feeling jittery, and headache. All vital signs within normal ranges. Left cervical lymph nodes noted to be swollen. Patient denies respiratory, cardiac, and gastrointestinal symptoms. Patient advised rest and home care: discharged from urgent care medically stable.
36 2021-03-12 pain in extremity Soreness in arm so strong it?s difficult to move the arm.
36 2021-03-13 pain in extremity Within 5 minutes of receiving the vaccine, I experienced extreme dizziness. This dizziness lasted fo... Read more
Within 5 minutes of receiving the vaccine, I experienced extreme dizziness. This dizziness lasted for 2 days. The following day I felt extreme fatigue, body aches and arm soreness at the injection site in addition to the dizziness. Exactly 7 days later on 3/13/21 (after my initial side effects had resolved), my left arm began to itch painfully and intensely. The itch began on my left wrist and by the end of the day, the itchy spot on my wrist had progressed to itchiness on the majority of my left arm. It's not very visibly red, but it's incredibly itchy and painful, like fiberglass under my skin. The itch is not obviously localized to the injection site but is on the same arm as the injection and nowhere else on my body. It has lasted for 24 hours, and I currently still have it today (3/14/21). I have taken antihistamines and NSAIDs and applied cortisone cream, but it is still very, very uncomfortable. It kept waking me up while I slept during the night. I am wondering if this could be "COVID arm."
36 2021-03-14 pain in extremity, migraine Severe pain in right arm, unable to move for 3 days Severe diarrhea for 2 days Debilitating migraine... Read more
Severe pain in right arm, unable to move for 3 days Severe diarrhea for 2 days Debilitating migraine pain for 1 day 101.3F fever for 1 day
36 2021-03-14 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (reported for herself). A 36-year... Read more
Sore arm; This is a spontaneous report from a contactable consumer (reported for herself). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL3247), on right arm via an unspecified route of administration on 27Jan2021 10:15 at single dose for covid-19 immunisation. The patient's Medical history and concomitant drug was not reported. The patient experienced sore arm on 28Jan2021 06:00. Prior to vaccination, patient was not diagnosed with COVID-19, Prior to vaccination, patient was not diagnosed with COVID-19, patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received within 2 weeks of vaccination. Outcome of the event was not recovered
36 2021-03-15 feeling jittery EXTREME tiredness, couldn't keep eyes open by 7pm. Woke up with a terrible headache and slept the en... Read more
EXTREME tiredness, couldn't keep eyes open by 7pm. Woke up with a terrible headache and slept the entire next day. Jittery, fast heartbeat, mild confusion/forgetfulness, feeling scattered, anxious and weepy all lasted into the 3rd day following the injection.
36 2021-03-15 night sweats, pain in extremity Immediate fever, night sweats, extreme fatigue, shortness of breath, chills, stuffy nose and sore ar... Read more
Immediate fever, night sweats, extreme fatigue, shortness of breath, chills, stuffy nose and sore arm lasting 48 hours
36 2021-03-17 feeling cold 7am-5:30pm (asleep for thr next 12 hours after that) I felt like all of my bones were swollen, my mu... Read more
7am-5:30pm (asleep for thr next 12 hours after that) I felt like all of my bones were swollen, my muscles hurt to use, had a searing headache, eyes wouldn't open all of the way, occasional stomach cramp, 1 bout of naseau, extreme fatigue and was freezing cold; muggy thoughts
36 2021-03-17 muscle spasms March 15, Monday - Pfizer at Pharmacy late afternoon at 3pm. Gas - approximately one minute after va... Read more
March 15, Monday - Pfizer at Pharmacy late afternoon at 3pm. Gas - approximately one minute after vaccination March 16, Tuesday - gas and bloat throughout the day, tight stomach before bed March 17, Wednesday- Gas and burping ..lower back cramp March 18, Thursday - Gas and burping All symptoms as of today that are on going.. Will report any further symptoms. I have a doctor appointment scheduled 3/26.
36 2021-03-17 pain in extremity Sore arm (lasted approximately 24 hours); chills (lasted approximately 3 hours)
36 2021-03-18 tremor, pain in extremity 3/7/21 late at night: Livedo Reticularis... dark purple veins in both legs & wrist/hand, shaking, t... Read more
3/7/21 late at night: Livedo Reticularis... dark purple veins in both legs & wrist/hand, shaking, teeth chattering, increase heartrate - went away within 30min...aches in legs & left chest lingered afterwards 3/18/21 late at night: Livedo Reticularis... dark purple veins in both legs & wrist/hand, shaking, teeth chattering, increase heartrate - went away within 30min...aches in legs & left chest lingered afterwards
36 2021-03-18 difficulty speaking Patient reported it was hard to swallow and had throat tightness and itching. She thought her voice ... Read more
Patient reported it was hard to swallow and had throat tightness and itching. She thought her voice was different. Patient evaluated with. Was given Epi and Benadryl. Continued to cough. EMS called and patient transported to Emergency Room for further evaluation.
36 2021-03-18 numbness severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; T... Read more
severe biopsy proven perniosis of bilateral hands; headaches; fatigue; left sided facial numbness; This is a spontaneous report from a contactable physician. A 36-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on left arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient has no known allergies and was not pregnant. She was not diagnosed with COVID prior to vaccination and has no other vaccine in four weeks. The patient received her vaccine at a clinic. On 16Dec2020, the patient developed severe biopsy proven perniosis of bilateral hands, right after the vaccine which was still lasting. She also had headaches, fatigue for 2 weeks post vaccination (as reported) and left sided facial numbness for hours post vaccination. She had pain and swelling of the fingers which inhibits her from working as an nurse. She has been on disability leave from work. All lupus and other autoimmune work up have been negative. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/ department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with amlodipine, prednisone course, topical steroids and pentoxifylline. The patient underwent lab test and procedure which included nasal swab which was negative post vaccination on an unspecified date. The outcome of the events was not recovered. The events were assessed as serious causing disability or permanent damage. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the perniosis of bilateral hands and other reported events due to temporal relationship Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-03-19 migraine, pain in extremity 5 hours after vaccine developed severe migraine, 8 hours after vaccine developed nausea, vomiting, s... Read more
5 hours after vaccine developed severe migraine, 8 hours after vaccine developed nausea, vomiting, severe leg pain, chills, and sweating. Developed diarrhea 20 hours after vaccine. Symptoms began to lessen 35 hours after vaccine.
36 2021-03-19 nerve pain Headache, fatigue, trigger of autoimmune inflammatory symptoms including fibromyalgia and neuropathi... Read more
Headache, fatigue, trigger of autoimmune inflammatory symptoms including fibromyalgia and neuropathic pain
36 2021-03-19 pain in extremity patient received dose that was not diluted properly. Pharmacy was able to get hold of patient after ... Read more
patient received dose that was not diluted properly. Pharmacy was able to get hold of patient after 2nd try and leaving message for her. Patient called back on 3/20/21 at 5:08 pm and reports she was groggy and felt like she was drunk for most of the day along with headache and arm soreness. She reports she is feeling better at time of call.
36 2021-03-20 pain in extremity Had a severe headache by 4:00 pm and then began having chills and body aches and a very sore arm. We... Read more
Had a severe headache by 4:00 pm and then began having chills and body aches and a very sore arm. Went to bed and the following day was just feeling very fatigued. Then around 6 o?clock I started getting horrible chills bodyaches and a low-grade fever. A large red rash appeared and my arm was incredibly sore and the skin was burning. I have experienced body chills off and on since the vaccine.
36 2021-03-21 pain in extremity Approximately 30 minutes after injection, arm pain and lethargy set in. I slept well last night but... Read more
Approximately 30 minutes after injection, arm pain and lethargy set in. I slept well last night but I've taken 3 naps, all more than an hour long. I ate lunch at my normal time, around 10:30am. I'm normally a snacky person, but since lunch I've been anti-food. Vaguely nauseated but mostly just no appetite and it's well after my normal dinner time. Also a general feeling of "don't feel good"
36 2021-03-21 tenderness Earache, swollen ear, tenderness, Spot bleeding Took tylenol, diphenhydramine
36 2021-03-21 tremor Tremors started one week after initial vaccine; full body - hands, arms, legs. Tremors occurred at r... Read more
Tremors started one week after initial vaccine; full body - hands, arms, legs. Tremors occurred at rest and continued while extremities were in use. No treatment. Tremors stopped within 48 hours of onset. Neurologist was notified with no recommendation for additional treatment at this time.
36 2021-03-21 weakness, tingling Vasovagal after vaccine. Dizzy, tingling and weakness after
36 2021-03-21 facial paralysis left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting; This... Read more
left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: ENG6202; expiration date: unknown), at vaccination age 36-year-old via an unspecified route of administration in the left arm on 02Mar2021 17:00 as a single dose for covid-19 immunisation. Medical history included pecans allergies. The patient was not diagnosed with Covid prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC), desogestrel, ethinylestradiol (ISIBLOOM), citalopram and vitamins nos (MULTIVITAMINS reported as WOMANS MULTI-VITAMIN). The patient did not receive other vaccine in four weeks The patient received the latest vaccine dose in a hospital. The patient had left side of my face is starting to droop and the beginning signs of Bell's-palsy are starting on 03Mar2021 06:00 AM. The patient did not received treatment for the adverse event. The patient has not been covid tested post vaccination. The outcome of the event was not recovered.
36 2021-03-23 burning sensation, pain in extremity 2-3 hours after receiving vaccine, I noticed an itchy throat and slight arm pain; on 02-27-2021, I w... Read more
2-3 hours after receiving vaccine, I noticed an itchy throat and slight arm pain; on 02-27-2021, I woke up with a headache and severe arm pain, couldn't lift it without extreme discomfort; at 1700-1800, I drove myself to get something to eat and after returning home I took two Tylenol for pain; after about 20-30 minutes of taking the Tylenol, I felt short of breath, my chest was tight, my heart was racing, and there was a burning sensation near the bottom portion of my heart, and I felt doomed so I drove myself to the ER because I did not want my children to witness me in distress; I was discharged o n 02-28-2021 with prescription for allergy medication and told to follow up with my HCP & cardiologist; on 03-01-2021 at 1444 a rash started on my left extending towards the injection site and my chest started to get tight, I left work and took a Benadryl and went to sleep; on 03-15-2021, the rash on my left arm reappeared but extended to the left neck and chest area and my chest started to get tight, so I took 2 Benadryl called my HCP for an appointment went to sleep; seen by HCP on 03-16-2021 who witnessed rash and was prescribed prednisone and referred to allergist for follow-up; symptoms were reported using V-safe
36 2021-03-23 flushing Intense flushing and itching down face, neck and chest.
36 2021-03-23 pain in extremity Went to the ED on 1/23 with complaints of left sided arm pain and left sided neck mass. Assessment s... Read more
Went to the ED on 1/23 with complaints of left sided arm pain and left sided neck mass. Assessment strongly suspected that she was experiencing cervical chain lymphadenopathy from the vaccine due to the vaccine being administered on the left side. Diagnosis Lymphadenopathy of head and neck .
36 2021-03-24 cold sweat Dizzy, nauseous, vomiting, sweaty/clammy
36 2021-03-24 feeling of body temperature change NAUSUA BEGAN AT 3:30 - QUICKLY FOLLOWED BY FEVER, CHILLS, HOT COLD FLASHES AND VOMITING. DIARRHEA AL... Read more
NAUSUA BEGAN AT 3:30 - QUICKLY FOLLOWED BY FEVER, CHILLS, HOT COLD FLASHES AND VOMITING. DIARRHEA ALSO. VOMITING WAS SEVERE UNTIL 6:30 PM WHEN I FINALLY FELL ASLEEP. FATIGUE.
36 2021-03-24 tingling, numbness, pain in extremity tingling/numbness in left hand, traveled up the arm; Tingling/numbness in left hand, traveled up the... Read more
tingling/numbness in left hand, traveled up the arm; Tingling/numbness in left hand, traveled up the arm/ Skin on jaw went numb for an hour/ recurring along with all over the body; lips began to go numb; left wrist felt as if it was filled with fluid with no visible swelling; Pain on the back of the left hand is intense and unrelenting.; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6208) via an unspecified route of administration, on 17Mar2021 at 3:00 PM (at the age of 36-years-old, not pregnant) as a single dose in the left arm for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. No known allergies. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks administered. On 18Mar2021 at 3:45 PM, the patient experienced tingling/numbness in left hand, traveled up the arm, lips began to go numb. The left wrist felt as if it was filled with fluid with no visible swelling. This has traveled all over various parts of the body. Skin on jaw went numb for an hour. Hand numbness was recurring along with all over the body at differing times. Pain on the back of the left hand is intense and unrelenting. The adverse events reported resulted in emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day on an unspecified date in 2021. The treatment administered for the reported events were Benadryl and Pepcid via intravenous (IV) route. The outcome of the events was not recovered.
36 2021-03-25 bell's palsy Bells palsy onset ~ 30 minutes after dose
36 2021-03-25 pain in extremity Both of my ankles started to itch approximately 36 hours after vaccine, the itching has gotten wors... Read more
Both of my ankles started to itch approximately 36 hours after vaccine, the itching has gotten worse and there is a bumpy rash on the outside of my ankles, worse on the left. The rash is about 2 sq inches on the left and one on the right. It started as an itch and now the rash is growing. I am only 4 weeks pregnant and did not know I was pregnant at the time of vaccine. Other adverse reactions was a sore arm which has mostly subsided and fatigue the day of the vaccine.
36 2021-03-25 weakness Immediately after getting the vaccine I felt very weak, as if I was going to pass out. A person on s... Read more
Immediately after getting the vaccine I felt very weak, as if I was going to pass out. A person on site took my blood pressure which was higher than normal. I was advised to wait longer than 15mins, but after 30mins waiting I still was not okay to leave. I had to call family to come for me, at which point the people on site told me to eat food. I was given water and licorice by the facility, my mother brought me tacos but I still felt very weak. (Weakness was not food related). I was in the waiting area for 1 1/2hrs, advised not to drive myself home, my mother had to drive me home and stayed with me. I also had trouble walking, and was helped to the car. I did not go to a hospital for these adverse reactions as I did not get a fever at any point, and wasn't exactly sure what could be done for me. Days following the vaccine I still felt very weak, slept a lot, and felt very out of it. It took 4-5 days to return to normal.
36 2021-03-25 breast pain, weakness, pain in extremity Pain in arm, fatigue, and dizziness began the night of the shot. The next day I had severe pain in ... Read more
Pain in arm, fatigue, and dizziness began the night of the shot. The next day I had severe pain in arm, armpit, left breast and center chest along with stabbing pains in my back and neck. I felt very dizzy, weak, exhausted and nauseated. I was having difficulty breathing and my blood pressure was 145 over 95 with a pulse of 120. The third day I did not feel as ill but still had severe pain in armpit and chest. Today, I feel okay but still having pain in my armpit.
36 2021-03-25 difficulty speaking Sharp Headache began that night 03/18/2021. The next day my body was achey and I felt sick the next ... Read more
Sharp Headache began that night 03/18/2021. The next day my body was achey and I felt sick the next 3 days. To be sure, I scheduled a covid test just to be sure. I am still having a hard time breathing and feel sick. Mucus and raspy throat. Kind of like something is stuck in my throat. Today is 03/25/2021 and I still feel raspy with Mucus and cough.
36 2021-03-25 feeling hot, flushing nauseous, light-headed, flushed, hot, sweaty laid on floor with feet up, started to feel better aft... Read more
nauseous, light-headed, flushed, hot, sweaty laid on floor with feet up, started to feel better after about 10 minutes
36 2021-03-26 breast pain, tenderness Redness and hard lump at injection site. Very swollen, tender, pain under right armpit and into righ... Read more
Redness and hard lump at injection site. Very swollen, tender, pain under right armpit and into right breast
36 2021-03-26 flushing, weakness Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-M... Read more
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild
36 2021-03-26 burning sensation The lower part of my forearm has a bad burning sensation. No redness or swelling. Injection site hu... Read more
The lower part of my forearm has a bad burning sensation. No redness or swelling. Injection site hurts as described it would.
36 2021-03-26 muscle twitching Twitch in right quadricep for 24 hours, onset 12 hours after vaccine Noticeable decrease in breast m... Read more
Twitch in right quadricep for 24 hours, onset 12 hours after vaccine Noticeable decrease in breast milk supply at 3.5 mo post partum; 40-60% decrease lasted for 10 days; normally pump 5 oz 2x/day (morning and night); instead, was only able to pump 2-3 oz 2x/day. Supply began to decrease within 24 hours of vaccine.
36 2021-03-26 feeling hot, flushing Warm sensation all over body, blurred vision in right eye, flushing, hives over chest, neck, and arm... Read more
Warm sensation all over body, blurred vision in right eye, flushing, hives over chest, neck, and arms, high heart rate and high blood pressure. Happened just minutes after injection. Given 50mg Benadryl and observed by Medics for an hour.
36 2021-03-26 tingling, numbness Within a few minutes of the injection into my left arm, my left arm felt tingly/numb. It hasn?t reso... Read more
Within a few minutes of the injection into my left arm, my left arm felt tingly/numb. It hasn?t resolved since (today is day 8 post injection). It always seems better by the evening but during the day it feels like a soft current flowing through the arm into the hand or as if you had blood flow cut off. It?s not intolerable but I?m aware of my left arm, like something is off. No idea how it could have come on so fast but it did. I am a neurologist and do not believe that any nerve was accidentally injected or damaged in my arm by the needle. Also, on 3/26 and 3/27, I began to experience tingling in both feet & ankles. This has been coming and going. The left arm tingling was present this morning but was better today though not resolved.
36 2021-03-26 feeling hot lightheaded, warm cheeks, declined transfer to observation tent, symptoms resolved
36 2021-03-28 pain in extremity Sharp and burning pain in left hip, buttock, and thigh followed by similar pain in left arm. Experie... Read more
Sharp and burning pain in left hip, buttock, and thigh followed by similar pain in left arm. Experiencing radiating pain, pins and needles, and muscle weakness in both left leg and left arm which are simultaneous. I also have mild pain in left ear. I took Ibuprofen for about a week but had to finally go to Urgent Care. After blood test and X-ray results came back normal, I was prescribed Gabapentin and was referred to a neurologist. I had an MRI on 03/25/2021 and waiting for the results.
36 2021-04-01 weakness patient felt like she was going to black out; slipping consciousness; nauseous; weaknesses; fatigue/... Read more
patient felt like she was going to black out; slipping consciousness; nauseous; weaknesses; fatigue/fatigue in waves; fever; swollen lymph nodes; right breast sharp cramping; palpitations; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 (lot number: EN6206) at the age of 36 years old, as single dose for covid-19 immunization. Medical history included gilbert's syndrome, past lyme disease (treated), anxiety and asthma.There were no concomitant medications. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9266, administration time: 02:15 PM, vaccine location: left arm, dose number: 1). Day 1 to 3 post vaccination (Mar2021), the patient experienced fatigue with fever. On day 4 to 5 the patient felt fine. On day 6 to 12 (Mar2021), the patient experienced extreme fatigue in waves, swollen lymph nodes and right breast sharp cramping, and some palpitations. On day 12 (20Mar2021 08:45), the patient had extreme wave of fatigue hit and the patient felt like she was going to black out, nauseous, weaknesses, slipping consciousness, called ambulance. It was reported as unknown if treatment was given to the patient for the adverse events. The events resulted in visit to emergency room/department or urgent care. The patient has not been tested for COVID post vaccination. The patient was not diagnosed with COVID prior to vaccination. No other vaccines in four weeks and no other medications in two weeks prior to COVID vaccination. The patient was not pregnant at the time of vaccination. The patient recovered from fever on unspecified date in Mar2021. Outcome of the rest of the events was unknown.
36 2021-04-04 seizure A few minutes after vaccination the pt had what appeared to be a seizure with momentary loss of cons... Read more
A few minutes after vaccination the pt had what appeared to be a seizure with momentary loss of consciousness. Profuse sweating, tunnel vision and syncope also present. EMS was called and patient was transported to hospital directly from the pharmacy.
36 2021-04-06 numbness Left arm/hand numbness; This is a spontaneous report received from contactable nurse. This is the se... Read more
Left arm/hand numbness; This is a spontaneous report received from contactable nurse. This is the second of two reports. A 36-year-old adult [non-pregnant] female received the second dose of intramuscular BNT162B2 (solution for injection; Lot EL9764 expiry not provided) as a single dose in the left deltoid on 16Feb2021 (at 36-years-old), for COVID-19 immunization. Relevant medical history included known allergy to coconut, obesity (BMI 32), and former smoker. Concomitant medications included ascorbic acid/ dexpanthenol/ ergocalciferol/ nicotinamide/ pyridoxine hydrochloride/ retinol/ riboflavin/ thiamine hydrochloride/ tocopheryl acetate (MVI), and levonorgestrel (MIRENA). The patient previously received COVID-19 immunization with intramuscular BNT162B2 (Lot EJ1685) in the right deltoid on 05Jan2021 at 13:00 (at 36-years-old) and experienced sensation change (pins and needles) in left arm and tested positive for COVID. The patient was not pregnant at the time of vaccination. The patient did not receive any immunomodulating or immunosuppressing medications or any other vaccinations around the time of the vaccination. The patient tested positive for COVID via oropharynx PCR on 23Jan2021. On an unspecified date in 2021 the patient experienced Left arm/hand numbness which required hospitalization. Treatment for the event included aspirin (81mg) for thirty days. The outcome of the event Left arm/hand numbness was recovering. The reporting nurse was unsure if the event was related to the use of the Pfizer product.; Sender's Comments: Based on temporal association, the causal association between the reported event numbness and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) :PFIZER INC-2021105933 PFIZER (Same reporter/patient/product, different event)
36 2021-04-12 pain in extremity, seizure increased seizure activity; I had the normal yet severe side effects of sore arm & neck; I had the... Read more
increased seizure activity; I had the normal yet severe side effects of sore arm & neck; I had the normal yet severe side effects of sore arm & neck; stiffness behind the ear, stiffness of the neck; stiffness of the neck and injection site arm; fatigue; fever; headache; sore throat; chills; I started suffering from tinnitus; dizziness; nausea; confusion; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the second dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 21Mar2021 14:45 (at the age of 36-year-old) as single dose for COVID-19 immunization. Medical history included epilepsy and asthma. The patient is not pregnant. Concomitant medication included levetiracetam. No other vaccine in four weeks. The patient previously received the first dose of BNT162B2 (Lot Number: EN6203) administered in left arm on 28Feb2021 14:30 (at the age of 36-year-old) as single dose for COVID-19 immunization. The patient had the normal yet severe side effects of sore arm & neck, stiffness behind the ear, stiffness of the neck and injection site arm, fatigue, fever, headache, sore throat, chills, for the first few days her 2nd dose. But on day 2, she started suffering from tinnitus, dizziness, nausea, confusion in both ears and increased seizure activity. The events started about 2 days after the second shot on 23Mar2021 12:00 PM; its been a week now and it still hasn't gotten better or gone away. She had an appointment with her pcp tomorrow but so far nothing has helped. Its debilitating and extremely hard to focus & function. She mainly just wanted to know if any other vaccine trial participant/recipients have reported anything similar & if so, how long can she expect this to last. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the events. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was not recovered.
36 2021-04-20 pain in extremity, tingling, numbness and pain in extremities experiencing symptoms similar to peripheral neuropathy; sharp pains shoot through my extremities; My... Read more
experiencing symptoms similar to peripheral neuropathy; sharp pains shoot through my extremities; My whole body tingled.; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EP7533), via an unspecified route of administration, administered in left arm on 05Apr2021 14:30 as single dose for covid-19 immunization at Pharmacy or Drug Store. Medical history included asthma, depression, Patient had allergies to medications, food, or other products included Corn, wheat, and sesame. Patient was not pregnant at time of vaccination. Family history included peripheral neuropathy, which runs in her family (sister, mother, maternal uncle, maternal grandmother). Concomitant medication(s) within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC); montelukast sodium (SINGULAIR). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6199), in left arm on 08Mar2021 14:30 for COVID-19 immunization. It was reported that starting about twelve hours after my second dose of the vaccine on 06Apr2021 03:00 AM the patient experienced symptoms similar to peripheral neuropathy, which runs in her family (sister, mother, maternal uncle, maternal grandmother). Her whole body tingled, and had sharp pains shoot through my extremities. Patient have never been diagnosed with peripheral neuropathy or experienced these symptoms before. It was 24 hours later. The sensations still persist but are less pronounced. The prozac that was on can cause leg twitches. Perhaps the vaccine was interacting with the prozac or triggering an underlying genetic condition. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
36 2021-04-24 tremor, migraine This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the ... Read more
This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 07Apr2021 16:20 as single dose for Covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) was advised because she has been in her house so long that she is basically an agoraphobe and psychologist qualified because diagnosed with ADHD and profound anxiety at the fear of dying from COVID, anxiety and Covid-19, Concomitant medications were not reported. The patient stated that yesterday 07Apr2021 she got her first round of Pfizer COVID-19 vaccine and came home and got the worst headache she ever had in her life. She states then she projectile vomited and started uncontrollably shaking. The patient stated that she was shaking uncontrollably so bad she had to take a bath. She once she took a bath, in the bath she was shaking, it was not until she raised her body temperature high enough that her body was like okay, it could let go a little bit, then she got into bed and the shaking started again. She stated she had to use her heating blanket and stayed in bed all night with it and she is still using it now. She doesn't know how she would be if she wasn't warm, she thinks the fact that she is warm, the shaking has subsided. Later, last night, around 2 or 3 the headache was piercing, her head was hurting so bad like someone was taking a nail in her left temple. If it was a stroke she would have dealt with it if she had someone there with her to help her deal with it. She has a horrible headache today. The patient stated that now it is like a regular migraine. It sounded crazy to say , but now it she stated that it was like a regular migraine, it has improved and no longer feels like she is having a stroke. The patient took two Tylenol yesterday for the headache and vomited pretty quickly after so she doesn't think she got much of it. She has not taken anything else because she does not have anything on her stomach so she does not want to take more Advil or whatever but she would like to, her head hurts really bad, she would love some pain relief. The projectile vomiting went until there was just bile. She did not eat very much yesterday. She is no longer actively vomiting, but she felt herself wanting to dry heave but feels there is nothing else to give. The patient stated that she hasn't eaten anything today so she does not know if she can keep anything down and doesn't have much water in her system. The outcome of the event headache was recovering while the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.
36 2021-04-24 tingling, cold extremities, numbness, weakness having discoloration on her toes; she was having numbness and tingling; she was having numbness and ... Read more
having discoloration on her toes; she was having numbness and tingling; she was having numbness and tingling; her extremities, from the knee down and both her hands and feet were cold,ice cold; Tachycardia; palpitation/palpitation complications without doing anything straight away; Pulse keeps raising, elevating to 148-157/Pulse went to 209; shortness of breath and basically blasting of air; Difficulty breathing; Dizziness; Weakness; Syncope episodes; Costochondritis; chest pain; The initial case was missing the following minimum criteria: suspect product was not reported or specified. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 (Batch/Lot Number: EL3246) (at the age of 36-year-old) as single dose for COVID-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included topiramate (TOPAMAX) at 250 mg, daily (2 DF 100mg and 1 DF 50mg at bedtime) taken for migraine, start and stop date were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 (Lot Number: EK5730) for COVID-19 immunization. The patient reported that since the second vaccination experienced tachycardia, palpitation, shortness of breath and basically blasting of air, difficulty breathing, dizziness and weakness, all on 18Jan2021. She reported pulse keeps raising, elevating to 148-157, she had palpitation complications without doing anything straight away. Elevated pulse and tachycardia, that all started and that was very concerning, pulse went to 209 and that was when she got transported to the emergency room. The patient reported also syncope episodes, costochondritis and chest pain on Jan2021. On 26Mar2021 the patient experienced having discoloration on her toes, numbness and tingling and that her extremities, from the knee down and both her hands and feet were cold, ice cold. The patient was transported to the hospital by ambulance three times due to the events (hospitalizations on 22Jan2021, 30Jan2021 and 25Mar2021). The patient underwent lab tests and procedures which included Troponin, D dimer, electrocardiogram (EKG), Chest X ray, Full blood count (CBC), exercise electrocardiogram (TMT) all resulted: normal, nuclear stress test: unknown results and pulse 148-157, 209, all on unspecified date. The patient outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia and other reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
36 2021-04-27 flushing I?m not 100 percent and I do have anxiety. But about 5 minutes after I received my 2nd dose I got a... Read more
I?m not 100 percent and I do have anxiety. But about 5 minutes after I received my 2nd dose I got a flush feeling in my chest and then all of a sudden my heart started racing and I felt like I was going to pass out. A nurse came over and felt my pulse. After a couple of minutes my heart rate slowed down. Like I said I do have anxiety attacks but I haven?t had one for a while now. Just wanted to report what happened to me because it was a scary feeling and maybe it was a coincidence. Haven?t had it happen again.
36 2021-04-28 pain in extremity Soreness and muscle aches in left arm and shoulder that began around 8 hours after the shot. Headach... Read more
Soreness and muscle aches in left arm and shoulder that began around 8 hours after the shot. Headache and fever of 99F around 16-18 hours after, took Advil and both went away after a few hours. Fatigue and sore arm for most of the next day. Fever of 100F started around 30 hours after the shot, took Tylenol. Symptoms gone after roughly 48 hours.
36 2021-05-02 pain in extremity, discomfort, tremor 5/1/2021 Drainage and weird taste in back of mouth 11:30a Slight redness left thigh warm to touch 12... Read more
5/1/2021 Drainage and weird taste in back of mouth 11:30a Slight redness left thigh warm to touch 12:30-1:15p Fatigue 12:30-current Nausea 12:30-current Headache 3:15-current Diarrhea 4:30-current Sore arm 8p-current General malaise, especially if standing up 9:30p-current Face pressure 11:30p-11:35p 5/2/2021 Shakes 5a-7a Chest pains 8a-current, intermittently Anal bleeding 2p, every bowel movement since, bright reed blood in toilet and on paper Lightheaded and faint called EMS Blood pressure 155/94 3p, they suggested to follow up with my PCP in AM Anal bleeding 5:30p Red streak R arm near injection site 6:15p-6:45p Red dots on L knee 6:15p-current (not itchy) Started period/spotting 1st one since conceiving last year. I am 12 weeks postpartum and exclusively breastfeeding. (light brown not heavy) 9:30p (with prior two children J did not start my period until babies were about one year old and weaning from breastfeeding)
36 2021-05-03 muscle spasms, pain in extremity Shivering and chills despite being 11c outdoors and being inside and in pajamas and under a duvet. S... Read more
Shivering and chills despite being 11c outdoors and being inside and in pajamas and under a duvet. Strong muscle spasm cramping in calves, made it difficult to walk to get even get water. Very sore arm, could not lift, and strong fatigue GI issues (slight diarrhea clumps but not many)
36 2021-05-03 difficulty speaking woozy, about to pass out/like you are going to pass out; heavy breathing/breathing was heavy, voice ... Read more
woozy, about to pass out/like you are going to pass out; heavy breathing/breathing was heavy, voice was deep, like she really had to work to breathe; racing heart/heart was racing; rash/ rash was under the skin/ it started in the thighs and spread down her legs; vascular rash/ rash was under the skin/ it started in the thighs and spread down her legs/ it seems like a vascular reaction; pain at the injection site./super painful injection site; felt really really really poor; voice was deep; heavy chest, chest pain; heavy chest, chest pain; feeling woozy/woozy, about to pass out; This is a spontaneous report received from a contactable consumer (patient). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8737), administered in left arm on 01Apr2021 01:15 PM (at the age of 36-year-old) at single dose for so she could be protected from COVID (as reported). It was reported that vaccine was not administered at military facility and vaccination facility type was hospital (reported as patient drove up to vaccine clinic). The patient's medical history included acute lymphocytic leukemia from 1992 to 1996 and not ongoing (she was immunocompromised when she was young, she was a cancer survivor). No family medical history relevant to events was reported. The patient declined being sick at the time of vaccination. No patient's concomitant medications were reported. No prior vaccinations reported within four weeks. No additional vaccines were administered on same date of the Pfizer suspect. The patient previously took gentamycin, amoxicillin and flu shot, culture specific to the flu (as reported), and she experienced allergy with all three on 1996. Patient said that she was immunocompromised when she was young, she was a cancer survivor. She said that right after remission she developed a gentamycin allergy and, because of the gentamycin and amoxicillin allergy she was allergic to the flu shot, not the flu but the egg culture, because the egg culture can be that reaction. Patient also said that she had a reaction to a flu shot back in 1996 or something, it was the same rash that was with the COVID vaccine. It was reported that patient had her first Pfizer Covid vaccine dose on 01Apr2021. She reported side effects of heavy breathing, racing heart, feeling woozy, rash, and pain at the injection site. It was reported that she would like more information and she wanted to know if she should get the second dose of the vaccine. Patient had both an event to report and a question. She said she had done application, the first vaccine was 2 weeks before the present report and she was not supposed to get the second until this Thursday (19Apr2021), she needed to look at a calendar. She said 01Apr2021 was her first vaccine and that she did already report her events. She said she had a bad reaction that borderline sent her to the emergency room but she instead took a BENADRYL and she laid down and then felt really really really poor the next 5 days. She said she had a terrible reaction, she didn't feel like her throat was shut, her breathing was heavy, her voice was deep, her heart was racing, like she really had to work to breathe, not like losing her airway passage, just that she had to work to breathe, she had a heavy chest, chest pain, a racing heart. She said she could best correlate it to how feels like low blood sugar, like you are going to pass out. It was also reported that patient experienced woozy, about to pass out. She said she ended up what she'd call a vascular rash. She said it started in the thighs and spread down her legs. She said it was not a rash at the injection site, the rash was under the skin rather than a topical rash. She said she had a photo of it, that it seems like a vascular reaction. She would like to file a report with us because she said she felt like she did not get anything out, she had logged what happened to them and there was no correlation, no confirmation. She said she could send the photo to them. She said she was scared to get second vaccine, she wonders if she should do her due diligence to do second dose, or if she should skip it. She said there was no protocol in place, she had a telemedicine call with her doctor, there was no $200 fee due, her physician said it sounds like patient had more than a normal reaction. She said there were other things that are scary, her doctor told her she should speak to an allergist, but she said it would cost her like $600. She said she didn't feel good on immediate injection, she felt like she probably shouldn't be driving her car. She looked for her notes then she said her only normal reaction was a super painful injection site but not a rash. She said the vascular rash subsided with the use of BENADRYL. She said she could not afford an allergist to figure out what's going on. She asked why someone as small as her would get the same dose as a 200 pound man and why the doses of the vaccine were not specific to size or weight based. She also asked if based on symptoms will someone in the medical Information department advised her not to get the second dose. Events onset date were reported as 01Apr2021. The case was reported as non-serious by the consumer. No events required emergency room visit. She confirmed that she did have a telehealth meeting with her general practitioner (also reported as no events required physician office visit), she said she talked to them on the phone. No investigations assessment and relevant tests were reported. The outcome of events was resolved on 02Apr2021 for "rash/ rash was under the skin/ it started in the thighs and spread down her legs" and "vascular rash/ rash was under the skin/ it started in the thighs and spread down her legs/ it seems like a vascular reaction", resolved on 08Apr2021 for "heavy breathing/breathing was heavy, voice was deep, like she really had to work to breathe" and "voice was deep", and resolved on 05Apr2021 for all other events.
36 2021-05-06 numbness, tingling blood clot; anemia; knee down felt tingly/like her legs were falling asleep; knee down felt tingly/l... Read more
blood clot; anemia; knee down felt tingly/like her legs were falling asleep; knee down felt tingly/like her legs were falling asleep; could not sleep; She was feeling uncomfortable constantly/she did not feel well; Shortness of breath; Her arm started hurting/was just at the injection site; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) at the age of 36-years, via an unspecified route of administration in left arm on 04Apr2021 12:15 at single dose for COVID-19 immunisation. Medical history included had a pregnancy (a while ago, not ongoing). No other products. The patient stated that she experienced shortness of breath on 08Apr2021 (4 days after receiving the first dose), it got so severe on day 7 that she went to the ER on 11Apr2021. She started getting progressively more shortness of breath. Twice, she called the nurse line for her doctor and was advised to go to the emergency room. Added she could not catch her breath, and it was worse at night, could not sleep, so she went to the emergency room, she was in emergency room for 2 and a half hours and then went home. She wanted to know if the second dose could cause issues or if she should get it, added that the paperwork said that people should not get the vaccine if they received an adverse reaction to the first dose or any vaccination. She did not know if this was normal for it to get progressively worse and 2 to 14 days later. Patient wanted to know if the shortness of breath was something that can get worse, if this was a reaction to the vaccine even though it happened so many days later. Patient added it was the only thing she could think of and that her heart rate, oxygen levels, and everything was good minus she felt like she could not catch her breath. The doctor in the ER gave her anti-anxiety medicine, something with an L, but the doctor gave her that and it really seemed to help. It was kind of like, she did not know, it made her feel calm enough to fall asleep. Caller added that she has that and an salbutamol (ALBUTEROL) inhaler. She was not sure whether progressively worsening shortness of breath had gotten any better or was still going on, added that yesterday was the day she did not need either treatment medication. The day before, she took just the anxiety medicine and not the albuterol. Yesterday, she took none. During the day on 11Apr2021 (Sunday), she had called because she was feeling uncomfortable constantly. She has two children and all day she did not feel well. She told her husband she did not feel well at all. Sunday when she went to lay down, she could not sleep. Patient reported that as her shortness of breath subsided, her arm started hurting again, thought this began on 19Apr2021 and was not sure, it went away completely and was just at the injection site, probably lasting half a day or so and then it went away, clarified as left arm, same as injection. Caller added that 15Apr2021 was after the ER visit, was that she was standing up doing things and from her knee down felt tingly. Stated that knee down felt tingly on 15Apr2021, which was after her ER visit occurred, she was standing up and doing things. She had not been doing things for long periods but her knee down felt tingly. Added not like numb, but like her legs were falling asleep. She was preparing dinner and moving around and felt tingling in both legs. This probably lasted about three hours. She just kind of took it easy and it started to subside and then it was gone. While mentioned investigations, patient stated the ER did an EKG, where they put stickers and monitor her heart. They did a chest x-ray, and they took blood. She believed they checked for blood clot tests and anemia. Patient did not know any results but stated the doctor came into the room and told her everything was clear and nothing came back with anything on it. She stated the date was either the night of 11Apr2021 or the morning of 12Apr2021 for the tests. Outcome of the events shortness of breath and arm hurting was recovered/resolved in Apr2021; of the event knee down felt tingly/like her legs were falling asleep was recovered/resolved on 15Apr2021; while of remain was unknown. No follow-up attempts are needed. No further information is expected.
36 2021-05-09 muscle spasms, inability to speak, weakness, feeling cold, numbness, tenderness, seizure like phenomena, cold extremities, tingling, pain in extremity Patient received Pfizer COVID-19 vaccine on 12/27/2021 and 01/17/2021. Previously checked for COVID... Read more
Patient received Pfizer COVID-19 vaccine on 12/27/2021 and 01/17/2021. Previously checked for COVID-19 infection 12/13/2020, 01/23/2021 and 04/06/2021 and was negative on each test. On 01/18/2021, patient states she had low-grade fever, fatigue, myalgia. Took Tylenol. Patient contacted office on 01/22/2021 stating the night prior (1/21/2021)her heart rate was up to 209 and had numbness and tingling in both upper extremities. Also with sharp pain down her legs and her hands were very cold. Patient had started taking a Kelp supplement on 01/21/2021 which was recommended by a provider. Reported later reported that she "felt like a truck hit her." She also noted onset of chest pain. She went to urgent care for evaluation 1/22/2021. Patient felt lightheaded while in urgent care as she was about to have her blood pressure taken and passed out for approximately 2-3 minutes. Ammonia inhalant was used and patient woke up. During evaluation by physician, patient had another few seconds of loss of consciousness. No tonic clonic movements. No tongue biting. Patient was seen at urgent care and had syncope times 4 episodes. Patient was not postictal. No evidence of seizure-like activity. No urinary incontinence or tongue biting. She felt like she was going to pass out and mention to the urgent care staff . Patient was transferred to the ED for further evaluation. Was admitted under observation. It was felt that the initial episodes of syncope may have had a psychogenic component due to history of pseudoseizures/convulsive syncope. Cardiac enzymes were negative. Ultrasound negative for DVT. D-dimer negative. Chest pain was reportedly reproducible on admission. Was given diagnosis of costochondritis. Received Toradol, tramadol, Ativan. Orthostatics were performed in the morning after admission for observation and she passed out while standing. Was given 1 L IV fluids with resolution of orthostasis and blood pressure subsequently remained stable. There was report of tachycardia. It was felt that the tachycardia was due to reflex tachycardia in the setting of vasovagal syncope. Patient discharged on ibuprofen and Tylenol p.r.n. COVID-19 test negative at that time. Patient also admitted to Hospital 01/31/2021 through 02/01/2021 due to chest pain. Also had seizure-like activity in CT scan. Seen by Neurology. Patient was able to remember what she thought to be ?seizure?. She was asked to raise her arms while getting her CT and when she did she feel that her ?arms got frozen?. And that she could not talk while she was still hearing people around. She said "everything went south". She remembered the attending and her getting back to normal immediately afterwards. When patient seen by nurse on the medical floor nurse has described her to be alert oriented x3. CT brain: No acute abnormalities Driver's license has been suspended for at least 6 months through 08/2021. On follow-up visit via video visit 02/18/2021, patient reported ongoing shortness of breath at at rest as well as chest pain also with palpitations. Also noted lightheadedness with ambulation. Patient seen by Cardiology 03/12/2021. Holter monitor 03/16/2021 with few isolated PACs. Pharmacologic stress test 03/2021 negative for ischemia with EF 70%. 2D echo (03/16/2021) with normal EF. No significant valvular abnormalities found. Suggested chest pain may be due to costochondritis. Seen in the office on follow-up 04/01/2021. Noted coldness of hands and feet since 01/22/2021. Ultrasound bilateral lower extremities negative for DVT 01/2021. Onset of discoloration of feet 03/26/2021. Also noted occasional muscle spasms and cramping of the right lower extremity below the knee. Noted particularly metatarsals and lateral surface of right lower extremity. Referred for lower extremity PVR ( 4/7/2021) showed elevated arterial pressures throughout both lower extremities suggesting non-compressibility. ABIs therefore unreliable. Strong pulsatile waveforms are maintained metatarsal region bilaterally suggesting no evidence of a arterial insufficiency at rest. Flat line digital waveforms suggest small vessel occlusive disease or vasospasm. X-rays of the toes negative for significant abnormality. Patient referred to vascular surgery for urgent evaluation. patient also refer to Rheumatology on 04/07/2021. On follow-up 04/07/2021 patient continue to note ongoing chest pain as well as shortness of breath. Patient started on aspirin 81 mg p.o. Daily on 03/25/2021. Shortness of breath is constant, unable to walk prolonged distances. Distal 2nd digits bilateral feet are deeper purple in color compared with prior visit 04/01/2021. Noted paresthesias of entire body from head to toes. Noted cold intolerance for few weeks intermittently. Notes discoloration hands from wrist to fingers and below knees to toes. States her extremities are ?freezing.? Was using a heating pad. States when she washes her hand in warm water the discoloration improved. During hospitalization CTA chest ( 01/31/2021) was negative for PE. Showed nonspecific, bilateral axillary subcentimeter lymph nodes. Minimal right breast calcification. Patient states she had mammogram performed 01/2021 and no significant abnormalities found. Patient followed at doctors. Hematology/Oncology aware of CT chest findings. Notably patient received COVID-19 vaccination prior to CT chest. Repeat CT chest requested by insurance however denied by insurance company. Left axillary ultrasound 04/26/2021 showed small axillary lymph nodes which have a relatively benign morphology. The largest node is actually decreased mildly in size when compared to 01/31/2021. Right axillary ultrasound 04/26/2021 showed small axillary lymph nodes as seen previously with 1 top normal size round lymph node with an indeterminate morphology but unchanged in size when compared to 01/31/2021. Patient has not been able to work since 04/01/2021 due to overall symptoms. Previously was working from home. Also works as an MA but discontinued in 02/2021 with onset of symptoms in 01/2021. On evaluation 04/07/2021 patient noted to have tenderness palpation along left lower quadrant. Initial CT abdomen and pelvis was denied by insurance company. Abdominal ultrasound 04/13/2021 unremarkable. Patient seen by vascular surgery on 04/12/2021 and recommended patient to start applying nitroglycerin to toes as well as initiation of a Plavix 75 mg daily. Also agreed with referral to Rheumatology. Patient has not yet received an appointment. Information was faxed to Rheumatology however referral was also placed by vascular surgery to rheumatology group. On evaluation in office 04/28/2021, patient reported chest pain all night where she "felt like something sitting on her chest" with associated shortness of breath. Radiated to neck. Also noted intermittent palpitations which can last for 5 minutes with associated chest pain. Notes left groin pain for the last 2 days. Symptoms lasted 2 hours, from 11:00 p.m. to approximately 1:00 a.m. and patient subsequently fell asleep. On awakening patient continues to notes chest tightness but less. Patient feels weak today. While patient was being examined on the examination table patient appeared weak and stated that she felt like she was going to pass out. Then noted left arm numbness. When asked to raise arms, left arm elevation less compared with right. However subsequently patient had difficulty elevating both arms. Patient also not moving both lower extremities to command. With cranial nerve testing, cranial nerves 2-12 intact except patient was unable to smile on command however while patient was crying facial muscles appeared symmetric. Repeat BP 120/78 with heart rate 75 and O2 sats 99% on room air. Blood pressure repeated another 5 minutes was 115/75 with heart rate of 76. patient referred to the ER for immediate evaluation by ambulance. Patient has been admitted to the hospital since 04/28/2021. On 4/28/2021, patient noted bruising along right brachial area, right upper extremity distally as well as left medial thigh. Noted dry patch along dorsum of left foot with associated redness for the last 3 days. Purplish discoloration of 2nd left digit and 2nd right digit had subsided since this weekend prior to visit 4/28/2021 and area is now scaly on both toes. Has been using nitroglycerin b.i.d. to toes since 04/12/2021 at recommendation of vascular surgery. States per patient's coloration of feet bilaterally improves with exposure to warm water. Also has been elevating the lower extremities. Noted significant constipation for which patient was seen by GI. Has been using Metamucil and MiraLax. States constipation persists. States she has to use a step stool to elevate her legs when trying to have a bowel movement. States she spent a long time in the bathroom when she has to have a bowel movement. Also notes bright red blood per rectum with each BM with wiping as well as on the stool. States she did not have bright red blood per rectum at time of recent GI evaluation. EGD/colonoscopy was initially scheduled for 05/14/2021 prior to admission to hospital.
36 2021-05-10 hot flush Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Alle... Read more
Bleeding; heavier menstrual bleeding; Along with a week and a half of heavy Fatigue; Sneexzing; Allergies; Hot flashes; Nausea waves for two weeks; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 (Batch/Lot Number: EW0151) as 2ND DOSE, SINGLE for covid-19 immunization, at the Age at Vaccination of 36 years old. The patient medical history was not reported. Patient was not Pregnancy at time of Vaccination. Historical vaccine included first dose of BNT162B2 on 20Mar2021 (Lot number: EP6955; Dose number=1; Vaccine location=Left arm) for covid-19 immunization, reported the first shot she had a slight headache hours after the shot and then got light embryos bleeding a few day afterwards. Concomitant medications (medications the patient received within 2 weeks of vaccination) included Implanon, Straterra, adderall, multivitamin, ashwa (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient experienced bleeding (medically significant), along with a week and a half of heavy fatigue (non-serious), sneexzing (non-serious), allergies, hot flashes, nausea waves for two weeks (non-serious), heavier menstrual bleeding (non-serious), all on 25Apr2021 with outcome of unknown. Reported as she never have period due to her birth control methods. She got heavier bleeding a few days after her second dose that lasted about a week, along with a week and a half of heavy fatigue, Sneexzing and feeling like she had allergies, with occasional hot flashes and nausea waves for two weeks. And even heavier menstrual bleeding starting 15 days after second shot. No treatment received for events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
37 2020-12-31 speech disorder TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10... Read more
TIA symptoms - difficulty speaking, reports leaning towards the left side and was dizzy for about 10min.
37 2021-01-01 weakness Overwhelming fatigue/weakness
37 2021-01-02 flushing chills and face felt flushed
37 2021-01-03 tingling 5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat.... Read more
5 minutes after the injection - felt a wave of tingling over upper body and itchy in back of throat. 10-15 minutes later, it happened again. Denies shortness of breath, some itchiness on tongue. Tongue was not swollen. Advised to take oral Benadryl. Total monitoring time = 40 minutes and was discharged/released home.
37 2021-01-03 numbness After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, a... Read more
After~50 minutes from receiving the vaccine, I experienced bilateral numbness of the ears, cheeks, and tongue. This lasted ten to fifteen minutes followed by mild itching of the ears, face, and neck. Upon returning home, contacted my primary physician to report the adverse reactions and self administered Benadryl which eliminated the s/s thus far.
37 2021-01-03 tingling, numbness Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18... Read more
Call to EE 12/22 regarding facial numbness/ tingling after vaccine. Notes she received vaccine 12/18. Was fine for first 15 minutes. Within 5-10 minutes of leaving, ee had facial numbness to right side of face and under bottom lip. Sx lasted about 3 hours and resolved 100%. No recurrence.
37 2021-01-03 flushing Flushed cheeks, tingling to lips
37 2021-01-03 night sweats severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a sp... Read more
severe fever; chills; severe night sweats; hives throughout my body; a rash on my face; This is a spontaneous report from a contactable nurse. This nurse reported for helf that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2, product: COVID 19, brand: Pfizer), via an unspecified route of administration on Left Arm on 19Dec2020 10:30AM at single dose for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Known Allergies to medications, food, or other products:Cocoa butter. Concomitant medications were unknown. Facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that "Starting seven hours after the vaccine, I experienced severe fever and chills. The next morning, despite multiple anti-pyretics, the fevers/chills were worse. Also I experienced severe night sweats, likely related to the fevers. Three days after the vaccine, I began to have hives throughout my body and a rash on my face. Responds to Benadryl, but eventually reappears." The event started from 19Dec2020 05:30 PM. Treatment was received for the adverse event included Anti-pyretics, anti-inflammatories, anti-histamine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility type vaccine was hospital. No other vaccine in four weeks. The patient recovered with lasting effects. No Covid prior vaccination. No Covid tested post: vaccination. The outcome of the event was recovered/resolved with sequel in Dec2020. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events severe fever and chills, severe night sweats, and hives and a rash on face were likely related to the use of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-04 numbness Developed left facial numbness but no weakness present; This is a spontaneous report from a contacta... Read more
Developed left facial numbness but no weakness present; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) with unknown lot number and expiration date, intramuscularly at the left arm on 17Dec2020 at 16:15 (04:15 PM) at single dose for COVID-19 immunization. The patient was vaccinated at a hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient's medical history included hypothyroidism, hypertension, and premenstrual dysphoric disorder (PMDD). The patient had no allergies to medications, food, or other products. Concomitant medication included atenolol, fluoxetine hydrochloride (PROZAC), and levothyroxine; all received within 2 weeks of vaccination. The patient reported that on 17Dec2020 at 18:00 (06:00 PM), she developed left facial numbness but no weakness present. Symptoms come and go. Sometimes last for hours, never had this before. The patient did not receive treatment for the event. The clinical outcome of the event was not recovered. The event was reported as non-serious. Information on the lot/batch number has been requested.
37 2021-01-04 tingling Facial swelling/tingling, lip swelling and tingling and tongue swelling
37 2021-01-04 migraine Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; s... Read more
Have had headache/migraine 6-24 hours after vaccine; intermittent severe stomach cramping; nausea; severe diarrhea; vomiting; This is a spontaneous report from a contactable nurse (patient). A 37-years-old female patient, non-pregnant, received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, in hospital, via an unspecified route of administration on 23Dec2020 at 10:30, at 37-years of age, at single dose in right arm for COVID-19 immunization. Medical history included anxiety, depression and migraines, all from an unknown dates. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), topiramate (TOPAMAX), buspirone hydrochloride (BUSPAR), ibuprofen and levocabastine hydrochloride (ZYRTEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache/migraine 6-24 hours after vaccine (onset reported also as 25Dec2020 at 12:00 - to be clarified) and, on 25Dec2020 at 12:00, also reported as 24-72 hours after vaccine, she experienced intermittent severe stomach cramping, nausea, severe diarrhea and vomiting. The patient didn't receive any treatment for the events. The outcome of the events was unknown at the time of the report. Information on the lot/batch number has been requested.
37 2021-01-04 pain in extremity It still hurts to abduct my left arm; This is a spontaneous report from a contactable Physician (pat... Read more
It still hurts to abduct my left arm; This is a spontaneous report from a contactable Physician (patient). A 37-year-old female patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at single dose in left arm for COVID-19 immunisation at the age of 37-year-old. Lot number was EJ1685. Medical history was unknown and concomitant medications were unknown. Patient was not pregnant at the time of vaccination. It was reported that since 19dec2020 it did still hurt to abduct left arm.. The patient was not treated for the event. The patient did not recover from the event.
37 2021-01-04 flushing Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25m... Read more
Patient became lightheaded, flushed, tachycardic, and developed hives. Patient was administered 25mg of diphenhydramine orally and observed. Patient quickly began feeling better, hives disappeared. The patient left with 2 other coworkers.
37 2021-01-04 tingling Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes... Read more
Received first COVID vaccine. A few minutes after vaccine, arm felt abnormal, tingly, then 5 minutes after that felt lightheaded and tachycardic. Rapid response called while patient laid flat, transported to the ED. In the ED, vital signs were stable and was able to ambulate without problems.
37 2021-01-04 pain in extremity severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-conta... Read more
severe sore arm in limb it was given; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 37-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), intramuscular in the right arm on 23Dec2020 10:15 at a single dose for COVID-19 immunization. The patient has no other medical history. The patient has no known allergies. The patient has no COVID prior vaccination, and COVID was not tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), escitalopram oxalate (LEXAPRO), and vitamin c (ascorbic acid). The patient has no other vaccine in the past four weeks. On 23Dec2020 01:00 PM, the patient experienced severe sore arm in limb it was given (by nighttime she was almost unable to use her right arm, improved by next morning), nausea, and fatigue. The outcome of the events was recovered in Dec2020. No treatment was received for the adverse events. The report was considered non-serious. No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
37 2021-01-04 tension headache tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested po... Read more
tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; sinus infection; tested positive for the COVID virus/she was having a symptom, she lost her sense of smell; Her nose being stuffed; tension headache on the back of head; her deltoid was hurting for 24 hours; active infection after getting the first dose; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the right deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had active infection after getting the first dose, consult if it was still recommended to get the second dose next week or she should be delaying getting the second dose. The patient got the COVID vaccine on the 18Dec2020. Then on the 24Dec2020 she tested positive for the COVID virus. She was due to get the second vaccine on 08Jan2021. She was asking should she still get the 2nd dose of the vaccine since came up positive. The patient was having a symptom, she lost her sense of smell of 22Dec2020. She lost her sense of smell on the evening on 22Dec2020, it still had not come back at all. She did have sense of taste on the tongue. She thought it was sinus infection, because her head didn't hurt and she was not stuffed anymore. She stated that after the vaccine, she had a tension headache on the back of head, and her deltoid was hurting for 24 hours. Her headache started the same day in the evening, went on till lunch time next day. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. Her nose being stuffed which she thought was a sinus infection started on Tuesday 22Dec2020, it was more located in the front middle of her forehead. She did not have her Card to provide Lot and Expiry, it was at work at the hospital. She was administered the vaccine on the right deltoid, since she didn't want to sleep on it. Prior to vaccine she has had no positive test for Covid. Caller stated that this was super unfortunately coincidental. She had had no antibody test. She had no reactions to vaccines in the past. Test: Respiratory Panel. Result: Negative on unknown date. The outcome of events drug ineffective, COVID-19 and sinus infection was not recovered. The outcome of event tension headache and muscle pain was recovered in Dec2020. The outcome of rest events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19 and other events, based on temporal relationship. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
37 2021-01-05 difficulty speaking 8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registe... Read more
8:00 am: tongue numbness and reported to observer 8:05 am: tongue swollen lips numb 8:10 am: registering in ER tachycardia. Throat mouth dry and tight change to hoarse voice lightheaded. EpiPen administered. Ekg done. Other meds provided: 500 ml saline bolus. Famotidine, prednisone, benadryl Angioedemia and readmittance to ER approximately 18hrs later: prednisone,epipen, benadryl iv and po, famotidine, saline bolus
37 2021-01-05 facial paralysis, face paralysis, numbness After receiving the vaccine, the patient ended up with a mild case of Bell's palsy. Symptoms includ... Read more
After receiving the vaccine, the patient ended up with a mild case of Bell's palsy. Symptoms include: mild numbness up to the maxillary bone, and a weak smile (doesn't go up on the right). Her Smile is asymmetrical.
37 2021-01-05 pain in extremity Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneo... Read more
Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#EK9231) for the first dose via intramuscular in the left arm on 22Dec2020 12:00 for COVID-19 immunization. Medical history included post viral syndrome (COVID) or long COVID from Mar2020. The patient had undetectable antibodies in Apr2020. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC +), colecalciferol (VITAMIN D), cobamamide (VITAMIN B12), bifidobacterium lactis (PROBIOTIC). The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies (NKA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19 since the vaccination. The patient had arm soreness 3 days, 1 headache, fatigue starting from night of injection increasing to requiring 1 hour nap on day 6 and 7, myalgias and arthralgias day 6 and 7; events onset date reported as 22Dec2020. Blood drawn 1 week after injection and the patient had undetectable antibodies in Dec2020, no movement in her CD4 or CD8 in T lymphocyte panel. The events resulted in doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.
37 2021-01-05 facial paralysis Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patien... Read more
Bell's Palsy; This is a spontaneous report from a contactable physician. A 37-year-old female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on 29Dec2020 17:50 (5:50 pm) at a single dose as Covid vaccine. Medical history included hypertension and depression. Concomitant medications included venlafaxine hydrochloride (EFFEXOR); olmesartan medoxomil (BENICAR); and unspecified medications for depression and blood pressure medication (hypertension). It was reported that the reporter's nurse got her vaccine last night, about 6'o clock at night, and woke up with Bell's Palsy on Dec2020. She woke up in midnight to go to the bathroom and when she looked in the mirror, she noticed that there was discrepancy. The physician examined her this morning, so it was in several hours getting the vaccine that she noticed it. She got the vaccination last night at 5:50 pm. When she went to bed it wasn't a problem. She woke up at midnight and noticed it. The patient was started on Medrol dose pack but she hasn't taken it yet because she's at work so she would start it today (unknown if the treatment was already received); it's steroid, Methylprednisolone, at 24 mg on day one and then decreases 4 mg a day over the next five days until it's done. The doctor inquired what should the patient do about her second dose and also asked if she should not get her second dose. The outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
37 2021-01-05 tension headache Diarrhea Sore arm at site of injection 1 day tension headache
37 2021-01-05 feeling hot Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours.
37 2021-01-05 feeling of body temperature change, flushing, tingling MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HE... Read more
MINUTES AFTER VACCINE WAS ADMINISTERED PATIENT FELT DIZZY THEN COLD FLUSHING FEELING FROM FEET TO HEART AND THEN THAT STOPPED AND TINGLING FEELING THROUGHOUT BODY AND THEN VERY WARM, AND FAINT FEELING. PATIENT DID NOT FAINT. PATIENT DID VOMIT ONCE. PATIENT HAD NOT EATEN BEFORE VACCINATION WAS ADMINISTERED. 1255 VITALS: BP: 126/91 P:100 SAO2 1303 VITALS: BP: 116/99 P: 96 SA02: 100% PATIENT STATES THEY ARE FEELING BETTER. GIVEN JUICE AND BANANA. 1312 VITALS: BP: 128/87 P: 74 SA02: 100% PATIENTS COLOR HAS RETURNED TO NORMAL. STATES THEY ARE FEELING MUCH BETTER. ABLE TO STAND AND WALK WITHOUT DIZZINESS. PATIENT STATED THAT THEY DID NOT FEEL THEY NEEDED ANY FURTHER TREATMENT OR CARE. PATIENT LEFT WITH HER WORKMATE.
37 2021-01-05 migraine Migraine headache, vomiting 2pm day of Overnight fever 101.5
37 2021-01-05 tingling Parasthesias began in my lower extremities intermittently about 36 hours following administration. T... Read more
Parasthesias began in my lower extremities intermittently about 36 hours following administration. These spread to my upper extremities and became consistent. Occasionally will appear in lips and trunk. These are associated with sensation of numbness and some discomfort in my extremities. I'm also experiencing significant brain fog, difficulty concentrating, and fatigue. Headaches are occurring about every other day. Symptoms are present currently and have remained relatively consistent in severity. Was evaluated by urgent care on December 28 and encouraged to observe. Was evaluated in the ER by neurology on January 4. There leading hypothesis is vaccine related immune response. Neurologic exam was largely normal, being evaluated by a specialist in the coming days.
37 2021-01-06 burning sensation 5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-... Read more
5 min after injection, pt developed L shoulder pain radiating to clavicle 4/10, now increasing to 6-7/10 and has decreased mobility of shoulder. sporadic burning sensation in arm between elbow and wrist.
37 2021-01-06 nerve pain, numbness Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left sid... Read more
Approximately 20 minutes after the first (and second) vaccine, I experienced numbness on my left side. Both times I was vaccinated in my left arm. The first shot I experienced numbness to my left face, neck, ear and eventually my left arm and leg. I had no trouble with movement, the sensation felt dull. There was no associated pain. Numbness resolved completely after 2 days. The second shot, I again about 20 minutes following experienced numbness to my left face and ear. This time it resolved after a few hours. Also, two days following the first shot, I experienced severe nerve pain in my low neck/ upper back radiating down my right arm. As I do not remember injuring it, I am unsure if this is related to the vaccine or not. It has lessened in severity over time but is still present 3 weeks later.
37 2021-01-06 migraine Migraine-like headache, low grade temp, extreme exhaustion, congestion
37 2021-01-06 tingling Patient began to have tingling under her right eye and face, then she began to have a rapid pulse (1... Read more
Patient began to have tingling under her right eye and face, then she began to have a rapid pulse (156), she felt chest heaviness, contact clinic. Clinic suggested taking patient to the hospital to be evaluated. Patient decline the ride to clinic but stated she would have her spouse take her to the hospital.
37 2021-01-06 burning sensation Per RN ->Patient received her Pfizer vaccine at 0835. At 0845, she came to me and reported that her ... Read more
Per RN ->Patient received her Pfizer vaccine at 0835. At 0845, she came to me and reported that her shoulder was achy and the pain rated 4/10 was radiating to her back. I checked the injection site and arm and it was not red, raised, or warm. Pt did not have any other symptoms, just the achy shoulder. Pt also reported a brief burning sensation in her shoulder that subsided within 1 minute. She later felt that same sensation in her forearm and it also subsided. It was recommended that she go to the ED for monitoring since the pain was radiating further from her shoulder. ED RN took her in at 0905 and I left.
37 2021-01-06 tremor Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely d... Read more
Pfizer BioNTech COVID-19 Vaccine EUA; when patient was in 15 minute observation she reported feely dizzy and getting "tunnel vision." Patient sat down on the floor of her own accord without injury or difficulty. Had patient elevate her legs above heart level. Checked patients vitals, her blood pressure was low, but O2, respiration and pulse were within normal range. Patient was shaking and reported her tongue felt "tingly" and "heavy on my chest." Patient reported she had a smoothie prior to coming in for her appointment. She was given sprite. Patient felt better, but approximately 7 minutes later reported her stomach felt queezy. Blood pressure had improved and other vitals were still stable. Patient still reported her tongue felt "tingly," but no swelling, trouble breathing, or throat tightness. Patient was picked up by her father 45 minutes later and was able to ambulate to the car (with supervision) of her own accord without assistance.
37 2021-01-06 flushing Pt reported immediate redness and lump to injection site and shortly after developed flushing to fac... Read more
Pt reported immediate redness and lump to injection site and shortly after developed flushing to face/neck/arms with itching about 10 minutes after vaccine. Pt received Benadryl PO with recovery. Provider notified and approved course of treatment. No other f/u concerns at this time.
37 2021-01-06 numbness, tingling Several minutes after the vaccination was administered she began experiencing numbness and tingling ... Read more
Several minutes after the vaccination was administered she began experiencing numbness and tingling down her right arm to her fingers.
37 2021-01-06 muscle spasms chills, sweating, tachycardia , leg cramps, headache,back and neck ache evaluated in ED, EKG, IV flu... Read more
chills, sweating, tachycardia , leg cramps, headache,back and neck ache evaluated in ED, EKG, IV fluids, dehydration, elevated ketones 01/5/2021 03:30am 01/07/2021 Reported Feeling better, discomfort in lymph nodes under arm , Temp 99.. sweating, HR +80
37 2021-01-07 weakness, pain in extremity At 8:10 am Thursday started with a fever and swelling of my lymph nodes under my arm on the injectio... Read more
At 8:10 am Thursday started with a fever and swelling of my lymph nodes under my arm on the injection side, left, and just not felling well. By 2:30 pm on Thursday had high fever, muscle, bone and joint pain, weakness, chills and sweats. Pain in my swollen lymph nodes under arm. Fever broke Friday at 9 am still experiencing pain in lymph nodes, some sweating, generalized tiredness and over all just not feeling well.
37 2021-01-07 night sweats, weakness Chills, Dizziness, Night Sweats, Headache, Nausea, Body Aches, Weakness, Fatigue and Joint Pain
37 2021-01-07 tension headache Experienced moderate tension headache that same evening; asymptomatic the following 2 days. At 2:0... Read more
Experienced moderate tension headache that same evening; asymptomatic the following 2 days. At 2:00 am on 1/7/21 and 1/8/21, I woke up to severe face/ears/neck/and chest itching without rash. No trouble breathing. Upon waking had small welts that resolved within an hour. Contacted PCP, continuing to monitor should symptoms persist throughout the following nights. If symptoms persist for 1 week, will schedule an appointment with PCP.
37 2021-01-07 flushing FLUSH THEN CHILLS Narrative:
37 2021-01-07 pain in extremity Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal conge... Read more
Fatigue, sore left arm; Resolved. 12/29/2020 with pruritic rash to left forearm, chills, nasal congestion, myalgias, then right forearm rash, itchy abdomen Benadryl/atarax without effect. COVID-19 test 12/28/2020 NEG result. Feeling slightly better today. COVID-19 test #2 scheduled for 01/04/2020.
37 2021-01-07 numbness and pain in extremities Neuropathy in vaccinated arm a few minutes after receiving vaccination. Resolved within an hour.
37 2021-01-07 night sweats Night sweats, intermittent sweating for three days
37 2021-01-07 flushing Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait ... Read more
Season received the Pfizer-BioNTech COVID 19 vaccine today at 8:30 and scheduled for 30 minute wait time because of prior history of anaphylaxis (non-vaccine). Within a few minutes she developed light-headedness and dizziness, these symptoms continued to worsen so she notified our nurse who was observing post-vaccine patients. She was promptly wheeled to our anaphylaxis room at 8:50 and placed in semi-Trendelenburg position. In addition to light-headedness and dizziness. she reported mild neck tightness and throat fullness. She had facial flushing and conjunctival injection with some tearing. She was monitored for Vital Signs and Oxygen Saturation. Within 20 minutes her symptoms progressed to chest heaviness, increased effort to take a breath and shortness of breath. She was mildly tachycardic with HR 96, though did not become hypotensive, B/P was 140/92. She had no gastrointestinal symptoms. She was anxious and "did not feel right", but did not report "impending doom". At 9:05 Epinephrine 1:1000, 0.3mL was administered IM, upper-outer thigh. Symptoms began improving within 8 to 10 minutes and were mostly gone by 9:20. At 9:17 she was given Diphenhydramine Solution 25mg, Famotidine 20mg, Prednisone 20mg. Her vital signs and Oxygen Saturation remained stable. (see flow sheet) Patient was monitored by an RN for 2 hours in our anaphylaxis room, on monitors, full crash cart present.
37 2021-01-07 pain in extremity Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that ... Read more
Sore arm for 72 hours Body aches, joint pain and fatigue starting at 27 hours post vaccination that lasted 12 hours
37 2021-01-07 pain in extremity Soreness and aching to left arm approximately 3hrs after vaccine. Nausea with dry heaves, body aches... Read more
Soreness and aching to left arm approximately 3hrs after vaccine. Nausea with dry heaves, body aches, sweats, extreme fatigue, and headache by 7:00 am the next day.
37 2021-01-07 tingling Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more... Read more
Sxs at injx site and fatigue. 12/22/2020 paraesthesias to upper/lower extremities, now becoming more consistent; headaches. Persistent sxs.
37 2021-01-07 sensory loss, tingling, muscle spasms, cold extremities, numbness Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and le... Read more
Tingling finger and toes, loss of sensation on injection arm, loss of motor function left arm and legs, numbness hands and feet, hands and feet became ice cold, headache, joint pain, muscle spasms, feeling drunk and dizzy, loss of consciousness 3x (reported by friend). confusion, inability to focus and complete thoughts and sentences. 911 called @12:04 PM by friend. At time of paramedics evaluation BP 175\100, O2 SAT 100%, loss of consciousness 2x(reported by friend) before being transported to University of Alabama at Birmingham (UAB) ER. No treatment except basic vitals taken, Held in waiting area for several hours then basic eval by ER doctor (unknown name) asked to attempt to stand, could not. Moved to ER room for couple hours, second eval by nurse to see of i could stand, had difficulty standing, asked to walk, shuffled feet to move and notified that i could go home
37 2021-01-07 pain in extremity, tremor headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wig... Read more
headache/had a headache for 24 hours; both arms being shaky; short of breath/shortness of breath wigged her out/shortness of breath; sore in both arms/Both of her arms were sore; Her sats dropped to 92% on a pulse ox/oxygen saturation dropped; shortness of breath wigged her out; This is a spontaneous report from a contactable nurse reporting for herself. A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunisation. The medical history included she had COVID back on 11Oct2020. The concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 21Dec2020 and 2nd dose is due on Friday. She reported being sore in both arms and short of breath, stats 92% on pulse ox. The day after the vaccine, on 22Dec2020 she had the same symptoms as when she had COVID. Both of her arms were sore. She was short of breath. Her sats (saturation) dropped to 92% on a pulse ox (oximetry). The shortness of breath wigged her out. She stated she experienced shortness of breath and her oxygen saturation dropped for 48 hours. She was healthy before this with no preexisting conditions. She didn't know if she should get the second vaccine. She read most people are getting a bigger response from the second vaccine. She stated she also had a headache on an unspecified date. She had a headache for 24 hours and she experienced both arms being shaky on an unspecified date. The patient stated her symptoms were similar to when she had COVID and that she did not wait 90 days before getting the first dose of the COVID vaccine since she had COVID. She was scheduled to receive her second dose of COVID vaccine on 08Jan2021. She wanted to know if she was going to end up with a bigger reaction. The patient would like to know if she should receive the second dose since she had a reaction to the first dose. The events were reported as non-serious. The event outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
37 2021-01-07 pain in extremity sore arm/ arm started to get sore; This is a spontaneous report from a contactable consumer (reporte... Read more
sore arm/ arm started to get sore; This is a spontaneous report from a contactable consumer (reported for herself). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscularly on 16Dec2020 at single dose at right upper arm for COVID-19 immunization. Medical history included Asthma: She explained she had seasonal asthma as a kid and as she got older, it got worse, she couldn't remember when. The patient's concomitant medications were not reported. The patient received the first COVID vaccine on 16Dec2020. She clarified further with the first vaccine, she was fine. She had a sore arm and that's it in Dec2020. With the first COVID vaccine, she had a sore arm but has recovered completely from it. She got the first vaccine and it didn't hurt or anything. Her arm started to get sore in the early hours of the morning like 1am. She thought it took her 2 days to recover completely and then she was fine. Investigation Assessment was no. Vaccination Facility Type was Hospital, not Administered at Military Facility. The outcome of the event was recovered on an unspecified date in Dec2020.
37 2021-01-08 tingling After a few minutes of administration, I felt tingling down my right arm, my right side of the face,... Read more
After a few minutes of administration, I felt tingling down my right arm, my right side of the face, and my tongue. My eye started to hurt with pressure. The tingling in my arm and hand went away after 30 minutes or so but there was still some tingling of my face, toungue and the pressure of the eye still remained. That night I took a Zyrtec and felt better for a few days. on 1/8 I started to feel tinging in my tongue and pressure in my right eye again. I took Zyrtec that night and it went away. Currently this morning I feel okay and hope it wont come back.
37 2021-01-08 pain in extremity Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my ... Read more
Approximately 10 hours after receiving the vaccine, I had a sore arm. Then experienced aches in my hip and knee joints, hot sweats alternating with chills, I did not take my temperature. I woke up the next morning with a headache and skin sensitivity. I took ibuprofen alternating with Tylenol and started to feel better. I felt back to normal about 36 hours after receiving the vaccine.
37 2021-01-08 feeling hot Headache, Myalgia, felt warm-feverish Narrative: Taking OTC NyQuil every 4-6 hours.
37 2021-01-08 feeling hot, tingling transient chest warmth and tingling in palate. self resolved in 2 minutes. no medications given. mo... Read more
transient chest warmth and tingling in palate. self resolved in 2 minutes. no medications given. monitored 30 minutes after symptoms resolved
37 2021-01-09 pain in extremity First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned... Read more
First vaccine received 12/18/2020. Diagnosed with COVID-19 12/28/20. Illness lasted 4 days. Returned to work 1/8/21. Second vaccine dose received 1/8/21 at 11:30am. Muscle aches, chills, and fever started at 19:30 on 1/8/21 and persisted throughout the night retning every 4 hours while alternating Tylenol 650mg every 4 hours and Ibuprofen 600 mg every 6 hours. Last fever was at 12:30pm on 1/9/21. Chills without fever at 4am on 1/10/21. Sweats and right arm localized redness and soreness persisted through 1/10/21 at the time of this report.
37 2021-01-09 muscle spasms Pfizer-BioNTech COVID-19 Vaccine EUA Miscarriage - (date of vaccination 1/6/21, miscarriage symptoms... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Miscarriage - (date of vaccination 1/6/21, miscarriage symptoms (cramping) started 1/8/21, confirmed 1/10/21; estimated date of delivery 8/30/21)
37 2021-01-09 pain in extremity Sore arm, upset stomach and fatigue.
37 2021-01-10 feeling hot, flushing, pain in extremity "After about 3 days of a sore arm ( I know this is normal) I started to get the feeling of flushing ... Read more
"After about 3 days of a sore arm ( I know this is normal) I started to get the feeling of flushing with minimal change in color to my face. My brain was telling me my skin felt hot but if you touched it or looked at it you would think maybe my cheeks were a little pink. I could feel this hot sensation on all of my skin on the top half of my body. This happened regularly for about 8 days. I have not felt the hot sensation since 1/3/21."
37 2021-01-10 weakness 1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizzi... Read more
1/9/21 Approximately 2:00 AM I was woken with Chills/joint pain/Injection Site Pain/Nausea had dizziness and weakness 1/9/21 Approximately 4:00 AM had headache/difficulty breathing/fast heartbeat along with the above 1/9/21Approximately 6:00 AM had a fever along with the above but the difficulty breathing and fast heartbeat had passed The remaining of Saturday Am I slept off and on with a terrible headache/difficulty catching my breath at times and taking IBP 2 times throughout the day/drinking plenty of fluids.
37 2021-01-10 flushing, migraine 2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous ... Read more
2 week migraine; headache; flushed/Got flushed; persistent extreme dizziness; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK5730, Intramuscular at single dose on 17Dec2020 19:00 on right arm for precaution as front line health care worker. Medical history included Hemiplegic migraine. Her mother also had migraines. Concomitant medication included ranitidine hydrochloride (ZANTAC) and H1 and H2 blocker. The patient called to report AE of flushed, persistent extreme dizziness, and a headache that has evolved into a 2 week migraine. She has a history of hemiplegic migraines and was taking and h1 and h2 blocker when she received the vaccine. She was calling on guidance whether or not to receive the second vaccine. She was scheduled for second dose on Thursday, but wanted to speak with someone before she got it to see if it was OK. About 15 minutes after receiving the first dose, she got flushed and extremely dizzy. She had a mild headache when she woke up on 18Dec2020 06:00, which then developed into a severe migraine on 22Dec2020 08:00 that she has had for 2 weeks and dizziness continues. She received it at work and there was no prescriber. She called and left a message with Pfizer but has not heard back from anyone yet about this. She would say the flushed and dizziness would be medically serious because she had allergies and had medication on board. She takes daily allergy medication and Zantac and not sure she would not have had a worse reaction if she hadn't had that on board. She took it every night. She had an H1 and H2 blocker on board. Flushed has improved but the dizziness has stayed constant. She had been treated twice for headache and now they have put her on a Prednisone taper. She got it on her right arm so she could work her arm out. On 22Dec2020, she saw a Neurologist for the Migraine. They gave her Toradol 30 mg and Zofran 4mg injection in office. They were given IM. Then, she had another office visit for urgent care on 02Jan2021, and that was for the exacerbation of the migraine. They prescribed 1 liter of fluids and then another Toradol injection, Zofran injection and Decadron injection. The dose of the Toradol was 30 mg, Decadron was 6 mg, and Zofran was 4mg. These were given IV in urgent care. The patient had no prior vaccinations within 4 weeks. The outcome of flushed/Got flushed was resolving. The outcome of other events was not resolved.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, dizziness, headache and migraine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-10 pain in extremity Arm soreness throughout entire arm hours 2-24 post vaccine, peak about 12hr then relenting. Myalgia... Read more
Arm soreness throughout entire arm hours 2-24 post vaccine, peak about 12hr then relenting. Myalgias sporadic and brief, with fatigue, 36 hours post vaccine, resolution within 12 hours.
37 2021-01-10 weakness For my first Pfizer shot I got fever of 102, chills, headache, muscle aches, malaise, weakness for 4... Read more
For my first Pfizer shot I got fever of 102, chills, headache, muscle aches, malaise, weakness for 4 hours about 16 hours after shot. Following this, the headache and fatigue remained the rest of the day. Periodic headaches noted in the weeks following. After my second Pfizer Covid shot I experienced nausea, diarrhea, extreme fatigue and exhaustion, malaise 4 days are shot lasting about 24 hours in duration.
37 2021-01-10 numbness and pain in extremities Neuropathy in vaccinated arm for a couple hours.
37 2021-01-10 numbness, tingling Patient developed numbness/tingling in her left ulnar distribution (middle/ring finger, pinky, and o... Read more
Patient developed numbness/tingling in her left ulnar distribution (middle/ring finger, pinky, and outer hand) after getting her vaccine yesterday. The sensation is most intense at the tip of the fingers and lessens proximally. She was vaccinated yesterday at 12:30 pm and it started today around 10 AM. No weakness or fevers. She is currently working and it is not causing any problems. Has RA and has had neuropathies in the past.
37 2021-01-10 tingling, flushing Patient experienced flushing, tingling in toes, pounding heart, and elevated BP of 142/80. Patient o... Read more
Patient experienced flushing, tingling in toes, pounding heart, and elevated BP of 142/80. Patient observed, and symptoms resolved without medication.
37 2021-01-10 pain in extremity arm soreness fever chills achiness runny nose
37 2021-01-10 bell's palsy, pain in extremity balls palsy headache arm sore
37 2021-01-10 pain in extremity, bell's palsy balls palsy headache sore arm
37 2021-01-11 slurring, muscle twitching, cold sweat 1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and b... Read more
1/8fever, chills, cold sweat, body aches, pain, 1/9 dizziness, vomiting bile, Hives on chest and belly twitching lips and slurred speech,
37 2021-01-11 unresponsive to stimuli, feeling of body temperature change 16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat ... Read more
16 hours post vaccine, I awoke to chills/feeling of fever. I suddenly felt nauseous. I went and sat on the floor of my bathroom and went unresponsive. Per my husband. My eyes rolled back in my head, my body went limp, and I was moaning. I did not come to for 30-60 seconds despite shaking, calling my name, and sticking his finger in my throat. I came to and was alert and oriented but have no recollection of the incident. EMS was called.
37 2021-01-11 tenderness Covid toes, red tender slightly swollen toes with mild purple discoloration at the tip of toes, deve... Read more
Covid toes, red tender slightly swollen toes with mild purple discoloration at the tip of toes, developed 3 days after receiving the first vaccine dosage in the series. I have tested negative for covid as of 1/10/21. It was initially thought that I had a skin infection from clipping my nails too short and was prescribed doxyclycline. I saw an improvement within a few days on the antibiotic but them saw a reappearance of the covid toes presenting symptoms on 1/8/21. I have since been told by a physician that I likely have covid toes and not a bacterial infection. I was told to take baby asprin and that is helping to reduce the symptoms. In the past few weeks I have had no symptoms of Covid besides the appearance of covid toes. I understand that covid toes are often a latent symptom and that the timing of the appearance of this symptom could be coincidental. I am mildly concerned that the first vaccine dosage could have caused a flair up of a potential previous covid infection or could have caused the red covid toes symptom itself.
37 2021-01-11 migraine Dizziness/nausea, migraine headache, loss of appetite, itchy throat, ear pain
37 2021-01-11 pain in extremity Dizziness; palpitations; resting tachycardia that persisted for 3 days; muscles aches; Chills; Restl... Read more
Dizziness; palpitations; resting tachycardia that persisted for 3 days; muscles aches; Chills; Restlessness; feeling unwell; arm pain; This is a spontaneous report from a contactable physician reported for herself. This 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730) via intramuscular on 23Dec2020 09:30 AM on left arm at single dose for COVID-19 immunisation. Medical history included chronic kidney disease, HTN (hypertension), persistent proteinuria. No known allergies. Concomitant medication included losartan. The patient did not have other vaccine in four weeks and did not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 24Dec2020, the patient experienced dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, and resulted in Emergency room/department or urgent care. Treatment included paracetamol (TYLENOL). The patient had COVID tested on 28Dec2020 post vaccination, covid test type post vaccination=Nasal Swab, covid test name post vaccination=PCR, covid test result=Negative. Outcome of events was recovered.; Sender's Comments: The reported events dizziness, palpitations, resting tachycardia that persisted for 3 days, muscles aches, chills, restlessness, feeling unwell and arm pain, were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinical course. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
37 2021-01-11 numbness Facial numbness and headache Have had of history of Bell?s palsy he
37 2021-01-11 pain in extremity I have a headache. My body is feeling fatigue, aching, and very soar. My arms are very heavy , soar... Read more
I have a headache. My body is feeling fatigue, aching, and very soar. My arms are very heavy , soar all the way down to my hands. A Slight cough has even occurred since the vaccine.
37 2021-01-11 pain in extremity I started getting a mild headache as soon as I got home last night after I got vaccinated. I rested,... Read more
I started getting a mild headache as soon as I got home last night after I got vaccinated. I rested, but this morning im still having headache. My body feels aching , chills and very fatigue, slightly soar. A mild mild cough has even occurred. Including Soar Arms all the way down to my hands.
37 2021-01-11 weakness Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chill... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 8hrs-40hrs after injection: fever (ranging from 102-104) chills, body aches, fatigue/weakness, loss of appetite, headache, vision changes, swollen right axillary lymph node (hard, painful) 40hrs-60hrs after injection: fever steady around 101, headache, fatigue, swollen right axillary lymph node (no longer hard, more disperse, still painful) 60+ hrs after injection: swollen right axillary lymph node (disperse, painful, bruising/discoloration) emailed ob/gyn about concern for swollen lymph node turning into mastitis, but referred to PCP
37 2021-01-11 numbness, tingling Received the vaccine on 12/31/20 at 1535 on the left arm. Swollen lymph node start on Friday 01/08/2... Read more
Received the vaccine on 12/31/20 at 1535 on the left arm. Swollen lymph node start on Friday 01/08/20 evening, around 2030 notice a lump on the left under armpit while doing self-breast exam during showering. On 01/09/20 the swollen increase, on 01/10/20 - 01/11/20 the swollen feel every painful, difficult, and comfortable when resting the left arm down, it feels like a golf ball under the armpit. Felt numbness and tingling on the left arm, hand and fingesr. On 01/12/20 lymph node still swollen, but less painful, with less numbness and tingling. Home treatment: Elevated the left arm while applying a warm compress and OTC Tylenol.
37 2021-01-11 flushing, feeling hot Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobb... Read more
Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; pulse and BP both were elevated (HR 122 BP 155/80); pulse and BP both were elevated (HR 122 BP 155/80); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (lot number: EL0140), intramuscular on 21Dec2020 10:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 21Dec2020 10:30, it was reported that shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby, the patient started to feel flushed in her face and very warm, and felt her heart racing. The nurse came and took her pulse and BP both were elevated (HR 122 BP 155/80), after three minutes her heart rate and BP came down and normalized again (HR 70 and BP 115/60). Stated that she has never had a similar experience. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The with outcome of recovered on unspecified dates.
37 2021-01-11 pain in extremity Sore arm fever chills body aches headaches fatigue
37 2021-01-11 pain in extremity Sore left arm accompanied with a red bump the size of a quarter, mild headache, and fever of 100.8.
37 2021-01-11 tingling The patient informed me right after she got the vaccine that she felt cold and tingly like after ane... Read more
The patient informed me right after she got the vaccine that she felt cold and tingly like after anesthesia. She also reported a metallic taste in her mouth. She was given water and observed for 30 minutes. I called and left a message for her on 1-12 to see how she was doing.
37 2021-01-11 tingling, numbness, pain in extremity This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; N... Read more
This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; Numbness and tinging began in my lower extremities about 36 hours following injection. It started as intermittent and became more consistent and spread to my upper extremities. It is sometimes present; ng began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; This is accompanied by headaches and significant brain fog, difficulty concentration, and fatigue; discomfort in her extremities; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685; expiry date: unknown) via an unspecified route of administration (right arm), on 21Dec2020 at 10:45 at a single dose, for COVID-19 immunization. Medical history included migraine and latex allergy. The patient's concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in a workplace clinic. On 23Dec2020, about 36 hours following injection, numbness and tingling began in patient's lower extremities. It started as intermittent and became more consistent then spread to her upper extremities. It is sometimes present in her core and lips. She was also experiencing some discomfort in her extremities. These were accompanied by headaches and significant brain fog, difficulty concentration, and fatigue. She was working on being evaluated by allergy and neurology. The patient did not receive treatment for the events. Outcome of the events was not recovered.
37 2021-01-11 muscle twitching Throat became very sore and staff member left work abruptly and went to an urgent care clinic. She h... Read more
Throat became very sore and staff member left work abruptly and went to an urgent care clinic. She had a negative strep test and a negative covid test. She also complained her right eye was twitching. Symptoms subsided in approx. 48 hours.
37 2021-01-11 numbness, tingling Vaccine given about 09:20, patient ambulated 30 feet without difficulty, began texting on phone and ... Read more
Vaccine given about 09:20, patient ambulated 30 feet without difficulty, began texting on phone and shared her right arm & finger was numb & tingling. Patient became anxious acting, claimed "I feel dizzy & heart racing." Patient monitored, 09:25 heart rate less than 100, states dizziness has resolved, patients respirations even & unlabored skin pink and dry. 09:30 Patient talking in a relaxed manner with co-workers, does continue to complain of "my fingers feel asleep". Pt monitored for over one hour. Patient ambulating without issues out of observation area, skin pink warm, dry, no acute distress reports numbness & tingling resolved, has full range of motion to right arm.
37 2021-01-11 numbness blood pressure increased and her pulse; blood pressure increased and her pulse; Chest pain; Numb fin... Read more
blood pressure increased and her pulse; blood pressure increased and her pulse; Chest pain; Numb fingers and later numb face; Mind fog; This is a spontaneous report from a contactable other HCP. This 37-year-old female other HCP (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1685), via intramuscular at left arm on 02Jan2021 08:15 AM at single dose for COVID-19 immunization. Facility type of vaccine was pharmacy or drug store. Medical history included panic disorder (last attack 2 years prior) and known allergies: latex, Iodine dye. Concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 02Jan2021 08:15 AM, within a few minutes while still under observation at pharmacy, her blood pressure increased and her pulse. Numb fingers and later numb face. Chest pain presented. She went to ER (emergency room) 3hours later with ongoing symptoms that never resolved until 6 or 7 that evening while still in ER waiting room. Mind fog (02Jan2021 08:15 AM) was currently ongoing. The treatment for events included lorazepam (ADIVAN), diphenhydramine (BENADRYL), ibuprofen. Outcome of event mind fog was not recovered, and the rest of events was recovered/resolved with sequel.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-11 burning sensation extreme joint pain, fever and chills, muscle aching, severe head ache (lasting 3 days), excessive fu... Read more
extreme joint pain, fever and chills, muscle aching, severe head ache (lasting 3 days), excessive full body sweating x3 days, extreme fatigue (sleeping >16 hrs per day x3 days, 1 short bout of nausea, sensitivity to skin on back and legs i.e. a cotton shirt against my skin felt like it was burning me. loss of appetite. multiple doses of OCT analgesics/fever reducers. loss of scheduled work x2 days.
37 2021-01-11 hypersensitivity of all senses, numbness left sided facial numbness, hyperesthesia, and left eye twitching
37 2021-01-11 pain in extremity sore arm, 600mg PO motrin taken one hour after onset
37 2021-01-12 pain in extremity Arm and shoulder pain to left arm started yesterday shortly after vaccine. When i woke up this morni... Read more
Arm and shoulder pain to left arm started yesterday shortly after vaccine. When i woke up this morning it was very painful and i had a limited range of motion to that arm. Both symptoms have improved slightly over the course of today. Also the vaccine was injected higher than the recommended two fingers below the acromian process in my arm.
37 2021-01-12 pain in extremity Fatigue, arm soreness, body aches, malaise, back pain, abdominal pain (all symptoms mild and resolve... Read more
Fatigue, arm soreness, body aches, malaise, back pain, abdominal pain (all symptoms mild and resolved in 1 day)
37 2021-01-12 hot flush, feeling cold Fatigue, hot and cold flashes, headache, sore throat, mild joint pain, Nausea
37 2021-01-12 feeling hot, feeling cold Following vaccination, I had a headache for few days along with some pain on injection arm. The hea... Read more
Following vaccination, I had a headache for few days along with some pain on injection arm. The headache continued and soon some fatigue and tiredness accompanied it for 7-10 days following vaccination. Then ten days after, I had an increase in symtpoms that included heightened fatigue, loss of appetite, feeling "cold"/ "hot" (no fever), and abdominal pain with nausea and some diarrhea. Two weeks after vaccination, I had an increased of fatigue and not feeling well, accompained by a fever of (101.5 F) and chills, sore throat, and lethargy. My symptoms of fever, chills, sore throat, body aches, congestion, and fatigue remained over the next few days and soon included chest pain and some increase work of breath. With two negative Covid tests through work, it was recommended I go to see a physician, who instead sent me to Immediate Care. There I had an EKG which showed sinus bradycardia and they sent me to ER due to my symptoms of chest pain and shortness of breath. At the ER, multiple tests were run to negative results. ER Physician suspects that some of my struggles could be related to Covid vaccine but that I also may have caught an non-Covid virus on top of it which led to acute bronchitis.
37 2021-01-12 pain in extremity, numbness Patient reported sore arm on night of vaccination. Around 36 hours later, started to develop lymph ... Read more
Patient reported sore arm on night of vaccination. Around 36 hours later, started to develop lymph nodes swollen under left arm. It is causing numbness in left arm from elbow to pinky finger.
37 2021-01-12 cold sweat Pfizer-BioNTech COVID-19 Vaccine EUA Patient is a 37 year old female who presents with dyspnea and m... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Patient is a 37 year old female who presents with dyspnea and myalgias following her second COVID vaccination today. Patient denies any history of vaccine associated reactions. After her first dose of the COVID vaccine she had fever, chills and myalgias as well as some sensory changes to the left arm. These symptoms lasted for around a day before resolving. Today, she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain is moderately severe and worse with deep inspiration. Patient also having back aches and feeling clammy. Patient re-presented to the vaccine site and was brought to the emergency department for evaluation. Patient received acetaminophen 1000mg orally, ketorolac 15mg IV, and lactated ringers 1000ml IV and was discharged.
37 2021-01-12 discomfort about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & ac... Read more
about 12 Hours after vaccine - developed severe chills, headache, fever (102 F - with ibuprofen & acetaminophen), severe muscle aches, could barely move or sleep About 24 Hours after vaccine - same symptoms continued but developed very painful golf ball size lump under left armpit (lymphnode) same side as injection; around noon - the fever started to break but remained elevated (101.7-101F); remaine din the low 100's all day with being on ibuprofen/acetaminophen and still achy/headaches but not unbearable About 48 Hours later - woke up at 3 AM with another 101 F - went to work but left around 9 AM not feeling well (may just have been from exhaustion from not sleeping well the previous 2 nights); lymphnodes still swollen and painful; 101 F around 7-8 PM About 72 hours later - no fevers, feeling better; developed rash on left arm below injection site (red, slightly raised, warm to touch, painful to touch but not itchy), lymph node still painful but not as big About 96 hours later - rash same size, slightly swollen, painful to touch; lymph node smaller in size but still painful to touch
37 2021-01-13 discomfort, flushing, weakness "Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minu... Read more
"Just wanted to pass along that after my second dose on 1/12/21 I experienced the following. 15 minutes post vaccine, my tongue went numb for approximately 30 minutes, then it resolved. 6 hours post vaccine I became very dizzy and flushed and began to feel achy. The following morning I felt well enough to come into work but then felt increasingly weak, achy, and tired and had to go home at 12pm. All side effects were resolved by 5pm. "
37 2021-01-13 feeling hot, pain in extremity 1/11-arm soreness, feeling of warmth in head and neck 1/12 Elevated heart rate, SOB, dizziness, body... Read more
1/11-arm soreness, feeling of warmth in head and neck 1/12 Elevated heart rate, SOB, dizziness, body aches 1/13-elevated heart rate, SOB, dizziness--slightly better than 1/12 1/13-symptoms subsided
37 2021-01-13 pain in extremity 1/11/2021 - stomach pain, headache, exhaustion, arm pain 1/12/2021- fever 100.0 and diarrhea for 3 d... Read more
1/11/2021 - stomach pain, headache, exhaustion, arm pain 1/12/2021- fever 100.0 and diarrhea for 3 days Took ibuprofen
37 2021-01-13 numbness Patient received her first dose of Pfizer vaccine on 1.8.2021. When receiving the vaccine, the patie... Read more
Patient received her first dose of Pfizer vaccine on 1.8.2021. When receiving the vaccine, the patient reports that her left cheek went numb. Patient reports the feeling came back the next day. Patient reports extreme soreness, to the point of not being able to use her arm. She also reports "excruciating" pain on her entire right side of the body that radiated into her knees and hips. Patient was seen by her PCP on 1.11.21. Patient was prescribed a steroid at the time. On 1/14, the patient returned back to work and describes her pain as tolerable now.
37 2021-01-13 tremor Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not ... Read more
Severe chills/severe shaking, tiredness, headache, muscle pain, pain at injection site, nausea, not feeling well. I had to stay home from work the day after the vaccine, I stayed in bed all day with a space heater on to 90 degrees in my bedroom just to get rid of the chills, I took Motrin 800 mg around the clock, Zofran as needed and I drank a lot of water.
37 2021-01-13 flushing after 10 minutes developed sensation of throat swelling, tongue tingling and facial flushing: transf... Read more
after 10 minutes developed sensation of throat swelling, tongue tingling and facial flushing: transferred to ED: no intervention, observed for 3 hrs & d/cd
37 2021-01-13 weakness headaches, body aches, cough, lower energy, poor sleep took ibuprofen and/or tylenol for the first 2... Read more
headaches, body aches, cough, lower energy, poor sleep took ibuprofen and/or tylenol for the first 24 hours to reduce symptoms of aches (alternated every 4 hours). took two days for symptoms to reduce completely
37 2021-01-14 feeling cold 20 MINS INTO COOL FLUSH FEELING ALL OVER , HEART RACING , WENT HOME AND HAD REALLY BAD HEART PALPUT... Read more
20 MINS INTO COOL FLUSH FEELING ALL OVER , HEART RACING , WENT HOME AND HAD REALLY BAD HEART PALPUTATIONS , CALLED THE NURSE . EKG WAS NORMAL .. Blood pressure was 130/99 which is higher than normal ..Provided IV FLUIDS . HEADACHES, NASUEA ,CHILLS.
37 2021-01-14 pain in extremity At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progre... Read more
At 2000 on 1/13/21, I started to experience intense ache at the injection site, which by 2200 progressed to myalgias in my back, especially lower back, neck, and right arm. At 2300, I started to have fever/chills, up to 39 C orally. This only partially responded to Tylenol. I was not able to sleep. At 2:30 am I noticed an unusual headache, 8/10, as well as bilateral eye pain on Moving eyes side to side as well as sensitivity to light. Headache was mostly frontal, which came and went every few minutes until exactly 11:38 am on 1/14/2021, when the fever and myalgias very suddenly got significantly better. Almost exactly 24 hrs to the minute after injection. On 1/15/2021, I still have significant pain in my left arm, swelling, redness and, now, itching at the injection site. My lower back still hurts.
37 2021-01-14 night sweats, weakness Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This i... Read more
Chills; Night Sweats; Body Aches; Dizziness; Headache; fatigue; weakness; joint pain; nausea; This is a spontaneous report from a contactable health care professional, the patient. A 37-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), in the right arm on 30Dec2020 13:00 as a single dose, for COVID-19 vaccination. The vaccine was administered at a Pharmacy or Drug Store. Medical History include drug allergy to sulfa. Concomitant medication included Microgestin, Biotin and Prenatal Vitamin. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 31Dec2020 , the patient experienced Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea. No treatment was received given for the event. The clinical outcome of Chills, Night Sweats, Body Aches, Dizziness, Headache, fatigue, weakness, joint pain, nausea was recovering.
37 2021-01-14 flushing, feeling hot I had a couple of heart palpitations the first 5 mins, the next 2 hours I could feel my heart beati... Read more
I had a couple of heart palpitations the first 5 mins, the next 2 hours I could feel my heart beating but wasn't irregular, I took a shower I realized I had a rash on my arms and thighs (front), did not hurt or itch, pinprick bumps, it felt like sandpaper. I had facial flushing, felt hot and turned red, I took pepcid and benydryl, I went to sleep because that was the end of my shift . The rash stuck around for 1.5 weeks for the rash to go away . I woke up 6 hours after and felt fine I only had the rash and I went to occumed to document my symptoms and everything was fine after that
37 2021-01-14 numbness, tingling Patient left after 15 minute wait time after receiving second COVID-19 vaccine. Patient then returne... Read more
Patient left after 15 minute wait time after receiving second COVID-19 vaccine. Patient then returned at 0632 to vaccine clinic stating that she was having numbness and tingling to jaw and lips and left ear. Vitals were obtained: 115/73, HR, 74, O2 Sat: 97% on RA. Patient denies any SOB of difficulty breathing. Patient has no noted welts or redness noted. 0635: Patient was given 25 mg of Benadryl, PO and patient is drinking her coffee. 0640: patient sitting up in chair, patient denies any tingling and or numbness to jaw, lips, and left ear. Patient states " I can not believe I am feeling so much better. I have no numbness at all." 0702: patient feeling much better, and denies any SOB, edema, numbness and or tingling. Patient vitals: B/P: 113/58, HR: 76, O2 Stat: 97% on RA. Patient did ambulate out of clinic with out issues. Advised patient on signs and symptoms to look out for and when to seek medical attention. Patient verbalized understanding.
37 2021-01-14 tingling Patient reported "tingling" sensation, bilateral upper extremities after second dose of Pfizer COVID... Read more
Patient reported "tingling" sensation, bilateral upper extremities after second dose of Pfizer COVID-19 vaccination. Sensation radiated to neck area. Also, reports "tingling" in toes. No there other symptoms. She did have this reaction with the first dose, subsided in within 2 hours. Patient was discharged to home in stable condition.
37 2021-01-14 migraine Severe Migraine 10/10 lasting 24 hours (felt like my head was going to explode ice applied to my ey... Read more
Severe Migraine 10/10 lasting 24 hours (felt like my head was going to explode ice applied to my eyes and next), Nausea, Body aches lasting 24 hours ( could not move without help pain 8/10), congestion, fatigue.
37 2021-01-14 pain in extremity Sore Arm, Achy, Tired, Fever; some symptoms started about one hour after injection and lasted for ap... Read more
Sore Arm, Achy, Tired, Fever; some symptoms started about one hour after injection and lasted for approx. 36 hrs.
37 2021-01-14 numbness Stated neck stiffness, numbness of both upper extremities, and body pain.
37 2021-01-14 hot flush, pain in extremity, weakness Very sore left arm the next day after injection. The next day after injection had chills, hot flashe... Read more
Very sore left arm the next day after injection. The next day after injection had chills, hot flashes, and low grade temperature of 99. Was restless and unable to sleep on the night of the 13th. Also had lower back pain as well as low energy and overall tired feeling. These symptoms lasted until the later morning of the 14th. Ibprofun was taken.
37 2021-01-14 numbness muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain... Read more
muscle pain, lightheadedness (comes and goes), nauseau (off and on), headache, right sinus/ ear pain, insomnia, faint chest pain, numbness right arm and leg, diarrhea, wheezing (off and on), fatigue.
37 2021-01-15 feeling hot The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I ... Read more
The patient was in observation for 5-10 minutes after the vaccine. She reported that she was hot. I asked her if she had any history of anaphylaxis. She said she did to morphine. Her bp was 119/74 with a pulse of 94. She said her nose was starting to get itchy, her ears and scalp were itchy, and her eyes were blurry. She had red blotches all over her neck and chest. She said her throat was tight. She was able to swallow the water she requested. I gave her 50mg of benadryl. She had no visible signs of being unable to breathe. I explained to her we could call 911. She reported she had no insurance. She said she was on her lunch break at the hospital and wanted to get back. She did walk back across the street unassisted. Clinical observer, followed her over just to verify she made it in the building. She ended up checking herself into the ER instead of returning to her shift.
37 2021-01-16 numbness Facial numbness (left nare, left side upper lip) started approximately 20 min post vaccine and laste... Read more
Facial numbness (left nare, left side upper lip) started approximately 20 min post vaccine and lasted approximately 45 minutes. Headache, Fever (Tmax 101.8), aches, chills started at 0330 day after vaccine given 1400 day prior to symptoms , ended by 2100 day after vaccine.
37 2021-01-17 discomfort 1347- PATIENT REPORTED NOT FEELING RIGHT, CHEST PRESSURE. PT COMMUNICATING IN FULL COMPLETE SENTENCE... Read more
1347- PATIENT REPORTED NOT FEELING RIGHT, CHEST PRESSURE. PT COMMUNICATING IN FULL COMPLETE SENTENCES WITHOUT DIFFICULTY. VITALS TAKEN. ESCORTED TO BED/LAID BACK. WATER OFFERED. PATIENT REPORTED CHEST TIGHTNESS WITH THROAT TIGHTNESS. BENADRY ELIXAR 25MG PO GIVEN @ 1406. CHEST SOUNDED TIGHT. PT UNABLE TO COMPLETE SENTENCES. VITALS REPEATED. 1430 PATIENT ESCORTED TO ER.
37 2021-01-17 pain in extremity 24 hrs hrs after had high fever to 101, chills, rigors, myalgias, dizziness, headache, nausea, minor... Read more
24 hrs hrs after had high fever to 101, chills, rigors, myalgias, dizziness, headache, nausea, minor arm soreness and itchiness . 48 hrs after developed supraclavicular tender lymphadenopathy, neck stiffness, and continued headache. Headache lasted 5 days.
37 2021-01-17 weakness AROUND 3PM: FATIGUED AND DIFFICULTY CONCENTRATING. AT 12MIDNIGHT: CHILLS, HEADACHE, JOINT PAIN, TEET... Read more
AROUND 3PM: FATIGUED AND DIFFICULTY CONCENTRATING. AT 12MIDNIGHT: CHILLS, HEADACHE, JOINT PAIN, TEETH WERE CHATTERING, MUSCLES WERE SORE. STOMACH WAS QUEASY. NEXT DAY: FEELING EXHAUSTED AND "HUNG OVER." WEAK AND ACHY. TOOK IBUPROFEN, REST, AND FLUIDS.
37 2021-01-17 tingling Patient's reaction(s) noted during COVID vaccine observation period: 15 minutes after Covid Vaccine ... Read more
Patient's reaction(s) noted during COVID vaccine observation period: 15 minutes after Covid Vaccine received, patient states that she has tingling on her lips and arms, lightheadedness, and nausea. Vitals taken; 0945: 148/86, HR 104, 100% RA, temp: 97.7 1015: 147/84, HR81, 100% RA, Temp: 98 Pt sitting comfortably in chair, drinking ice water. No further evaluation, spouse drove patient home. Disposition: Home
37 2021-01-17 tingling Shortly after the vaccination I stated experiencing the tingling and prickery sensation in my face, ... Read more
Shortly after the vaccination I stated experiencing the tingling and prickery sensation in my face, my HR was elevated and my throat felt like it was thinkening and getting swollen but I could still swallow and talk. I was taken to the Urgent Care who sent me to the ER because I was having throat issues. The urgent care had given me 2 benedryls before going to the ER. I sat there several hours in the ER but was never seen and went home because I had begun to feel a little better. The next day I had to take benadryl in the morning and the afternoon because I still felt the sensation where my face felt a little stiff and shortly after the symptoms began to subside. I had a little body aches and sore throat but they were very minor.
37 2021-01-17 burning sensation, tingling The patient describes her symptoms as pins and needles on the right side of her body including burni... Read more
The patient describes her symptoms as pins and needles on the right side of her body including burning of the right foot. The injection site is swollen as well. The patient also describes a right foot injury including fracture occurring on 1/7/21. Mild symptoms started on the evening of 1/15/21. On 1/16, she awoke with numbness on the right side of the body. On 1/18 the symptoms evolved into pins and needles. This was the second dose of the vaccination series. The first dose caused some chills lasting several hours. The patient was seen at an urgent care earlier in the day, but reports not receiving a conclusive answer as to the basis of her symptoms. She stated that she intends to be seen at the ER. As a pharmacist I can not provide any additional workup, which was explained to the patient.
37 2021-01-18 cold extremities, night sweats 1 st dose- 5 hours after given experienced - cold to lower extremities , and hands. Followed by nigh... Read more
1 st dose- 5 hours after given experienced - cold to lower extremities , and hands. Followed by night sweats during the night. Following day some discomfort at injection site, and muscle pain to left side of body, mostly in gluteus . Fatigue lasts 2 day after injection. 2nd dose- at time of injection sensation of warmth in right arm with pain to site. 6-7 hours later joint pain in hands, injection arm elbow, and right knee, some dizziness. During night increased pain in injection site, continued joint pain, new symptoms muscle pain in gluteus and lower calf's all left side. Around 4 am woke up with extreme headache, nausea, and joint/body stiffness. Symptoms subsided through the day, by evening around 7 pm only some joint pain, and injection site discomfort. Fatigue remains.
37 2021-01-18 discomfort Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was hav... Read more
Felt tachycardia immediately, thought she was anxious. After 35-45 minutes she felt like she was having a hard time swallowing which progressed to tongue swelling, all taste buds popped up and sore, hives on face & neck, reddened face. Itchy neck and face. Took double dose of Atarax and went to bed. Felt extremely fatigued unsure if double dose of Atarax. Woke with swelling all over body. Woke up feeling heaviness as if she had "sumo wrestler" on her body. 24 hours post vaccine heaviness started to lift but felt as if she had a vise on her lungs. Continuing to take Atarax every 6 hours per MD order.
37 2021-01-18 weakness low energy confused, foggy memory bumps on tongue and in mouth tired heart rate was high 120,150- hi... Read more
low energy confused, foggy memory bumps on tongue and in mouth tired heart rate was high 120,150- high 160s
37 2021-01-19 feeling hot, flushing 37yo female with PMH HTN and allergy to pencillin (hives) had no reported reaction to dose #1 of COV... Read more
37yo female with PMH HTN and allergy to pencillin (hives) had no reported reaction to dose #1 of COVID-19 Pfizer BioNTech dose #1. Post vaccination with dose #2, patient c/o feeling warm, flushed, and appeared anxious stating "This is the way I get." No supportive treatment nor antidote given. Patient states she feels better. Under observation by clinic team members. Ambulated to door without assistance with no c/o dizziness. Discharged to self.
37 2021-01-19 tingling, feeling cold Experienced some tingling in the left arm starts at the injection site and radiates down to the fing... Read more
Experienced some tingling in the left arm starts at the injection site and radiates down to the fingers. can feel the sensation in all 5 fingers, fingers feel cool to the pt but her hands feel of equal temp to the examiner, was able to use her phone to text
37 2021-01-19 flushing Felt flushed. Passed out after a minute.
37 2021-01-19 hot flush Patient describes chills, shivering, fever, headache, stomach issues, sweating and hot flashes. Sums... Read more
Patient describes chills, shivering, fever, headache, stomach issues, sweating and hot flashes. Sums headaches up to have last 3 days. Also includes body aches.
37 2021-01-19 feeling hot Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours... Read more
Started off getting very itchy, then hives developed, and I turned red, I became very hot...24 hours later I had flu like symptoms along with a blistering rash on my neck, face and scalp..with a few spots on my chest and back. These started to heal 5 days after injection, then started to resurface. On Day 3 I started getting short of breath and intermittent chest pains accompanied by a heart rate ranging from 110 to 126. I developed a severe headache and fatigue.
37 2021-01-20 muscle twitching, pain in extremity, muscle spasms, numbness Headache Beginning within 10 minutes of first injection (Pfizer Lot EL0142 administered 12/30/20) an... Read more
Headache Beginning within 10 minutes of first injection (Pfizer Lot EL0142 administered 12/30/20) and continuous, but exacerbated by second injection; Blurred vision; nausea; toe and finger cramping; chills; right eye and cheek spasm with numbness; swelling and itchiness at vaccine site; pain in left arm from second injection; fever 3 degrees above baseline
37 2021-01-20 feeling cold I developed the expected side effects of fever, chills, and body aches. The body aches were mostly ... Read more
I developed the expected side effects of fever, chills, and body aches. The body aches were mostly in my neck and hips. They slowly improved but lingered in my neck. Then on Sunday 1/9 I developed severe 10/10 pain in my neck and shooting down my left arm and down my shoulders and back. It was unrelieved by ibuprofen, norco, heat, essential oils, and changing of positions. I was unable to sleep. I went to my chiropractor and she was unable to adjust me due to severe pain. She applied icy hot, did some gentle massage, and gave me curcumin for the inflammation . She believed it was an inflammatory response in my cervical spine. It slowly improved to a 8/10 pain, but I was still unable to sleep laying down. I was unable to work for 3 schedule shifts. I saw my chiropractor 4 times total that week. On 1/16 I went to urgent care because the pain was not getting better. She said I had torticollis and gave me naproxen and a stretching exercise. It is still lingering muscle pain, but I am able to finally sleep and function normally. I had never experienced pain like that before and I hope I never do again.
37 2021-01-20 tingling One day after receiving dose #2, I developed aching left lower back pain and tingling/pins and needl... Read more
One day after receiving dose #2, I developed aching left lower back pain and tingling/pins and needles sensation on front of left thigh. I made a PCP 6 days later as symptoms were not subsiding. Clusters of raised rash appeared 2 days after PCP visit (9 days after second dose of vaccine). At that time I was diagnosed with shingles.
37 2021-01-20 burning sensation Patient developed itchy hives to body 10 min post-vaccination. She also reported burning feeling to ... Read more
Patient developed itchy hives to body 10 min post-vaccination. She also reported burning feeling to her face and itchy mouth. No swelling noted or reported. Skin red.
37 2021-01-20 pain in extremity Soreness at the injection site/arm; Soreness at the injection site/arm; I am currently breastfeeding... Read more
Soreness at the injection site/arm; Soreness at the injection site/arm; I am currently breastfeeding at time of vaccination; I am currently breastfeeding at time of vaccination; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. This consumer (mother) reported for herself that: a 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231), via an unspecified route of administration in Left arm on 08Jan2021 11:15 at single dose for COVID-19 immunization. Medical history included ongoing breast feeding. There were no Known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination and did not have covid-19 tested post vaccination. The patient was currently breastfeeding at time of vaccination and would continue to do so. The patient experienced soreness at the injection site/arm starting a couple hours after administration on 08Jan2021 13:15 and lasting 1 day. The patient did not receive any treatment for events soreness at the injection site/arm. The outcome of events soreness at the injection site/arm was Recovered in Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021022052 Same reporter/drug, different patient/event (baby/mother case)
37 2021-01-20 migraine Within 6 hours (up to 25 hrs post vaccine) experienced somnolence, brain fog, GI upset, chest pressu... Read more
Within 6 hours (up to 25 hrs post vaccine) experienced somnolence, brain fog, GI upset, chest pressure/tightness, nausea and a migraine (hx of chronic migraines). Chest tightness persisted for 3-4 days, and intermittently still occurs
37 2021-01-20 migraine Within 8 hours (up to 25 hrs post vaccine) experienced somnolence, brain fog, GI upset, chest pressu... Read more
Within 8 hours (up to 25 hrs post vaccine) experienced somnolence, brain fog, GI upset, chest pressure/tightness, nausea and a migraine (hx of chronic migraines). Chest tightness continued for 3-4 days. Vitals were WNL.
37 2021-01-20 pain in extremity, tingling extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint... Read more
extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; extreme joint and muscle aches (ankles,elbows,hips,lower back,calves were the worst)/aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent; fever/low grade fever; nausea; gas which lead to vomiting; gas which lead to vomiting; extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst)/ lower back pain; chest similar to what one would experience during hyperventilation; tingling feeling in hands/fingers, lips; tingling feeling in hands/fingers, lips; headache; Slept most of the day evening; This is a spontaneous report from a contactable nurse (reported for herself). A 37-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 08Jan2021 10:15 at single dose at right arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication received in two weeks included lisdexamfetamine mesilate (VYVANSE) in two weeks (did not take on vaccine days). The patient previously received the first dose of bnt162b2 (lot number: EJ1685) on 18Dec2020 10:00 at single dose at right arm for COVID-19 immunization. No other vaccine in four weeks. On 09Jan2021 12:00, 12hrs after injection extreme joint and muscle aches even after 1gm of Tylenol (ankles, elbows, hips, lower back, calves were the worst), fever, nausea/gas which lead to vomiting (even after 25mg phenergan) and headache this last 6hrs. The aches and joint pain continued but less intense, arches of feet to fingers, hips and lower back were most prominent. Tylenol did not relieve symptoms, but was able to sleep. Slept most of the day evening in Jan2021. 48/60hrs after injection the lower back pain remains intense as well as low grade fever (Jan2021). Also have a tingling feeling in hands/fingers, lips, chest similar to what one would experience during hyperventilation on 09Jan2021 12:00. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient didn't have Covid prior vaccination and didn't have Covid tested post vaccination. The outcome of Arthralgia and Pain in extremity was recovering, of Pyrexia and Low back pain was not recovered, of the other events was unknown.
37 2021-01-20 flushing, tingling, numbness, burning sensation, feeling hot red flushed on one side of her face; both sides of her face were very red, hot, and blotchy; both si... Read more
red flushed on one side of her face; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; both sides of her face were very red, hot, and blotchy; She feels like her skin is burning; right side of face started feeling numb and tingling; right side of face started feeling numb and tingling; Chills; low grade fever; Fatigue; back and body aches; normal body aches/back and body aches; Nausea; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL3246), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The first vaccine BNT162B2 she received on 18Dec2020. She didn't have any side effects to it. It's lot number was EH9899. Caller just wanted to report her adverse reaction to the COVID 19 vaccine. She got it for work. She got her second vaccine on Thursday. The first vaccine was fine. That Friday she was sick. On 07Jan2021, the patient experienced low grade fever, fatigue, back and body aches, nausea. On 08Jan2021, the patient experienced chills, and normal body aches. On 10Jan2021, the patient experienced right side of face started feeling numb and tingling. This started around her jaw line at 8 o'clock. Then it worked up her face. It was only on the right side. She then monitored it. She went to bed. She woke up at 4 am, and she felt like her face was on fire on an unspecified date. It was tingly. Her face was bright red and blotchy on both sides of her face. She took Benadryl, and put cold compresses on her face. This morning, both sides of her face were very red, hot, and blotchy. She feels like her skin is burning. She feels like she had a burn on her face.It is very odd. There were a couple of days between her reaction and when it started. It has worsened. This morning for work she couldn't put her video on. The outcome of the event low grade fever, back aches, nausea, was recovered on 08Jan2021, fatigue, normal body aches/body aches, chills was recovered on 09Jan2021, the outcome of the events right side of face started feeling numb and tingling was not recovered, while unknown for the other events. Treatment was received for the events "Her face was bright red and blotchy on both sides of her face.", She feels like her skin is burning.
37 2021-01-21 numbness, pain in extremity ABOUT 15 MINUTES AFTER VACCINATION, TYHE PATIENT COMPLAINED OF ARM NUMBNESS, TINGLING IN MOUTH/TONG... Read more
ABOUT 15 MINUTES AFTER VACCINATION, TYHE PATIENT COMPLAINED OF ARM NUMBNESS, TINGLING IN MOUTH/TONGUE AND METALLIC TASTE. THE PATIENY WAS ADMINSTERED 50MG OF BENADRYL AND MONITORED FOR AN ADDITIONAL 30 MINUTES. THE PATIENT SAID THE TINGLING IN TONGUE IMMEDIATELY RESOLVED AFTER BENADRYL AND JUST HAD MINOR ARM SORENESS.
37 2021-01-21 pain in extremity Fatigue, achiness, headache, sore arm for about 24 hours
37 2021-01-21 numbness, tingling I received my 2nd dose of the Pfizer covid-19 vaccine to my left arm on Monday 1-11-21 around 1330. ... Read more
I received my 2nd dose of the Pfizer covid-19 vaccine to my left arm on Monday 1-11-21 around 1330. Following this, I experienced pain at the injection site until 1-12-21 when the pain spread to my left axilla. I also experienced notable swelling to the left axilla and numbness and tingling that radiates down my left arm and into my left pinky and ring fingers. My first dose was also administered to my left arm with only soreness at the injection site experienced. I have not previously experienced any reactions to vaccines in the past.
37 2021-01-21 tremor, feeling of body temperature change, migraine I received the vaccine at 11am on Wednesday morning, and by about 830pm Wednesday night, I could sen... Read more
I received the vaccine at 11am on Wednesday morning, and by about 830pm Wednesday night, I could sense something was off. I couldn't focus on work, and I felt my eyesight starting to get fuzzy. I realized there was an issue, and decided to go to bed. As soon as I laid in bed, the chills started, and for the next hour I couldn't stop shaking. I couldn't get comfortable, hot/cold, hot/cold, the chills were incessant and I couldn't will myself to sleep. I finally fell asleep and proceeded to toss and turn. I woke up at 5am on Thursday and could barely move. My body was so sore and my head was pounding with a migraine. I was trying to take care of the kids, unsuccessfully, while battling all the symptoms. The day progressed slowly, and I started to feel better mid day after a few more hours of sleep. Around 6pm is when the fever kicked in, hovering right about 99.5. I drank Pedialyte and went to bed not long after I got the kids in bed. At 2am I woke up with another headache and took more Tylenol. By 6am today, Friday, the fever broke and I am back to normal.
37 2021-01-21 flushing Light sensitivity, skin sensitivity, flushed skin. My whole body itched.
37 2021-01-21 burning sensation, numbness, tingling, cold extremities On 12/27 feet started feeling like pins sticking in then numbness & cold non stop. This sensation gr... Read more
On 12/27 feet started feeling like pins sticking in then numbness & cold non stop. This sensation gradually moved up to the waistline area. Then total numbness, heaviness in legs, making it difficult to walk. There is also a raised, red rash that burns. Her symptoms are not better.
37 2021-01-21 tingling Pt. C/O tingling of the left hand including the palmer surface, full ROM no motor weakness. No resp... Read more
Pt. C/O tingling of the left hand including the palmer surface, full ROM no motor weakness. No respiratory issues, no other complaints
37 2021-01-21 pain in extremity starting in the evening of the day of the vaccine, began experiencing pain in my left pinky. The f... Read more
starting in the evening of the day of the vaccine, began experiencing pain in my left pinky. The following day (1/20), the pain was worse leaving me unable to do daily tasks. It increased through the day at work (1-handed work) to the point of being unable to use 3 fingers without excruciating pain. On 1/21, saw a neurologist who diagnosed parsonage turner's syndrome due to the covid vaccine.
37 2021-01-22 weakness 1/19/2021-right after injection light headiness , dizziness and balance off, some fatigue 1/20/2021-... Read more
1/19/2021-right after injection light headiness , dizziness and balance off, some fatigue 1/20/2021- weakness, fast heart beat, fatigue 1/21/2021- Chest pain and some shortness of breath, heaviness in chest and fast heart beat, anxiety, tiredness and irritability, overwhelming feeling, anxious, fatigue (feeling really sick) 1/22/2021 some chest pains not as bad as Thursday, shortness of breath but also improving, irritability, anxious 1/23/2021 chest pain, shortness of breath improving, anxiety and nervousness, fatigue
37 2021-01-22 weakness 1/7/21: had thee COVID vaccine on 1/5/20 and developed symptoms an hour after administration chills,... Read more
1/7/21: had thee COVID vaccine on 1/5/20 and developed symptoms an hour after administration chills, sweats and bodyaches. Also developed nausea, diarrhea and chest pain. Woke up this morning with cough and congestion. 1/10/21: called this morning to give us an update on her symptoms and see about a COVID swab. states that she is currently hooked up to an IV due to dehydration and no urine output. she has had zofran and pain medication for her severe abd pain. They have strep swabbed and flu swabbed but have not COVID swabbed. Encouraged getting a COVID. She states she will ask them for one and will call us with an update either today or tomorrow. 1/10/21: called and left voicemail stating that she was being discharged. they did COVID 48-72 hours for results. On ABX and Phenergan and Zofran alternating. Got two bags of LR has UTI and Kidney infection. CT with contrast lungs clear. Negative for flu and strep. Strep culture pending. added to spreadsheet since she was COVID tested. 1/14: Called regarding her Covid test. It was reported as negative. is still very sick with fever, sore throat, congestion, nausea. I spoke with Doctor regarding the extent of her symptoms following the vaccine. Doctor recommended that she be seen by her PCP as she has not improved. 1/14: called and went to her PCP as advised by Doctor. now has a UTI and URI. She is on Macrobid and Levoquin as well as Zofran and Phenergan. Her BP was 117/60 and dehydrated. Her PCP told her to monitor her BP and return to ER if not improved and also return to ER if symptoms became worse. will call on Monday 1/18/2020 and update us on her condition 1/17:COVID tests were negative, over 48 hours since a temp above 100.4, 99.1 was the last temp doing better. No more vomiting and no diarrhea. still has a cough and is still on ABX from all of her symptoms. Is on a cough suppressant so recommend her working from home since she is able and will update us towards the end of the week on how she is doing. 1/20: Received the COVID vaccine on 1/5/21. Released yesterday to work from home. No longer has vomiting or diarrhea. COVID, FLU and strep tests negative. Diagnosed with allergic reaction to COVID Vaccine. had kidney infection and UTI. CT of abdomen done with contrast. CXR to r/o pneumonia. continues to have a runny nose, no fever. Continues to have laryngitis and fatigue. called today to get released. Encouraged to call back when she gains more strength and can return. My PCP diagnosed me with a severe allergic reaction to the covid shot. I had the rapid covid test ran twice and the test sent out twice, all 4 tests came back negative. I had the flu test ran and it came back negative. So did the strep culture. I had 2 full lab workups ran and they both came back normal including my vitamin levels. The only thing that was out of alinement was my white cell count was high due to an infection. Today, I am currently running a fever of 99.4. I still have a cough that is rather irritating. I still do not have a voice. I am retaining color back in my skin. I am still tired and weak but have managed to work and do small things around the house such as cook dinner, wash laundry, clean dishes, and shower. These were daily tasks that I wasn't able to do during the first 2 weeks after taking the shot.
37 2021-01-22 inability to speak, migraine, facial paralysis, speech disorder I began to have extreme headache (occipital neuralgia distribution and intensity) 10 hours after sho... Read more
I began to have extreme headache (occipital neuralgia distribution and intensity) 10 hours after shot, which worsened over the next day. During that next day I had some word-finding impairment and dulled thinking. 34 hours after shot, I experienced a transient Bell's palsy like episode with right-sided facial drooping (eye ptosis, cheek muscle flattening) and impaired speech, which lasted about 1-2 hours and self-resolved. I called doctor who put me in contact with on call doctor who said symptoms sounded like a complicated migraine with neurological involvement. I have had a migraine once or twice in the past, but nothing chronic and nothing like this episode. The next day (Thursday 1/21/21) I had fatigue, and by Friday 1/22/21 all symptoms had resolved.
37 2021-01-22 tingling, migraine Injection site pain first 24 hours extending across shoulders and neck to other arm. At about hour 3... Read more
Injection site pain first 24 hours extending across shoulders and neck to other arm. At about hour 38 developed parasthesias of the left arm and complex migraine
37 2021-01-22 tingling dizziness, headache, nausea, tingling in hands, chest pain
37 2021-01-24 numbness Initially she was fine during 15 minutes observation period. Facial redness/itching developed around... Read more
Initially she was fine during 15 minutes observation period. Facial redness/itching developed around 15-20 minutes after shot on 1/7/21. No rash anywhere else on body. Numbness in face. Headache. Per patient, co-nurses told her she had facial swelling. No trouble breathing. No throat swelling. No cough. Got famotidine and Benadryl. blood pressure was elevated (228/120). She felt better after about 2 hours.
37 2021-01-24 numbness Pt given 2nd Covid vaccine. Stated she had lip tingling/numbness and left sided facial numbness. No ... Read more
Pt given 2nd Covid vaccine. Stated she had lip tingling/numbness and left sided facial numbness. No SOB, no difficulty breathing or airway issues. 25 mg IM benadryl given at 17:33. Currently at 18:13 pt states it is not getting worse and the numbness is currently over her left eye brow and chin. Pt stated she feels comfortable to leave but pt was advised to wait.Pt stated that after her first vaccine she had some numbness on right side of face that lasted 3 days post injection but no difficulty breathing or with airway. She had read on line that 1% of people may get numbness so felt comfortable getting second dose since she had no airway problems. At 18:29 pt left, refused to go to ER per clinic recommendations.
37 2021-01-24 muscle spasms lost consciousness; Severe cramping; diarrhea; This is a spontaneous report from a contactable other... Read more
lost consciousness; Severe cramping; diarrhea; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249, expiry date unknown), via an unspecified route of administration on the left arm on 13Jan2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing. The patient has no known allergies. Patient is not pregnant at the time of vaccination. Concomitant medications included cyanocobalamin (VITAMIN B-12), Iron, and Vitamin D (VITAMIN D NOS); patient received these medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Jan2021 04:00 AM, the patient experienced severe cramping, followed by episode of diarrhea. During the cramping, she lost consciousness for an unknown amount of time. No therapeutic measures were taken in response to the events. Outcome of the events at the time of last observation was recovering. The events were reported as non-serious.; Sender's Comments: A possible contribution role of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of lost consciousness cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
37 2021-01-24 facial paralysis suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous ... Read more
suspect that it may be Bell's Palsy; tingling in the left side of her tongue; This is a spontaneous report from a contactable nurse. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at 0.3ml single injection in the left arm on 22Dec2020 09:00 for covid-19 prophylaxis. Medical history included persimmon fruit allergy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced tingling in the left side of her tongue on 22Dec2020, the event was reported as serious per medically significant, suspect that it may be bell's palsy on an unspecified date. The adverse event was not required a visit to emergency room or physician office. Caller was an employee health nurse that reported that she had an employee that received the first dose Covid-19 vaccine on 22Dec2020 and as they were administering the vaccine, the patient developed tingling in the left side of her tongue. The caller said that the patient reported that the tingling was still there. She said that the patient was concerned that it might cause her to get bell's palsy. Caller wanted to know if this was this common and whether she could move forward with getting the 2nd dose of the vaccine. The caller said that the patient received the vaccine in her left arm. The caller said that the patient reported that the tingling in her tongue was mild and not stopping her from eating and she was not having any respiratory issues. Caller said that the only allergy that the patient has was to Persimmon fruit. The side effect mentioned is not necessarily Bell's palsy since the characteristic eye drooping is not present. The outcome of events for tingling in the left side of her tongue was not resolved, for suspect that it may be bell's palsy was unknown. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility: No. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No relevant tests. Drug result was related.; Sender's Comments: The causality between the reported tingling in the left side of her tongue, which was suspected that it may be Bell's Palsy and the administration of COVID-19 vaccine, BNT162B2, cannot be denied, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
37 2021-01-25 migraine, hot flush Pt. C/O hot flash and dizziness at the time of vaccination then 2 minutes later she developed a migr... Read more
Pt. C/O hot flash and dizziness at the time of vaccination then 2 minutes later she developed a migraine headache at 4:37. She had difficulty walking from her chair to the medical cot due to pain but responded to taking a dose of her own medication of 400mg of Advil and also placing cold packs no her forehead and neck. The pain gradually eased and she was able to leave the clinic at 17:06 feeling better.
37 2021-01-25 hot flush Pt. developed slight tightness in her chest felt flushed, had some mild erythema at her injection si... Read more
Pt. developed slight tightness in her chest felt flushed, had some mild erythema at her injection site. After medical evaluation, she felt reassured and did not want to use her inhaler, said she would use it later if tightness returned.
37 2021-01-25 bell's palsy mild bells palsy symptoms effecting right side face
37 2021-01-25 hypersensitivity of all senses, numbness numbness of left side of face/scalp; hyperesthesia of left face/scalp/ear; left sided submandibular ... Read more
numbness of left side of face/scalp; hyperesthesia of left face/scalp/ear; left sided submandibular lymphadenopathy; This is a spontaneous report from a contactable physician. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), intramuscular on 08Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing.The patient had no known allergies. It was unknown if patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had the first dose of bnt162b2 for covid-19 immunization on 18Dec2020 (lot number unknown), via intramuscular route in the left arm. The vaccination was administered in the hospital. On 08Jan2021, the patient experienced numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment as gabapentin for the reported events. The patient was not tested for covid post vaccination. The events numbness of left side of face/scalp, hyperesthesia of left face/scalp/ear, and left sided submandibular lymphadenopathy were not recovered. Information on lot number/batch number was requested.
37 2021-01-26 pain in extremity Arm soreness
37 2021-01-26 burning sensation Intense burning to bilateral soles of feet at 12hrs post vaccine administration.
37 2021-01-26 pain in extremity Its been a little over 2 weeks; Since the 2nd dose I have had swollen lymph nodes, head aches and fe... Read more
Its been a little over 2 weeks; Since the 2nd dose I have had swollen lymph nodes, head aches and feeling fatigue. I have not been well. My Axilla Lymph nodes became so swollen that it has caused me to have urgent ultrasound and even a lymph nodes biopsy. Including, I have taken Tylenol Extra Strength for headaches and even Advil Migraine. Also - Since the Injection My right Arm has continued to be soar and still a bit swollen. 01/27/2021 .
37 2021-01-26 pain in extremity Sore arm and back pain starting 4 hours after injection , chills and abdominal cramping 11 hours aft... Read more
Sore arm and back pain starting 4 hours after injection , chills and abdominal cramping 11 hours after vaccination administered Sore arm - lasted 4 days Back pain - lasted 2 days Chills and abdominal cramping lasted 2 hours
37 2021-01-26 burning sensation Systemic: Anaphylaxis-Severe, Systemic: Other- Angioedema, complained of systemic burning sensation ... Read more
Systemic: Anaphylaxis-Severe, Systemic: Other- Angioedema, complained of systemic burning sensation most severe on face-Severe
37 2021-01-26 tremor Woke up with headache, Temp = 101, chills, whole body shaking during night 1/7/21 in am temp = 99, n... Read more
Woke up with headache, Temp = 101, chills, whole body shaking during night 1/7/21 in am temp = 99, no further chills
37 2021-01-26 cold sweat dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back ... Read more
dyspnea; myalgias; chest pain/Chest pain is moderately severe and worse with deep inspiration; back aches; feeling clammy; This is a spontaneous report from a contactable pharmacist. A 37-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248, expiration date unspecified), via an unspecified route of administration on 11Jan2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 21Dec2020 and experienced fever, chills, myalgias, and some sensory changes to the left arm; and vancomycin and experienced allergies. On 11Jan2021, the patient experienced dyspnea and myalgias following her second vaccination today. It was reported that she received the second dose of the vaccine around noon and then began having dyspnea and chest pain around an hour later. Chest pain was moderately severe and worse with deep inspiration. Patient was also having back aches and was feeling clammy. Patient represented to the vaccine site and was brought to the emergency room department/urgent care for evaluation. Patient denied any history of vaccine associated reactions. The patient received therapy for the events which included acetaminophen, ketorolac and intravenous (IV) fluids. The patient had no other vaccine in four weeks. Outcome of events was unknown.; Sender's Comments: Based on the time association, the events are possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-01-26 pain in extremity itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles);... Read more
itching; frontal headache; eye pain on movement; sensitivity to light; arthralgias (wrists, ankles); nausea; chills; fever/chills (up to 39 C); myalgias in the back and contralateral arm; left arm soreness; Redness and swelling at injection site; Redness and swelling at injection site; Lower back pain; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot: EK9231) on 13Jan2021 11:45 at a single dose for covid-19 immunization. Medical history included GERD (gastrooesophageal reflux disease), environmental allergies, Penicillin (but not augmentin) allergies and sulfa allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC), esomeprazole, and vitamin d. Histrical vaccine included the first dose of BNT162B2 (lot number: EJI685) on 23Dec2020 12:15 in the left arm, for covid-19 immunization. On 13Jan2021 20:00, patient experienced left arm soreness. Then at 21:00, she experienced myalgias in the back and contralateral arm. At 23:00, she had fever/chills (up to 39 C). The next day (14Jan2021) at 2:30, she had frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), persistent fever and nausea. All these symptoms persisted until exactly 11:48 on 14Jan2021, when everything suddenly got better. Still occasional chills but no fever for the rest of the day, left arm pain persists into 15Jan2021. Redness and swelling at injection site are worse. There was also now itching. Lower back pain persists. The outcome of events left arm soreness, "Redness and swelling at injection site" and lower back pain was not recovering. She was recovering from " myalgias in the back and contralateral arm", fever/chills (up to 39 C), frontal headache, eye pain on movement, sensitivity to light, arthralgias (wrists, ankles), nausea, chills Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
37 2021-01-27 facial paralysis, bell's palsy 37yo female received first COVID vaccine lt arm on 1/15/21. She denies any immediate adverse reacti... Read more
37yo female received first COVID vaccine lt arm on 1/15/21. She denies any immediate adverse reactions. Day 6 (1/22) she c/o right ear pain. 1/23 continued ear pain with nasal congestion 1/24 symptoms continue with difficulty chewing about 1100am. 1700 c/o tongue -upper lip swelling and rt facial droop, forehead-eyebrow paralysis - to ER where diagnosed with Bells Palsy. ER provider dx viral like illness and bells palsy attributed to viral prodrome. Given tapering dose prednisone, Sudafed for congestion/ear fullness and ophthalmic eye drops. Seen by HCP 1/27 and again 1/28 with improvement of symptoms but facial droop continues. Pt states is better. Prescribed Valtrax Additional information for Item 18: Medical center notified of case and monitoring.
37 2021-01-27 tingling, numbness 5 minutes post vaccination- in observation location and left hand & forearm starting to feel numb & ... Read more
5 minutes post vaccination- in observation location and left hand & forearm starting to feel numb & tingling - This continued for days and progressively improved about 10 minutes post vaccination - headache sharp, right side. Moved to observation chair for further assessment and vitals check. Upon getting up to go to the new chair, was lightheaded. Vital signs taken and revealed tachycardia and increased BP beyond normal values. Prior symptoms persist. Healthcare workers continue to monitor me while sitting on chair. Oral Tylenol for headache was given. Approximately 30-45 minutes in I feel chest palpitations and an uneasy 'anxious' type of feeling even though I am just sitting down and staying calm. Due to all these symptoms plus the BP and HR remaining high they gave me Benadryl 25mg IM to the right arm as well. The BP started to slowly go down after about 2 hrs as well as HR. Allowed to leave hospital vaccination clinic, while BP and HR still high, was better than the first 2 hours. New symptoms on day 2, pain left arm at injection site and muscles, fatigue and some intermittent nausea. The symptoms continued for 3-4 days post vaccination. I monitored Vitals at home. BP finally stabilized to my normal range around the 4th day.
37 2021-01-27 tingling, feeling hot PATIENT RECEIVED INITIAL COVID VACCINE YESTERDAY AT NOON. STATES SHE HAD A MILD REACTION WITH ARM R... Read more
PATIENT RECEIVED INITIAL COVID VACCINE YESTERDAY AT NOON. STATES SHE HAD A MILD REACTION WITH ARM REDNESS APPROXIMATELY 30 MINUTES AFTER VACCINE, THEN 3-4 HOURS LATER FACE WAS HOT,RED, BLOTCHY, & TINGLY. APPROXIMATELY 12 HOURS AFTER VACCINE, THE REDNESS SIGNIFICANTLY INCREASED FROM BLOTCHY TO FULL REDNESS, & ALSO HAD HIVES ON NECK, CHEST AND BOTH ARMS, AND THROAT SWELLING STARTED. PATIENT TOOK BENADRYL 50MG AT 3-4 HOURS POST VACCINE AND 25MG AT ~12 HOURS POST VACCINE.
37 2021-01-27 feeling hot Rash/Rash extended to chest and down to stomach; Rash and pain at injection site; Rash and pain at i... Read more
Rash/Rash extended to chest and down to stomach; Rash and pain at injection site; Rash and pain at injection site; Significant swelling in armpit with warmth; Significant swelling in armpit with warmth; pain; Swelling of lymph nodes under arm and into chest. All on L arm side where injection was administered; Significant fatigue for 4 days following; This is a spontaneous report from a contactable contactable Other-HCP (patient) . A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at left arm on 13Jan2021 09:30 AM at SINGLE DOSE for COVID-19 immunization.No pregnant.Medical history included asthma. The patient had COVID prior vaccination .Facility where the most recent COVID-19 vaccine was administered was Living Facility.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (received within 2 weeks of vaccination) fexofenadine hydrochloride (ALLEGRA) paracetamol (TYLENOL). On 14Jan2021 16:00 the patient developed Rash and pain at injection site, rash extended to chest and down to stomach, significant swelling in armpit with warmth and pain, swelling of lymph nodes under arm and into chest. All on Left arm side where injection was administered and significant fatigue for 4 days following. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit.No treatment received.The events were assessed as non-serious. The patient had been tested for COVID post vaccination on 17Jan2021 (test type = Nasal Swab Covid test name post vaccination= Rapid). The outcome of the events was recovering Information on lot/batch number has been requested.
37 2021-01-27 muscle twitching tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; ar... Read more
tired; slept most of the day; Headache; Chills; Joint pain; Sore throat; muscle pain/muscle ache; arm was hurting more than sore/arm pain at injection site; Nausea; Loose stools; Left eye twitching; feeling pretty ill/ under the weather; a little short of breath/shortness of breath; Metal taste in her mouth; Itchy everywhere; asthma has flared up a little bit; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH3246, expiry date unknown), intramuscular (right arm), on 08Jan2021, at single dose, for covid-19 immunization. Medical history included asthma since 2004 (diagnosed about 17 years ago). Concomitant medication included formoterol fumarate, mometasone furoate (DULERA) (has been on this for about 2 months) for asthma. The patient previously took formoterol and budesonide (SYMBICORT) for asthma. The patient stated she was a technician and she has a couple of questions about the Covid vaccine. She got the vaccine on 08Jan2021. Since she got the vaccine, papers said she would feel under the weather for a few days but she was still feeling pretty ill; she wanted to know if this was normal and when should she be concerned, wondering if she should call her doctor. She was encouraged to reach out to her HCP for any medical advice. She also stated that 5-10 min after the vaccine on 08Jan2021, she started to feel a little short of breath/shortness of breath but that resolved. Also, afterwards on 08Jan2021 she had a metal taste in her mouth and was itchy everywhere on that day. She went home and around 9PM on the day of the vaccination, she started to feel under the weather on 08Jan2021. Then she woke up on Saturday 09Jan2021 with headaches, chills, joint pain, sore throat, muscle pain/muscle ache, arm was hurting more than sore/arm pain at injection site, nausea, loose stools, and left eye twitching. On Sunday 10Jan2021, she was very tired and slept most of the day. She added that she has been reporting this to the link that was provided to her. She has been taking Tylenol and ibuprofen to treat these symptoms and; was also using her inhaler because it seemed like asthma has flared up a little bit on Jan2021. No other vaccines administered on the same date with the Pfizer vaccine. The adverse events did not require a visit to the emergency room or physician office. No prior vaccinations within four weeks. The outcome of the events feeling pretty ill/ under the weather, slept most of the day and, asthma has flared up a little bit was unknown. The outcome of events a little short of breath/shortness of breath, metal taste in her mouth, and itchy everywhere was recovered on 08Jan2021. The outcome of joint pain was recovering. The outcome of arm was hurting more than sore/arm pain at injection site was recovered on 13Jan2021. The outcome of the other remaining events was not recovered.
37 2021-01-28 hot flush 10 minutes following injection, feeling hot and flush, nausea. Instructed by nurse at clinic to ta... Read more
10 minutes following injection, feeling hot and flush, nausea. Instructed by nurse at clinic to take benedryl. i stunted to remain at site additional time, mild improvement of symptoms by time permitted to leave. Symptoms returned intermittently throughout the day, and included headache and chest palpitations. Resting HR 110 to 120 bpm. Treated with additional doses of benedryl, tylenol, and Ibuprofen. Persisted for over 24 hours. Throughout night also developed vomiting, sinus congestion, sorethroat, chills, and intense body aches. Contacted PCP office and instructed to continue with OTC treatments and rest.
37 2021-01-28 feeling hot, flushing 5 minutes after the injections, body warm with a flushed Sensation throughout entire body. Felt oozy... Read more
5 minutes after the injections, body warm with a flushed Sensation throughout entire body. Felt oozy, dizzy, sat about 5 minutes. At location where she did receive the injection, was juice, crackers. Sore arm for 2 days.
37 2021-01-28 migraine Approx 1 hour after vaccination of 2nd vaccine, I began having vertigo until noon of that day. head... Read more
Approx 1 hour after vaccination of 2nd vaccine, I began having vertigo until noon of that day. headache persisted multiple days after vaccination. Next day after vaccination I developed systemic edema, rash on legs below knees, migraine, generalized pain, malaise, fatigue. also developed reddened warm area to injection site, dx as cellulitis. Psoriasis areas flared, psoriatic arthritis areas increased in pain. Seen primary care physician after symptoms did not cease on day 6 (Monday) after getting dose 2. Said it was side effect from vaccine and prescribed prednisone taper, doxycycline, and lasix
37 2021-01-28 feeling hot, tremor Got my shot at 3p. but 340p became short of breath, throat felt tight/itchy. woke up at 2am shaking... Read more
Got my shot at 3p. but 340p became short of breath, throat felt tight/itchy. woke up at 2am shaking, later that day developed at headache, felt warm but couldn't stop shaking. Headache became too unbearable I've been developing a headache every day since the shot.
37 2021-01-28 weakness On 1/28 at ~1330 employee woke up from nap with chest pains. No previous history of chest pain or an... Read more
On 1/28 at ~1330 employee woke up from nap with chest pains. No previous history of chest pain or any other significant health issues. No medication was taken at time of vaccination or prior to appointment. Was advised to seek care. Went to urgent care and diagnosed with costochondritis. Given Toradol shot and chest pain began relieve within 30 min. 1/29 reports no chest pain, but still has weakness and persistent headache.
37 2021-01-28 flushing Pt. developed feeling of flushing and dizziness immediately after receiving the vaccine , then C/O p... Read more
Pt. developed feeling of flushing and dizziness immediately after receiving the vaccine , then C/O palpitations and chest tightness a few minutes later at 6:14pm. After vital signs were found to be stable and improving with reassurance her complaints resolved without medication or treatment.
37 2021-01-28 migraine pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not m... Read more
pain on arm/body/body; nausea; brain fog; migraine; swollen arm; pain at injection site; could not move; fever; increase blood pressure; chest tightness; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The Vaccine vail was not mixed with Sodium Chloride prior to administration; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (15Jan2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Pharmacist. A 37-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number: EL0140, expiration date: Mar2021), via Intramuscular on left arm on 02Jan2021 at 18:00 at 0.3 mL, single for covid-19 immunisation. The relevant medical history was not reported. Concomitant medications were reported as none. The patient previously took Tylenol one hour prior to the vaccination on 02Jan2021 at 1 tablet by mouth. Patient complained of nausea, brain fog on 02Jan2021 at 06:20 pm. Pharmacist recommended to admit ER for safety and to monitor. Patient received the injection at 6pm. Patient was recommended by Pharmacist to admit ER for safety. Patient decided to admit ER at 10 pm. No other symptoms were reported from patient. The patient was admitted to hospital on 02Jan2021 and was discharged on 03Jan2021. While at the hospital, patient informed that she had fever, increased in blood pressure, and chest tightness on 03Jan2021 (reported as mid night). Patient admitted to hospital on 10 pm and was discharged the next day with ibuprofen/Tylenol/ zofran and continue to monitor for symptoms. After discharged, while at home, patient informed about migraine, swollen arm, pain at injection site and body that she could not move at 9:00 am on 04Jan2021. Patient informed that she admitted to hospital again about the pain on arm/body. The patient received 1 dose of 0.3ml and before it was possible that the vaccine was not mixed with sodium chloride prior to administration, an error due to mixture to communicate clearly adequately between our colleagues. Patient received the vaccine at 6 pm on 02Jan2021. After speaking with our colleague about 15 minutes ran to check on the patient if she was feeling okay. Patient complained feeling a bit nausea, brain fog, no other symptoms. Patient stated that she was okay. They stayed back at the store to keep track of patient to admit to ER after her shift at 10 pm. Patient informed she had fever, chest tightness, increase blood pressure at the hospital, then was discharged the next day with ibuprofen/tylenol/Zofran. The following day during at home patient complained at migraine, swollen arm, Pain at the injection site and could not move due to the pain. Patient decided to admit back to hospital for additional information about her pain. They contacted patient again after 3 days, patient informed. She was better and had returned to work on 13Jan2021. The outcome of the events was recovered on 11Jan2021. The pharmacist considered the events were related to suspect product Covid-19 by Pfizer.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported nausea, brain fog, pain on arm/body, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
37 2021-01-28 unresponsive to stimuli stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy;... Read more
stroke; unresponsive; unable to move one side of her body; fell down the stairs; fever; felt groggy; This is a spontaneous report from a contactable consumer and a non-contactable consumer (patient's sister). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for an covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was an oncology nurse practitioner working received the Pfizer BioNtech vaccine on Thursday 14Jan2021. On Friday 15Jan2021, the patient visited her family members and told them she had a fever and felt groggy. She went to sleep around 8pm-9pm that evening (15Jan2021). Around 2am-3am in the morning Saturday 16Jan2021, the patient fell down the stairs and her family member found her - unresponsive and unable to move one side of her body. Her family member moved her to the couch. Around 7am-7:30am, the patient was still unresponsive and unable to move one side of her body. Her family dialed an ambulance took her to an hospital. At present - her family reported that the healthcare professional they spoke to said the patient had a stroke. She had received multiple scans (MRI, brain scan) in the hospital and was awaiting a Neuro consult. It was unknown if treatment received. The outcome of events was unknown. Information about lot/batch number has been requested.
37 2021-01-28 burning sensation, flushing within 5 minutes had itching at the site and burning sensation down arm to 4th and 5th digits, becam... Read more
within 5 minutes had itching at the site and burning sensation down arm to 4th and 5th digits, became flushed about neck and face area and was taken to the ED for evaluation by paramedic. Within 20 minutes the adverse mild reaction had subsided without medications and the employee was discharged from the ED.
37 2021-01-31 tremor, muscle twitching, tingling, burning sensation Patient's reaction(s) noted during COVID vaccine observation period: Received 2nd dose vaccine @174... Read more
Patient's reaction(s) noted during COVID vaccine observation period: Received 2nd dose vaccine @1745 began with tremors and tingling. 1755: B/P 121/76. 1800: c/o tingling/burning and twitching in legs and tingling/burning in arms. 1805: B/P 113/69, HR 72, O2 sat 98%, temp 98.3. Pt does have history of COVID diagnosis July 2020 required hospitalization for decreased O2 sats, dx: pneumonia. 1815: B/P 112/69, HR 86, O2 Sat 99%. Also began to have sharp pain high in shoulders and increased muscle soreness. 1830: B/P 129/76, HR 90, O2 Sat 98%. Actions Taken: Reassurance, monitoring Disposition: Taken to ED via W/C accompanied by clinic staff at 1835 In the ED, pt received diphenhydramine IV, IV fluids, ondansetron IV , famotidine IV, methylprednisolone IV and ibuprofen PO. Discharged from ED at 2308
37 2021-01-31 weakness Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 15-20 minutes after receiving the injection, fel... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 15-20 minutes after receiving the injection, felt dizzy, nauseated, shaky. Tongue felt like it was swelling similar to previous allergic reactions I have had, lips were tingly, vision started to blur. Given 25 mg benadryl PO. Walked to urgent care in building, given IV methylprednisone and odansterone, oral famotidine. BP initially very high, was 154-100 at time of discharge from urgent care at approximately 11:30 am. Temp 97.4 at discharge. The following morning: vomiting, copious diarrhea, fever, body aches, stomach pains, fatigue, headache, weakness, dizziness, joint pain. Treated with fluids, rest, benadryl. Temperature high of 100.8 (not taking it consistently though). Today, 02.01.2021 temperature 99.8, still aches and weakness but improving. Normal temperature is ~97.7 on home thermometer.
37 2021-01-31 weakness Pfizer-BioNTech Coiv-19 vaccine EUA- HA and dizziness that morning, mid morning nauseated and diarrh... Read more
Pfizer-BioNTech Coiv-19 vaccine EUA- HA and dizziness that morning, mid morning nauseated and diarrhea by noon vomiting. Wednesday evening fever 103.7 with body aches, chills, \weakness fever did not get below 100.4 until Friday afternoon,
37 2021-01-31 pain in extremity Radiating shoulder pain and injection site pain to R shoulder where covid injection was given. The i... Read more
Radiating shoulder pain and injection site pain to R shoulder where covid injection was given. The injection felt very painful and was "high" up on her shoulder. The pain continues and radiates down her arm, especially when lifting and typing. No numbness or tingling.
37 2021-01-31 migraine Vaccine caused MS related symptoms which included, optic neuritis, photophobia, cluster migraines, f... Read more
Vaccine caused MS related symptoms which included, optic neuritis, photophobia, cluster migraines, fatigue, nausea, chills, confusion, diarrhea
37 2021-02-01 pain in extremity Dizziness, spinal pain, Pain all over the body, the injection arm, and chest. The chest pain is extr... Read more
Dizziness, spinal pain, Pain all over the body, the injection arm, and chest. The chest pain is extreme.
37 2021-02-01 pain in extremity Dose 1: Thursday, January 8, 2021 Swollen throat lymph nodes/Sore arm Dose 2: Friday, January ... Read more
Dose 1: Thursday, January 8, 2021 Swollen throat lymph nodes/Sore arm Dose 2: Friday, January 29, 2021 Day 1 - Sore arm Sunday, Jan. 31 - (NEW) Marble size lump on left clavicle (Swollen, painful - Possible lymphadenopathy) Tuesday, Feb. 2 - (NEW) swollen/painful injection site on left arm Continued marble size lump on left clavicle
37 2021-02-01 facial paralysis Facial swelling and temporary paralysis to left side of face started 1/10/21. Swelling lasted two da... Read more
Facial swelling and temporary paralysis to left side of face started 1/10/21. Swelling lasted two days. Facial paralysis 24 hrs, and facial symmetry still not corrected as of 2/2/2021. Entire facial rash started 1/21/2021. Rash started on face and moved down neck and chest. I took Benadryl for three days, which didn?t help. I then started a steroid regimen. 40 mg for three days. 20 mg for three days. I took last dose on Friday, 1/29/21. Rash was resistant to steroid until day three of regimen. Mild shortness of breath occurred 1/23/21, and lasted no more than an hour.
37 2021-02-01 pain in extremity Roughly 45 minutes after receiving dose 2 of the Pfizer vaccine, my face began to feel funny and the... Read more
Roughly 45 minutes after receiving dose 2 of the Pfizer vaccine, my face began to feel funny and then became itchy. This is the same thing that happens when I eat shellfish. It didn't last for more than 45 minutes, and I didn't need to take anything for it. I also woke up in the middle of the night with horrible pain throughout my entire left arm, from my shoulder down through my hand. This lasted a couple hours and then returned to just moderate soreness at the injection site only.
37 2021-02-01 pain in extremity STARTED WITH STRONG HEADACHE, PHOTOPHOBIA, FEVER, BODYACHE, JOINT PAIN , LEFT ARM PAIN SINCE 2/2/202... Read more
STARTED WITH STRONG HEADACHE, PHOTOPHOBIA, FEVER, BODYACHE, JOINT PAIN , LEFT ARM PAIN SINCE 2/2/2021 12AM
37 2021-02-01 numbness Swollen arms & severe rash on arms and back and right hand has numbness & some numbness in left hand
37 2021-02-02 tremor 01/25/2021-1/26/2021: photophobia, headache, general exhaustion, left shoulder discomfort 01/31/2021... Read more
01/25/2021-1/26/2021: photophobia, headache, general exhaustion, left shoulder discomfort 01/31/2021- dyspnea, tachypnea, palpitations, nausea, indigestion, dizziness, blurred vision, tremors/shaking 02/01/2021-on-going: dizziness and intermittent blurred vision and palpitations
37 2021-02-02 tingling C/O pulling feeling or tingling sensation in chest. difficulty swallowing in neck area of esophagus.... Read more
C/O pulling feeling or tingling sensation in chest. difficulty swallowing in neck area of esophagus. VS monitored x3 over one hour. Breath sounds clear. Vital signs stable during observation. Discharged home to self. No Distress noted at time of discharge. Pt states took Benadryl 50 mg at 4pm before vaccine given.
37 2021-02-02 face paralysis Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 ex... Read more
Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; Patient developed GBS with 4 extremity weakness and facial weakness; This is a spontaneous report from a contactable pharmacist (patient). A 37-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. Ek5730) at single dose, in the right arm, on 18Dec2020, at 03:30 PM, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. On 18Dec2020, at 07:00 PM, the patient developed Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness. Emergency Room Visit required. Hospitalization required (7 days admission in hospital). Treatment required: IVIG. The adverse events were assessed as serious (hospitalization and disability). Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, on 10Jan2021, the patient has been tested for COVID-19 and resulted negative. COVID-19 test type post vaccination: COVID-19 PCR test (Nasal Swab).; Sender's Comments: Based on the close temporal relationship, the association between the events Guillain-Barre syndrome (GBS) with 4 extremity weakness and facial weakness with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
37 2021-02-02 burning sensation Patient received COVID-19 vaccine on 1/11/2021 at 1538p per vaccine documentation. On 1/11/2021 at ... Read more
Patient received COVID-19 vaccine on 1/11/2021 at 1538p per vaccine documentation. On 1/11/2021 at 1607p, Patient complained of having itching and hand burning. Patient was administered PO Benadryl 50mg at 1607p. At 1617p, patient complained of increased shortness of breath and audible wheezing. Patient was administered Epi 0.3mg IM herself and verbalized relief 2 minutes after Epi was administered. Patient was transferred to Hospital's ER for further evaluation. Patient was prescribed Benadryl 25mg, Pepcid 20mg, Singulair 10mg, and Prednisone 20mg by the ER.
37 2021-02-02 tremor Tiredness, more then 24 hours later started with nausea and repeated vomiting, with diarrhea, fever ... Read more
Tiredness, more then 24 hours later started with nausea and repeated vomiting, with diarrhea, fever 99, sweating, lethargic and shaking. All symptoms hit me all at once and all faded all at once. I had covid in mid April 2020. I had the same symptoms as the with the covid except drawn out.
37 2021-02-03 pain in extremity, night sweats 30 mins after injection of second dose a metallic/medicinal taste was discovered in my saliva. Four... Read more
30 mins after injection of second dose a metallic/medicinal taste was discovered in my saliva. Four hours after dose began feeling nausea. Day 2 nausea and metallic/medicinal taste in saliva continued. Metallic/medicinal taste in saliva stopped mid morning of day 2. Day 2 experienced chills, headaches, elevated body temperatures, severe night sweats, and stiff body. Day 3 headaches and stiff neck. Also injected arm was very sore during the two day experience.
37 2021-02-04 flushing EMS evaluated treated and transported- Difficulty breathing, tongue swelling, flushing, airway swell... Read more
EMS evaluated treated and transported- Difficulty breathing, tongue swelling, flushing, airway swelling 12:22 patient received covid 19 Pfizer vaccine 12:23 EMS called off to assess patient c/o of difficulty breathing, tongue swelling, flushing. 12:28: 50 mg IV diphenhydramine - some improvement seen- patient transferred to higher level of care per EMS
37 2021-02-04 numbness Numbness on arm that received shot, up neck and on same side of face/head
37 2021-02-04 hot flush, tingling, feeling hot, numbness Symptoms reported, "I was driving home after the vaccine and felt really hot, like a hot flash and f... Read more
Symptoms reported, "I was driving home after the vaccine and felt really hot, like a hot flash and felt my heart palpitating", that lasted for approximately one hour. Symptoms of "tingling at all 10 finger tips that has gone away but now have a little numbness in both hands". Reported driving home and calling primary care physician to report symptoms but has not received a call back.
37 2021-02-04 feeling cold, tingling pain at injection site; Ten min after dose my arm felt cold. felt my hands to my cheeks, both hands ... Read more
pain at injection site; Ten min after dose my arm felt cold. felt my hands to my cheeks, both hands felt same temp but injected entire arm felt a cold sensation like my nerves were cold throughout arm; ten min after dose, tingling also like it was colder than the other arm; This is a spontaneous report from a non-contactable Pharmacist (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at 18:00 at single dose in arm for COVID-19 immunisation at the age of 37-year-old. Medical history included anxiety and depression. It was unknown if the patient was pregnant. Concomitant medications were unknown. The patient reported that on 20Jan2021, ten min after dose, arm felt cold; the patient felt her hands to her cheeks (as reported), both hands felt same temp but injected entire arm felt a cold sensation like nerves were cold throughout arm.; tingling also like it was colder than the other arm. It lasted about 30 min, then it got about 50% less intense. Intensity continued till the time of report. The morning of the report on 21Jan2021, the patient woke up with dull pain at injection site. The patient was not treated for the events. The patient did not have COVID prior vaccination, and she was not COVID tested post vaccination. The patient was recovering from the events. No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information expected.
37 2021-02-05 weakness Fever 102, diarrhea, nausea, tachycardia, hypotension, weakness, fatigue, body ache, chills. Start... Read more
Fever 102, diarrhea, nausea, tachycardia, hypotension, weakness, fatigue, body ache, chills. Started 5 hours after the vaccine and lasted 72 hours. This happened after both the first and second vaccine
37 2021-02-05 feeling cold Patient presented with chills, upset stomach, blurry vision, lightheadedness and the feeling that sh... Read more
Patient presented with chills, upset stomach, blurry vision, lightheadedness and the feeling that she would pass out. These symptoms presented less than 2 minutes after receiving her Pfizer vaccine. Her blood pressure was slightly elevated when EMS evaluated patient. The feeling resolved after 15 minutes and the patient went home.
37 2021-02-05 tremor Severe to Violent tremors
37 2021-02-05 feeling jittery, pain in extremity The patient felt extremely warm, jittery, her heart was racing, and her face was swelling 10 minutes... Read more
The patient felt extremely warm, jittery, her heart was racing, and her face was swelling 10 minutes after receiving the vaccine. Her face swelled slightly and her arm had shooting pain up and down. The symptoms started with dry mouth and a weird taste in her mouth. That sensation continued for approximately 30 minutes.
37 2021-02-06 hot flush 9pm had chills then a hot flash, slight stomach ache. Went to go use the restroom and passed out and... Read more
9pm had chills then a hot flash, slight stomach ache. Went to go use the restroom and passed out and fell. Woke up and was stood up by friends and passed out again. I do have a history of vasovagel syncopy but it hasn?t happened in over 10years
37 2021-02-07 numbness, pain in extremity, tingling Dose #1 administered on 1/11/21 with terrible arm/back pain and achiness x19 days. Finally subsided... Read more
Dose #1 administered on 1/11/21 with terrible arm/back pain and achiness x19 days. Finally subsided 2 days before vaccine #2. Morning after does #2 I woke with awful arm pain, swelling. Hand/finger tingling and numbness has continued to worsen since . Ibuprofen and Tylenol taken x 3 days with no relief. Ice and heat also done with no relief. Pain is unbearable today. PCP contacted, waiting to hear back.
37 2021-02-07 muscle spasms, weakness Nausea/vomiting with movement of head-3 hours after shot; loss of balance with inability to walk; na... Read more
Nausea/vomiting with movement of head-3 hours after shot; loss of balance with inability to walk; nausea/vomiting while sitting or attempting to stand-2 days; leg cramps/charlie horses- 3-5 days; general weakness in arms and legs- weeks/current; difficulty with fine motor movements in fingers and weakness in arms and hands-current
37 2021-02-07 numbness, tingling, nerve pain, burning sensation On day 16 post-injection, I started experiencing left sided pins/needles/numbness. I went to the ER... Read more
On day 16 post-injection, I started experiencing left sided pins/needles/numbness. I went to the ER and they did a CT and CTA which was normal. The next day or so I went to neurology who ordered blood tests (Lyme's, Vitamin deficiencies, Sjrogen's antigens, CRP, ferritin, Copper, ACE, TSH, Vitamin D , ANA) that were all negative. Next I had a MRI of the head and spine with and without contrast which was normal. The pins and needs have now spread all over my body. I full body neuropathic pain (burning sensation, numbness, tingling, sharp pain like stabbing, left eye pain, feeling like bugs are walking on me, and zapping pain). Neurology is continuing to work up my symptoms but they were new onset after COVID vaccine.
37 2021-02-07 pain in extremity Very sore upper arm and shoulder; Very sore upper arm and shoulder/pain through shoulder and neck th... Read more
Very sore upper arm and shoulder; Very sore upper arm and shoulder/pain through shoulder and neck throughout the night; pain through shoulder and neck throughout the night; difficulty sleeping; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 14:00 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included birth control (not specified). On 15Jan2021 16:00, the patient experienced a very sore upper arm and shoulder, pain through shoulder and neck throughout the night, caused difficulty sleeping; ibuprofen helped, lasted 1 day. Therapeutic measures were taken as a result of events. Outcome of events was reported as recovered. Follow-up attempts are completed. The following information on the batch number has been requested.
37 2021-02-07 pain in extremity arm pain, redness at injection site, swelling at injection site, warmth at injection site, headache,... Read more
arm pain, redness at injection site, swelling at injection site, warmth at injection site, headache, dizziness, nausea, fatigue
37 2021-02-07 pain in extremity headache, fatigue, arm pain, dizziness, nausea, body aches
37 2021-02-08 pain in extremity, migraine First day: Fatigue Extreme Restless Leg (Advil calmed) Fever (101.4 at highest, Advil, damp washclot... Read more
First day: Fatigue Extreme Restless Leg (Advil calmed) Fever (101.4 at highest, Advil, damp washcloth on forehead) Chills Muscle ache in hips (hot rice pillow, Advil) Pain at injection site 2nd day: Lower fever (99.7, Advil, no damp wash cloth, seemed too cold) Chills Muscle ache in hips and hands (hot rice pillow, Advil) Fluttering under right breast (about 2 seconds long, happened 6 times) Start of migraine (Aleve, took edge off but not completely gone) Pain at injection site Day 3: Migraine (Aleve) Muscle aches in hands (Advil) Late in day, around 2pm, migraine turns into headache in left eye socket by around 7pm pain feels more like congestion in same area. (Aleve, doesn't seem to help much, neither does Advil) Day 4 (Morning): Headache/congested feeling in left eye socket continues (Aleve or Advil, neither help so far)
37 2021-02-09 night sweats Extreme tiredness; chills; fever; muscle aches; runny nose; sore throat; nausea; pale skin; malaise;... Read more
Extreme tiredness; chills; fever; muscle aches; runny nose; sore throat; nausea; pale skin; malaise; night sweats; This is a spontaneous report from a contactable 37-year-old Other HCP reported for herself. A 37 Years old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 on Arm left at single dose (lot: EL0140) for covid-19 immunisation. Medical history included PTSD, and anxiety. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine (LAMICTAL), clonazepam (KLONOPIN) and Zinc. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 11:45 AM arm left at single dose (lot: EJ1685) for covid-19 immunisation. Covid test date (nasal swab Rapid) on 03Jan2021: positive. The patient experienced Extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats all on 24Jan2021 12:00 AM which were non serious. No treatments were received. Outcome of the events was recovering.
37 2021-02-09 flushing Facial flushing. HR 72, O2 97%. Slight erythema of L arm injection site. Declined meds. NO SOB, resp... Read more
Facial flushing. HR 72, O2 97%. Slight erythema of L arm injection site. Declined meds. NO SOB, respiratory symptoms.
37 2021-02-09 weakness, pain in extremity Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches ever... Read more
Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches everywhere, chills, temp 99.9, no appetite, head pounding, at 15 hours later, back pain continued and wrapped around quads and down to shins and calf?s, aches stopped but stayed strong at jaw. Neck pain stopped the following morning 7am, headache persude lethargy, and weakness rest of day, more appetite but not back to normal, light headed rest of day.
37 2021-02-09 weakness Lump nodes swell; Feeling unwell; Nausea; Headaches; Dizziness; Weakness; Injection site pain; This ... Read more
Lump nodes swell; Feeling unwell; Nausea; Headaches; Dizziness; Weakness; Injection site pain; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 24Jan2021 (08:00) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the school/student health clinic. Medical history included asthma. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 24Jan2021 (14:00), the patient had "lump" nodes swelling; was feeling unwell; had nausea; headaches; dizziness; weakness; and injection site pain. The patient did not receive any treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
37 2021-02-09 pain in extremity Shortly after vaccination patient reporting nausea, chills, and headache and later developed arm and... Read more
Shortly after vaccination patient reporting nausea, chills, and headache and later developed arm and shoulder pain. Nausea, chills, and headache sooner resolved but arm pain persisted. Two days after vaccination primary care provider prescribed naproxen and tramadol and instructed patient to take acetaminophen. Two weeks after initial primary care provider visit patient returned with continued shoulder pain. Diagnosed with subacromial bursitis and provider recommended corticosteroid injections.
37 2021-02-09 weakness Tachicardia, restless night, severe weakness, strong headache, chills and sweating
37 2021-02-09 tingling, feeling hot Very heavy sweats; Entire body tingling started; Body felt hot all over; Body just felt weird and of... Read more
Very heavy sweats; Entire body tingling started; Body felt hot all over; Body just felt weird and off; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 13Jan2021 at 18:00, at a single dose, for COVID-19 immunization. The patient's medical history included allergies to penicillin. The patient's concomitant medications included ergocalciferol (VITAMIN D) and ethinylestradiol/ norgestimate (ORTHO TRI-CYCLEN). The patient was not diagnosed with COVID-19 prior to vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 15Jan2021 (day 2; also reported as 08Jan2021), entire body tingling started. On days 3 and 4 (16Jan2021 and 17Jan2021), the patient had very heavy sweats. No fever, just body felt hot all over, and body just felt weird and off in Jan2021. The side effects went away on day 9 (22Jan2021). No treatment was given for the adverse events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on 22Jan2021. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
37 2021-02-09 throat numbness Within minute of injection began to have numbness at back of throat and tongue; Within minute of inj... Read more
Within minute of injection began to have numbness at back of throat and tongue; Within minute of injection began to have numbness at back of throat and tongue; This is a spontaneous report from a contactable nurse (patient). A 37-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL1287; expiration date: unknown), via an unspecified route of administration left arm on 20Jan2021 14:45 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies before vaccination. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) and cetirizine hydrochloride (ZYRTEC). The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EH9899) at the age of 37-year-old via an unspecified route of administration left arm on 28Dec2021 11:00 AM at a single dose for covid-19 immunization. The patient received her vaccine Public Health Clinic/Veterans Administration facility. The patient reported that within minute (20Jan2021 02:45 PM) of injection, began to have numbness at back of throat and tongue. No swelling or difficulty breathing was experienced by the patient. The patient received treatment for the adverse events which included diphenhydramine 50mg IM. The patient did not have COVID tested post vaccination. The adverse event required a doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered in Jan2021.
37 2021-02-09 night sweats covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test resu... Read more
covid test date: 03Jan2021, covid test result: Positive; covid test date: 03Jan2021, covid test result: Positive; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, lot # EJ1685) at single dose at left arm on 02Jan2021 11:45 for covid-19 immunisation. Medical history included post-traumatic stress disorder (PTSD), anxiety. No allergies to medications, food, or other products. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has received no other vaccines within 4 weeks prior to the COVID vaccine. On 03Jan2021 the patient has been tested for COVID-19 with rapid nasal swab test resulted positive. It was unknown if treatment was received. The outcome of events was unknown. Later the patient received the 2nd dose of bnt162b2 (BNT162B2, Lot # EL0140) at single dose at left arm on 23Jan2021 for covid-19 immunisation, administered at Pharmacy or drug store. The patient's concomitant medications in 2 weeks of this vaccination included: Lamictal, Klonopin, multivitamins, D, C, B, Zinc. On 24Jan2021 12:00 AM the patient experienced extreme tiredness, chills, fever, muscle aches, runny nose, sore throat, nausea, pale skin, malaise, night sweats. No treatment received for the adverse events. The outcome of events was recovering.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag. Instead, the positive COVID represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
37 2021-02-10 feeling jittery, hot flush, tremor A few minutes after vaccine was given patient notes hot flashes, severe palpitations, sweating, chil... Read more
A few minutes after vaccine was given patient notes hot flashes, severe palpitations, sweating, chills, hands shaking, nausea, confusion, headache and jittery feelings. Symptoms resolved within a couple of hours after being given IV fluids, tylenol and zofran.
37 2021-02-10 feeling hot Mild tightness in chest and shortness of breath; Mild tightness in chest and shortness of breath; Te... Read more
Mild tightness in chest and shortness of breath; Mild tightness in chest and shortness of breath; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; Temperature started rising 10 hours after second dose (8:00pm). Took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had 100.0 fever; This is a spontaneous report from a non-contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EK9231, via an unspecified route of administration on 20Jan2021 10:00 dose 2 at SINGLE DOSE for covid-19 immunisation. Vaccine location Right arm, Facility type vaccine: Hospital. The patient medical history was not reported. The patient received first dose of vaccine bnt162b2 lot number=EL1284, on 30Dec2020 at 02:45 PM, vaccine location right arm. Concomitant medication included levothyroxine (LEVOTHYROXINE). The patient reporter that " on 20Jan2021 the temperature started rising 10 hours after second dose (at 8:00pm). Patient took 2 ibuprofen and went to sleep, woke up hot throughout the night. At 5:30am took 2 ibuprofen. At 6:30am had fever 100.0°. Fever continued to get under control and rise again off and on for the first 36 hours. Mild tightness in chest and shortness of breath began 24 hours after the second dose and continues 6 days later." The action taken was not applicable. Chest discomfort and dyspnoea were not recovered other event were recovering. No follow-up attempts are possible. No further information is expected.
37 2021-02-10 weakness, burning sensation, feeling cold Received my vaccine on 12/23, woke up 12/24 and was really tired as morning went on I got really col... Read more
Received my vaccine on 12/23, woke up 12/24 and was really tired as morning went on I got really cold and could not get warm, throat started to hurt, body aches and had low grade temp of 100.5, 12/25 felt the same but throat was really sore, 12/26 tested positive for Covid, 12/27 lost sense of taste and smell, 12/28 had horrible shortness of breath and burned when I breathed. 12/29 and 12/30--was very tired, body aches and generally did not feel well. 1/1 woke up and felt well, 1/2 had shortness of breath with activity and not feeling well in general. 1/3 had severe shortness of breath and tachycardia at rest--had to report to ER. 1/4-still had shortness of breath and burning while breathing and then had nausea, vomiting and diarrhea throughout the night. 1/5 went to er because I was so nausea and could not keep anything down and was having heart racing and chest pain. received fluids in er and nausea medications. 1/6, 1/7, 1/8 and 1/9 was very weak and still did not feel well, short of breath. 1/10 woke up and had lung burning, chest pain , shortness of breath and heart racing--was seen in ER for chest pain. week of 1/10 was very tired and short of breath. finally returned to work 1/18---still am short of breath, heart races and tire easily
37 2021-02-10 weakness Within the first 15 minutes of receiving the first Pfizer dose, I felt dizzy. I was felt extremely f... Read more
Within the first 15 minutes of receiving the first Pfizer dose, I felt dizzy. I was felt extremely fatigued and ended up having to go to bed at 6:00pm that day. Then days later, I began to feeling a shortness of breath that lasted about 1.5 week. I literally could not breath normally. My body would force me to yawn to get enough oxygen into my system.
37 2021-02-10 flushing upper chest flushing without urticaria
37 2021-02-14 numbness Mild Facial and tongue numbness.
37 2021-02-14 migraine The day after vaccination I lost vision for an hour then had onset migraine. Migraines continued and... Read more
The day after vaccination I lost vision for an hour then had onset migraine. Migraines continued and then had sudden onset of vertigo, ataxia, nausea, and vomiting 6 days following vaccine. I could not walk with the ataxia for several days and ended up in ED 8 days after vaccine for persistent vertigo, migraines, and nausea not improved with antivert and imitrex. I do have a history of migraines but I have never experienced this vertigo and migraines lasting days on end. I am now currently 19 days past vaccine and still with vertigo and migraines.
37 2021-02-15 flushing About 5 minutes after injection during observation patient came up complaining of dizziness and feel... Read more
About 5 minutes after injection during observation patient came up complaining of dizziness and feeling flushed. Patient appeared pale and stated a general feeling of being unwell. Paramedic and RN assessed vital signs and allowed patient to lay down. Paramedic reports clear lung sounds. She initially had a low blood pressure but it returned to normal within 5 minutes. Otherwise VSS. Color returned to face and patient began feeling better. Patient drank a small water bottle after transitioning from observation chair to lay on bench.
37 2021-02-15 weakness, feeling cold After receiving the second shot at approximately 1030AM, I returned home and felt fairly normal. In ... Read more
After receiving the second shot at approximately 1030AM, I returned home and felt fairly normal. In the evening, I started to feel very weak and developed a fever of 101.9 and took 500mg tylenol and continued to hydrate with water and powerade. Throughout the evening, I checked my temperature, it ranged from 101.9-102.8. I also developed strong chills, which caused me to shiver to the point where my significant other thought I may be seizing. (this also happened with the first shot - fevers and chills). I went to bed, waking up 3 hours later and I had to change my pajamas as I was soaked in sweat. I became nauseous and vomited a decent amount of what appeared to be red blood - but did not want to go to the ER as I was cold and exhausted and extremely feverish. Throughout the next 36 hours I continued to run a fever and struggled to do basic household chores (wash a dish, walk up and down the stairs, change shirts, etc) without assistance - normally not things I would need help with. Having had COVID nearly 90 days ago, the aftermath of the vaccination was worse than the actual illness for me.
37 2021-02-15 migraine At the time of the adverse event I was 12 weeks pregnant with my first pregnancy. Estimated due date... Read more
At the time of the adverse event I was 12 weeks pregnant with my first pregnancy. Estimated due date is 08/15/2021. Sunday afternoon developed a mild headache, about 24 hours after my second vaccine dose. As the evening progressed the headache got worse and developed into a debilitating migraine type headache. I have a history of hormonal migraine headaches, I would get them monthly, 1 week before my period would start, but have not gotten any since becoming pregnant. Because I am pregnant, I can not take my usual migraine medicine, so I took a dose of Tylenol PM extra strength, applied an ice pack to my head and went to bed. The next morning when I woke up the headache was gone and I felt fine.
37 2021-02-15 hot flush, pain in extremity Chills, drenching sweats, severe muscle and joint pain- started 12 hours after vaccine and continued... Read more
Chills, drenching sweats, severe muscle and joint pain- started 12 hours after vaccine and continued for 48hrs Headache- ongoing for 6 days; Rash (itchy with some hives) on face, arms and shoulders- showed up on day 5 post vaccine and resolved with benadryl; Hot flashes- ongoing for 6 days; Fatigue- severe for 48hrs and moderate ongoing still on day 6 post vaccine; Diarrhea- day 5 has since resolved; Arm pain- moderate for 48hrs and resolved by day 4 Lack of appetite- ongoing for 6 days; Generally I just do not feel good and am surprised many of these side effects have lasted so long.
37 2021-02-15 pain in extremity Dose 1: Moderate Pain in the arm, moderate swelling approx 4-5 hours after injection Dose 2: Sever... Read more
Dose 1: Moderate Pain in the arm, moderate swelling approx 4-5 hours after injection Dose 2: Severe pain in the arm, moderate swelling approx 4-5 hours after injection, approx 20 hours after injection: continued arm swelling/pain, joint pain, body aches, chills, nausea, x1 vomiting, headache, fatigue, fever. Slept 20 hours. Approx 44 hours after injection: same symptoms but mild, swollen axillary lymph node left arm (same as injection arm) this has lasted until today so far (2/16/2021).
37 2021-02-15 speech disorder, weakness Required Emergency room visit the day after the vaccination for dehydration and headaches. Received ... Read more
Required Emergency room visit the day after the vaccination for dehydration and headaches. Received a bag of fluids and discharged home. Over the weekend was weak and sore with delayed speech, had a full stroke workup (negative) at Emergency Department and returned to work on 2/8. However, symptoms had not resolved. Left school on 2/9 due to inability to walk due to severe muscle soreness/aching. Instructed to stay home for the rest of the week per her PCP. No further information available at this time.
37 2021-02-16 seizure At 4 Am the morning after my second vaccine I had a seizure.; I was found non responsive; blood pres... Read more
At 4 Am the morning after my second vaccine I had a seizure.; I was found non responsive; blood pressure of 227/153; This is a spontaneous report from a contactable Other Health Professional (patient). A 37-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 01Feb2021 10:00 at single dose on right arm for COVID-19 immunisation. Medical history included high blood pressure. Historical vaccine included 1st dose of BNT162B2 on 11Jan2021 08:00 am via intramuscular on right arm for COVID-19 immunisation. Patient was not pregnant. Concomitant medication included labetalol and HCTZ. At 04:00 am of 02Feb2021, after second vaccine patient had a seizure. Patient was found non-responsive with a blood pressure of 227/153. Emergency room was visited. Patient have no history of seizures and it was concluded by PCP that this was an adverse response to the vaccine. Treatment was received. Outcome of the events was recovered/resolved with sequel. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events seizure, loss of consciousness and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
37 2021-02-21 pain in extremity I was suppose to receive my 2nd Covid vaccine dose on Thursday 2/11 at the Drive Thru site; but my a... Read more
I was suppose to receive my 2nd Covid vaccine dose on Thursday 2/11 at the Drive Thru site; but my appointment got cx?d due to our weather. So it got rescheduled to Thursday 2/18 at 12p. My 1st dose was Moderna. I gave the lady my card and a Moderna sticker is clearly on it and readable. She came back to my vehicle and gave my 2nd injection; apparently she gave me Pfizer (I didn?t know that until she handed my card back to me). She handed my card back; I looked down at it and saw it said Pfizer. I said, ?What just happened? I got Moderna the 1st time why does my 2nd one say Pfizer?? She didn?t have anything to say. She then left immediately to go get someone else to talk to me. This person said I wasn?t the 1st person this has happened to. It still has the same mRNA molecules in both vaccines. She also said I shouldn?t need another dose of any vaccine. I should be okay even though I got the different vaccine. I was also told by her that when the sites run out of Moderna or Pfizer; then they are giving (employees and the public) the opposite one that they have on hand. (I don?t know how true this is but this is what I was told). After this happened I contacted my Director and my Manager and informed them of what happened. They both said I did nothing wrong Director contacted our Employee Health office. Then the Employee Health Nurse called me to check on me and get some information. Nurse called me again on Friday to see how I was and to take more information to fill out an incident report. Then she was going to talk to the Head Pharmacist again and get back to me about what he said. I haven?t heard back from her yet. I?m still upset because that incident should never have happened (and it?s bad that it happened to an employee). Our employees need to slow down. They need to make sure their name badge is visible (the lady giving mine- I never saw her badge). Then they need to verify what vaccine they have in their hand with the pt/person again before they inject it to avoid another situation from occurring like mine). What I?m more upset about is: there is no research as far as what having 1 dose of Moderna and 1 dose of Pfizer is going to do to my body?? Am I protected at all? Am I more protected? Will I have bad side effects later? We don?t know. That?s the scary part. I just don?t want this to happen to another employee or anyone else. So far the only thing I had happen to me since the injection is a painful sore left arm. I have no idea what effects I may have later...??.... from having Moderna in my system; then Pfizer.
37 2021-02-21 flushing, feeling hot Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. S... Read more
Patient was observed for 30 minutes following her vaccine and then was dismissed of, symptom free. She then returned after 12 minutes complaining of feeling hot and flushed and throat, face and arms itching. Her O2 sat was 99% on room air, heart rate 71, respiratory rate of 18. She was given Benadryl 50 mg PO and after 10 or 15 minutes stated she did not have any of noted symptoms any longer.
37 2021-02-21 weakness, discomfort Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that starte... Read more
Pregnancy EDD 5/22. Approximately 21 weeks at time of vaccination. Had flu-like symptoms that started approximately 12 hours after vaccine. I felt weak, achy and tired. Symptoms resolved around 36 hours after vaccine.
37 2021-02-22 breast pain 1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Ma... Read more
1/7 I started having breast pain. 1/8 I had a fever and chills, breast redness and diagnosed with Mastitis in my right breast. I had severe fatigue and was prescribed a 7 day antibiotics and within 3-4 days I begin to feel back to normal. On 1/8 I had a COVID test which was negative. My breast milk supply went down on the right breast until the mastitis was resolved.
37 2021-02-22 flushing Flushing and headache
37 2021-02-22 breast pain On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into t... Read more
On 2/15 I begin to have chill, body aches, headache, fatigue and breast pains which continued into the next day. I was again prescribed the same 7 day antibiotic and disagnosed again with Mastitis but this time the symptoms lasted a little longer and after about day 5 I began to feel myself again. A mammogram and an ultrasound has been ordered to see why I developed the Mastitis so frequently but is not scheduled for another few weeks out from today.
37 2021-02-22 unresponsive to stimuli Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident.... Read more
Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident. Pt noted to be slumped in chair, hives noted to forehead, diaphoretic, arms rigid, non-responsive to stimuli, Incontinent of bladder. Pt lowered to ground Zoll applied, COR called. Vital signs: 108/58 100% RA 77 26. Pt given EPI-Pen @ approx. 1352. COR Team arrived, pt mildly responsive. Assisted to Backboard and sent to ER with ED Provider. Pt was monitored in the ED for 3 hours with no recurrent symptoms. Pt advised to follow up with PCP and an allergist and avoid getting the 2nd dose of the covid vaccine.
37 2021-02-23 migraine Fatiga extrema, fiebre muy alta, escalofríos, nodulo debajo del brazo izquierdo, migraña, dolor de... Read more
Fatiga extrema, fiebre muy alta, escalofríos, nodulo debajo del brazo izquierdo, migraña, dolor de cabeza.
37 2021-02-23 pain in extremity, feeling of body temperature change Light headed immediately following vaccine (may not be related to vaccine, because I have long stand... Read more
Light headed immediately following vaccine (may not be related to vaccine, because I have long standing pre-syncope). Felt sluggish and tired the rest of the day. Overnight, I got a severe headache and throbbing in my arm where I received vaccine that kept me awake. Went to bed cold and then woke up several times very hot and sweaty, but don't know if this was related to vaccine, since this happens on occasion without the vaccine.
37 2021-02-23 tingling Patient complained of being lightheaded with tingly toes.
37 2021-02-24 pain in extremity Arm became sore and swollen and warm to the touch. Also on the 4th day showed signs of a reaction, w... Read more
Arm became sore and swollen and warm to the touch. Also on the 4th day showed signs of a reaction, with red patches and appear to mimic the after effects of a bee sting of sorts.
37 2021-02-24 flushing BP measured 168/95. Currently experiencing malignant hypertension with blood pressures averaging 180... Read more
BP measured 168/95. Currently experiencing malignant hypertension with blood pressures averaging 180/110; feel flushed; 10 weeks post partum; 10 weeks post partum; This is a spontaneous report from a contactable other healthcare professional (patient). This reporter reported information for both mother and fetus. This is the maternal report. A 37-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201) at arm left via an unspecified route of administration on 08Feb2021 16:45 at single dose for covid-19 immunisation. Medical history included 10 weeks post partum vaginal delivery without complications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included colecalciferol (VITAMIN D), enzymes nos, fungi nos, herbal nos, minerals nos, nutrients nos, probiotics nos, proteins nos, vitamins nos (ATHLETIC GREENS), and prenatal vitamin. The patient, 10 weeks post partum without any PHMx of hypertension (HTN), received vaccine and immediately started to feel flushed, was laid supine and Blood pressure (BP) measured 168/95. Currently experiencing malignant hypertension with blood pressures averaging 180/110, unable to be controlled w amlodipine prescribed by MD. Event onset date was 10Feb2021 12:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events malignant hypertension and feel flushed was not recovered.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded assuming a plausible temporal association and considering the known safety profile of the product. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate ,Linked Report(s) : US-PFIZER INC-2021167922 mother/child cases
37 2021-02-24 pain in extremity Fatigue and muscle aches that interfered with normal daily activities, stayed in bed for about 2 day... Read more
Fatigue and muscle aches that interfered with normal daily activities, stayed in bed for about 2 days. Sore arm. No fever or other symptoms. Pregnant 30 weeks and 5 days at time of second dose administration. Estimated date of delivery 2021.
37 2021-02-24 tenderness, pain in extremity, tremor I received my second dose of the Pfizer Covid vaccine on 01-13-2021 at 8:30am in my left upper arm. ... Read more
I received my second dose of the Pfizer Covid vaccine on 01-13-2021 at 8:30am in my left upper arm. By 3pm that day, my left arm was very tender to the point I couldn?t lift it up and I began having whole body chills and shivering along with extreme fatigue. I went to bed at 5:30pm that night and woke up around 11:30pm to my whole body shaking and shivering and my teeth where chattering together. My husband said I was confused at that time and kept repeating that I was freezing. I must have had 5 blankets piled on top of me to try to get me to warm up. By the next morning, I soaked through the bedsheets and had extreme fatigue (like I had a hard time keeping my eyes open) all over body aches, fever and chills. I remained this way for the next week. At the end of the 1st week I still had chills, extreme fatigue, nausea and horrible headaches and my left arm pain turned into left elbow joint pain. By the end of the 2nd week, I still had extreme fatigue, headaches and left elbow pain along with body tremors. On 1-28-2021, I went to the hospital due to having two episodes where I felt so dizzy I had to lay down on the ground until the dizzy spells subsided. I was given IV fluids and sent home with orders to rest. By the end of the 3rd week I no longer had body tremors or dizzy spells but I still had extreme fatigue needing multiple naps a day along with headaches at which time my primary doctor prescribed me Imitrex to help alleviate the headaches and I still had left elbow joint pain. I also developed bronchitis. It is now February 25, 2021 and I am still having fatigue and mild to moderate headaches along with the left elbow joint pain along with some right elbow joint pain. I have been out of work for over a month now due to my fatigue and joint pain.
37 2021-02-25 flushing SOB, facial flushing, tachycardia, dizziness, cleared by EMS
37 2021-02-27 tremor Fever, chills, body ache, headache, arm- vaccine site pain, cold all day, very shaky
37 2021-02-27 flushing Immediately after vaccine felt flushed with high heart rate and lightheaded. An hour after, develope... Read more
Immediately after vaccine felt flushed with high heart rate and lightheaded. An hour after, developed chronic mild headache, chronic mild lightheadedness, and chronic moderate fatigue which are expected symptoms with the immune response. HOWEVER, symptoms did not improve in 3 days and actually very slowly worsened until I couldn?t function for work about 2.5 weeks after the vaccine. At this point, the lightheadedness and fatigue were severe and headaches varied between moderate to severe, resulting in me being out of work for 9 consecutive work days. Had multiple MD visits with tons of tests. During the time I was out, I developed severe lower abdominal pain for two days and severe lightheadedness/nausea/mild vomitting due to being nauseated with chronic headaches. OTC meds did not help much for the headaches nor other symptoms. I have never dealt with symptoms like these before and am very healthy. At the 4.5 week mark post vaccine, these symptoms finally started to very slowly improve, VERY slowly. Tests at MD were inconclusive. I?m still dealing with chronic mild headaches, lightheadedness, and this past Friday now unusual chest pains that move location and severity.
37 2021-02-28 bell's palsy, pain in extremity, numbness, facial paralysis 2/19/21 patient notice lump under Lt arm (painful), which resolved in 1 week. On 2/25/21 she felt ti... Read more
2/19/21 patient notice lump under Lt arm (painful), which resolved in 1 week. On 2/25/21 she felt tightness and pressure on Lt side of the neck and behind Lt ear which was progressing to numbness. On 2/28/21 she noticed LT facial droop and consulted her MD, who diagnosed her with Bell's Palsy and informed her that could be a side effect from Covid 19 vaccine.patient says that her Lt side of face is still numb and she cannot close her Lt eye, which causes dryness and discomfort. She was started on antiviral medication and steroids by mouth.
37 2021-02-28 weakness 2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomac... Read more
2nd dose: Fever; extreme chills; all over muscle aches; loss of taste; extreme fatigue; upset stomach; dehydrated; weakness; loss of appetite; chest tightness; feel like a panic attack; This is a spontaneous report from a contactable Other Healthcare Professional, the patient. A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly on 19Jan2021 at 11:00 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient has no allergies to medications, food, or other products. Historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1686) on 30Dec2020 at 19:00 intramuscularly as a single dose in the right arm for COVID-19 vaccination after which the patient experienced fatigue, muscle soreness in neck and shoulders and vaccination site pain. The patient was not pregnant at the time of vaccination. The vaccination was administered in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MIDOL) and ibuprofen(MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 19Jan2021 at 23:30 she began to experience fever, extreme chills, all over muscle aches, loss of taste for a day ,extreme fatigue, upset stomach, dehydrated, weakness, loss of appetite, chest tightness that would come and go making it feel almost feel like a panic attack. She further stated that she has lingering side effects such as extreme fatigue, muscle aches and chest tightness after day three of receiving this second dose that comes and goes. Currently on day seven and still have those lingering three side effects. Fatigue has been extreme at times. The patient did not receive any treatment for the events. The clinical outcomes of the events Fever, extreme chills, myalgia, loss of taste, extreme fatigue, upset stomach, dehydration, weakness, loss of appetite, chest tightness and panic attack were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107223 Same reporter, Same product, Same patient, same and different events (First Dose)
37 2021-02-28 numbness Client vaccinated during drive-through event, in a remote, rural setting approx 40 minutes from near... Read more
Client vaccinated during drive-through event, in a remote, rural setting approx 40 minutes from nearest hospital, and instructed to wait 30 min due to past h/o anaphylaxis. At 20 min post-vaccine, she reported feeling "funny," with swelling, tightness, and numbness in her face and inside of her mouth, although "not as bad as last time." Noted to be tachy in the 130's, and making constant mouth movements due to the increasing numbness. After brief explanation, adult Epipen admin to rt thigh. O2 sat remained in upper 90's throughout, and no resp distress was ever noted. BP fluctuated between 96/60 and 142-92 during the course of management. 50mg IM diphenhydramine followed the Epipen, as ambulance was enroute, unknown ETA. With constant monitoring, client reported chest tightness and variable feeing of swelling, tightness, and numbness inside her mouth and face/chin. After 20 min, with some improvement of symptoms, transported by ambulance to ED, where she received continued monitoring and steroid admin. According to ER note, she was released to home after some hours of observation.
37 2021-02-28 migraine HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migrain... Read more
HSV 1 eruption and subli; withdrawal bleeding 3 days late and heavier and longer than usual; migraine; Left index finger petechiae; had an insect bite; lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile); temperature was 101 F; Acne flare-up; no withdrawal bleeding and she was on oral contraceptive pill (OCP)/withdrawal bleeding 3 days late; woke up at 2:00 AM and 2:35 AM because of the tenderness rolling over and she had to take central analgesia to be able to sleep; puffy face; tenderness at the site of injection; Constipation; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), via an unspecified route of administration on the left arm, on 06Jan2021 15:45, at single dose, for covid-19 immunization. The patient has no medical history; unknown if there were any allergies. Concomitant medications included oral contraceptive pill (OCP) and multivitamins. The patient had no Covid prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the Covid vaccine. She took pre-vaccination analgesia. The vaccine was given at the hospital. On 06Jan2021 (day 0) she experienced tenderness at the site of injection. She also experienced constipation on 06Jan2021. However, she couldn't "comment" about temperature since she was taking NSAIDs. She woke up at 2:00 AM and 2:35 AM on 07Jan2021 (day 1) because of the tenderness rolling over and she had to take central analgesia to be able to sleep. On 07Jan2021 she experienced tenderness at the site of injection and; puffy face but it wasn't angioedema. Her O2% was "99-98% repositioning" on 07Jan2021. She still had constipation and still couldn't comment about temperature since she was taking NSAIDs. On 08Jan2021 (day 2) she had an acne flare-up; and no withdrawal bleeding and she was on oral contraceptive pill (OCP). For the constipation she started on OTC fiber gum. On 09Jan2021 (day 4) she experienced lymphadenopathy on the left deltopectoral (1x1 cm tender freely mobile) and on the left supraclavicular (2x1 cm tender freely mobile) which hadn't resolved. She still was experiencing constipation. Her temperature was 101 F on 09Jan2021. On 10Jan2021 (day 5) she had withdrawal bleeding 3 days late and heavier and longer than usual, migraine, constipation, and left index finger petechiae because on "23/11" she had an insect bite on 10Jan2021. On 11Jan2021 (day 6) her lymphadenopathy on the left posterior cervical (1x1 cm tender freely mobile) hasn't resolved; she still had migraine and was now back to regular bowel habit. On 15Jan2021 (day 10) she had HSV 1 "eruption and subli". She received treatment (also reported as symptomatic treatment) for all these adverse events. At the time of the report, she recovered from constipation on 11Jan2021 with lasting effects; while she also recovered from all the other remaining adverse events on Jan2021 with lasting effects. She has not been Covid-tested post-vaccination.
37 2021-02-28 pain in extremity Raised red circular lump at the injection with left arm soreness. Treatment: Tylenol with improveme... Read more
Raised red circular lump at the injection with left arm soreness. Treatment: Tylenol with improvement of soreness. Outcome: Continue to work does not interfere with ADLs. Recommend to use OTC hydrocortisone cream.
37 2021-02-28 weakness Received the 1st dose February 24th at 11am. Around 4:00 pm started feeling extremely fatigued and t... Read more
Received the 1st dose February 24th at 11am. Around 4:00 pm started feeling extremely fatigued and that progressed all evening. Fatigue has persisted for 4 days. Starting Friday February 26th I've had a sore throat, congestion and very sore weak joints. Sunday the 28th being by far the worst day. Today Monday March 1st I am feeling some better but not great.
37 2021-02-28 pain in extremity Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fa... Read more
Soreness in arm extending beyond injection site; Soreness in arm extending beyond injection site; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) via an unspecified route of administration on 28Dec2020 (at the age of 37-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hepatitis C. The patient was not pregnant at the time of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included buprenorphine, naloxone (SUBOXONE); bupropion (WELLBUTRIN); meloxicam; and lamotrigine (LAMICTAL); all from unknown dates for unspecified indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have allergies to medications, food, or other products. On 28Dec2020 the patient experienced soreness in arm extending beyond the injection site and fatigue for 2 days. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 tests on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 with results of negative. The patient did not receive treatment for the events. The events did not cause hospitalization. The outcome of soreness in arm extending beyond injection site was not recovered. The outcome of fatigue was recovered. No follow-up attempts are needed. No further information is expected.
37 2021-02-28 pain in extremity arm started to get sore; This is a spontaneous report received from a contactable consumer (patient)... Read more
arm started to get sore; This is a spontaneous report received from a contactable consumer (patient). A 37-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration on the left arm, on 26Jan2021 12:00, at single dose, for covid-19 immunization, at the workplace clinic. There were no medical history and concomitant medications. The patient has no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in four weeks. On 26Jan2021 at 17:00, the patient's arm started to get sore and continued to get more sore throughout the evening. It was much better when she woke up in the morning of 27Jan2021, and the pain was fully resolved by 17:00 on 27Jan2021. No treatment was given for the event. The patient recovered from the event on 27Jan2021 at 17:00.
37 2021-02-28 pain in extremity extreme body fatigue, chills (~10 hours); heavy/sore arm (48 hours)
37 2021-03-01 feeling hot 12 hours after vaccine administration I felt intense heat throughout my body and my heart rate incre... Read more
12 hours after vaccine administration I felt intense heat throughout my body and my heart rate increased to 167. This happened 4 times in 1 hour then ended. I called 911 fearing of a heart attack.
37 2021-03-01 tingling On 2/17 woke up with 102.3 fever, tongue, lips, eyes swollen, inside mouth/throat irritated, injecti... Read more
On 2/17 woke up with 102.3 fever, tongue, lips, eyes swollen, inside mouth/throat irritated, injection site red and swollen, tingling down left arm extreme fatigue. Increased Blood Pressure and Heart rate
37 2021-03-01 muscle spasms Right shoulder vaccine injury with pain beginning on 1/28/2021. Vaccine injected too high resulting ... Read more
Right shoulder vaccine injury with pain beginning on 1/28/2021. Vaccine injected too high resulting in Right shoulder and neck pain, spasms and bursitis. PT, steroids and pain meds. Treatment ongoing.
37 2021-03-01 pain in extremity Shortly after the shot was administered my left arm started hurting. Nothing too bad. Later that nig... Read more
Shortly after the shot was administered my left arm started hurting. Nothing too bad. Later that night it became extreme. I took Ibuprofen for it and went to bed early. I had a hard time sleep because it hurt so badly. The next day I couldn't move my arm without assistance from the other arm. Thursday, 2/25/21, over night I developed a cough and woke up with a sore throat that progressively got worse as the day went on. Fatigue and body aches accompanied this as well. Friday morning, 2/26/21, my arm was 75% better, but my throat, cough, body aches, and overall fatigue were getting worse. I decided on getting a covid test before going to work that morning. I went to urgent care in and took a rapid test as well as a PCR test. Both rest resulted in negatives. Over the weekend my symptoms were staying the same. The sore throat and cough were progressing. By Monday, 3/1/21, mid morning the Doctor I work for sent me to a walk in clinic for another rapid and PCR covid test. Rapid came back negative and PCR is still pending. The girl assisting me suggested I report my symptoms. I haven't been since even with a minor cold since 2009. I woke up Tues. ,3/2/2021, with white pustules on my throat and very hard to swallow along with very heavy brain fog. I have not had any fever this whole time. I take my temperature multiple times a day. I am starting on a 3 day dose of a zpak today, 3/2/21.
37 2021-03-02 flushing Hives, flushing, headache, itchiness began about an hour after administration of the vaccine Tylenol... Read more
Hives, flushing, headache, itchiness began about an hour after administration of the vaccine Tylenol, Famotidine Symptoms began to subside about 20 minutes after administration of medication
37 2021-03-02 discomfort I got uncontrollable chills for 2 hours, a fever of 100.6 that has lasted at least 23 hours as of th... Read more
I got uncontrollable chills for 2 hours, a fever of 100.6 that has lasted at least 23 hours as of the time of submission, extreme body aches, breast tenderness, and a headache that felt like my skull was being crushed in--the worst of my life.
37 2021-03-03 pain in extremity 102 fever chills body aches headache sleepy arm pain nausea from 2/14/21 at 1 AM - fever broke at 4... Read more
102 fever chills body aches headache sleepy arm pain nausea from 2/14/21 at 1 AM - fever broke at 4 PM, felt off the next day as well, but OK to work etc.
37 2021-03-03 cold sweat PT STATED SHE IS NORMALLY FATIGUED AND LETHARGIC AFTER VACCINES. NORMALLY TAKES BENADRYL AFTER VACCI... Read more
PT STATED SHE IS NORMALLY FATIGUED AND LETHARGIC AFTER VACCINES. NORMALLY TAKES BENADRYL AFTER VACCINES. PT WAS ADMINISTERED VACCINE AND WAS IN OUR OBSERVATION AREA AND STARTED COMPLAINING OF CHEST TIGHTNESS, CLAMMY HANDS AND LIGHTHEADEDNESS. PROVIDER APPROACHED PATIENT AND PT COMPLAINED OF SOME THROAT TICKLING BUT NO BREATHING ISSUES. EMS ASSIST WAS CALLED. WHEN EMS ARRIVED TO THE PT, SHE VOMITED. EMS TRANSPORTED PT TO ER.
37 2021-03-03 numbness, tingling Restless leg syndrome, muscle pain, joint pain, chills/fever, cold/numb hands and feet, tingling arm... Read more
Restless leg syndrome, muscle pain, joint pain, chills/fever, cold/numb hands and feet, tingling arms and fingers, dizzy, nausea, head pressure, headache, brain fog,/slow sensitive to cold/heat/body temperature fluctuations, heart palpitations, Acetaminophen, Ibuprofen, Naproxen -- > no relief from even the higher doses
37 2021-03-03 difficulty speaking Throat swelling, tongue tingling, voice change
37 2021-03-03 tingling, numbness patient states had small reaction to Gardasil vaccine with numbness and tingling, wanted to continue... Read more
patient states had small reaction to Gardasil vaccine with numbness and tingling, wanted to continue with covid 19 vaccine. she had vaccine and immediately after receiving vaccine stated with itching and tingling. Gave her 50mg Benadryl and still having numbness and tingling and states " Throat was closing up. Gave epi-pen and symptoms improved then transported to ER.
37 2021-03-04 difficulty speaking 3:08pm 37yo active duty female presents with a change of voice and swelling of the throat and tingli... Read more
3:08pm 37yo active duty female presents with a change of voice and swelling of the throat and tingling tongue. Patient denied any difficulty breathing and was able to swallow and control secretions. Patient has had an anaphylactic reaction with pork and beef in the past. Patient states she is on numerous amounts of medication. Epinephrine was delivered via IM on right thigh at approximately 3:08pm. EMS was called at 3:10pm and arrived at 3:13pm. At 3:11pm, patient reported tongue was no longer tingly but still numb. SPO2 98%, HR110, BP 148/100. Patient was released upon stabilization.
37 2021-03-04 discomfort Hives all over body. Started as red bumps like big bites and then turned into hives 2 days later. Ve... Read more
Hives all over body. Started as red bumps like big bites and then turned into hives 2 days later. Very itchy and uncomfortable. Went to a dermatologist and she gave me a steroid to clear it up. Never had hives or any other skin condition prior.
37 2021-03-04 numbness Left side of face and neck became numb like I was given Novacaine. Last for over 48 hours with gradu... Read more
Left side of face and neck became numb like I was given Novacaine. Last for over 48 hours with gradual decrease in numbness after 12 hours
37 2021-03-04 migraine Migraine pt has history of migraines and pressure started 1407 and then continued to get worse. pt... Read more
Migraine pt has history of migraines and pressure started 1407 and then continued to get worse. pt instructed to rest a bit longer in observation area and started feeling better 1500
37 2021-03-04 face paralysis Right sided transient facial weakness of lower half of the face. First noted in the morning, asymmet... Read more
Right sided transient facial weakness of lower half of the face. First noted in the morning, asymmetric smile, difficulty moving lower half right side of face, improved throughout the day, fully resolved within 3 days.
37 2021-03-05 flushing Flushing, swelling of upper left lip. Itchiness on face, brain fog. BP 150/105 (pulse 119). Final BP... Read more
Flushing, swelling of upper left lip. Itchiness on face, brain fog. BP 150/105 (pulse 119). Final BP 129/97 (pulse 93).
37 2021-03-05 numbness Numbness to right side of cheek/lip Rash to bilateral hands/arms/abdomen/legs/back/chest Arm injecti... Read more
Numbness to right side of cheek/lip Rash to bilateral hands/arms/abdomen/legs/back/chest Arm injection pain. Mottling to skin all over Warmth radiating up my arm to my face where it?s numb Body aches
37 2021-03-06 feeling hot COMPLAIMED OF FEELING HOT, STOMACH UPSET, BLURRY VISION, LIGHT HEADED, VS BP - 97/72 HR 81, OBSERVED... Read more
COMPLAIMED OF FEELING HOT, STOMACH UPSET, BLURRY VISION, LIGHT HEADED, VS BP - 97/72 HR 81, OBSERVED 30 MINS, OFFERED WATER AND PATIENT CONSUMING, BP RECHECKED POST 30 MINS NOW 118/72. PATIENT STATES FEELING BETTER, AND NEEDS TO EAT.
37 2021-03-06 tremor Dizziness, shaky, HA- cleared by medics
37 2021-03-06 tingling, numbness I received the shot in my left arm. Tingling in left side of face on cheek bone started shortly afte... Read more
I received the shot in my left arm. Tingling in left side of face on cheek bone started shortly after I received the shot. I let the pharmacist know and I waited a bit longer. I thought it was maybe from anxiety and I was clenching my teeth. Throughout the morning the tingling spread throughout my left cheek and top and bottom jaw on left side, felt some numbness. Also felt some tingling and numbness in my left hand and lower part of left arm. Off and on tingling went through back of neck into my head on my left side. Tingling in cheek hung around all day and is still there this evening.
37 2021-03-06 pain in extremity Severe left arm/shoulder pain, unable to sleep first night due to the pain despite taking Tylenol an... Read more
Severe left arm/shoulder pain, unable to sleep first night due to the pain despite taking Tylenol and topical voltaren gel.. as of today 3/7/2021 there is still discomfort in the shoulder joint specially with movement, but not severe pain
37 2021-03-07 pain in extremity 2 days after receiving my first dose of the Pfizer vaccine I experienced moderate pain in my lower r... Read more
2 days after receiving my first dose of the Pfizer vaccine I experienced moderate pain in my lower right leg. I was uncertain where the pain came from (I did not injure myself, etc.) it took approximately a week, but the pain subsided. I received my 2nd dose, and again, 2 days later I just started experiencing the same pain in the same exact spot in my lower right area of my leg,
37 2021-03-07 tingling Felt tingling in RUE (resolved), followed by throat tingling. Patient self-medicated with Benadryl 2... Read more
Felt tingling in RUE (resolved), followed by throat tingling. Patient self-medicated with Benadryl 25 mg PO. Felt throat tightening - consulted with provider, who gave Benadryl 50 mg IM. Vitals within normal limits. Resolved.
37 2021-03-07 feeling hot While in observation, patient reported being very hot and itchy. Rash on chest, neck and arms. Com... Read more
While in observation, patient reported being very hot and itchy. Rash on chest, neck and arms. Complaining of throat feeling a little tight prior to going to ED. While in Ed, given famotidine, solumedrol, and Benadryl. Prescribed EpiPen, famotidine and prednisone at discharge. Patient states she has rash on chest, neck and arms after 1st vaccine and was given Benadryl and steroid shot.
37 2021-03-07 pain in extremity Within 12-14 hours from receiving the 1st dose of the vaccine, I began to have symptoms that initial... Read more
Within 12-14 hours from receiving the 1st dose of the vaccine, I began to have symptoms that initially started as general malaise, fatigue, and muscle and aches and pains. By 2am On 2/09/21, I began having chills and by 6am, I had a fever of 101. F. Pain at the injection site started to develop , which I understood is a normal side effect of vaccines in general, but then over the course of hours to days, the pain began to radiate up my arm to my shoulder, and up my neck, to my head where a severe headache would ensue and render me unable to perform my daily activities. For days I was feeling unwell causing me to call out sick from my job as a nurse more than once. I also feel pain in my axilla and breast tissue adjacent to my arm pit, directly beneath the injection site. I also experienced nausea when the headache and muscle aches were at their worst. The fever eventually subsided after a few days, but the headache has persisted despite taking Ibuprofen as directed by my physician via a telehealth visit on day 3. (I called for an appointment on day 2, but they only had the next day available.) The headache pain is heavy, sharp, piercing, and throbbing, definitely interrupting with my daily activities. I have to go lay down and apply an ice pack to my head and neck area several times a day. These symptoms had been persisting for several days in a row and after being seen by my doctor again on the 8th day because of the symptoms, she recommended I go to the emergency room to address the persisting headaches and rule out any head bleeding and report the symptoms related to the vaccine. I was also advised by my physician to consider skipping the 2nd dose of the vaccine because of my severe reaction to the first one.
37 2021-03-08 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA Sore arm - started an hour later until 3/9 around 2pm Injection... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Sore arm - started an hour later until 3/9 around 2pm Injection site soreness - started about an hour later and has continued Fatigue - started about 10pm on 3/7 until around 11pm on 3/8 Body aches - started about 10pm on 3/7 until 12pm on 3/9 Headache - started about 10pm on 3/7 until 12pm on 3/9 Swollen lymph nodes on left side, behind hear and throat - started about 10pm on 3/7 until 2pm on 3/9 Sore throat on left left - started about 10pm on 3/7 and has continued
37 2021-03-08 pain in extremity Sore arm the following day. More prominent when raised arm above my head.
37 2021-03-08 slurring VACCINE L ARM @0732. DURING CHECK OUT, AFTER 15 MINUTES, REPORTED RACING HEART, "HEAD WOOZY", AND FA... Read more
VACCINE L ARM @0732. DURING CHECK OUT, AFTER 15 MINUTES, REPORTED RACING HEART, "HEAD WOOZY", AND FATIGUE. ON EXAM, SOME SLURRING OF SPEACH AND EYES CLOSED- IMPROVED AFTER 10 MINUTES. MEDS: CYMBALTA, CELEBREX, ZYRTEC, MINIPRES. MINITORED ADDITIONAL 30 MINS. WALKING, TRANSFERRED TO STRETCHER WITHOUT DIFFICULTY. RELEASED AT 0830.
37 2021-03-09 feeling hot Patient experienced sweating, dizziness and tingling on the mouth. She was sweating profusely and fe... Read more
Patient experienced sweating, dizziness and tingling on the mouth. She was sweating profusely and feeling hot. Pharmacist gave her Benadryl and after 20 minutes , she said she felt better . Observed the patient for few more minutes until she was okey. Patient advised to call primary care doctor if anymore reaction.
37 2021-03-09 flushing Patient reported swelling of arm and feeling dizzy. She laid on the ground and became panicked. Wi... Read more
Patient reported swelling of arm and feeling dizzy. She laid on the ground and became panicked. Within a couple of minutes she started getting red blotches that could be seen on her chest and neck area and started to flush. She was given benadryl. Symptoms resolved after several minutes.
37 2021-03-09 numbness, facial pain The left side of my face swelled a bit, became red and numb. By the next day, the redness and swell... Read more
The left side of my face swelled a bit, became red and numb. By the next day, the redness and swelling has mostly disappeared, but the numbness is still there. I can feel it in my ear, my eye, my teeth, lips, and whole left side of my face just aches.
37 2021-03-09 numbness woke up with eye swelling. Now with jaw and chin numbness
37 2021-03-10 speech disorder, pain in extremity 2 hours after injection got extremely tired and had rashes similar to that of a scalding water burn ... Read more
2 hours after injection got extremely tired and had rashes similar to that of a scalding water burn on the tops my feet. They are circular in shape and the skin between my toes hurt. The rash covers the majority of the tops of my feet. They are itchy. I have almost slept since 8pm last night and it is now 3:15 the following afternoon. My husband had difficulty waking me up. I have been extremely foggy and jumbleing my words each time I wake up and when I try to text I dont realize I'm typing words that do not make sense. I also have the normal symptoms like headache and sore arm. Tops of my hands seem puffy and red. Extreme thirst and hunger.
37 2021-03-10 bell's palsy ADVERSE EVENT - BELLS PALSY- RIGHT TREATMENT - DELAYED TO JUST OVER 72 HOUR FROM ONSET - EVENING 2/2... Read more
ADVERSE EVENT - BELLS PALSY- RIGHT TREATMENT - DELAYED TO JUST OVER 72 HOUR FROM ONSET - EVENING 2/23/21 PREDNISONE 60 MG ORALLY DAILY FOR 7 DAYS & VALCYCLOVIR 1 G TID FOR 7 DAYS NEAR TOTAL RECOVERY BY 3/8/21
37 2021-03-10 migraine, tremor Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingl... Read more
Aprox 3 min after injection, broke out in rash and hives, severe itching in neck, face, chest, tingling lips and shaking. EMS was on scene at clinic immediately removed me from car and checked vitals, BP was high 176/94, took by ambulance to ER at Medical Center. Treated in ER for 4.5 hours. Developed migraine, received benadryl, steriods,and medicine for the migraine. Sent home told take benadryl for 2 days and do
37 2021-03-11 numbness, pain in extremity 10 minutes after vaccination the entire left hand side of my face went numb as if I'd had a dental p... Read more
10 minutes after vaccination the entire left hand side of my face went numb as if I'd had a dental procedure (I was injected on the left side). The nurses on site looked me over and said I was ok to go home at the end of my wait time. The effect faded as the day went on and was gone the next morning. I was vaccinated on a Tuesday morning and on the following Thursday morning I woke up with swelling covering almost my entire bicep area on the side I was vaccinated. The area is about 8 inches by 4 inches. It is swollen, red, hard to the touch, painful and mildly itchy. As of today (Friday) it has gotten a couple of inches bigger and not improved at all.
37 2021-03-11 hot flush After 60 minutes from receiving the first shot my face became flush and hot like a bad sunburn. Thi... Read more
After 60 minutes from receiving the first shot my face became flush and hot like a bad sunburn. This only showed on my cheeks and a little on my forehead in color and felt hot to touch. The rest of my face being warm but not with the red coloring. The flush coloring faded after 4 hours and my face felt less hot but still warm. I didn't take anything but water and some food. A bad headache was included in this feeling and now my face feels and looks closer to normal after 9 hours. I did not run any fever and I did feel that laying down was the only thing to do. Yet while resting, lights flashed from my right side to the center (when looking into the darkness) which was very new and different. I only mention this as I have no clue how that could be related but I've never experienced this...
37 2021-03-11 numbness, tingling Immediately after injection I felt a tingling in my back that went away within 25 minutes. My left a... Read more
Immediately after injection I felt a tingling in my back that went away within 25 minutes. My left arm started tingling/feeling numb in small areas starting days after injection from vaccine site up to my neck. Days later it spread down to my left hand. It has now been over a month straight of my entire left arm and left hand tingling/feeling numb, with my hand and fingertips being the worst. The symptoms affect me all day every. I?ve also had very bad headaches with the pain behind my eyes multiple times a week since the injection.
37 2021-03-11 flushing Patient began feeling tongue swelling, tightness in throat, progressed to headache, flushing, chest ... Read more
Patient began feeling tongue swelling, tightness in throat, progressed to headache, flushing, chest tightness. Patient refused 911-EMS. Ambulated to ER, escorted by RN.
37 2021-03-11 tingling Received 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead o... Read more
Received 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Developed Shortness Of Breath, tingling in arm and chest, heavy arm. VSS. Observed and symptoms resolved with 20 minutes. Released home
37 2021-03-12 tingling 1)Tingling sensation in legs, more noticeable with movement 2) menstruation cycle full flow slowing ... Read more
1)Tingling sensation in legs, more noticeable with movement 2) menstruation cycle full flow slowing , cycle normal 3-5 days, slowing after 2 Days
37 2021-03-12 tremor Chills/shaking, sweating, body aches, blinding headache- 11 hours after shot Fever 24 hours after sh... Read more
Chills/shaking, sweating, body aches, blinding headache- 11 hours after shot Fever 24 hours after shot
37 2021-03-13 pain in extremity The next day my arm was very sore. I got a painful, red, itchy rash at the injection site. It was... Read more
The next day my arm was very sore. I got a painful, red, itchy rash at the injection site. It was also very hot to the touch. Today is Sunday and it?s pretty much better. Still a little sore but the rash is mainly gone and it?s no longer hot. Other than the rash I got a headache, tiredness, and muscle aches on the following day after injection 03/10 but those only lasted that day.
37 2021-03-14 muscle spasms, pain in extremity 36 hours after 2nd vaccination experienced episode of rapid onset, violent chills similar to muscle ... Read more
36 hours after 2nd vaccination experienced episode of rapid onset, violent chills similar to muscle spasms. This resulted in difficulty breathing and inability to stand. Also experienced abnormally heavy menstrual bleeding starting 30 hours after vaccination. Other symptoms included arm pain and swelling, severe headache and joint pain, lymph node swelling, fatigue, nausea, loss of appetite, diarrhea and dizziness and tachycardia upon standing.
37 2021-03-14 pain in extremity, weakness, numbness Tongue, lips, face went numb at around the 5 min mark. Then hands and arms. I was dizzy and weak, ha... Read more
Tongue, lips, face went numb at around the 5 min mark. Then hands and arms. I was dizzy and weak, had a hard time walking. I noticed my vision was blurred. I couldn't see freckles on my arms that I usually can see. After 40 mins the numbness improved. On the drive home I was swept with head-to-toe numbness for about a min with the feeling like I was going to throw up and chest pain. The chest pain continued to come and go a few times for the next 10-12 hours. I was very dizzy and very weak. My vision went back to normal about 5 hours later. But I remained dizzy and weak for about a week. I still have dizziness on and off throughout the day that I never had before though. All those symptoms I feel like are outside of what was expected and concern me but other than that I had symptoms that I expected as well like my arms was sore for maybe 3 hours total the day after, I was tired, and had an elevated temp around 100 degrees.
37 2021-03-15 cold sweat 2 nd dose Covid19 vaccine , Pfizer on 3/11 at 3 pm She start feeling sick on 3/12 at 3 am : fever... Read more
2 nd dose Covid19 vaccine , Pfizer on 3/11 at 3 pm She start feeling sick on 3/12 at 3 am : fever up to 103 F , cold sweats , body aches , she was in bed for 2 days This morning fever is 102 F Since yesterday - sore throat and blisters in her mouth and lips, feeling fatigue like running 1 mile No cough , no shortness of breath , no dyspnea of exertion Fine dry rash on face ( not itchy) and at the side of injection ( itchy) + nausea, no vomiting Appetite is fine No diarrhea Taking over the counter - Tylenol
37 2021-03-15 unresponsive to stimuli Scenario: Pharmacist administered immunization and patient had immediate reaction to imz. The patie... Read more
Scenario: Pharmacist administered immunization and patient had immediate reaction to imz. The patient has multiple health conditions such as lupus, cerebral palsy, and is currently on dialysis. She indicated on the PQCF that she had never had an adverse reaction after a vaccine but after the incident, her husband indicated this was normal and not uncommon. SIG: Pharmacist Administered Immunization What happened (Describe in detail, what occurred)? * The patient came in for a covid vaccine; this was the first of a 2 series of Pfizer. * The pharmacist injected the immunization and a few minutes afterwards the husband called for the pharmacist to come because his wife didn't feel well. She immediately became unresponsive and her eyes rolled back into her head but she came to. She was responding somewhat to questions but she was also slightly mentally impaired at baseline due to her co-morbidities. She never fell to the ground or wanted to lie down, so not a true faint. * The pharmacist offered to call 911 but they both declined. The patient was given water and a banana and taken to a private area to recover until she fell well enough to leave. How did it happen? * The Pharmacist administered an appropriate, routine vaccine per protocol. *Patient had an somewhat immediate reaction (~4 minutes) after the vaccine. *The pharmacist followed the adverse event protocol. CPR was not administered nor benadryl. Why did it happen (Root Causes)? * Unknown; patient has no known allergy to the vaccine but has had adverse reactions to different procedures in the past. Plan of Action * Make sure all pharmacists are refreshed and aware of the adverse reaction protocol. *Document reaction as a SCRT and with VAERS. What specific task will take place to prevent future recurrence? *N/A. Who: * Pharmacist Where: * clinic When: *All pharmacists at location must review by 3/20.
37 2021-03-15 one side paralysis The patient was observed for 15 minutes in the observation area without incident. She arose and wal... Read more
The patient was observed for 15 minutes in the observation area without incident. She arose and walked to the exit and then apparently fainted on the sidewalk outside the vaccination clinic. She was attended to by medical staff on site and because she was responding slower than expected and complained of pain on the right side of her head and weakness of her left arm and leg an ambulance was called via 911. Care was assumed by paramedics who placed her in the ambulance where she was warmed and examined further. She eventually denied any continuing pain or weakness (per ambulance crewman) and she was released to the care of her boyfriend / fiance.
37 2021-03-15 pain in extremity Two hours you noticed swelling but I didn't think much of it. I started feeling a little weird and p... Read more
Two hours you noticed swelling but I didn't think much of it. I started feeling a little weird and pain in the arm. About 01:00, I woke up and I was in a lot of pain. I had hives all over me. Hives were spreading all over my body: hair; arm with the injection; we called 9-1-1 I went to the hospital. They gave me some meds through IV. By that time, I had taken Bendryl and I was there about 4 hours with IV. I felt better but hives didn't subside. That Sunday afternoon they started getting worse again and I went back to the hospital (16th)and they gave me rounds of something through IV. On 17th, I went back to hospital - they gave me another shot for the hives. I worked on the 18th - but was they said I should go home because I didn't look well. My lip started swelling that night. On the 19th, I went to my doctor and the Dr, used an epi-pen on me and gave me a shot of something for the welts still on my body. They still didn't go away. Symptoms have calmed down - but I still have spots on me. I am on Prilosec and anti-itch - Atarax and some others.
37 2021-03-15 tingling very mild tingling face. muscular changes in face during first 18 hours post vaccine. slightly fatig... Read more
very mild tingling face. muscular changes in face during first 18 hours post vaccine. slightly fatigued day 2 slightly elevated heart rate during intense exercise days 3-4 Generally, however, I feel fine and plan to get the second dose!
37 2021-03-16 numbness Dizziness, numbness in left arm, heart palpitations, nausea, blurred vision. Began within the hour o... Read more
Dizziness, numbness in left arm, heart palpitations, nausea, blurred vision. Began within the hour of the dose. Dizziness, arm numbness, blurred vision lasted less than 24 hours. Heart palpitations lasted 3 days. Breastfed twins also fussy, irritable, trouble sleeping, smaller appetites for three days.
37 2021-03-16 feeling hot PT RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE (LOT NO. EN6207, EXP 07/2021). FIVE MINUTES AFTER ... Read more
PT RECEIVED FIRST DOSE OF PFIZER COVID-19 VACCINE (LOT NO. EN6207, EXP 07/2021). FIVE MINUTES AFTER RECEIVING DOSE, PT COMPPLAINED OF FEELING HOT, DIFFICULTY SWALLOWING, AND DIFFICULTY BREATHING. HX OF ANAPHYLAXIS AND CARRIES AN EPIPEN AROUND. PT RECEIVED ONE DOSE OF EPIPEN (LOT NO. 0FM407, EXP 02/2022). NO OTHER VACCINES RECEIVED WITHIN THE LAST 14 DAYS ON PATIENT?S RECORD. TRANSPORTED TO EMERGENCY DEPARTMENT FOR FURTHER EVALUATION. EMERGENCY DEPARTMENT VISIT TIME SEEN BY PROVIDER: 0958, 17 MAR 2021. CHIEF COMPLAINT: ALLERGIC REACTION. NO SKIN RASH, DIZZINESS, OR FAINTING EPISODE. HAD DIFFICULTY BREATHING BUT NOT HAD ITCHING OR SWELLING. SYMPTOMS STARTED PRIOR TO ARRIVAL AND IS STILL PRESENT BUT IMPROVING. VAERS REPORT: . PATIENT DISCHARGED FROM THE EMERGENCY DEPARTMENT AT 1143, 17 MAR 2021. CONDITION: STABLE. CLINICAL IMPRESSION: ANAPHYLAXIS DUE TO A DRUG.
37 2021-03-16 pain in extremity, weakness about 6 hours after injection I started to feel fatigued, weak- walking from room to room I have to ... Read more
about 6 hours after injection I started to feel fatigued, weak- walking from room to room I have to stop and rest, shortness of breath resulting in taking inhaler, shivering, chills, and nausea , and arm pain
37 2021-03-17 flushing, weakness, tingling *Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gab... Read more
*Pressure in the head *Pulling and warmth in the face *Tingling in the tongue, feet and fingers: Gabapentin *Extreme exhaustion and sleepiness *Body ache: Tylenol *Headache- Tylenol *Extreme thirst *Nausea: Ondansetron *Vomiting *Constipation: Senna with Docusate Sodium *Weakness *Some difficulty breathing
37 2021-03-17 burning sensation 37 y/o with signs and symptoms of anxiety, hyperventilation and stated difficulty breathing s/p COVI... Read more
37 y/o with signs and symptoms of anxiety, hyperventilation and stated difficulty breathing s/p COVID 19 vaccine today. Pt evaluated and move to triage, given benadryl IM50mg. Pt's symptoms abated with continued statement of a feeling of something in her throat with a feeling of her internal organs burning. The symptoms decreased over a 5 min period. Within 15 mins of the benadryl administration symptoms returned. Patient put on O2 mask 6l/m given IM epi pin, 911 called, EMS arrived within 5 mins. Pt symptoms abated prior to EMS arriving. Pt v/s stable once transferred to EMS. EMS moved patient to ER.
37 2021-03-17 tenderness, tingling, pain in extremity, numbness Moderate to severe arm pain (numbness, tingling, radiating, heavy feeling, sensitive to touch throu... Read more
Moderate to severe arm pain (numbness, tingling, radiating, heavy feeling, sensitive to touch throughout arm, muscle soreness, muscle weakness), headache, fatigue, fever. Began about 30 mins after injection to 3 days after receiving injection. Site tenderness currently.
37 2021-03-17 pain in extremity Patient reports that she started having "chest bone pain" on 3/9/2021 after first dose Pfizer Covid... Read more
Patient reports that she started having "chest bone pain" on 3/9/2021 after first dose Pfizer Covid vaccine on 3/7/2021. States her heart rate became irregular and elevated on 3/16/2021 and that she developed left calf pain; Patient was already on apixaban (DVT). Patient went to Emergency Department 3/17 - was ruled out for Pulmonary embolism; will have stress test 3/18 and see her cardiologist next week.
37 2021-03-17 pain in extremity Severe upper arm pain (pressure type pain). Severe pain for 2 days, moderate pain for an additional ... Read more
Severe upper arm pain (pressure type pain). Severe pain for 2 days, moderate pain for an additional 2 weeks
37 2021-03-18 throat numbness Itching, numb tongue and throat within hour after vaccine. Diarrhea within two hours. Rash on cheeks... Read more
Itching, numb tongue and throat within hour after vaccine. Diarrhea within two hours. Rash on cheeks three days later.
37 2021-03-18 pain in extremity Nausea, stomach pain, and right arm pain radiating to upper torso
37 2021-03-18 weakness The patient was given Pfizer COVID-19 Vaccine and approximately 15 minutes later, after standing up ... Read more
The patient was given Pfizer COVID-19 Vaccine and approximately 15 minutes later, after standing up in observation area became lightheaded, weak, and dizzy. She then stated that her chest and neck felt tight and was immediately administered 0.3 mg epinephrine IM. Five minutes later the symptoms persisted and she was given a second dose of epinephrine and IM diphenhydramine. The patient was transferred to the emergency room where she was evaluated and discharged several hours later with no other concerns.
37 2021-03-19 flushing Had a flushing throughout body a few minutes after vaccine Had significant dizziness and lightheade... Read more
Had a flushing throughout body a few minutes after vaccine Had significant dizziness and lightheadedness especially when going from laying down to sitting or standing for about 2 weeks after 2nd vaccine.
37 2021-03-19 numbness pulsating pain, lower back, numbness of hands/legs, diaphoretic, waited 15 minutes, resolved.
37 2021-03-20 pain in extremity Diarrheas' for 24 hours, other symptoms- arm pain
37 2021-03-20 pain in extremity, tenderness On Tuesday night my arm started to hurt. On Wednesday morning my arm hurt too much to move or touch... Read more
On Tuesday night my arm started to hurt. On Wednesday morning my arm hurt too much to move or touch. I was exhausted all day Wednesday, and then slept 12 hours overnight. I felt a little headachy and nauseated all day Wednesday.
37 2021-03-20 numbness, tingling Patient was instructed to remain in store for at least 15 minutes after vaccination to monitor for a... Read more
Patient was instructed to remain in store for at least 15 minutes after vaccination to monitor for any adverse effects. She c/o tingling and numbness from shoulder to her fingers on the left arm (vaccine site) approximately 10-15 minutes after vaccine was administered. Symptoms persisted approx. 30 minutes after vaccine. Patient reported symptoms had improved and decided to leave the store; she smiled and waved before leaving pharmacy.
37 2021-03-20 pain in extremity Reviewed shot 3/18/21 at 5:00 pm. Next day fever, headache, sore arm. On March 21 woke with all over... Read more
Reviewed shot 3/18/21 at 5:00 pm. Next day fever, headache, sore arm. On March 21 woke with all over body red rash. Still running fever and sore throat.
37 2021-03-21 difficulty speaking Per pt "Within moments of vaccine I developed a headache, felt like my heart was racing / pounding o... Read more
Per pt "Within moments of vaccine I developed a headache, felt like my heart was racing / pounding out of my chest. Quickly became short of breath, cough, nauseous and dizzy. I reported my symptoms to the RN in the observation room and took Benadryl. My HR was in the 130s at that time. I then used my EpiPen. They gave me 2 puffs of an albuterol inhaler and a 2nd EpiPen before taking me to the ER where IV allergic reaction protocol was initiated ( famotidine, iv fluids, solumedrol) and a 3rd EpiPen was given along with a duoneb and iv lorazepam. My symptoms improved after the 3rd EpiPen and seems to slowly resolve over the next 48 hours. " Per ED note Patient is a 37 y.o. female presenting to the ED with shortness of breath and throat tightness. Immediately after getting a COVID vaccine today, patient developed sudden onset of shortness of breath, voice hoarseness and throat tightness. She gave herself IM epinephrine, Benadryl, and albuterol puffs through the inhaler prior to arrival. She was in her normal state of health prior to today. Patient has hx of vocal cord dysfunction, mast cell activation syndrome, and anaphylaxis, and has required epinephrine drips in the past with ICU hospitalizations. Has also needed intubation in the past. Initial evaluation reveals patient to be tachypneic, tachycardic and anxious. +stridor and hoarse voice. Patient gave herself IM epinephrine prior to arrival along w Benadryl and albuterol puffs. Says her symptoms feel similar to what she has had before w anaphylaxis. Patient was given additional IV methyprednisolone, pepcid, Duonebs, and ativan. She was monitored and her work of breathing improved. No additional epinephrine was needed and patient was monitored in the ED for a few hours."
37 2021-03-22 migraine, pain in extremity Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue... Read more
Hives, fever, chills, body aches, migraines, vertigo, photosensitivity, phonophobia, nausea, fatigue, dizzy light-headed, loss of voice, sob, diarrhea, and sore arm. No outcome still ongoing testing and seeing specialists.
37 2021-03-22 burning sensation Rash on both ears, spread to behind ears and neck. Rash is itchy and burns.
37 2021-03-23 flushing About 30 minutes after my injection, I started to feel a tingly feeling in my throat, then felt like... Read more
About 30 minutes after my injection, I started to feel a tingly feeling in my throat, then felt like my throat was slightly tightening. I was driving and pulled over to monitor. It stayed the same for about 10 minutes, then started resolving. I never had any trouble breathing and I could sip water. When I returned home, my husband commented that I looked ?flushed.? I called my PCP who recommended to monitor myself, but that I was probably fine and no need for any treatment. I have not had any issues since and now am 24 hours post injection. There is no phone number to the site in which I received my vaccine. I have been trying to connect with someone who can advise on whether it is safe for me to receive my second dose. I would be so grateful for any advice on how to proceed as I really want to get the second shot, but also am concerned if there is a risk that I could have a severe allergic reaction upon receiving it. I have searched the agency website and see where a second dose is not recommended for anyone that has had a severe or non-severe allergic reaction to the first dose. What I had was not severe, but I am unclear if it was enough to preclude me from receiving a second dose. I would so appreciate any insight, guidance, or connection to someone who can advise on how to proceed. Thank you.
37 2021-03-23 tingling Developed lightheadedness, nausea (no vomiting, b/ tinnitus, and tingling in b/l hands. All symptoms... Read more
Developed lightheadedness, nausea (no vomiting, b/ tinnitus, and tingling in b/l hands. All symptoms resolved by 20 minutes of monitoring. Vitals WNL.
37 2021-03-23 tingling Left hand, arm, face, lip were tingly. Slightly dizzy when symptoms began. Tingly feeling has lasted... Read more
Left hand, arm, face, lip were tingly. Slightly dizzy when symptoms began. Tingly feeling has lasted almost 24 hours to varying degrees but has not fully gone away yet.
37 2021-03-23 hot flush Light headed and hot flash pt drank water BP 130/86, refused transport
37 2021-03-23 pain in extremity Muscle aches, pain in left arm, low fever 99.2
37 2021-03-23 pain in extremity Nausea, Metallic taste in mouth, headache, entire arm in pain for 24 hours. I was better by the fol... Read more
Nausea, Metallic taste in mouth, headache, entire arm in pain for 24 hours. I was better by the following day 3/20.
37 2021-03-23 migraine Nausea, body aches, severe migraine, chills started the next morning and lasted for 24 hours.
37 2021-03-24 pain in extremity I went to give patient vaccination and as soon as I gave it I was not sure if I had drawn any vaccin... Read more
I went to give patient vaccination and as soon as I gave it I was not sure if I had drawn any vaccine into the syringe, I put into sharpes container before having a chance to inspect for traces of vaccine, I then decided to draw up remaining doses to see how many were left and there were 5 , I thought she was second dose out of new vial so I felt confident she had not received the vaccine, I readministered vaccine but later in the day I was short 1 dose based on getting 6 doses per vial, so patient may or may not have received 2 doses. I contacted patient 3/25/21 to check on her and only adverse reaction she is reporting is a moderately sore arm.
37 2021-03-25 feeling cold, feeling hot, tingling Almost immediate pain in right hip area followed by rapid heart rate. Then experienced sweating and... Read more
Almost immediate pain in right hip area followed by rapid heart rate. Then experienced sweating and overheating followed by chills and inability to get warm. Arms and hands started tingling and feeling numb and then it moved to my legs. Took Tylenol and tried to drink water and eat a little. Slept for several hours and then had a bad headache causing a little bit of nausea and still very sensitive in right hip area, took more Tylenol.
37 2021-03-25 bell's palsy Fever; Chills; Bell's Palsy; Swelling and muscle weakness on the left side of the face; Swelling and... Read more
Fever; Chills; Bell's Palsy; Swelling and muscle weakness on the left side of the face; Swelling and muscle weakness on the left side of the face; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6198, first dose) solution for injection intramuscular in the left arm on 06Mar2021 at 08:45 (at the age of 37-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with Covid-19 on 26Jul2020 and penicillin allergy. Family medical history included diabetes. There were no concomitant medications. Past drug history included known allergies to codeine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient experienced Bell's Palsy, swelling and muscle weakness on the left side of the face on 07Mar2021 at 05:00. It started with left arm swelling and muscle weakness on the left side of the face, left face pain diagnosed as Bell's palsy and developed headache (07Mar2021). The next day (08Mar2021) at 1pm started with fever and chills. The was no emergency room or physician office visit. No treatment was provided for the events Bell's Palsy, swelling and muscle weakness on the left side of the face. The outcome of the events Bell's Palsy, swelling and muscle weakness on the left side of the face was recovering. The outcome of the events headache, fever and chills was unknown. Since the vaccination, the patient has not been tested for COVID-19.
37 2021-03-25 pain in extremity Shot at 3pm....By 8pm had a very sore arm and was moderately fatigued by 10pm mild joint aches and m... Read more
Shot at 3pm....By 8pm had a very sore arm and was moderately fatigued by 10pm mild joint aches and moderate fatigue. 8am next morning moderate joint pain - in particular one ankle felt very stiff. Arm was more sore could not lift this continued until around 4pm now mild joint pain arm still painful but much less so appears to be resolving. Still mild fatigue as of 7pm as well as random pain in joints off and on.
37 2021-03-26 muscle spasms I want to make a report because I had a sole of my foot that started swelling (mild) on Thursday (I ... Read more
I want to make a report because I had a sole of my foot that started swelling (mild) on Thursday (I got my shot on Wednesday). Then after that it felt my forehead akin was swelling. Now my chin and lips and right foot are swelling more. Other (more normal) side effects I had were: tired and headache, on Wed night fever and nausea (only short time, 1-2 hours), On Thu swelling started (See above for description) and pain underneath my left armpit and swelling there too, small shocks/cramps in my arm muscles, especially left side.
37 2021-03-26 tremor Moderate joint pain starting Tuesday afternoon, March 23, 2021, and still having as I fill this out ... Read more
Moderate joint pain starting Tuesday afternoon, March 23, 2021, and still having as I fill this out on March 27, 2021. Most severe in the elbow of the left arm (injection arm) but felt in both elbows and knees. Hands shaking/tremoring starting Thursday evening, March 25, 2021, resolved March 27, 2021.
37 2021-03-26 tingling, numbness Patient reported feeling numbness and tingling in her Right arm (opposite of injection site). She w... Read more
Patient reported feeling numbness and tingling in her Right arm (opposite of injection site). She was not feeling any other symptoms (shortness of breath, itching, feverish, dizzy, etc.). She stated she was comfortable going home and would follow up with provider next week (or seek medical attention if it became severe).
37 2021-03-26 hot flush, slurring, tremor Started with lethargy and hot flashes, followed by extreme shortness of breath, difficulty speaking ... Read more
Started with lethargy and hot flashes, followed by extreme shortness of breath, difficulty speaking and holding up my head and keeping my eyes open. Then trembling. The local nurse at the vaccination sight reported high blood pressure, rapid pulse and seemingly extremely low blood sugar. I didn?t go to the ER because my supervisor agreed to take me home since we were volunteering at the sight prior to me receiving the vaccine. I had to keep eating every hour or so due to blood sugar seeming very low. Shortness of breath continued. Pulse rate still high as I could sleep with my head down due to racing pulse in my head. Later that night I had small bumps on my arms with no itch. Then I had extreme fatigue and muscle fatigue. I kept experiencing extreme episodes of hot flashes. I woke up in the middle of the night with a headache and uncomfortable hot flashes. I drank 100% juice and ate a few goldfish. I had mild nausea and food aversions. The next day the bumps were gone. I went to work but was sent home. I was told I should have gone to the ER but I don?t have insurance. Once home, I went through 5 hours of extreme chills unlike anything I have ever experienced. I had to cross my arms over my chest and stack on blankets to regulate. If I moved my arms for more than five minutes or pulled the blanket down, I began uncontrollably trembling. I still had trouble regulating my blood sugar on day two. It?s day three and no bumps and no chills. Less muscle fatigue as well. I am still pretty exhausted and tire easy when doing things. I did experience the common soreness in the muscle the vaccination was administered, but I figure that is normal. I am hopeful that I am improving and out of the danger zone. I took Garden of Life Elderberry with added nutrients last night and today I took my normal detox probiotic. I have been pushing fluids and have broken my intermittent fasting to try and keep my blood sugar up. I feel like my system is finally regulating and now I just have lingering exhaustion from the events that took place.
37 2021-03-27 night sweats, migraine Severe head pain, migraine level, severe body aches all over, fever, chills, night sweats, nausea, p... Read more
Severe head pain, migraine level, severe body aches all over, fever, chills, night sweats, nausea, productive cough, fatigue
37 2021-03-30 migraine Dizziness, blurred vision, extreme aches, joint aches, difficulty walking, nausea, fever, chills, th... Read more
Dizziness, blurred vision, extreme aches, joint aches, difficulty walking, nausea, fever, chills, throw up, rash all over body, difficulty breathing, migraine
37 2021-03-30 pain in extremity Pain in arm and fatigue 1-2 days after receiving vaccination. Was 12 weeks 2 days pregnant on vaccin... Read more
Pain in arm and fatigue 1-2 days after receiving vaccination. Was 12 weeks 2 days pregnant on vaccination date, estimated due date of 9/27/2021. Fetus confirmed healthy day prior to vaccination via ultrasound on 3/18/2021. Had routine prenatal check on 3/31/2021 and fetal heartbeat could not be found. Fetal demise confirmed via ultrasound the same day, 3/31/2021. Estimated fetus age at demise was 13 weeks 1 day.
37 2021-03-31 weakness, numbness couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went num... Read more
couldn't see right; Felt like she was going to throw up; lips, tongue, face, hands and arms went numb; lips, tongue, face, hands and arms went numb; Extreme weakness and dizziness; Extreme weakness and dizziness; had chest pains that would come and go near my heart; This is a spontaneous report from a contactable consumer reported for self. This 37-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 12:00 Left arm at single dose (Lot EM9810) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history included Hashimoto's thyroiditis (autoimmune disease) and Allergies to food and Gluten, methergine. No covid prior vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID), and calcium carbonate, colecalciferol (VITAMIN D 2000). No other vaccine in four weeks. Extreme weakness and dizziness, lips, tongue, face, hands and arms went numb. She couldn't see right. Had chest pains that would come and go near heart. Felt like she was going to throw up. The numbness only lasted about an hour. The extreme weakness and dizziness lasted about a day. The chest pains started about an hour after the vaccine was given and lasted on and off for about 12 hours. All events were on 03Mar2021 and non serious. No covid tested post vaccination. No treatments were received. Outcome of the events was unknown. Information about batch number has been requested.
37 2021-04-03 burning sensation, tingling After a few minutes, I started to feel chest pains which started to intensify, then my breathing sta... Read more
After a few minutes, I started to feel chest pains which started to intensify, then my breathing started to get shallow. Next, I was feeling tingling in my extremities. Then like the flick of a switch, I went into anaphylactic shock. I couldn't breathe and struggled to get the words out to get an epi pen. I was then injected with 3 epi pens while the ambulance was called. I also felt tingling in my tongue and mouth. The following day at home, I had another reaction. It started with tingling in my throat then the shallow breathing again. Chest pains again, then anaphylactic shock again. The next day, allergy symptoms came back, but not anaphylactic shock. This time, the addition of burning in my biceps on both sides, which traveled down to my forearms. Later on, the burning traveled down my torso to my legs. There is also some burning in my ears and scalp. My breathing is shallow, and it seems like when the allergy meds start to wear off, the symptoms keep coming back. They're happening now as I write this
37 2021-04-04 numbness, bell's palsy, facial pain, facial paralysis On 3/19/21, presented to ED with new right facial droop and numbness. CT head negative, neurology co... Read more
On 3/19/21, presented to ED with new right facial droop and numbness. CT head negative, neurology consult and thought to be Bell's Palsy. Discharged home on Solumedrol 5 day pack. Patient noted asymmetry in her taste sensation and then started to have R sided facial pain, followed by R sided facial droop. On 3/23/21, brain MRI showed no acute infarction, intracranial hemorrhage or mass lesion, very minimal asymmetric enhancement of the labyrinthine segment of the right facial nerve as compared to the left side.
37 2021-04-06 numbness Approximately 21 days after second vaccine, employee began to have neurological symptoms consisting ... Read more
Approximately 21 days after second vaccine, employee began to have neurological symptoms consisting of right side facial numbness, drooling, tongue numbness, right arm/foot numbness. Employee was hospitalized for nine days and diagnosed with Nervitis/Myelitis. She has again been hospitalized (4/6/21) with worsening symptoms.
37 2021-04-07 bell's palsy My blood pressure also went up to 153/103; I had all signs of early stages of Bells Palsy; This is a... Read more
My blood pressure also went up to 153/103; I had all signs of early stages of Bells Palsy; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 22Mar2021 14:45 (Batch/Lot Number: ER2613) as SINGLE DOSE for COVID-19 immunization. Medical history included low blood pressure. The patient had allergies with orphenadrine (K FLEX). Concomitant medications included melatonin (MELATONIN) and paracetamol (TYLENOL) both taken from unknown dates and indications, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 15:45 (when the patient was almost home), half of her lips started to go numb on right side. The next morning, the rest of right side of face had went numb. She went to urgent care after work and doctor told her that she had all signs of early stages of Bell's Palsy. Her blood pressure also went up to 153/103 (unit of measure not reported) on 23Mar2021. The patient required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care for both events. No treatment was also received for both events. She was not diagnosed with COVID-19 prior to vaccination and no tested for COVID-19 since the vaccination. Outcome of the events were not recovered. Follow up attempts are needed. Further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Palsy Bells cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
37 2021-04-07 facial paralysis, tingling, facial pain face feels very heavy/Nose and cheeks being squeezed tightly/hard to move muscles in face; tingling;... Read more
face feels very heavy/Nose and cheeks being squeezed tightly/hard to move muscles in face; tingling; feel pressure like being squeezed from outside in and inside out; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 24Mar2021 12:45 (at the age of 37-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), and patient was a new mother (baby was almost 2 months old). Patient had no known allergies. No COVID prior vaccination, and no COVID tested post vaccination. Concomitant medication included daily vitamin. On 24Mar2021 13:00 (also reported as 30 min after vaccine), patient's face started to feel pressure like being squeezed from outside in and inside out. It got worse following hour. Patient had no issues breathing yet (2 hours post vaccine) but face felt very heavy. Sometimes patient had tingling, nose and cheeks being squeezed tightly, and it was hard to move muscles in face. Otherwise patient felt ok. No treatment received for events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
37 2021-04-09 weakness, numbness Gravida 1 at 20 weeks gestation when she received her second vaccine dose. EDD is 8/19/2021. Current... Read more
Gravida 1 at 20 weeks gestation when she received her second vaccine dose. EDD is 8/19/2021. Currently still pregnant. Presented to the emergency department with weakness and post a fall after her legs gave out. Progressive lower extremity weakness and numbness with MRI changes in brain and spinal cord concerning for acute disseminated encephalomyelitis (ADEM), transverse myelitis. Has been hospitalized since 4/5 and given IV solumedrol, IVIG, and consideration of plasmapheresis and potentially cyclophosphamide if she continues to worsen. Still admitted with continued worsening on 4/10.
37 2021-04-11 pain in extremity my arm has a big bump it is hot to the touch and painful. It started as 2 bumps that looked like a b... Read more
my arm has a big bump it is hot to the touch and painful. It started as 2 bumps that looked like a bee sting or bite. Then by Saturday 4/10/21 it was one big bump. I believe it is called the covid arm.
37 2021-04-15 numbness, tingling Lump in her left armpit; Left side numbness and tingling; Left side numbness and tingling; This is a... Read more
Lump in her left armpit; Left side numbness and tingling; Left side numbness and tingling; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 09Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included sertraline hydrochloride (ZOLOFT), gabapentin, and calcium carbonate/ colecalciferol (VITAMIN D 2000). The patient previously took ketorolac tromethamine (TORADOL) and experienced allergies; and the first dose of BNT162B2 on 21Dec2020 at 06:00 PM for COVID-19 immunization (intramuscular in left arm). The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a hospital facility. On 11Jan2021, the patient had a lump in her left armpit and it finally has shrunk. The patient also had left side numbness and tingling on 11Jan2021. The adverse events resulted in emergency room or department or urgent care. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
37 2021-04-15 tingling, tenderness, numbness March 29 - 30 - None March 31 - April 2 - Swollen tender right side (shoulder through abdomen) Apri... Read more
March 29 - 30 - None March 31 - April 2 - Swollen tender right side (shoulder through abdomen) April 4 - April 7th - Golfball sized swelling over left hand, shortness of breath April 9 - present headache, shortness of breath, numb tingling on right side of face. Heavy numb arms and hands
37 2021-04-15 weakness Within one hour of the shot administration I became tachycardia, hypertensive, and with chills. Over... Read more
Within one hour of the shot administration I became tachycardia, hypertensive, and with chills. Over the next 48 hours my symptoms worsened to include headaches, dizziness, fatigue, and near syncope requiring an emergent visit to the ER. My symptoms persisted and two weeks later I required another visit to the ER and was admitted to the hospital overnight due to tachycardia, hypertension, diarrhea, chest pressure, headaches, fatigue, weakness, chills, and near syncope. Since the onset of events post the Pfizer vaccine, I have required multiple visits with MDs/specialist for management of symptoms and course of treatment. My local physician suspected postural orthostatic tachycardia syndrome (POTS) of which I seeked medical opinion and met with a world expert and after meeting with him, he concluded my symptoms were in fact in line with POTS. Since then I have continued to experience flare-ups and episodes of tachycardia, most recently 4/14/2021. It has now been over 3 months since the onset of symptoms post vaccine and I continue to require treatment and management of above symptoms. I have not returned back to previous level of function nor have I been able to return to work. I do not have any prior medical history of this condition or set of symptoms.
37 2021-04-17 burning sensation, tingling, speech disorder anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheez... Read more
anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing. Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
37 2021-04-17 cold extremities, tingling heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Ti... Read more
heart arrhythmia; Cool limbs so blood circulation issues; Cool limbs so blood circulation issues; Tightness of throat; Hard to breathe; Dizzy and light-headed; prickly over the whole body; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) on 31Mar2021 05:00 PM, at age of 37 years old at single dose for COVID-19 immunization. Medical history included known allergies: Hives/Prickly/itchy/tight throat: Green Tea. Sensitive: Outdoor Maple & Boxelder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. There was no covid prior vaccination. No covid test post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. Patient experienced tightness of throat, hard to breathe, dizzy and light-headed, prickly over the whole body, elevated heart rate, and heart arrhythmia. Cool limbs so blood circulation issues. Adverse event started date on 31Mar2021 05:15 PM. Adverse event (AE) resulted in Doctor or other healthcare professional office/clinic visit. The seriousness criteria was reported as non-serious, no resulted in death, no Life threatening, no caused/prolonged hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect. Received treatment for the adverse events, included two diphenhydramine hydrochloride (BENADRYL) and one after 6 hours. Since the vaccination, the patient had not been tested for COVID-19. Patient was recovered from the events. Information on the lot/batch number has been requested.
37 2021-04-22 feeling cold, weakness, feeling hot Lower back aches, Hot/cold/chills, no energy, no appetite
37 2021-04-24 migraine, difficulty speaking, pain in extremity Brain fog; Anxiety; Worst headache of my life/back of head felt like a brick was in it/Headache was ... Read more
Brain fog; Anxiety; Worst headache of my life/back of head felt like a brick was in it/Headache was migraine wrong entire head; Worst headache of my life/back of head felt like a brick was in it/Headache was migraine wrong entire head; Extreme nausea; Fatigued and worn out from nothing/horrible waves of exhaustion; Change in voice/Raspy voice; Sore arm; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided via an unspecified route of administration, administered in left arm on 02Apr2021 16:00 as single dose for Covid-19 immunisation. Medical history included bacterial allergy, cystitis interstitial, irritable bowel syndrome, depression and anxiety. Concomitant medications included clonazepam (KLONOPIN) and acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. On 02Apr2021, the patient experienced worst headache of her life (back of head felt like a brick was in it and headache was migraine wrong entire head), extreme nausea (even after 8 mg of Zofran), fatigued and worn out from nothing, change in voice on second day (raspy voice), sore arm, brain fog and anxiety. On 09Apr2021, the patient still experiencing brain fog, anxiety, and horrible waves of exhaustion. The outcome of the events was not recovered. Information on batch/lot number was requested.
37 2021-04-24 muscle spasms Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley hors... Read more
Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; Unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking I had a charley horse. Confirmed pulmonary embolism on 24Feb2021; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 37-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 19Jan2021 11:00 AM at single dosefor covid-19 immunization. The patient took second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Pas drug event included Known allergies: cinnamon. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norethisterone acetate (JUNEL) taken for an unspecified indication, start and stop date were not reported. The patient previously took cinnamon and experienced drug hypersensitivity. The patient experienced "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021" (medically significant, life threatening) on 20Jan2021 09:00 with outcome of recovering, "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021" in Jan2021 with outcome of recovering. The patient underwent lab tests and procedures which included COVID tested post vaccination Nasal Swab, PCR (sars-cov-2 test): negative on 03Feb2021, negative on 10Feb2021, negative on 17Feb2021, negative on 10Mar2021, negative on 17Mar2021, negative on 26Mar2021, negative on 05Apr2021, negative on 07Apr2021. Therapeutic measures were taken as a result of "unreported possible deep vein thrombosis day after 1st shot. 4 days of thinking i had a charley horse. confirmed pulmonary embolism on 24Feb2021". Facility type vaccine was Hospital. No other vaccine in four weeks. AE resulted in Life threatening illness (immediate risk of death from the event). Ae treatment included treatment for Pulmonary Embolism, medications. No COVID prior vaccination. Information on Lot/Batch number has been requested.
37 2021-04-27 seizure she was an epileptic and she do take anti-seizure meds. She have had 3 seizures in the last 24 hours... Read more
she was an epileptic and she do take anti-seizure meds. She have had 3 seizures in the last 24 hours; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER 8731), via an unspecified route of administration, administered in Arm Left on 09Apr2021 15:15 as [SINGLE DOSE] for covid-19 immunisation (Age at vaccination: 37 years). Medical history included epilepsy. Concomitant medications included lamotrigine and hyoscine butylbromisde (COLOSPAN). On 13Apr2021, 13:00 the patient stated that she was an epileptic and she do take anti-seizure meds. She have had 3 seizures in the last 24 hours. The patient was not pregnant. The patient did not have covid prior vaccination and was not test post vaccination. The patient did not received any treatment for the event. Outcome of the event was not recovered.
37 2021-04-28 pain in extremity Clotting; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it... Read more
Clotting; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunisation. Medical history included allergies and asthma. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergies. The patient previously received first dose of BNT162B2 on 17Feb2021 for COVID-19 immunisation; and experienced thrombophlebitis and leg swelled up and got very sore, painful, and red (lot number: EL9266 at 04:00 PM). About 2 weeks after the first dose, patient's leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis. She received the second dose on 10Mar, and her leg got worse a few days later. She visited the emergency room and was sent to a specialist who put her on blood thinners for clotting. Patient stated that the only significant change or occurrence in her life was that she received the vaccine. The events resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the event clotting was unknown, while not recovered for the other events. Information on the lot/batch number has been requested.
37 2021-04-30 pain in extremity, facial paralysis sleepy; tired; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; ... Read more
sleepy; tired; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; tested positive for covid-19 after receiving the first dose of the covid-19 vaccine; body ache; runny nose; left eye was throbbing; she couldn't swallow like her body forgot how to do it; feeling she had something in her throat; severe headache; tension on her neck that felt like a neck injury; neck pain; jaw was paralyzed; pain in arm; This is a spontaneous report from a contactable lactation registered nurse (patient). A 37-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number and expiration date unknown) via an unspecified route of administration on 06Jan2021 around 5 pm (at 37-year-old) at single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included amitriptyline since 2018 at 10 mg nightly, 20 mg and 30 mg for migraine and stopped after COVID, and she was feeling tired/ sleepy and that made it worse; riboflavin sodium phosphate (VITAMIN B), and magnesium. The next day on 07Jan2021 about 7:59 am (around 13 hours after receiving the vaccine), all of a sudden she was driving and her jaw was paralyzed, it's became hard, she couldn't move it and it was very painful. she never had that and she was driving with her two little kids and it freaked her out and she tried to park and she finally parked being it lasted for a couple of minutes. When she looked at the time again it was 8:03 am, it was gone. She needed to get her kids to safety because she was driving but then it went away. On 09Jan2021, she started to have all of a sudden this tension on her neck that felt like a neck injury, it was hard to move her neck to a certain side and started while she was working. It was progressing and she thought she hurt herself. The pain began to lead to a severe headache. The neck pain felt like an injury lasted for a couple of days, but headache persisted and was intense, it lasted for 2 weeks and her coworkers thought she had COVID. She worked on 09Jan2021 and 10Jan2021 and then called out after that. On 12Jan2021 and 13Jan2021 the pain was not just in her head but in the left eye, it was throbbing and severe pain deep inside. It lasted for a couple of days lasted for over a week, it was not as bad as the first couple of days, the pain was the most severe on the 12Jan2021 and 13Jan2021 and couldn't do anything and stayed in bed. It felt like it was nerve pain and she never had that before, it was definitely different. She took daily anti migraine medicine and as long as she took it she doesn't have migraine headaches. For her Sumatriptan 50 mg, she took it twice on 12Jan2021, but because of the side effects it makes her nauseous and she couldn't take it anymore, she just has the prescription. She was only allowed to have 10 a month. It is sumatriptan and it didn't work either and she was supposed to take it to reverse the headache and it didn't work. For the amitriptyline, its 10 mg and had to triple to 30 mg. She took it at nighttime, but one of the side effects is that it made her sleepy but she didn't sleep. She has a 3 month supply and had plenty, if she needed to adjust but that was her first time she was taking that much, her doctor said she could up her dose to 20 mg, her gave her permission before because it can be used at higher doses if needed, she did try the 20 mg but that did not work so she had to triple to 30 mg. Once she realized that was not helping she just said forget it. She had to triple the dose of her migraine medicine and she was taking 3000-4000 mg of paracetamol (TYLENOL) even that couldn't take it down and even did cold compresses. The headaches lasted for a couple of weeks and then she finally got COVID. The headache after that was different, not as intense, and even taking paracetamol a couple times per day was dealing with this headache, the fever the body aches. It is not like the headache she got from the vaccine. It lasted for another week with COVID and was different and managing the headache. So currently she was good. She stopped taking amitriptyline, she was taking it for 3 years and was switched to Vitamin B2 and magnesium in the last month and had no headaches. She had to switch after getting COVID because she felt more tired and sleepy and felt that the amitriptyline would make it worse so she had to find something else. She was good with the new medications. She was cleared to go back to work on 03Feb2021. She was pretty much good by 03Feb2021. She was told by her MD not to get a second dose but her employer stated she could be terminated if she was not fully vaccinated. She was concerned and scared of having this reaction again. Her arm pain hurt for a few hours but because she has other pain she thought it was her left arm but she really couldn't recall. she did have pain in her arm, it was normal pain nothing significant. It started at 11 pm on 06Jan2021 and lasted until Saturday 09Jan2021 and remembered that she had a hard time helping at work because she has to used the arm but the arm soreness was just like with any other vaccine, nothing abnormal. From 10Jan2021 to 13Jan2021 she kept feeling she like had something in her throat in the morning, and when she would start drinking she couldn't swallow like her body forgot how to do it. She would hold it in her mouth and then 30 seconds later she would start swallowing and then it went away. It was just in the morning for like 4 days. It cleared by 14Jan2021, clarifies it ended then. Caller stated her husband took a test on 11Jan2021 and didn't get his results until 14Jan2021 and showed he was positive and he was already isolating and she was at home with the kids. States her husband was the one that brought it in. She did start to have COVID symptoms until 23Jan2021, she had fever, chills, body ache, runny nose, shortness of breath and diarrhea. She was prescribed a z pack, azithromycin, and it helped with cough, the congestive cough and nasal spray for her runny nose. It was water coming out of her nose, most runny she has ever felt. She got testing and kept going for testing because she felt so sick and it was negative (on 13Jan2021 and 18Jan2021). She finally tested positive on 25Jan2021. No additional therapies for COVID-19. No other test performed, they see patients that keep testing positive 3 months later after no symptoms and just want to wait for symptoms to go down. The patient was not hospitalized, not admitted to an Intensive Care Unit. The outcome of the event paralyzed jaw was resolved on 07Jan2021, neck pain/ tension was resolved on 11Jan2021, headache was resolved on 03Feb2021, throbbing eye was resolved on 19Jan2021, pain in arm was resolved on 09Jan2021, "feeling she had something in her throat" and swallowing impaired was resolved on 14Jan2021, of other events were unknown. Reporter seriousness for Jaw was paralyzed: unknown Reporter seriousness for headache: serious, affected her ability to perform and no one wanted to see her in person and only had virtual visits with the doctor Reporter seriousness for tested positive for COVID-19 after receiving the first dose of the COVID-19 vaccine: Unspecified Reporter seriousness for tension on her neck that felt like a neck injury: Not serious Reporter seriousness for left eye was throbbing: Medically significant Reporter seriousness for pain in arm: Not serious Reporter seriousness for feeling she had something in her throat: Not serious The primary reporter considered the events paralyzed jaw, neck pain, headache, throbbing eye, pain in arm, "feeling she had something in her throat" were related to BNT162B2; while event tested positive for COVID-19 was unrelated. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events
37 2021-04-30 weakness, pain in extremity thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in... Read more
thrombotic strokes; right cerebellar stroke; vertebral artery dissection/ tore a vertebral artery in her neck; two sub acute strokes; vertigo; nausea; weakness; fatigue; sore arm; mild chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318) via an unspecified route of administration, administered in Arm Left, at the age of 37-year-old, on 04Feb2021 16:30, as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines 4 weeks prior. Concomitant medication included ongoing drospirenone, ethinylestradiol (DROSPIRENONE/ETHINYLESTRADIOL) taken for contraception. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EL3302) single dose, at the age of 37-year-old, on 14Jan2021 1500PM in the left arm, for covid-19 immunisation and experienced fatigue and a sore arm. On 05Feb2021, the patient experienced fatigue, sore arm, mild chills, and body aches. On 08Mar2021, the patient was hospitalized because of vertebral artery dissection after an intense workout that morning/ she tore a vertebral artery in her neck which she immediately clotted and led to her having a stroke. The patient had vertigo, nausea and weakness on 08Mar2021 and went to the ER and they found she had a thrombolytic stroke in the cerebellum as a result of the vertebral artery dissection. The patient was admitted to the hospital on 08Mar2021 then she was discharged 11Mar2021. While she was in the hospital, they did an MRI and found two sub-acute thrombolytic strokes or blood clots in her brain. The patient tore the artery in her neck which led to the right cerebellar stroke; her blood was really clotty but they could tell by the imaging that the two subacute blood clots that led to having the other two strokes were there approximately three weeks before but not much older than that (without exhibiting symptoms, so she had three thrombotic strokes in total). Since she was discharged she has been out of work and will be on FML for two to three months and going to physical therapy from the effects of the strokes. Adds while she was in the hospital they were trying to determine the cause of the two sub-acute strokes that were unrelated to the dissection. They did several tests including: EKG which was normal; TEE scope down her throat to look at her heart which was normal; and blood work to check for a clotting disorder which was also all normal. So far nothing has been found. Outcome of mild chills, body aches, and sore arm was recovered on 06Mar2021; outcome of vertebral artery dissection and right cerebellar stroke was recovering; while it was unknown for the other events.
37 2021-05-04 feeling jittery Experiencing A-Fib symptoms for last 3 weeks; Jittery; high HR (normally very low); palpitations; sh... Read more
Experiencing A-Fib symptoms for last 3 weeks; Jittery; high HR (normally very low); palpitations; shortness of breath with any exertion; This is a spontaneous report from a contactable consumer. A non-pregnant 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 29Mar2021 09:30 (Batch/Lot Number: ER8737) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, gastrooesophageal reflux disease, IBS, Ehlers Danlos Hypermobility Symdrome, POTS, hypothyroidism and hyperparathyroidism. Patient has no known drug allergies. Concomitant medications included duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR) and levothyroxine sodium, all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 dose 1 (Lot number: EN6199), ON 08Mar2021 08:45 AM, on left arm for COVID-19 immunisation. The patient has no COVID prior vaccination and not tested post vaccination. 3 weeks (2nd vaccine was on 29Mar) and just put 2 and 2 together. 7+ A-Fib instances recorded on smartwatch. Jittery, high HR (normally very low), palpitations and shortness of breath with any exertion, all on 01Apr2021 06:30. It was unknown if treatment was received. The outcome of the events was not recovered.
38 2020-12-31 feeling cold, tingling, numbness 25 minutes after the vaccine was given, I felt a rush of cold go down my left arm and had a cold sen... Read more
25 minutes after the vaccine was given, I felt a rush of cold go down my left arm and had a cold sensation and then tingling/numbness to my left wrist and left hand for about 36 hours until it gradually subsided.
38 2020-12-31 pain in extremity Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second ti... Read more
Chills, started 8:30 ish in the morning after I woke up today and lasted for half an hour. Second time I had severe chills around 1:45 pm in the afternoon. And My right arm has soreness.
38 2021-01-01 flushing Pain and itching at injection site after about 2-4 hours lasted to the next day approximately 24 hrs... Read more
Pain and itching at injection site after about 2-4 hours lasted to the next day approximately 24 hrs Face flushing started about 2-4 hours after vaccine and lasted only about 4 hours. Nausea started about 6 hours after vaccine and lasted about 10 hours
38 2021-01-03 throat numbness, tingling, numbness 40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb. T... Read more
40 mins after receiving the vaccine the right side of my throat, ear, forehead and arm went numb. The right site of my body started tingling. Burning , red, swollen and itching at the injecting site.. Area around injection site was the size of a softball very painful, itchy, burning sensation, swollen, and red. I took Benadryl
38 2021-01-03 discomfort, burning sensation, feeling hot, pain in extremity Have a fever with a high of 99.6 Fahrenheit; felt winded like she has exerted herself more than expe... Read more
Have a fever with a high of 99.6 Fahrenheit; felt winded like she has exerted herself more than expected/shortness of air; Coughing/cough got worse; She is covid positive/Tested positive for COVID 19; She is covid positive/Tested positive for COVID 19; Shortness of breath/Shortness of breath was reported as worsened/feels winded; Tachycardia; Has been sick ever since; Felt like she was in a fog, on a cloud, heavy and out of it; She felt hot and weird but had no fever; Headache; Burning sensations in her legs; Extreme fatigue, want to go to bed; headache went away and she felt like the congestion was clearing up some; Arm was sore; This is a spontaneous report from a contactable ICU nurse (patient [Registered nurse ADN]) via Pfizer-sponsored program. A 38-year-old female patient received single dose of BNT162B2 (lot number: EK5730) , via an unspecified route of administration (right arm) on 16Dec2020 20:30 for immunization (for front line health care worker). Medical history included allergies; acid reflux; patent foramen ovale (PFO); supraventricular tachycardia (SVT) without treatment, vitamin D low and ongoing smoker. The patient had no other history/family history. Concomitant medication included loratadine (CLARITIN) taken for at least 5 years for allergy, famotidine from Dec2020 for acid reflex, and vitamin D taken for 5 or more years for vitamin D low; all given orally and were ongoing. The patient had no other prior vaccines within 4 weeks of Covid vaccination. Patient had been taking Covid tests on and off due to her immunocompromised daughter. On 15Dec2020 she took the PTR that took three to four days for results; she tested negative for Covid and was completely asymptomatic. She then received the COVID 19 vaccine 16Dec2020. Her test was positive for COVID 19 on 18Dec2020 and she had been sick ever since. She received the vaccine at the hospital where she works. The vaccine was not administered at facility. She further reported she was fine after getting the COVID 19 vaccine. Her right arm was sore/ started to hurt about four or five hours later on 16Dec2020 but then was fully after 24 to 48 hours. She started to feel sick on 18Dec2020 (Friday evening). States she went to bed Friday morning after the night shift. She felt fine, better than normal. That same day (18Dec2020) she woke up at 1700 and felt like she was in a fog, on a cloud, heavy and out of it. She walked around for a while and that sensation didn't go away. She felt hot and weird but had no fever. Then at 1830 she got the alert on her phone that told her she was positive for COVID 19. She started to feel other symptoms on 18Dec2020 including headache, shortness of breath, tachycardia, burning sensations in her legs; extreme fatigue, wanting to go to bed that persisted from Friday to Sunday. Then on 20Dec2020, Sunday afternoon, her headache went away and she felt like the congestion was clearing up some. Mentions she did have a fever (onset date unspecified) with a high of 99.6 Fahrenheit; but it went back down to 99.0 Fahrenheit (date/s unspecified). On 20Dec2020 the patient experienced coughing. On 21Dec2020 (Monday) she started coughing more but states her O2 was fine and her breathing was okay. However, when walking around she felt winded like she has exerted herself more than expected. She then clarified that on 21Dec2020, she experienced shortness of air and the cough got worse but it has now plateaued. She did call her HCP and they were holding off on treatment at the time. No investigation assessment was performed. The patient was not admitted to an Intensive Care Unit. The patient did not display clinical signs at rest indicative of severe systemic illness nor did she require supplemental oxygen or receive mechanical ventilation. No preexisting diseases worsened during the SARS-CoV2 infection. The patient considered shortness of breath, and tachycardia as serious: medically significant while the events headache, burning sensations in her legs, fatigue, Coughing, and feels winded were considered as not serious. The events headache, shortness of breath, tachycardia, burning sensations in her legs, fatigue, Coughing, and feels winded were ongoing at the time of reporting. Shortness of breath worsened. The patient recovered from arm was sore on an unspecified date in Dec2020; and was recovering from tachycardia, sick, headache and congestion. The outcome of felt like she was in a fog, on a cloud, heavy and out of it; felt hot, and fever was unknown while not recovered for the other events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including chest x-ray, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-03 pain in extremity I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chill... Read more
I began feeling tired around 2pm 24 hours after vaccination. I also had a head ache, fever and chills around 3-4pm fever was low grade stayed around 99.8 the following day which was the 23 of dec i had a headache all day and felt fatigued on the 24 i felt normal. My arm was sore VERY sore for about 4 days. I did test positive for covid on 11/2/2020 with moderate symptoms
38 2021-01-04 numbness, tingling Approx. 15 min after dose 1 onset numbness/tingling sensations from bil elbow to hands, and bil knee... Read more
Approx. 15 min after dose 1 onset numbness/tingling sensations from bil elbow to hands, and bil knee to feet. Denied loss of sensation described as pins and needles. Seen in the Emergency Department and released: Received IV fluids and all labs were within normal limits.
38 2021-01-04 slurring, flushing Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a sponta... Read more
Headache; Hypertension; Face flushed; Extremely tired; Slow Motion; Slurred Speech; This is a spontaneous report from a contactable healthcare professional. A 38-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscularly on 29Dec2020 08:00 at left arm at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. Patient previously took metronidazole (FLAGYL) and experienced allergy. Patient experienced headache, hypertension, face flushed, extremely tired, slow motion, and slurred speech on 29Dec2020 09:30. Treatment was not received for these events. Outcome of the events was resolving.
38 2021-01-04 pain in extremity I felt fine initially just so soreness of my arm. The next day I started with the chills and a littl... Read more
I felt fine initially just so soreness of my arm. The next day I started with the chills and a little bit of the headache, I just kinda figured it was a response to the vaccine and did not think much of it. Through the night I had fever (100.8F), chills and headache. I took some Excedrin and Wednesday morning I felt ok. I decided to go to work but the screening told me because I had fever in less than 24 hrs I could not go to work I had to report to the COVID hotline. They sent me to get tested because of the fever. I got tested at hospital and was tired the rest of the day but no fever and the next day I was ready to go to work but I had to wait for the test results that would come 24hrs later. The test came back positive. So I could not return to work until yesterday.
38 2021-01-04 pain in extremity In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms su... Read more
In first few days after vaccination experienced arm pain, headaches and body aches. All symptoms subsided by day 7. On day 10 (12.31) began to again experience arm pain and new rash over injection site. Pain spread to opposite arm and then became generalized. Pain worse in armpits. Rash turned into raised bullseye over injection site prompting MD visit. COVID tested completed and was negative blood work sent and is pending. I was started on Pepcid/benedrly and doxycycline.
38 2021-01-04 hot flush, burning sensation, feeling of body temperature change, tremor, tingling It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In ... Read more
It was extremely painful when I received the vaccine and I immediately felt my fingers tingling. In about 10 min I felt very hot in my face, back and felt like I was going to pass out. My heart was racing, it was about 130. My BP initially was 139 and then 160 after that. I never passed out but I felt those waves with a tingling to my face and my neck as I was going to pass out and I started shaking and my heart was racing and my BP was up and it lasted about 45 min before it started going down. They gave me some Ibuprofen at the Employee health and they kept observing me and it started getting better after 45 min. I still felt the waves of feeling flush and hot and cold and very fatigued.
38 2021-01-04 flushing, feeling hot Within first 5 mins - Sudden onset of warm sensation (similar to the feeling of IV contrast administ... Read more
Within first 5 mins - Sudden onset of warm sensation (similar to the feeling of IV contrast administration), flushed feeling, pale, near syncope followed by nausea and dry heaving. Lasted 30 mins. Felt fatigued and mild headache for next 24-48 hours.
38 2021-01-04 tingling, numbness tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to ... Read more
tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; tongue started to get a little bit of numbness and tingling/the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; numbness and tingling progressed up my cheeks and up underneath my eyes on both sides; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 26Dec2020 11:30 AM at single dose for covid-19 immunization. The COVID-19 vaccine was given at nurse's hospital vaccine clinic. Medical history included narcolepsy with cataplexy. Concomitant medication in two weeks included venlafaxine hydrochloride (EFFEXOR SR), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took naproxen and erythromycin; and experienced drug allergy. On 26Dec2020, the patient stated "At about 1150 my tongue started to get a little bit of numbness and tingling. I didn't really feel nervous but I thought maybe some type of anxious reaction. So I thought I'd give it just a little time and over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks and up underneath my eyes on both sides. I was not feeling anxious about the vaccination. I didn't have any trouble breathing or difficulty swallowing. It felt like Novocain that was wearing off like after you have dental work done. I decided to take 25mg Benadryl to see if it went away. And it definitely got better about 25 minutes after I took the Benadryl. Within an hour I would say it was 95% gone. Still just like a trace numbness on my cheeks. When I woke up this morning (27Dec2020) I noticed the facial numbness had completely resolved." The adverse event start time also reported as 11:45 AM. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 27Dec2020. Information on the Batch/Lot number has been requested.
38 2021-01-05 flushing, feeling hot 20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it ... Read more
20 minutes post immunization patient developed hives over face and neck, stated tongue felt like it was tingling, patient felt flushed and warm and stated she "just didn't feel right" patient evaluated by provider - claritin 20mg given, vitals taken after another 30 minutes of being observed patient stated she"felt better"-hives gone
38 2021-01-05 flushing A couple minutes after injection I felt flush over my chest area. It lasted about 30 seconds then my... Read more
A couple minutes after injection I felt flush over my chest area. It lasted about 30 seconds then my heart started racing. My iwatch heartrate notified me that my heart rate was 162. This lasted for about 7 minutes. My throat felt a little scratchy but not to where I had anaphylaxis reaction to seafood.
38 2021-01-05 flushing, feeling hot About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, ... Read more
About 1 minute after receiving the vaccine, I suddenly felt hot and sweaty. After about 20 minutes, I began experiencing mild itching on my face, chest and upper body (no hives or rash) and my face was flush. At about 40 minutes, began experiencing nasal congestion, runny nose and and a slight tickle in the back of my throat. A few hours later, all symptoms resolved.
38 2021-01-05 numbness Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, f... Read more
Having trouble clearing my throat, felt like it was closing up; Having trouble clearing my throat, felt like it was closing up; Uncontrollable rigors; High heart rate; Numb lips and hands; Numb lips and hands; Nausea; Shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A 38-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685, expiry date 30Dec2020) intramuscular (Arm Left), on 30Dec2020 09:15, single dose, for COVID-19 immunization. Relevant medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had gall bladder removed, and had tonsils removed. It was reported that the patient cannot take NSAIDS, patient was not allergic to them. No allergies to food or other products. Concomitant medications included rizatriptan and paracetamol (TYLENOL). On 30Dec2020, within about 10 minutes of the injection of the vaccine, the patient had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea. The patient was discharged from the ED, went home and took a nap. Later that evening, the patient began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath, and was admitted to the ED again and given more IV medications. Therapeutic measures given in response to the event included administration of IV medications, epinephrine injection and breathing treatment. Prior to the COVID vaccine, the patient did not receive any other vaccines within 4 weeks, was not tested or diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was in the workplace clinic. Outcome of the events was recovering at the time of the report.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events oropharyngeal discomfort, throat tightness, chills, heart rate increased, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
38 2021-01-05 pain in extremity I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour ma... Read more
I received my COVID-19 vaccine on 12/20/2020, all was fine despite a sore arm. Around the 48-hour mark, I developed extreme dizziness and I received medical care at ER on the 23rd of December.
38 2021-01-05 migraine, tingling Migraines, right side of face swollen, nausea, tingling
38 2021-01-05 flushing Mild Headache; Flushing; Nausea Monitored for 35 mintes Symptoms resolved prior to being released t... Read more
Mild Headache; Flushing; Nausea Monitored for 35 mintes Symptoms resolved prior to being released to home.
38 2021-01-05 numbness, tingling Numbness and tingling on the injection site and the left side of your face. Also reports a metallic ... Read more
Numbness and tingling on the injection site and the left side of your face. Also reports a metallic taste in her mouth
38 2021-01-05 tenderness Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localize... Read more
Provider arrived for her Covid vaccine. After vaccine was administered she had an immediate localized reaction of tenderness and slight redness. No other symptoms. Provider was placed in the observation area and given and ice pack for the area and made aware that we do have oral Benadryl available. After about 2-3 min Genoveva alerted me that she was now having some itching/scratchiness to the back of her throat and requested Benadryl. 25 mg PO with water was administered and she was immediately escorted to the ED for evaluation with an RN, per protocol.
38 2021-01-05 feeling cold Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this toda... Read more
Shortness of breath; Sore arm like she got kicked in the arm by a horse. Her arm felt like this today.; Chest pain; Headache; Body aches; Fever; Chills; fatigued; feels cold; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2 (lot number: EL3246), via an unspecified route of administration, at deltoid right, on 30Dec2020 07:45, at single dose, for COVID-19 immunization. Medical history included chronic asthma from an unspecified date, stomach surgery a year and a half ago, sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has had asthma stuff since she was very young. Is relatively healthy. No family medical history. No relevant tests. The patient's concomitant medications were not reported. No additional vaccines administered on same date of Pfizer suspect. No prior vaccinations within 4 weeks. The patient previously took flu vaccine on 01Oct2020 and experienced fatigued, tired, and sore arm like she got kicked in the arm by a horse. It was reported that received COVID-19 vaccine yesterday (30Dec2020). Been having some chest pain. Started a couple hours after receiving the COVID-19 Vaccine. Chest pain doesn't whole heartedly go away. Gets more intense and then relaxes. Wants to know if this is common or something she just has to deal with. Doesn't know if this is stomach pain. Had stomach surgery a year and a half ago. Sometimes has stomach pain that feels like chest pain since her stomach has been surgically altered. Has been taking heartburn and gas medications. Chest pain is not going away. Wants to know if this is common. Tried to look online and only found common side effects. Her husband looked it up and two people died from a heart attach after receiving the COVID-19 Vaccine. She is getting older, but is not that old. Caller works in behavioral health. Had an instant headache. Clarified chest pain: Is always lingering in the background. Doesn't fully go away. Comes and goes in waves. Gets intense and relaxes. Chest pain was pretty sharp this morning and it made her short of breath. Doesn't know if it was the pain that took her breath away. Occurred at 10:00. Indication: Has older people she takes care of. Her mother is super frail and has dementia. Her uncle is elderly and has heart issues. Wants to do her part so she doesn't catch it. No further details provided. In regards to the two people who had heart attacks and died after COVID-19 Vaccine, caller has no patient identifiers or NDC/Lot/Exp to provide. Stated this people were in the UK and the information was just something her husband read on the internet. Also experienced body aches, fever, and chills between 14:30 and 15:00 yesterday, 30Dec2020. Is super fatigued. Doesn't know if she is febrile, hasn't checked temperature. Still feels cold and has chills today. Does not have a headache today. It was also reported that fatigued and tired with Flu Vaccine (historical vaccine). Sore arm like she got kicked in the arm by a horse. Her arm felt like this today (31Dec2020). Therapeutic measures in response to chest pain is received, treatment included heartburn and gas medications. Gas medication is Equate brand Simethicone Extra Strength Gas Relief (NDC: 49035-487-02, Lot:H22016, Exp: Sep2022) at 125mg liquid-gel. Heartburn medication is Equate brand Cimetidine 200mg tablet (NDC: 49035-820-72, Lot: Doesn't know if lot number is OJE2445C or 0JE2445C, Exp: Jun 2022). Stated writing is so tiny. Gas and heartburn medication has not helped with chest pain. The outcome of the event chest pain was not recovered, of the other events were unknown.
38 2021-01-05 pain in extremity Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and ge... Read more
Woke up with sore left arm and some redness and swelling at injection site on 1.5.21. Chills and generalized body aches began about 1230, temperature taken at that time was 99.0. Continued with work and by 1530 began to have increased myalgias and pain in knees, took temperature 100.0 and took 400mg Ibuprofen. Fever broke, began to have diaphoresis and felt body aches were gone with exception to left arm. Woke up 1.6.21 and with pain in left axilla and noted to have tender and swollen lymphnodes. Took another 400mg Ibuprofen about 0830. Muscle pains remain to arm, axilla and neck.
38 2021-01-05 pain in extremity dizziness, fatigue, arm soreness, myalgia
38 2021-01-05 pain in extremity pain all over the body, swelling of neck, axilla and arm, pain on left side of arm.
38 2021-01-06 pain in extremity AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIEN... Read more
AT APPROXIMATELY 5PM ON DAY OF VACCINATION, DEVELOPED SORENESS IN LEFT ARM. AROUND 10PM SHE EXPERIENCED EXTREME PAIN, COULDN'T LIFT HER ARM OR MOVE THE FINGERS ON THAT ARM. IT ADVANCED TO HER NECK AND BACK, SEVERE HEADACHE, STATING IT FELT LIKE SHE HAD BEEN HIT IN THE HEAD WITH A HAMMER. SHE ALSO FELT HEART POUNDING AND HAD CHEST PAIN. DESCRIBES ALL THE PAIN AS THROBBING. SHE RAN FEVERS (HIGHEST WAS 100.3) AND HAD CHILLS. DIDN'T GET OUT OF BED UNTIL 11:30 THE FOLLOWING MORNING.
38 2021-01-06 facial paralysis Bell?s Palsy
38 2021-01-06 flushing, hot flush FEELING FLUSHED, MILD FACIAL FLUSHING Narrative: 0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84... Read more
FEELING FLUSHED, MILD FACIAL FLUSHING Narrative: 0825 C/O FEELING HOT , MILD FACIAL FLUSHING 120/84 P101 99% RA R 18 0837: 50MG BENADRYL GIVEN IM, 0841: C/O DRY MOUTH, FEELING SHAKY 0834: 124/83 P 102 99.4 100% RA 0850: C/O DRY MOUTH, COLD 0840: 118/77 P: 104 100% RA 100% RA.... 0855: 118/84 P101 100% RA T 99.0 0905: TRANSPORTED BY EMT
38 2021-01-06 numbness Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of... Read more
Facial numbness on the right side since Saturday 1/2/2020 woke up to half of my face numb the tip of my tongue tingled . and pressure on my right eye and I was not able to focus. I have headaches that come and go. my back is achy since last week and yesterday half of my body felt numb.
38 2021-01-06 flushing I became flush in my face and broke out with a rash on my arms and back. I just took Benadryl at hom... Read more
I became flush in my face and broke out with a rash on my arms and back. I just took Benadryl at home.
38 2021-01-06 flushing My face became flush and broke out rash on back and shoulder.
38 2021-01-06 numbness, pain in extremity Post Second dose, my right arm is numb from elbow down to the proximal side of my hand. My pinky fin... Read more
Post Second dose, my right arm is numb from elbow down to the proximal side of my hand. My pinky finger and ring finger are numb. Restless arm. Pain is all the way up to my neck.
38 2021-01-06 numbness, tingling right 2nd toe numbness that spread to great toe and then midfoot. The next day the left foot was nu... Read more
right 2nd toe numbness that spread to great toe and then midfoot. The next day the left foot was numb. Some paresthesias in hands but that quickly resolved. Right foot still feels "asleep" most of the time, regardless of positioning. No weakness.
38 2021-01-07 numbness 1150 Post injection my tongue started to feel numb and tingling. Tongue started to swell. Over th... Read more
1150 Post injection my tongue started to feel numb and tingling. Tongue started to swell. Over the next 20 minutes the numbness and tingling progressed to the roof of my mouth, my gums, my lower lip, underneath my tongue, up my cheeks, and underneath my eyes on both sides. Because it kept slowly progressing I took 25 mg oral Benadryl. About 20 minutes after the Benadryl I noticed that my tongue didn?t feel or look as swollen. Within an hour I would say 95% better. I just had some trace numbness on my cheeks bilaterally. Symptoms returned again about 12 hours later. Again took Benadryl, this time 50 mg. All symptoms have resolved
38 2021-01-07 flushing, feeling hot FLUSH IN FACE, HEAT ON FACE, HEADACHE, DIZZINESS
38 2021-01-07 numbness I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart ra... Read more
I was having trouble clearing my throat, felt like it was closing up; high heart rate/rapid heart rate agai; uncontrollable rigors; numb lips and hands; numb lips and hands; nausea; shortness of breath, difficulty catching my breath; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1685, intramuscular in the left arm, on 30Dec2020 09:15 at a single dose for COVID-19 immunization. Medical history included bariatric surgery, had anterior vaginal repair and bladder sling, had her gall bladder and tonsils removed. Concomitant medication included rizatriptan and paracetamol (TYLENOL). The patient had no known allergies but mentioned that she cannot take the NSAIDs eventhough she was not allergic to them. She had no allergies to food or to other products. It was reported that within about 10 minutes of the injection of the vaccine, she had trouble clearing her throat, felt like it was closing up, had uncontrollable rigors, high heart rate, numb lips and hands, and nausea on 30Dec2020 at 09:30 AM. She was discharged from the ED (emergency department), went home and took a nap. Later that evening, she began to have a rapid heart rate again, began to had shortness of breath, difficulty catching her breath and she was admitted to the emergency department again and given more IV medications. The onset of the events was reported to be 30Dec2020 at 09:30 AM with outcome of recovering. As a result of the events, the patient visited that Emergency room/department or urgent care. Treatment received with IV medications (unspecified), breathing treatment, and epinephrine injection. The patient had no covid prior vaccination. She had not had Covid test post vaccination.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events throat tightness, heart rate increased, chills, hypoaesthesia oral, hypoaesthesia, nausea and dyspnoea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
38 2021-01-07 flushing Patient present some flushing after vaccine administration
38 2021-01-07 numbness Reported numbness on the left side of face after receiving first dose of vaccination and left deltoi... Read more
Reported numbness on the left side of face after receiving first dose of vaccination and left deltoid. Was transferred to emergency department at local hospital.
38 2021-01-07 flushing The patient present some flushing after vaccine administration and he doctor give Benadryl 50 mg IM... Read more
The patient present some flushing after vaccine administration and he doctor give Benadryl 50 mg IM one dose.
38 2021-01-07 slurring, facial paralysis Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, ... Read more
Thursday morning 1/7/21, right side of face noticed jaw drooping, later progressed to bad headache, bad taste in mouth then lost sense of taste. Pain on the right side of face/jaw area. Trouble speaking. Went to ER at hospital then transferred to another ER.
38 2021-01-07 feeling cold While waiting ini observation area pt reported "not feeling well" was given water and asked to stay ... Read more
While waiting ini observation area pt reported "not feeling well" was given water and asked to stay for aditonal amoutn of time. SOrtly after she reported "feeling like i am goinog to pass out" . Lightheaded dizzy, no other physical complaints. Pt is cool, lips pale.
38 2021-01-07 flushing, tingling Within 3 minutes of receiving vaccine, associate became flushed, tachycardic, tingling to chest and ... Read more
Within 3 minutes of receiving vaccine, associate became flushed, tachycardic, tingling to chest and abdomen, and weakness of legs. She was observed for 35 minutes by Drs. during this time period. Symptoms resolved in entirety during this time. Associate was later contacted by Dr. via phone follow-up 1 hour after leaving vaccine clinic and associate reports symptoms continue to be resolved and did not reoccur.
38 2021-01-07 tingling nausea, tingling in hands, states slight airway restriction, Benadryl 25mg given po at 11:40am, Puls... Read more
nausea, tingling in hands, states slight airway restriction, Benadryl 25mg given po at 11:40am, Pulse 72, O2 SAT 100%, Patient was observed for 20 minutes, patient left at 12pm stating feels better returning to work.
38 2021-01-07 flushing pt became flush nauseated increased anxiety increased hypertension short lived no hivea no swellin... Read more
pt became flush nauseated increased anxiety increased hypertension short lived no hivea no swelling
38 2021-01-08 feeling hot About 15 minutes after the injection I felt a warm sensation throughout my body and it went away imm... Read more
About 15 minutes after the injection I felt a warm sensation throughout my body and it went away immediately. About 10 minutes after that, my throat started feeling scratchy/itchy/tingling, then my tongue and lips. After about 10 minutes it went away. I felt ok so I left the vaccination area and went back to my department I work in. For several hours the same symptoms came and went in waves, lessening over time. At 8:30pm the same day, I took 25 mg PO Benadryl to feel safe while sleeping. I felt fine the next day and reported it to the pharmacist in the vaccination clinic. I never felt like my airway was compromised.
38 2021-01-08 pain in extremity Left armpit swelling with pain and soreness
38 2021-01-08 cold sweat Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, ever... Read more
Woke up at 2:30 am feeling nauseous, broke out in cold sweat, got out of bed, went to restroom, everything went black and felt like I was going to pass out. Husband got to me and laid on the floor. Never passed out completely, but it was a very weird and odd feeling. Felt better after about 20 mins. Have felt great since. So did not go to primary care physician but felt the need to report.
38 2021-01-09 tingling, discomfort Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat fel... Read more
Body and extremities started tingling and felt very heavy, heart felt like it was racing, throat felt like it was slightly swollen, chills, head felt foggy, instant fatigue
38 2021-01-09 pain in extremity Fatigue, body aches, arm pain, chills
38 2021-01-09 pain in extremity Headache, body aches, arm soreness, nausea, chills
38 2021-01-09 tremor, feeling cold I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respi... Read more
I felt fine after the shot all day. I went to bed at 1030pm, woke up at 1130 hyperventilating (respiratory rate was 40+ and I couldn?t lower it), shaking uncontrollably (felt increasingly cold, though my temp was normal; my skin was cold to the touch but I felt like it was burning off), tachycardic (heart rate was 140bpm and I normally am at 60-80 at rest). My throat felt like it was closing and my face was swollen. I should have gone to the ER, but I wasn?t thinking clearly and didn?t know what to do with my small children. It took 2 hours until I stopped shaking, my heart rate returned to normal, and my breathing was under control. Since then I have mainly been fatigued, taking Tylenol for overall aches, and have not been able to tolerate much activity (can only stand for about 5 minutes at a time).
38 2021-01-09 weakness I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tens... Read more
I felt weak and with muscle fatigue the day after the shot. Also had a headache and neck muscle tension and mid back muscle tension. Joint pains as well. These subsided after 48 hours except for the neck and upper back muscle fatigue and mild soreness. This gave me a low grade headaches almost daily since the vaccine. I took ibuprofen a few times which helped. On the 6th I awoke at night and felt weak all over. I felt like I was falling in my bed. Mild dizziness. I went to work and felt extremely fatigued with muscle weakness but no neuro deficits. I feared some terrible autoimmune illness and took Decadron that day- 4mg tab BID. This helped my muscle weakness but left me with insomnia. The decadron is now wearing off after 4 days and I still have muscle weakness/fatigue. It takes considerable effort walking up the stairs. Yesterday my masseter muscles became fatigued with little chewing. My arms feel heavy when I lift them. The strange thing is that at night when I lie down I feel like my sympathetic nervous system is being triggered. I will get palpitations and feel just strange- I can't describe it. I took valium to sleep last night -5 mg tablets that my doctor gave me Saturday as there seems to be an anxiety panic component going on. I have no history of diagnosed anxiety or panic attacks- I have never felt this way before. Today I feel a little better but still have considerable muscle fatigue and neck and upper back muscle soreness and overall muscle tightness in my arms and legs- feels good to stretch kind of feeling. I have mild dizziness when standing up and turning too abruptly. But no considerable focal neuro deficits.
38 2021-01-09 feeling hot, feeling cold, tenderness, pain in extremity, weakness Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am ... Read more
Received vaccine on 1/6 at 0800pm 1/7 - 730am woke up with a very soar arm, difficult to move. 10am felt very tired, like I was about to catch a cold. 12pm felt cold, had a temp of 99.9 F 3pm was very tired, chills, mild nausea, temp 100.8 F - took tylenol at this point 1000mg. Tylenol helped reduced fever and chills. Still continued to feel very tired and had no energy. Stomach continued to feel sensitive and had very little appetite. 10pm - fever returned 100.6 with chills - took another dose of 1000mg tylenol and went to sleep. Through out the night was hot and cold. 1/8 7am - I woke up had temp of 100.1F - no chills, still very tired, arm still very sore. Did not take tylenol. 9am - temp now 99.7 F - still very tired 10am - temp now 98.6F - nausea resolved, still had no appetite. Very tired, body felt sore and left armpit hurt when I moved, I noted no lymph nodes. Remainder of day I remained fever free, but continued to feel very tired and took a few naps. (this is not my norm, I do not nap). By dinner time appetite was better but stomach still felt tender. 1/9 - woke up feeling great, lots of energy, even went for a jog. Arm still a little sore.
38 2021-01-09 pain in extremity Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, di... Read more
Severe arm pain, swelling at injection site, redness, warm to touch. Feverish, chills, headache, diarrhea, severe body aches, joint pain.
38 2021-01-09 pain in extremity Shot given in L deltoid. Day 3-10 post vaccine I had extreme pain in what seemed like my left trapez... Read more
Shot given in L deltoid. Day 3-10 post vaccine I had extreme pain in what seemed like my left trapezius muscles. The pain was much worse in the evening/night and was sometimes absent during the day. Also on day 14 post vaccine (1/7/2021) I developed a cold sore for the first time in my life.
38 2021-01-09 face paralysis, numbness The patient presented with left eye peripheral visual loss, left upper and lower extremity and facia... Read more
The patient presented with left eye peripheral visual loss, left upper and lower extremity and facial numbness sensation and weakness. This started 1 hour after receiving COVID-19 vaccine at her place of employment. Pt was brought to CRMC via EMS.
38 2021-01-09 muscle twitching Three days after receiving first vaccine, I woke up with fasciculations in my left lower lip. The tw... Read more
Three days after receiving first vaccine, I woke up with fasciculations in my left lower lip. The twitching was visible standing 2 ft from my mirror. It lasted approx 30min then spontaneously resolved. No other symptoms.
38 2021-01-10 pain in extremity, numbness (Saturday)rigors @about 730 PM with temp of 100.9. Tylenol 650mg taken. (Sunday)Body aches in th... Read more
(Saturday)rigors @about 730 PM with temp of 100.9. Tylenol 650mg taken. (Sunday)Body aches in the morning with temp of 100.5. Ibuprofen 600mg taken. Felt better about 3pm. (Monday) Pain/discomfort to armpit and numbness to Left arm (Arm that injection was given)
38 2021-01-10 flushing 38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immed... Read more
38-year-old female who is healthcare worker and received first dose of COVID vaccine (Pfizer). Immediately after receiving the vaccine, patient developed lightheadedness, flushing, hives, wheezing and throat swelling. Patient was treated in an emergency department with epinephrine, gradually improved and was able to be sent home with an EpiPen, prednisone, hydroxyzine, and famotidine. The next day, patient again developed shortness of breath and her husband administered the EpiPen. EMS arrived and gave another dose of IM epinephrine and IV diphenhydramine. On arrival to the emergency department, the patient was altered, diaphoretic, tachypneic, tachycardic, and stridulous. Patient was given multiple doses of IM epinephrine and started on epinephrine drip. Stridor continued and was unresponsive to nebulized albuterol. Patient was then intubated and placed on mechanical ventilation. Other treatments included solumedrol, pepcid, magnesium sulfate, nebulized epinephrine, and IV fluids. admitted to the intensive care unit, weaned off epinephrine drip, and extubated the next day. Patient was monitored on hospital floor for one additional day and was then discharged with no residual symptoms.
38 2021-01-10 pain in extremity 9:30 pm chills, escalating to shivering, then a fever and severe headache and arm pain throughout th... Read more
9:30 pm chills, escalating to shivering, then a fever and severe headache and arm pain throughout the night. Woke with a temp of 101.3 at 8am the next day, body aches, and headache. Fatigue and sweats until fever broke about 11am after more sleep. The afternoon decreased symptoms until only a mild headache and fatigue that night.
38 2021-01-10 tremor Awoke that night after receiving 2nd dose of Pfizer COVID-19 vaccine with fever, sweats/chills and b... Read more
Awoke that night after receiving 2nd dose of Pfizer COVID-19 vaccine with fever, sweats/chills and body aches. Experienced difficulty sleeping the rest of the night due to symptoms and restlessness. Following day, I continued to have fever averaging 100 degrees F, body aches, chills and headache that brought me to tears. That evening, began experiencing severe nausea and involuntary shaking. Reported to ER for management of symptoms. Received fluids, ibuprofen, Zofran and Reglan as well as potassium. It is currently the following Monday so 5 days post vaccine and I continue to have intermittent nausea and headache.
38 2021-01-10 tremor Beginning the evening after receiving vaccine 1/5/21 patient complains of nausea, headache. The ne... Read more
Beginning the evening after receiving vaccine 1/5/21 patient complains of nausea, headache. The next day the patient symptoms were chills, headache, restless legs, and a slight tremor. By Saturday 1/9/21, the patient was experiencing worsening restless legs, and tremors to the point she could the sleep or work. Patient reported symptoms to the pharmacy on monday 1/11/21, chills, nausea, and headache had subsided and tremors and restless legs were improving.
38 2021-01-10 flushing Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 mi... Read more
Experienced flushing and lightheadedness, required extended monitoring. Returned to work after 35 minutes of monitoring.
38 2021-01-10 flushing Experienced flushing and lightheadedness. Required extended monitoring. Patient returned to work aft... Read more
Experienced flushing and lightheadedness. Required extended monitoring. Patient returned to work after 35 minutes of monitoring.
38 2021-01-10 flushing Felt and appeared flushed, as well as feeling her throat closing up and being "unable to breathe" wi... Read more
Felt and appeared flushed, as well as feeling her throat closing up and being "unable to breathe" within 6 hours of receiving the immunization
38 2021-01-10 tingling Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain... Read more
Fever up to 101.2 F, chills, severe headache( left temporal, right temporal then spread to forebrain, even walking coughing makes brain hurt like tingling, loose stool, long bone pain, peri orbital edema, neck stiffness, new onset low back, loss of appetite, loss of taste, insomnia, fatigue and dizziness. I feel like I have all repeat symptoms of covid, with worse headache and neckstiffness than actual infection. Fever last for 3 days and disappeared but headache continues and ended up in ER. CTA negative, D dimer<200
38 2021-01-10 tingling, feeling hot Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for severa... Read more
Metallic taste in mouth, tingly behind eyes, lightheaded, warm sensation throughout chest for several hours, racing heart rate, sudden hot feeling, extreme headache, extreme fatigue, brain fog, irritability, pain at injection site.
38 2021-01-10 speech disorder Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing a... Read more
Metallic taste in the back of throat between 15-20 minutes post vaccination, noticeable swallowing and throat irritation at 20-25 minutes post vaccination, tongue and lip numbness and throat tightness at 25-30 minutes, dry hacking cough at 30 minutes. Treated in the ED approximately 1 hour post vaccination, at time of arrival in respiratory distress with subcostal retractions, coughing, speaking 1-2 word sentences, with tachycardia and tachypnea. Treated with IM epinephrine, IV solumedrol and IV Benadryl and IV Benadryl with marked improvement in symptoms.
38 2021-01-10 flushing Patient present flushing after vaccination
38 2021-01-10 feeling hot Pfizer vaccine given at 2:55pm. 3:10 Patient felt hot, diaphoretic, dizzy. Assisted patient to wheel... Read more
Pfizer vaccine given at 2:55pm. 3:10 Patient felt hot, diaphoretic, dizzy. Assisted patient to wheelchair. Patient symptoms improved briefly. Continuously monitored oxygen saturation and pulse. 3:12pm 110/60, P 78, O2 98% RA. 3:15pm call 911 to requested EMS due to patient reporting shortness of breath, throat tightening, chest tightness. 3:18pm 130/80, P 101, O2 99% RA, administered oral diphenhydramine 25mg and 0.5mg Epi (1:1000) via IM injection in right deltoid. 3:25pm 130/80, P 85, O2 93%. Ambulance arrives at 3:28 pm received report and transports patient via ambulance to Hospital.
38 2021-01-10 pain in extremity Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the ev... Read more
Sore throat for a few hours after the injection Painful body aches, body sweats and chills in the evening - Aleve worked temporarily and then the side effects got worse, took another Aleve and eventually was able to sleep it off Arm aches at site of injection - still tender t otouch
38 2021-01-10 pain in extremity That evening I started getting a sore arm. The next morning I woke up w/ a slight headache and just ... Read more
That evening I started getting a sore arm. The next morning I woke up w/ a slight headache and just did not feel right. As the day progressed I started having body aches, chills, extreme fatigue, still sore arm. I could not stand for long periods of time or I would start to fell like I was going fall right there in the floor.
38 2021-01-10 pain in extremity The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after ... Read more
The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after shot I started to feel extreme fatigue, muscle aches, slightly sore throat, mild congestion. I had a temperature of 99.1. I went to an urgent care and my BP was elevated (very unusual for me) 140/100 and HR 110 and temp still 99.1. They did a rapid swab on me that was negative. I continued to feel awful the rest of the day. On Sunday the next morning I awoke because I had a very swollen and sore lymph node in my left armpit. I took tylenol and did warm compresses. I had continued fatigue on Sunday and slept the whole day. I also continued with a high heart rate 110-130 with activity. My Bp was 117/70I had a pulse oximeter at home. My temp stayed 99. Monday morning I woke up feeling better. My HR was in the 80 and temp 98.3 and fatigue is gone. I still have mild soreness in my left arm but the redness is fine and warmth is gone. My left armpit is still sore
38 2021-01-10 feeling hot, numbness within minutes entire body numbness and "hot", followed by full body erythema. Was transported to th... Read more
within minutes entire body numbness and "hot", followed by full body erythema. Was transported to the ED for treatment.
38 2021-01-11 tremor At approx 0000 on 1/11 I started running a fever (102.3 oral), having severe body aches, massive hea... Read more
At approx 0000 on 1/11 I started running a fever (102.3 oral), having severe body aches, massive headache and uncontrollable shaking and chills
38 2021-01-11 feeling hot, flushing Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness ... Read more
Became very hot, flushing, dizziness, lightheaded, felt like passing out. Followed by jaw tightness and pain, tongue swelling, lip swelling, difficulty breathing, chest tightness, fast heartbeat, increased blood pressure. Given benadryl, epi, solu-medrol and pepcid. Kept for observation. After release, continuing to have intermittent hot flashes, itching all over face and body, occasional jaw tightness, sore throat and tongue, increase in pulse, O2 sats in low 90s,
38 2021-01-11 weakness I awoke the next morning after my 2nd dose with the following side effects: Extremely light headed ... Read more
I awoke the next morning after my 2nd dose with the following side effects: Extremely light headed to the point it was hard for me to walk without feeling like I would pass out, body aches, severe headache, nauseous but never vomited, extremely tired as if I were given a sleep aid, and weak. I called my primary care physician to see if there was anything I could take to help, they advised me to take Ibuprofen and Tylenol. I started to feel better a few hours after taking Ibuprofen. The next day I just had a headache and am feeling tired. I would say the most extreme symptoms lasted about 10 hours and started to slowly feel better after that.
38 2021-01-11 speech disorder, tingling, muscle spasms Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and w... Read more
Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak; Jaw/neck/throat area became tight like tensing up; Hard to talk, was shouting out one word at a time; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms; My fingers move often, like a compulsion; This is a spontaneous report from a contactable health care professional, the patient (patient). A 38-years-old non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1284), intramuscular in the left arm on 28Dec2020 19:00 as a single dose, for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital The patient had no known medical history or allergies. Concomitant medication included bupropion (BUPROPION), propranolol (PROPRANOLOL), sertraline (SERTRALINE), ethinylestradiol, levonorgestrel (PORTIA 21). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 28DEC2020, the patient experienced Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion. Adverse event resulted in a physician office visit. No treatment was given for the event. The clinical outcome of Left arm and hand were tingly and weak, later that night right arm and hand also became tingly and weak. Jaw/neck/throat area became tight like tensing up. Hard to talk, was shouting out one word at a time. My hands, fingers and my arms on both sides continue to not feel normal. They are tingly, weak, achy, tired. Typing, texting are hard. Hard to hold up arms. My fingers move often, like a compulsion was not recovered.
38 2021-01-11 pain in extremity Left arm started hurting me the day after the vaccine and everyday the pain got worse it travel in t... Read more
Left arm started hurting me the day after the vaccine and everyday the pain got worse it travel in to my neck and back side of my upper back. On 01/12/2021 couldn't go to work due to the pain been higher and I couldn't turn my neck to the left side
38 2021-01-11 pain in extremity Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side on... Read more
Lymph nodes swollen under L) arm X 5 days very painful , Fatigue X 3 days , headache on left side only including neck and torso left side only X 4 days .
38 2021-01-11 numbness R sided facial numbness approx 30 mins after vaccine. R lip felt swole/big then R lower face. I took... Read more
R sided facial numbness approx 30 mins after vaccine. R lip felt swole/big then R lower face. I took 1/2 Benadryl after.
38 2021-01-11 pain in extremity Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I f... Read more
Severe fatigue; Headache; Body aches; Feel like my skin is crawling; Nauseous; Arm is very sore; I feel like I'm dying; This is a spontaneous report from a contactable healthcare professional. A 38-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as COVID-19 vaccine), via an unspecified route of administration left arm on an unspecified date (unknown lot number and expiration date) at a single dose; and via an unspecified route of administration left arm on 04Jan2021 18:00 [06:00 PM] (lot number: Eh9899; expiration date: unknown) at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had known allergies to amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine administered in a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. On 05Jan2021 17:00 [05:00 PM], the patient experienced severe fatigue, headache and body aches- feel like her skin is crawling and was hit by a freight train. The patient has never had a reaction like this before. The patient was also nauseous, and her arm is very sore, but she doesn't even notice since she feeling like she's dying. The patient has not been tested for COVID-19 since the vaccination. The treatment received by the patient for the adverse event included paracetamol (TYLENOL)/ibuprofen around the clock (OTC medication). The patient reported that the events was non-serious. The adverse event resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the event was not resolved. The following information on the batch/lot number has been requested.
38 2021-01-11 pain in extremity, feeling hot Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked lik... Read more
Swelling that looked like an egg under my arm, very visible very very sore; Swelling that looked like an egg under my arm, very visible very very sore/couldn't move my arm without it hurting; rash; hot to the touch; bruising; dizziness; nauseous; headache; body ache; muscle ache; very tired; joint pain; loss of appetite; This is a spontaneous report from a contactable healthcare professional. A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ET1685, expiration date not reported), via an unspecified route of administration on the left arm, on 30Dec2020 at 11:45 at a single dose for Covid-19 immunization. Medical history included latex and shellfish allergy. Patient was diagnosed with Covid-19 prior to vaccination. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ergocalciferol (VITAMIN D), calcium, topiramate, and cyanocobalamin (vitamin B12). The patient previously took erythromycin, terbutaline, iodine and experienced drug allergies. On 30Dec2020 at 11:45, the patient experienced swelling that looked like an egg under her arm, very visible very very sore, rash, hot to the touch, bruising, dizziness, nauseous, headache, body ache, muscle ache, very tired, couldn't move arm without it hurting, joint pain, and loss of appetite. On 04Jan2021, the patient had a nasal swab and was tested for COVID-19, both with unknown result. The patient did not receive treatment for the events. The outcome of the events was recovering. The reporter assessed the events as non-serious.
38 2021-01-11 migraine caller stated that vaccine caused chills, heart rate increase, nausea, vomiting, body aches and mig... Read more
caller stated that vaccine caused chills, heart rate increase, nausea, vomiting, body aches and migraines lasting 72 hours.
38 2021-01-12 tingling @0928 about 20 minutes post vaccine, she stated she was starting to feel tingling to her neck and ar... Read more
@0928 about 20 minutes post vaccine, she stated she was starting to feel tingling to her neck and arms bilaterally. NAD, no SOB, v/s 154/110 (normal for her is 102/80s). 98% RA, hr 95, 96.9 temp and no pain. Did report dizziness. patient has a history of anaphylaxis. Evaluated her for 30 minutes after onset of symptoms. C/o anxiety and feeling seasick, never experienced respiratory distress at the end of her additional 30 minutes she reported feeling better.
38 2021-01-12 feeling jittery, pain in extremity, tingling, tremor Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took al... Read more
Began with shooting sharp pains in left foot gradually going up my left leg. At that point I took aleve and a trazadone in hopes of getting some rest. I fell asleep. I woke up around 0200 on 1/13/21 with extreme muscle and joint aches, a sensation of pins, needles, and tingling all over my body I felt very jittery and was actually shaking slightly throughout the ordeal. I felt like my nervous system was overloaded and my perception of pain was extremely heightened. At one point during this 4 hour period I had a visual hallucination. By 0600 I was feeling better- more relaxed. Muscle aches and sore joints are still present today. Also have a slight increase in temp 99.6 and injection site pain.
38 2021-01-12 flushing Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. ... Read more
Patient presented to Facility MD Experiencing Flushing, HA, elevated BP, Faint with Rapid HRT Beat. She was given water, Juice and laid down. After 30-40 minutes sxs subsided. Spoke to pt said she was Feeling much Better. Spoke to nurse at Rehab center. Pt reported she was Feeling much better By 5pm on 1-12-21.
38 2021-01-12 pain in extremity Soreness (Left Arm) x 2 days Fatigue (Intermittently) / 7 days Fever (Intermittently) / 7 days Body ... Read more
Soreness (Left Arm) x 2 days Fatigue (Intermittently) / 7 days Fever (Intermittently) / 7 days Body Ache/ 3days Chills /24 hrs.
38 2021-01-12 tingling, numbness, nerve pain Systemic: Nerve pain along left arm up along shoulders into neck, numbness, tingling, seems to subsi... Read more
Systemic: Nerve pain along left arm up along shoulders into neck, numbness, tingling, seems to subside after 30 minutes, but still lingering; symptoms lasted 1 day.
38 2021-01-12 tingling, numbness Systemic: Tingling/Numbness/Right side of face (injection given on right side); symptoms lasted 1 da... Read more
Systemic: Tingling/Numbness/Right side of face (injection given on right side); symptoms lasted 1 day
38 2021-01-12 weakness nauseous , weakness, fever, racing heart. All symptoms started about 5 hours after vaccination. Feve... Read more
nauseous , weakness, fever, racing heart. All symptoms started about 5 hours after vaccination. Fever highest so far at 101.6 , heart rate 132 at highest taken.
38 2021-01-13 tenderness 1/11:motrin 800mg 1 hr prior to injection. minor pain at injection site. no redness or swelling no... Read more
1/11:motrin 800mg 1 hr prior to injection. minor pain at injection site. no redness or swelling noted. 1/12: still minor soreness at injection site but around bed time , I noticed pain in my armpit and swelling( fluid filled area) around possible lymph node. Palpable lymph node along left clavicle with similar fluid filled swelling. Took motrin throughout the day and 50 mg of benadryl at bedtime. 1/13: Left arm pit still swollen. more tender with movement. While at work i put hot compress in my arm pit to help with the pain and shortly after i noticed my left arm had bright red streaks from my arm pit to my wrist. It also was very mottled looking. My arm felt tight/heavy or kind of like a pinched nerve feeling.. I took motrin throughout the day for soreness and took benadryl at bedtime. I place ice pack under my arm during the evening as well. 1/14: Swelling remains in the armpit. Tenderness is getting better. Similar swelling around clavicle . Still taking motrin for inflammation and using ice pack under my arm.
38 2021-01-13 cold sweat, weakness 1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injecti... Read more
1/12: 12:01am: Shaking chills, body pain, headache, nausea, faint, skin sensitivity, pain at injection site left arm. Temp 98.6 1/12: 0600am: Shaking chills, cold sweat, faint, nausea, headache, body pain, fatigue, skin sensitivity, pain injection site. 1/12: 0630am: Same as above, Temp 100.9, took Ibuprofen 3 tabs. 1/12: 0730am: Less of all symptoms, ate food. 1/12: 12:30pm: Headache, body aches and pains, weakness, fatigue, nausea, skin sensitivity, pain at injection site. 1/12: 1:12pm: Temp 99.5. took ibuprofen 3 tabs. 1/12: 2:15pm-3:40pm: Breakthrough body aches, pains, headache, skin sensitivity, pain at injection site. 1/12: 7:40pm: Body aches, tired. Temp 98.3. took Ibuprofen 3 tabs. 1/13: 0800: Slept well, no further pain medication, no further side effects except mild soreness at injection site. 1/24: 0800: no soreness to injection site.
38 2021-01-13 numbness Facial numbness, face turned red elevated BP
38 2021-01-13 feeling hot Patient presented for her second Pfizer vaccine January 11, 2021. She waited her 15 minutes and sta... Read more
Patient presented for her second Pfizer vaccine January 11, 2021. She waited her 15 minutes and started to pull away when she noticed that she was beginning to get warm. She looked in her car mirror and noticed a rash on her neck and chest. She then pulled back around to let us know of her reaction. Vital signs checked. BP was 122/68. HR was 97. Sp02 was 99% on RA. She denied any SOB. At 1657 she was given Benadryl 25 mg po that she swallowed without any difficulties. She reported that she began to feel better. Rash started to look better. Patient will wait another 15 minutes to make sure that her symptoms resolve. Patient is A0x4. She is talking without difficulty.
38 2021-01-13 pain in extremity Soreness at the injection site, arm pain
38 2021-01-13 pain in extremity Soreness at the injection site, arm pain, headache and full body chills
38 2021-01-13 feeling cold Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At ... Read more
Symptoms - EE reports after vaccine she waited the 30 minute observation period and felt fine. At approximately 7:00 pm EE reports she went to store and when she went to get out of her car she felt really dizzy. EE reports she hadn?t eaten much that day so tried to eat some chocolate covered pretzels and coke. EE denied syncope. EE reports she started feeling ?chest tightness? and starting panicking. EE denies airway issues and SOB. EE said she got nervous and went to hospital across the street for assessment. EE reports at triage her SPO2 was 100% but slightly tachycardiac. EE reports after her triage assessment she called her daughter to come pick her up and did not seek further medical care. EE reports when she got home she started with generalized itchiness, denies rash. EE reports she took 50 mg Benadryl, 25 mg Atarax, and 40 mg Pepcid at 8:45 PM. EE reports not change in itchiness and took 2nd dose of 50 mg Benadryl around 01:30 (1/14). EE reports she woke up around 06:45 (1/14) with bilateral arm bruising from scratching overnight per EE and feeling chilled. Last day of work and shift - ? scheduled to work tonight (1/14) Home remedies? ? see symptoms for home remedies Any improvement? ? mild improvement Recommendation? EE encouraged to continue to monitor symptoms and to contact EH vaccine support line with further questions or concerns. EE encouraged to take Claritin and Benadryl as outline by the Medical Directive at hospital. EE educated to only take Benadryl if she will be at home today and that is she unable to take Benadryl when at work, EE verbalized back understanding. EE educated if she is still feeling unwell for her shift tonight, to notify her manager and to manage per hospital Illness in the Workplace Policy. EE denied further questions at this time.
38 2021-01-13 tingling Tingling (pins and needles) in bilateral hands, lasted approximately 24 hours, now improving but not... Read more
Tingling (pins and needles) in bilateral hands, lasted approximately 24 hours, now improving but not resolved No treatment yet
38 2021-01-13 grand mal seizure Unprovoked seizure (clonic tonic) 13 days later, requiring hospitalization and testing
38 2021-01-13 hot flush, feeling hot Within 10 minutes of receiving the vaccine, my heart began to race and I became very warm and sweaty... Read more
Within 10 minutes of receiving the vaccine, my heart began to race and I became very warm and sweaty. I was brought into another room for monitoring and my heart rate was above 100. After some breathing exercises, it came back down to the high 70s for a few minutes but then increased again into the 90s, at one point it was 113. My chest and throat then began to feel tight and I began sweating again. My face also felt funny on my right cheek. At that point I was first given 25 mg of benedryl then epinephrine. I was then taken to the emergency room via ambulance and was observed for approximately an hour. I was given an additional 25 mg of benedryl and discharged at 4:55pm. I was diagnosed with an allergic reaction and prescribed 25 mg of benedryl every 6 hours over the next 24 hours. The following morning, I experienced a hot flash with profuse sweating followed by chills. I was very tired and felt feverish throughout the day on 1/12 and stayed home from work. On 1/13 I still felt tired but was able to work. Today I feel mostly normal but still occasionally have had heart palpitations.
38 2021-01-14 tingling, numbness Left side of face numbness and tingling (mild). No assymetry. Worsened ove 4-6 hours. Gone the next... Read more
Left side of face numbness and tingling (mild). No assymetry. Worsened ove 4-6 hours. Gone the next day.
38 2021-01-14 migraine Migraine headache; This is a spontaneous report from a contactable nurse reporting for herself. A 38... Read more
Migraine headache; This is a spontaneous report from a contactable nurse reporting for herself. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular from 20Dec2020 11:00 in left arm to 20Dec2020 11:00 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included cetirizine hydrochloride (ZYRTEC). On 20Dec2020 17:00, the patient experienced migraine headache approximately 6hrs after injection. The patient recovered on unspecified date. No treatment was given to the patient for the event. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The event was considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.
38 2021-01-14 pain in extremity My entire arm is painful and there is now a knot under my left arm pit that is tender and there is r... Read more
My entire arm is painful and there is now a knot under my left arm pit that is tender and there is rash also under the same arm pit.
38 2021-01-14 pain in extremity My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted... Read more
My heart rate, I was like in AFib; very high fever of 103; dizzy, light headed; arms sore; exhausted like an extreme fatigue; palpitations; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration on 30Dec2020 at 38-years-old at a single dose for COVID-19 immunization. Medical history included blood clotting disorder from an unknown date and unknown if ongoing. The patient experienced the following events and outcomes: my heart rate, I was like in AFib (medically significant) on 31Dec2020 with outcome of recovering, very high fever of 103 (non-serious) on 31Dec2020 with outcome of unknown, dizzy, light headed (non-serious) on 31Dec2020 with outcome of unknown, arms sore (non-serious) on 31Dec2020 with outcome of unknown, exhausted like an extreme fatigue (non-serious) on 31Dec2020 with outcome of not recovered, palpitations (non-serious) on 31Dec2020 with outcome of not recovered. The clinical course was reported as follows: The patient stated, "the day after the shot I got a very high fever of 103. I was dizzy, lightheaded. My heart rate I was like in AFib, it was going from 60s to 50s all over the place. And this was the next day after the vaccination. That evening nothing my arms was just sore. But the next day all of these side effects just started in and even still today I just feel so exhausted like an extreme fatigue and I am still getting like palpitations." The patient stated, "So I went to urgent care and they check my vitals and stuff and when they wanted me to send me to the hospital. But I told them I will get a ride and I go by myself just because I didn't want, capable of an ambulance ride and I ended up just going home because I couldn't get a hold up anybody. So, I came home and took my blood thinner medication because I do have blood clotting disorder." In regard to the outcomes of the events, the patient stated, "I am not experiencing all of them still definitely my heart is much better. I am still getting palpitations but nothing near how it was that first day. I am experiencing extreme fatigue."
38 2021-01-14 migraine Nausea, racing heart, shakey, migraine, sore throat
38 2021-01-14 tremor Racing hearr, shaking, body aches, head hurts so bad i cant walk, sore throat
38 2021-01-14 tremor Shakiness, feeling of wanting to faint, headache, fatigue, exhaustion , nauseous So far I have taken... Read more
Shakiness, feeling of wanting to faint, headache, fatigue, exhaustion , nauseous So far I have taken Excedrin
38 2021-01-14 pain in extremity Sore arm and pain at injection site
38 2021-01-14 feeling jittery Took 2nd dose shot at approx 9am on 1/13/21. By approximately 5pm began to experience flu like symp... Read more
Took 2nd dose shot at approx 9am on 1/13/21. By approximately 5pm began to experience flu like symptom with no fever. Body aches, chills, jittery/insomnia. I took 4 doses of ibuprofen between 6pm on 1/13 and 6pm on 1/14. Effectiveness of ibuprofen was none to minimal. and symptoms fully returned within 3-4 hours. Symptoms lasted from 6pm on 1/13 until going to sleep at 10pm on 1/14. Woke up on 1/15 at 6am and all symptoms were resolved. I has no symptoms from 1st dose other than pain at the injection site for 24 hours.
38 2021-01-14 feeling jittery Took second dose shot at 9am on 1/13/21 - by 5pm the same day I started to experience flu like sympt... Read more
Took second dose shot at 9am on 1/13/21 - by 5pm the same day I started to experience flu like symptoms - no fever but had muscle aches, chills, jittery/restless/insomnia, fatigue - these symptoms continued until 10pm on 1/14. Took four doses of ibuprofen between 6pm on 1/13 through 6pm on 1/14. The ibuprofen was eith ineffective or slightly effective for a short period of time but all symptoms returned within 3-4 hours after taking ibuprofen. All symptoms resolved upon waking at 6am on 1/15/21.
38 2021-01-15 numbness, discomfort, pain in extremity, tingling Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in ... Read more
Approximately 28 hours after injection I started experiencing intermittent numbness and tingling in the right hand. At 33 hours post injection developed a deep dull aching pain throughout entire right arm. This worsened, and after 2 more hours intermittent sharp shooting pain down the arm. Pain rated 6 out of 10 intermittently with a constant 3 out of 10 full ache. Difficulty falling asleep due to discomfort and at one point the pain woke me up from sleep. It was resolving by early the next morning, and disappeared by hour 48 post injection. These pains were not inclusive of the soreness and tenderness of the injection site or the muscle pain when lifting the arm. Those symptoms are still present to a minimal extent 54 hours after injection, at the time I am writing this report.
38 2021-01-15 numbness Chills, muscle aches, low grade fever 99.7, whole left arm numbness
38 2021-01-15 pain in extremity Headache, joint pain, back pain. Swelling of joints on left side, which is the side immunization was... Read more
Headache, joint pain, back pain. Swelling of joints on left side, which is the side immunization was received. Entire upper arm where injection was received is sore all the way to elbow. Elbows and knees hurt like they were hyperextended. These symptoms started at 1000 am the day after the immunization.
38 2021-01-15 tingling sudden onset redness with rash to face and neck, generalized itching to upper body, skin tingling
38 2021-01-16 inability to speak, hot flush Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle i... Read more
Allergic reaction started about 30-35 minutes after injection. First symptom was dry mouth, tickle in throat, and felt like tongue was swelling followed by hot flashes, ?cloudy? brain. My words didn?t want to form although I knew what I wanted to say. I was speaking very slowly. Heart rate was fast.
38 2021-01-16 pain in extremity Fever, chills, tiredness, fatigue, massive headache, body aches, sore and bump on my left arm. These... Read more
Fever, chills, tiredness, fatigue, massive headache, body aches, sore and bump on my left arm. These have caused me to not come to work for two days. I came back to work 1/16/21, still having headache, soreness on my left arm and feeling tired.
38 2021-01-16 weakness, tremor Fever, shaking chills >12 hours, drenching sweats, severe myalgias, headache, generalized weakness, ... Read more
Fever, shaking chills >12 hours, drenching sweats, severe myalgias, headache, generalized weakness, fatigue
38 2021-01-16 weakness Shortness of breath, cough, dizziness, severe air hunger, weakness, fatigue,
38 2021-01-17 flushing, feeling hot Became flushed from head to toe, rapidly, and became "very hot."
38 2021-01-17 feeling cold I received my second COVID-19 vaccine at 820 am on 1/9/2021. I was feeling well, no signs of illness... Read more
I received my second COVID-19 vaccine at 820 am on 1/9/2021. I was feeling well, no signs of illness prior to the injection. Around 6 pm I developed at headache, 7 pm developed fevers, chills, and a cough. The fevers, chills, headache, and cough were gone the next day by about 1 pm. The cough returned the following day and persisted getting worse each day leading to wheezing and shortness of breath. I had a negative COVID-19 test and negative chest x-ray. The PCP has diagnosed me with bronchospasms possibly associated with the vaccine as the cough came on following the vaccine. I have no know asthma, but they are also going to rule out an underlying asthma that could have been triggered by the vaccine. I have been taking oral prednisone and using steroid inhalers with significant improvement, but the symptoms have not completely resolved. I am still under the care of my PCP for ongoing management.
38 2021-01-17 slurring Join pain, muscle pain, triggered my neurological disorder (common when I'm fighting illness), dizz... Read more
Join pain, muscle pain, triggered my neurological disorder (common when I'm fighting illness), dizziness, head fog, disorientation, slurred words, tiredness, and headaches.
38 2021-01-17 involuntary muscle movements Patient is a 38 y/o female physician with ADHD and depression presenting with concern for involunta... Read more
Patient is a 38 y/o female physician with ADHD and depression presenting with concern for involuntary choreiform movements that began 1/9. Patient has never had this problem before. She does not note any associated symptoms. She denies extremity weakness, paresthesias, seizures, headache, chest pain, abdominal pain, nausea, vomiting, fevers, and other symptoms. She cannot think of any inciting injury or event that led to this. She did receive the second dose of the Pfizer COVID vaccine on 1/7, and is unsure if this is related.
38 2021-01-17 feeling hot Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presented for her second Pfizer vaccine January 11, 20... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presented for her second Pfizer vaccine January 11, 2021. She waited 15 minutes and started to pull away when she noticed that she was beginning to get warm. She looked in her car mirror and noticed a rash on her neck and chest. She then notified staff of reaction. Vital signs checked. BP was 122/68. HR was 97. Sp02 was 99% on RA. She denied any SOB. She was given diphenhydramine po that she swallowed without any difficulties. She reported that she began to feel better. Rash started to look better. Patient waited another 15 minutes. Patient was alert and oriented x4 and was talking without difficulty.
38 2021-01-17 face paralysis, bell's palsy Vaccination on 1/6/2021. Pt noticed pain behind her R ear on 1/11/2021. Pt then noticed right-sided... Read more
Vaccination on 1/6/2021. Pt noticed pain behind her R ear on 1/11/2021. Pt then noticed right-sided facial weakness and asymmetry on 1/12/2021. Pt went to ED for evaluation. Pt diagnosed with Bell's Palsy and given Valacyclovir and prednisone to be taken orally for 7 days and referred to Neurology for ongoing care.
38 2021-01-17 feeling cold about 10 hours after second vaccine shot - mild fever, chills, headache and inflammation of lymph n... Read more
about 10 hours after second vaccine shot - mild fever, chills, headache and inflammation of lymph nodes in armpit, along collarbone and in neck on shot side. Fever broke about the 20 hr. mark. nausea and diarrhea on second day. followed by additional fever and chills at 48 hours post shot. second fever subsided next morning with headache continuing for third day. lymph node inflammation is continuing at this time (day 5 post shot)
38 2021-01-18 discomfort 12/30- possible exposure to COVID (+) med student 1/5- tested negative 1/8- tested negative, went t... Read more
12/30- possible exposure to COVID (+) med student 1/5- tested negative 1/8- tested negative, went to clinic and was diagnosed with a head cold, BP elevated 1/9-1/10- had 100.1. fever, lethargic, high BP, lymph nodes swollen 1/12- BP uncontrolled, Increased metoprolol to 2 pills instead of 1 1/15- noticed pressure on L side of neck, temp higher on this side compared to right 1/17- L earache, decreased hearing, feels clogged, pain intermittent
38 2021-01-18 flushing 1638: Presented with dizziness, lightheaded, feeling flush, feels impending sense of doom, BP 138/82... Read more
1638: Presented with dizziness, lightheaded, feeling flush, feels impending sense of doom, BP 138/82 (high for patient), Heart rate 75, Patient alert and oriented X3, Respiration easy and unlabored, Denies shortness of breath 1645: BP: 138/82 HR 82 99% Biox 1647: Went to get husband in the parking lot 1648: EMS called 1650: Husband with patient, patient still nausea 1653: Petechial rash observed to upper chest 1654: resting in supine position in recliner 1655: 118/70, HR 99, 99% Biox, 20 respiration 1700: EMS here 1703: no flu shot this year 1706: Left with EMS ? Patient reques
38 2021-01-18 numbness A few hours after the vaccin I became aware of numbness on the left forearm that extended from the l... Read more
A few hours after the vaccin I became aware of numbness on the left forearm that extended from the left forearm down the side of the arm near the thumb and forefinger area down to the wrist area. I had no weakness or loss of function but it was numb. I was seen in the ER where they did a visual check and was advised to monitor and if it worsened to contact my PCP. And after about 3 days I noticed it had resolved with no new symptoms since. I also had really intense joint and muscle pain also.
38 2021-01-18 tingling ABOUT 15 MIN AFTER VACCINE I FELT A WEIRD SENSATION UNDER MY SCAPULA AND TINGLING DOWN THE LEFT SIDE... Read more
ABOUT 15 MIN AFTER VACCINE I FELT A WEIRD SENSATION UNDER MY SCAPULA AND TINGLING DOWN THE LEFT SIDE OF MY BACK. 30 MIN AFTER I FELT TINGLING ON MY LIP AND LEFT CHEEK. 1 HOUR AFTER TINGLING SENSATIONS UP AND DOWN LEFT SIDE OF MY BODY EXCEPT MY FACE. I MESSAGED MY PCP AT THAT TIME. MY VITALS WERE NORMAL, I DID NOT HAVE ANY DIFFICULTY BREATHING, AND I JUST FINISHED WORKING NIGHT SHIFT SO I SLEPT 9 HOURS. WHEN I WOKE UP I HAD THE TINGLING/KIND OF ITCHING UNDER MY SKIN FEELING RANDOMLY ALL OVER MY BODY EXCEPT MY FACE. I WAS A LITTLE TACHYCARDIC BUT I WAS FEELING ANXIOUS ABOUT WHAT I WAS PHYSICALLY FEELING. ONCE I CALMED MYSELF DOWN MY HEART RATE WENT BACK DOWN TO MY BASELINE. STILL NO VISIBLE RASH OR DIFFICULTY BREATHING, AND FELT FINE OTHERWISE. HAD DINNER AND WENT BACK TO SLEEP ANOTHER 8 HOURS. WOKE UP 7AM STILL WITH TINGLING SENSATIONS ALL OVER MY BODY BUT DIDN'T FEEL IT AS MUCH AS BEFORE. NOW IT IS ABOUT 33 HOURS AFTER THE VACCINE AND I STILL HAVE THE TINGLING/ITCHING RANDOMLY ALL OVER BUT TINGLING HAS BEEN CONSISTENT ON THE PALM OF MY HANDS. OTHERWISE I FEEL FINE.
38 2021-01-18 tingling, pain in extremity, burning sensation Nausea, Brain Fog, sore arm, shoulder and neck, tingling and burning in hands and feet occasionally ... Read more
Nausea, Brain Fog, sore arm, shoulder and neck, tingling and burning in hands and feet occasionally and pain in hip joint
38 2021-01-18 flushing, weakness, numbness, tingling Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to ... Read more
Received dose at 1205 noon on January 15, 2021. I completed the 30 minutes after vaccination due to history of food allergies/medication allergies/intolerances and is prescribed epinephrine. After 30 minutes no reaction was seen in return to work, as a healthcare, CMA. At 1500 hrs. became incredibly dizzy, flushed, hot sweats. Sat down with cool window open, facecloth. Legs became tingling and numb, blood pressure was taken at over 130/90, nausea increasing, could not keep eyes open due to dizziness and light, with headache developing. After 30 to 45 minutes of observation from healthcare staff/coworkers became incredibly weak in arms and legs, head became incredibly faint, nausea increased, headache, dizziness, extreme fatigue in regards to wanting to sleep. At which time clinical lead nurse/supervisor brought myself to emergency room department for further evaluation. Was brought into emergency room for further evaluation developed at this time a lump in throat feeling, and was given an IV of Benadryl 25mg and Pepcid 20mg with an hours of observation. Within an hour of observation extreme fatigue tingling numbness and dizziness head decreased. And was discharged from emergency room for vaccine reaction around 20:00. Home with Benadryl 25 mg and Pepcid 20 mg, 3 times daily to treat reaction. After reaction been dealing with headaches and nausea.
38 2021-01-18 hot flush With first vaccine c/o racing heart rate. 1340 - c/o racing heart; spb 115/69, p 87, rr 22, sats 98 ... Read more
With first vaccine c/o racing heart rate. 1340 - c/o racing heart; spb 115/69, p 87, rr 22, sats 98 1342 - 50 mg Benadryl given po 1345 - 136/74, 87, 20, 95% 1347 - fanning herself c/o hot flashes 1350 - walked with pt. states feeling better c/o hot flashes 1400 - c/o hot flashes 1405 - 131/69, 82, r 20, 98% 1420 - p 89 1450- 80
38 2021-01-18 muscle spasms felt muscle spasms almost every ten minutes for three days in row; This is a spontaneous report fro... Read more
felt muscle spasms almost every ten minutes for three days in row; This is a spontaneous report from a contactable healthcare professional (patient herself). A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date not reported), via an unspecified route of administration in the left arm on 19Dec2020 07:45 at single dose for COVID-19 immunisation. Medical history included Bell's palsy from Jun2020 to an unknown date, and low Vitamin D. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included zinc (ZINC), ergocalciferol (VIT D), vitamin c, vitamin b6, and cyanocobalamin (VITAMIN B12). One week and a half after she received her COVID vaccine, on 30Dec2020 at 10:00, the patient felt muscle spasms almost every ten minutes for three days in row. No treatment was received for the adverse events. Clinical outcome of the event was unknown.
38 2021-01-19 feeling hot, flushing, tingling Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Diffic... Read more
Felt hot, flushed, tingling. Then mouth and throat started to burn. Throat felt like closing. Difficult to swallow water. Able to take Benadryl liquid within 5 minutes of reaction starting and drink water (4 bottles of 16 ounces). 15 minutes later felt returning to normal status. No epinephrine used.
38 2021-01-19 tenderness, pain in extremity Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hr... Read more
Nausea.Headache, fatigue, muscle aches,body soreness; and soreness at vaccination site - about 6 hrs later; Two days after vaccine tender to touch left elbow started hurting - later that day I could feel a hard rod-like structure in the elbow on that side > Two days after vaccine - whole arm was hurting. Developed Lymphadenopathy. Fourth day after vaccine: Auxiliary tail of Left breast was hard as well. Called my PCP - warm compresses and Ibuprofen. My arm - I still feel a hard vein in my left arm. The other symptoms went away after 6 or 7 days. (Although nausea stopped after two days.)
38 2021-01-19 flushing Patient c/o "flushing" at 1725. Patient offered water. 1730 patient complained "I am not going to l... Read more
Patient c/o "flushing" at 1725. Patient offered water. 1730 patient complained "I am not going to lie, I am not feeling well." Reported that "the water didn't want to go down" and c/o "throat shutting down." Reports feeling nauseous and started to itch both lower arms. 1737 0.5ml epinephrine administered IM to right deltoid, 911 called. BP 132/82, pulse 92, O2 96% on RA. EMS arrived at 1745 and transported to ER at 1758. Called client morning of 1/15 and reported Benadryl given IV while transported to ER, discharged to home at 2130 on 1/14.
38 2021-01-19 numbness Starting 25-30 minutes after the first dose of the Pfizer-BioNTech Vaccine was administered, patien... Read more
Starting 25-30 minutes after the first dose of the Pfizer-BioNTech Vaccine was administered, patient started to experience numbness in her face, chest pressure and gastrointestinal discomfort.
38 2021-01-19 numbness Twenty minutes after injection patient noted left sided facial numbness (Same side as injection). Sh... Read more
Twenty minutes after injection patient noted left sided facial numbness (Same side as injection). Shortly after that she noted some tingling in her throat. She was given diphenhydramine 50mg and monitored for roughly 1 hour total after her injection before having complete resolution of the tingling in her throat and marked improvement in facial numbness.
38 2021-01-19 pain in extremity When I got up at 0530 yesterday (1/19) my right arm was so sore I couldn't lift it. I got to work at... Read more
When I got up at 0530 yesterday (1/19) my right arm was so sore I couldn't lift it. I got to work at 0700 and felt really drained and tired. I fell asleep without realizing it at some point and a coworker saw me and woke me up at 0930. I attended a lecture at 1000 and started feeling chills, aches, and was sweating. I tried to take notes but couldn't remember how to spell a lot of basic words and couldn't get my brain to focus. My boss sent me home at 1145. I was driving home and when I got off the interstate I couldn't remember which way to turn at the light off the exit. I had to pull up a navigation app on my phone to remember how to get home. When I got home I took my temperature and it was 98.5F. I slept for 3 hours, picked my kids up from school, and then slept for another 2 hours. I took my temperature at 1900 and it was 98.5F still. My chills and aches had lessened but not disappeared by the time I went to bed at 2100, but by the time my alarm went off at 0530 this morning I felt completely back to normal.
38 2021-01-19 pain in extremity general fatigue (sleepiness), muscle aches, headache, left arm sore - 2-3 days and then the symptoms... Read more
general fatigue (sleepiness), muscle aches, headache, left arm sore - 2-3 days and then the symptoms resolved
38 2021-01-20 burning sensation, pain in extremity Burning pain in feet, discoloration of multiple toes
38 2021-01-20 pain in extremity, nerve pain, weakness I got the vaccine at 11am on 1/19/21 by 8pm of 1/19/21 I had a low grade temp and was tired so I wen... Read more
I got the vaccine at 11am on 1/19/21 by 8pm of 1/19/21 I had a low grade temp and was tired so I went to bed. By 1am I woke up with uncontrollable shivering and had an alarming temperature of 104. I then took alternating Tylenol and ibuprofen and for the next 24 hours and I had a continuous fever for the entirety of 1/20/21 that would range from 101-103 with taking the constant Tylenol and ibuprofen. In addition I had shooting nerve pain down my legs, I was so weak I felt like I could not move, terrible body aches, and had what felt like dizziness and blurred vision at the same time. By 1/21/21 I started to improve but still had an increased temp of 99 and body aches but not as bad as the day prior. I am a healthy 38 year old with a good BMI no medical history and am very concerned about the temperature of 103-104 in regards to those with underlying heart or health conditions which may not be able to withstand that high of a temperature or a continuous temperature like I had for an extended period of time . I would have gone to the emergency room but I am a healthcare professional with the education and experience to know what to do in this situation
38 2021-01-20 pain in extremity LT arm was so sore I could not move it. 01/19/2021 Rash all over my up body (shoulders neck head), a... Read more
LT arm was so sore I could not move it. 01/19/2021 Rash all over my up body (shoulders neck head), arm still sore. Took over the counter meds. Lt arm still hurts 01/20/2021 No more rash, but shoulders and upper back are super tight. I am also super tired today. 01/21/2021
38 2021-01-20 migraine Mild nausea; Flu-like symptoms; headache; mild dizziness; mild brain fog mid afternoon; having some ... Read more
Mild nausea; Flu-like symptoms; headache; mild dizziness; mild brain fog mid afternoon; having some sensitivity to sound and light; having some sensitivity to sound and light; I'm suspecting this may be triggering a migraine; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for herself). A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL1283, expiry date not reported), via an unspecified route of administration on 09Jan2021 07:00 at a single dose on the left arm for COVID 19 immunization. Medical history included GERD (gastrooesophageal reflux disease), migraines, and indoor allergies. The patient was not pregnant at the time of the vaccination. The patient had no Covid prior to vaccination. Concomitant medication included mometasone furoate (FLONASE), taken within two week prior to vaccination. The patient previously took codeine and was allergic to it; and flu vaccine and experienced intolerance and short term dizziness. Patient had first dose of Pfizer COVID 19 bnt162b2 as COVID 19 immunization on 19Dec2020 at 07:30 AM, intramuscularly on the left arm. No other vaccines were taken in the four weeks. Patient received second Pfizer dose on Saturday (09Jan2021) at approximately 7:00am. Consistent with prior history of dizziness following flu vaccines, patient started to develop mild dizziness and mild brain fog mid afternoon (reported as 09Jan2021 11:30). Flu-like symptoms and headache started around 8:00pm and resolved around 6:00pm on Sunday (the following day; 10Jan2021). Mild nausea also experienced Sunday morning (10Jan2021). Unfortunately, patient was still experiencing dizziness and brain fog that comes and goes and was worse midafternoon. Patient was having some sensitivity to sound and light, and suspecting this may be triggering a migraine since 09Jan2021 11:30. As treatment to the reported events patient received Aleve. The patient was not tested for COVID post vaccination. The patient recovered from flu-like symptoms and headache on 10Jan2021 18:00. The patient had not recovered from mild dizziness, mild brain fog, mild nausea, some sensitivity to sound and light and migraine.
38 2021-01-20 feeling cold Patient reports body aches, chills, fever, chest pain, which is her main concern, as it started this... Read more
Patient reports body aches, chills, fever, chest pain, which is her main concern, as it started this morning.
38 2021-01-20 unresponsive to stimuli Prior to vaccination, patient denied previous reactions to vaccines or injectable products. Patient ... Read more
Prior to vaccination, patient denied previous reactions to vaccines or injectable products. Patient received Pfizer COVID-19 vaccine at approximately 10:55 am. Patient requested to sit down as she became faint. After sitting, patient became unresponsive with eyes rolling back in head, and gasping for breath/gurgling. Patient's head was also bobbing up and down slightly. Patient was then transferred to the floor. After moving to the floor, patient became slightly responsive but was still disoriented. 0.3 mg of epinephrine was administered into the right thigh at approximately 11:04 am. Patient's condition continued to improve, although she became nauseous with no emesis. EMS arrived at the scene and patient was monitored in the ambulance per EMS discretion but then left the scene with her husband.
38 2021-01-21 pain in extremity Muscle ache, fever, chills, nausea, fatigue, sore arm.
38 2021-01-21 pain in extremity Next day after of tired, fatigue, muscle ache, chills, arm ache, shortness of break and took a tyle... Read more
Next day after of tired, fatigue, muscle ache, chills, arm ache, shortness of break and took a tylenol. 01/13/2021 walk -in clinic and high heart rate and shortness of breath and fatigue. Covid -19 positive 12/04/2020
38 2021-01-22 tenderness, pain in extremity 5 days after receiving vaccine (only have sore arm for two days) began to have pain all along collar... Read more
5 days after receiving vaccine (only have sore arm for two days) began to have pain all along collarbone on left side and enlarged lymph nodes, one the size of a grape. Tenderness to point that uncomfortable to wear seat belt or even undergarments cause pain. Occasional tylenol for pain and monitoring. At this time, still swollen and sore.
38 2021-01-22 pain in extremity Cold like symptoms, dry cough, sleepiness, sore arm, chills- woke up the next day all of this. Felt ... Read more
Cold like symptoms, dry cough, sleepiness, sore arm, chills- woke up the next day all of this. Felt a lot better 2 days out.
38 2021-01-22 burning sensation Upon walking to the 15 minute observation area I felt a burning sensation that came over my entire b... Read more
Upon walking to the 15 minute observation area I felt a burning sensation that came over my entire body like alcohol in my veins. I felt it in my stomach, head, hands, all over. I told the workers that I didnt feel well. They moved me to the bathroom and propped me up over the sink sitting in a chair. I felt very lightheaded at that point and somewhat responsive but was feeling very bad. I looked at my iwatch and my heart rate was 198. I felt lightheaded like I was going to pass out. They had me move to the floor to prop my feet above my head. They checked my blood pressure and it was normal. I had them get my purse with my Xanax. I took 1.5 tablets of .25mg Xanax. My heart rate slowly went back to normal around 80BPM after about 15 minutes. The rest of the day I felt very tired. I felt normal again at 8pm with bo further side effects.
38 2021-01-23 feeling hot feeling hot and nauseous
38 2021-01-24 tingling, feeling hot 1307 2nd dose Pfizer COVID-19 vaccine administered. 1327 responded to patient who had been sitting ... Read more
1307 2nd dose Pfizer COVID-19 vaccine administered. 1327 responded to patient who had been sitting in her car post vaccine. Patient reported that she had noticed anterior chest pain (4/10) as well as a weighted pressure. I assessed the patient while she remained in her car. She has a history of high blood pressure, taking medication and has been under control. She also reported diagnosis of asthma. Lisinopril 5mg daily, she had taken this morning. Albuterol metered dose inhaler (not used today). She denies heartburn nor taking any medication for it. She had eaten a hamburger 30 minutes prior to vaccination. 1335 patient reported that her chest pain turned more into a warmth that spread across the chest and a tingling sensation down only the right arm. 1344 she rates the discomfort in chest as a 2/10 the tingling in right arm is gone. She denies the following symptoms: difficulty breathing, changes to vision/hearing, dizziness/lightheadedness, facial and throat swelling, & nausea. Patient remained very calm during this observation time and spoke in complete sentences. She was comfortable with her mask on. Patient denied these symptoms occurred with her first dose of COVID-19 vaccine nor any other vaccination. Obtained automatic blood pressure device measured 142/91 (63 beats/min) at 1351. Patient was able to teach back when she will seek Emergency care: difficulty breathing, face/throat swelling, persistent and or worsening chest pain/pressure. Patient and I both agreed she was safe to leave the vaccine clinic.
38 2021-01-24 breast pain Pfizer-BioNTech COVID-19 Vaccine EUA On 1/23, I had a low-grade fever (highest measurement was 99.6)... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA On 1/23, I had a low-grade fever (highest measurement was 99.6), and my blood pressure was a bit low (92/58 by a home blood pressure measuring device). I also had some mild breast pain that could be related to my period. On 1/23 and 1/24, I had vaccine site muscle pain, fatigue, and dizziness.
38 2021-01-24 weakness, feeling hot The day following the 2nd vaccination dose, I had zero symptoms other than a slightly sore injection... Read more
The day following the 2nd vaccination dose, I had zero symptoms other than a slightly sore injection site. Around hour 30 following the vaccination I began to feel warm, and I got up to brush my teeth and cool off in the bathroom. As I was brushing my teeth, I started experiencing an increasing ringing noise in both my ears that I thought was strange and somewhat alarming, but I didn't feel any signs of dizziness or dysphoria. The next thing I remember is waking up the bathroom floor with my husband standing over me. Apparently I experienced a complete lose of consciousness and feel to the floor, hitting my chin on the bathroom vanity as I feel and splitting my chin open, which I have zero recollection of. My husband states that when he found me, that my eyes were open, but I was staring blankly at him with a glazed over look and my whole body was limp and diaphoretic. I came too in about 30 seconds after he found me, but I was very confused, not making a lot of sense, and felt very disoriented and weak. It took about 20 mins for my fever to break, and to have the strength and power to get up and walk to bed. We changed all my clothes because I had soaked through them, and he got me into bed after cleaning/bandaging up my chin. I then slept solidly until noon the next day, which is very unlike me, but since then I have felt relatively fine with no other experiences of fever/chills/disorientation, just some continued mild fatigue off and on. After discussing with my nursing colleagues, they all had similar experiences around hour 24-30 post 2nd vaccine with fevers, chills, restless sleep, or just general malaise, but no one experienced a complete loose of consciousness, so I reached out to my PCP yesterday, and she confirmed today that I should report this to VAERS. I have never experienced any form of loss of consciousness/fainting/black-out/syncope prior to this, which is another reason I thought it was important for me to report this.
38 2021-01-24 flushing The patient had redness. chest flushing, and itching about 15 minutes after she received the vaccine... Read more
The patient had redness. chest flushing, and itching about 15 minutes after she received the vaccine. She was given 50mg of diphenhydramine. The itching subsided within 30 minutes after receiving the diphenhydramine. The patient experienced some nausea as well. After monitoring the patient for about an hour she was sent home from work due to the grogginess from the diphenhydramine.
38 2021-01-25 weakness 01/12/21 body aches x 24hrs 01/19/21 Rt back pain, rt chest/torso pain, weakness, headache. 01/2... Read more
01/12/21 body aches x 24hrs 01/19/21 Rt back pain, rt chest/torso pain, weakness, headache. 01/23/21 blisters developed with burning pain and was diagnosed with Shingles at the urgent care Center and more headache
38 2021-01-25 pain in extremity, seizure, tremor AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVER... Read more
AT 2130 ON 1/20/21 DEVELOPED SHAKES, THAT PROGRESSED TO 'CONVULSING. DEVELOPED FEVER OF 104.3. SEVERE ARM, NECK, AND CHEST PAIN. SHORTNESS OF BREATH THAT IMPROVED OVER TIME. ON 1/23/21 COMPLAINED OF SEVERE ITCHING OVER ENTIRE BODY
38 2021-01-25 weakness First it was dizziness, light headed, nausea, and vomiting, headaches, and extreme weakness. Went to... Read more
First it was dizziness, light headed, nausea, and vomiting, headaches, and extreme weakness. Went to the Hospital received IV fluids and sent home. Wasn't any better and lost my taste and smell for 3 days. Went to the Clinic, was tested for Covid-19 and the flu both negative. Went back to the Clinic and had chest x-ray, diagnosed with right middle lobe pneumonia. Sent home with doxycycline and zofran. Took the Medication as directed. Still feeling dizzy and lightheaded, and still winded and extremely tired after doing the slightest bit of house work, whether it would be sweeping the floor, doing dishes, or laundry. I get extremely after doing one activity. I still have not driven.
38 2021-01-25 feeling of body temperature change, night sweats, weakness I had terrible insomnia and the worst headache Wednesday night. When I finally went to sleep I tosse... Read more
I had terrible insomnia and the worst headache Wednesday night. When I finally went to sleep I tossed and turned and was cold and hot. I woke up with barely any strength. I slept from 8am-1:30pm Thursday. I had body aches, an upset stomach, muscle aches, and overall felt yucky. Friday I went to work for a presentation and was feeling awful. I had a fever and took some ibuprofen. My injection site was swollen and warm to the touch. I was dripping sweat last night Friday night. My lymph nodes are still swollen under my arm where I got the vaccine and my neck.
38 2021-01-25 numbness, tingling Tingling, numbness of lips, inside cheek and tongue for approx. an hour. Given oral 50mg benadryl a... Read more
Tingling, numbness of lips, inside cheek and tongue for approx. an hour. Given oral 50mg benadryl at 1025, nothing progressed or got worst.
38 2021-01-25 pain in extremity arm soreness slight fever (100.0) fatigue lightheaded/dizzy
38 2021-01-25 tremor fever, body aches, neurological tremors to leg
38 2021-01-26 tremor Elevated heart rate and blood pressure for 2 days starting on day 2. Slight shaking as a result. Mus... Read more
Elevated heart rate and blood pressure for 2 days starting on day 2. Slight shaking as a result. Muscle pain from day 1-3
38 2021-01-26 slurring Headache that did not dissipate with normal migraine meds or 1000 mg Tylenol. Fatigue. Brain fog, po... Read more
Headache that did not dissipate with normal migraine meds or 1000 mg Tylenol. Fatigue. Brain fog, poor ability to concentrate and word find, almost slurring words. Dry, wheezing cough. Shortness of breath. All acute symtpoms began 4 days after injection, lasting 24 hra. Wheezing, dry cough, and shortness of breath are now lingering
38 2021-01-26 migraine Headache, nausea, general soreness through out body, chills, migraine, difficulty breathing with non... Read more
Headache, nausea, general soreness through out body, chills, migraine, difficulty breathing with non-productive cough (on day 2). treated with Tylenol, IBU, and routine migraine medication, hydration.
38 2021-01-26 migraine Headache/migraine, lasted 12-15 hours, took ibuprofen
38 2021-01-26 migraine Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the ... Read more
Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.
38 2021-01-26 numbness, feeling hot Patient reported feeling of warmth in chest 10 minutes after vaccine administration. She then repor... Read more
Patient reported feeling of warmth in chest 10 minutes after vaccine administration. She then reported warm sensation and numbness in bilateral hands ~20 minutes after vaccine administration. All symptoms above resolved within 40 minutes after vaccine administration. She remained well appearing throughout observation period and had no evidence of airway compromise, facial swelling or vomiting during 40 minute observation period. Her vitals remained stable throughout: BP 97/61, HR 68 BP 107/70, HR 60
38 2021-01-26 pain in extremity Sore arm, extreme gas, some nausea
38 2021-01-26 pain in extremity Soreness in left arm with a knot/lump where injection was given.
38 2021-01-26 numbness, tingling The day after the vaccine my face went numb and tingly. I've been dizzy and weak with my right hand ... Read more
The day after the vaccine my face went numb and tingly. I've been dizzy and weak with my right hand and arm. 3 weeks later symptoms are still the same. I went to my local hospital a week ago. My primary physician and neurologist are currently treating me with running diagnostic/lab tests.
38 2021-01-26 pain in extremity, tremor Took my shot at 1:00pm. Around 8:00pm, I started to have stomach cramps. At 1:00am the next morning ... Read more
Took my shot at 1:00pm. Around 8:00pm, I started to have stomach cramps. At 1:00am the next morning I started having chills and shaking which continued until 4am when I started having back cramps and arm cramps where I had my shot. I also felt feverish and had a very bad headache, so I took 600mg of ibuprofen. I went in to work that morning and had chills and my skin hurt when my clothes touched my skin. I continued to have a headache also. I was sent home by my boss at 12pm on 1/5/21 because I looked and felt so bad and slept through the afternoon and for 10 hours that night. The next day, I continued to take 6oomg of ibuprofen every 6 hours and still had a lot of fatigue. The day after I was tired but them remained symptom free.
38 2021-01-26 tingling Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip t... Read more
Within 2 minutes of receiving vaccine, patient reported experiencing throat swelling, face and lip tingling. Patient was administered diphenhydramine PO while in clinic. At this time, patient declined to be seen in the ED and was released from clinic after additional monitoring. Patient received a course of prednisone from another physician later that day. 2 days later the patient began experiencing severe abdominal pain and was seen in the ED. Labs, right upper quadrant ultrasound, and abdominal CT were within normal limits and was determined that symptoms were likely still part of COVID vaccine anaphylactic reaction. The patient was evaluated by the acute care surgery service who did not find anything concerning and was discharged home from the ED with return precautions and instructions to follow-up with primary physician. The patient follow-up with PCP and was continued on a 5 day course of steroids. The patient will not receive a second vaccine dose at this time and was referred to see an allergist for further testing.
38 2021-01-26 hot flush, discomfort hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a s... Read more
hot flash; arm was very sore at the injection site; diagnosed with an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 38-year-old female patient (not pregnant) received first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand= Pfizer/Biontech, lot/batch number and expiry date were not reported), via an unspecified route of administration in the right arm on 11Jan2021 14:45 at SINGLE DOSE for Covid-19 vaccination. She received the vaccine in a facility. Medical history included gastrooesophageal reflux disease. No other vaccine in four weeks. Concomitant medications included ergocalciferol (VIT D) and lansoprazole (PREVACID). On 11Jan2021, within about 10 minutes of getting the vaccine she reported that her heart began to race and she became sweaty and uncomfortable. After another 5 minutes or so she began to have difficulty breathing as her chest and throat felt very tight and restricted. She also became lightheaded. Her heart rate was over 100, then dropped into the 70s, then shot back up over 100. Her face had a weird sensation as well. She was given Benadryl first and then epinephrine and had to go to the emergency room via ambulance for observation. She was released after an hour and had to take Benadryl every 6 hours for the next 24 hrs and diagnosed with an allergic reaction. On 12Jan2021, she had a hot flash upon waking up and felt generally under the weather all day. Her arm was very sore at the injection site. She missed a day of work due to the whole ordeal. On 13Jan2021, she felt more normal but still have some tightness in her chest with a fluttering feeling. The outcome of event diagnosed with an allergic reaction was not recovered; for other events was recovered. Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on a compatible temporal association and known product safety profile, causality between event allergic reaction to vaccine and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-27 difficulty speaking, migraine C-O was working in the vaccine clinic today assisting in scheduling customers. She obtained her seco... Read more
C-O was working in the vaccine clinic today assisting in scheduling customers. She obtained her second COVID-19 vaccine at approximately noon today. At 1330 she approached my desk with c/o left sided abdominal pain, scratchy throat, voice changes, and feeling tachycardic. Denied hx. Anaphylaxis or hx. Adverse reactions to any vaccines. She was given 50mg of diphenhydramine at 1332. At this time her pulse was 125, oxygen saturation 97%, unable to obtain BP due to small cuff size available. Med rec completed. Medical history taken, no contraindications to COVID-19 vaccine noted. She was advised to lay down during this time and reported feeling a little better within 30 minutes of taking diphenhydramine, though noted onset of headache starting and mentions hx migraines. By 1409 her pulse was reduced to 98 bmp. 1434 C-O reported feeling a little lightheaded upon standing from laying, pulse 92 and oxygen saturation 98. C-O was advised to sit and dangle for a time and then she decided to lay back down. At 1443 C-O reported improvement in symptoms except now had headache and drowsiness, BP 118/78, Pulse 90, oxygen saturation 98. C-O requested to leave to coordinate pickup from relative and I felt she was stable and did not require further treatment or monitoring at this time so agreed she could leave
38 2021-01-27 pain in extremity Chills; heart started beating really bad/heart beating fast for 45 mins/ tachycardia/ heart rate was... Read more
Chills; heart started beating really bad/heart beating fast for 45 mins/ tachycardia/ heart rate was 100-150/ heart started beating fast; palpitations; heart rate was in 130s - it was sinus tachycardia; TSH was high/ slightly elevated/ TSH was higher than before; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 20Dec2020, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine last 20Dec2020. On her first shot, she did good the first couple of days but had a sore arm in Dec2020. However, on 24Dec2020 while at work, her heart started beating really bad/heart beating fast and she had tachycardia/palpitations for 45 mins. She then mentioned she was a nurse and that the doctor hooked her up to a monitor and her heart rate was in 130s - it was sinus tachycardia on 24Dec2020. She informed that she had filed a report with the CDC. She went to the emergency room and her heart rate was 100-150 on 24Dec2020. She got fluids and her labs looked good, labs were normal on 24Dec2020. The only thing on 24Dec2020 was her TSH was high/ slightly elevated but her T4 was normal. Then she took it easy the next day. On Saturday, 26Dec2020 she began experiencing chills and took Tylenol and; her heart started beating fast again. She went to the emergency room and they repeated the labs, and everything was normal on 26Dec2020. Her TSH was higher than before on 26Dec2020. She went to see her doctor and the doctor thought that it was from her drinking a lot of caffeine before the vaccine and then her body building up antibodies days later. She was going off on tangent and unable to clarify details. She wanted to know if there was any data between the vaccine and the thyroid. Her doctor "feels like safe" and she had sinus tachycardia. She was asking if there were any reports on elevated TSH and tachycardia as a vaccine side effect. She further informed that she was trying to decide whether to take her second shot or not. She wanted to know if it was safe to take her second shot. Her doctor said it would be fine, but she wanted to know what Pfizer has to say. The outcome of the events was unknown. Information about the lot/batch number has been requested.
38 2021-01-27 inability to speak, migraine, numbness Complex migraine with neurological symptoms: numbness to R upper extremity, trouble speaking. Pati... Read more
Complex migraine with neurological symptoms: numbness to R upper extremity, trouble speaking. Patient presented to Emergency Dept. Sxs resolved in one hour.
38 2021-01-27 muscle twitching Day after receiving vaccine I began having a twitch on the left side of my face beside my nose. It h... Read more
Day after receiving vaccine I began having a twitch on the left side of my face beside my nose. It has lessened since it began, but is still present.
38 2021-01-27 pain in extremity Dose #2 overnight I experienced extreme soreness in my arm, probably around midnight to 2 AM. It pr... Read more
Dose #2 overnight I experienced extreme soreness in my arm, probably around midnight to 2 AM. It progressed overnight to similar symptoms as I had the 1st vaccine: with body aches, chills, headache, fatigue but this time no tongue tingling and no strange taste in my mouth. The symptoms lasted 3 days. I did develop joint pain and extended muscle soreness that I did not have with the first dose and those are still present.
38 2021-01-27 night sweats Fever with otc meds to reduce, chills, body aches, night sweats,nausea, headache, extremely swollen ... Read more
Fever with otc meds to reduce, chills, body aches, night sweats,nausea, headache, extremely swollen lymph node
38 2021-01-27 discomfort Immediately after receiving the vaccine, patient noticed that she had a metallic taste in her mouth.... Read more
Immediately after receiving the vaccine, patient noticed that she had a metallic taste in her mouth. Approximately 4 minutes later she called the attention of a staff member to alert them that her tongue felt tingly. The RN was called to come observe patient, blood pressure taken at this time, reading was 118/82. Patient began complaining that mouth and tongue both felt numb and it was becoming hard to swallow. EMS was called at this time along with MD. MD directed nurses to continue to monitor patient, while on the phone with MD, patient stated that her chest felt heavy. MD ordered patient to receive 0.5 ml of Epinephrine. Patient received dose of epinephrine. BP taken again at 1:18, 3 minutes after Epi injection, reading was 124/86. Patient began complaining of a "heaviness feeling" in legs at approximately 1:19. Ambulance and EMS staff arrived at 1:21. Ambulance left with patient at 1:26. Spoke with patient at 4:45 pm, patient has made a full recovery and is at work.
38 2021-01-27 tingling, numbness Numbness and Tingling in both thighs/legs/feet.
38 2021-01-27 tingling Post vaccine, patient described chest pain, metallic taste in mouth, dry tongue and L foot tingling.
38 2021-01-27 numbness, tingling head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contacta... Read more
head numbness and tingling; head numbness and tingling; This is a spontaneous report from a contactable consumer (patient) reported that a 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on the left deltoid on 09Jan2021 12:00 at a single dose for Covid-19 immunization. The vaccine was administered at a hospital. Medical history was reported as none. Family medical history included her mother has multiple sclerosis and her sister has lupus. There were no concomitant medications. On the 9th, this past Saturday, she had first dose of COVID vaccine. Then on Monday, the 11th around 2:00 pm (14:00), she started having in her head numbness and tingling. Still has numbness and tingling in the head. The outcome of the events was not recovered.
38 2021-01-28 weakness, feeling cold, feeling hot 1/27/2021 - Freezing cold, shivering, full body muscle aches, shot site pain worse than before. Symp... Read more
1/27/2021 - Freezing cold, shivering, full body muscle aches, shot site pain worse than before. Symptoms continued through the night, requiring multiple blankets, layers of clothing, and figuring how to lay to avoid pain. 1/28/2021 - I had to call off from work. Exhaustion found; remained in bed all morning. Muscle pain worsened, but improved at about 6pm. Continued to be cold, but no shivering; improved at about 2pm. But started having cycles of cold/hot. Headache developed. 1/29/2021 - Returned to work late. Continued weak muscle pains, cold/hot cycles, and headache. All mild.
38 2021-01-28 flushing, tremor Anxiety, flushing, EPs-tremors 12:30 increasing. MD on site assessing. Pharmacist administered epi p... Read more
Anxiety, flushing, EPs-tremors 12:30 increasing. MD on site assessing. Pharmacist administered epi pen at 12:40. 911 called. Left facility at 12:45
38 2021-01-28 feeling cold, tingling, feeling hot Day after vax, soreness, fatigue, that night felt. Pins and needles throughout body with cold and ho... Read more
Day after vax, soreness, fatigue, that night felt. Pins and needles throughout body with cold and hot sensations.
38 2021-01-28 pain in extremity Red blotchy swollen fingers and toes. Really sore arm and severe headache.
38 2021-01-28 pain in extremity The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first ... Read more
The first round of the vaccine she only had a super mild sore arm and a slight headache.; The first round of the vaccine she only had a super mild sore arm and a slight headache.; sore; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on 28Dec2020 at SINGLE DOSE at left deltoid for covid-19 immunisation. Medical history included ongoing pernicious anaemia, a b12 deficiency. She gives herself B12 shots. She was diagnosed 2-3 years ago. She also had a Myomectomy, 15 cm uterine fibroid , removed this past summer. Concomitant medication included ongoing cyanocobalamin (B12 [CYANOCOBALAMIN]) for pernicious anemia. The first round of the vaccine she only had a super mild sore arm and a slight headache. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks. She has been working from home. She has not been exposed to people. She keeps feeling like she needs to stretch because she is sore. The patient underwent lab tests and procedures which included COVID 19 test on an unspecified date: negative, COVID-19 antibody test on an Unspecified date, Result: negative. The outcome of the events was unknown.
38 2021-01-28 pain in extremity muscle and joint pain chills nausea headache sore, swollen and red arm
38 2021-01-28 cold sweat, feeling hot, pain in extremity, involuntary muscle movements nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivit... Read more
nasty headache; felt hot; Shivers; achy; Nauseous; eyesight/ felt like she was straining; sensitivity to light; eyeballs felt sore; cold sweats; when she talked, she felt like she had to close her eyes because of pressure; arm was hurting really bad; received the 2nd vaccine yesterday/ date of the first vaccine was 28Dec2020; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 14Jan2021 15:30 to 14Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included ongoing pernicious anaemia, a B12 deficiency diagnosed 2-3 years ago (she gave herself B12 shots and she cannot convert B12 through her food), and myomectomy (15 cm uterine fibroid, removed this past summer). Concomitant medication included ongoing cyanocobalamin (B12) for pernicious anemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: 30Apr2021), intramuscularly on the left arm, deltoid on 28Dec2020 at a single dose for COVID-19 immunization; and a flu shot (the MA gave it in the back of her arm, it was pretty significant). The patient was a nurse and informed that she received the second COVID vaccine the day before report (14Jan2021). She woke up on the day of report on 15Jan2021 03:00 with a nasty headache, she felt hot, had the creepy crawly shivers, was achy and when she talked, she felt like she had to close her eyes because of pressure, and she was nauseous. She figured this was probably normal but she couldn't get a hold of her doctor and the hospital she worked at did not know what to tell her. She was wondering if she can take Tylenol or ibuprofen and has even thought about drinking caffeine, that it might help her headache. She didn't have a prescribing doctor as she got it at work. The first round of the vaccine she only had a super mild sore arm and a slight headache. She received the second vaccine at 3:30pm and then went to bed when she got home. She woke herself up at 3 am because her arm was hurting really bad. She started feeling like she couldn't keep her legs still. She felt hot, achy, and was shivering. She hasn't taken her temperature. When she woke up at 3 am she got on her phone, and her eyesight felt like she couldn't quite focus. It wasn't bad, but she felt like she was straining. Then her head started hurting at 5-7 am. She was very sensitive to light. She woke up and couldn't go back to sleep. She had cold sweats, and was shivering. Every time she stood up, she was chattering. She felt achy almost like growing pains. She woke up with the arm pain, and then 10-15 minutes later, she started feeling that creepy crawly feeling. She got up and the cool fan hit her, and she realized how bad she was shivering. The shivering intensified at times but hasn't gotten worse. She had just called employee health and realized that when her eyes were open when she was talking was when she felt nauseated. She has noticed the nausea in the past half hour. She did not know if it was related to the headache or what. She had to cover her eyes, her eyeballs felt sore. When she talked with her eyes open, she felt a little queasy. She was just straining to see. Her vision was not blurry but she can tell she was straining. She did not know if it was because of the headache and nausea. When she got out of bed, the cold fan did not feel cold but it made her shiver. She was a nurse was trying to be socially responsible as she did not want to get COVID. She was a little suspicious because of the headache after the first one. She hasn't been around anyone in a couple of weeks and had been working from home. She has not been exposed to people. She kept feeling like she needed to stretch because she was sore. The patient was tested for COVID pre-surgery (myomectomy) and was negative. She was also tested for COVID antibodies and she did not have any. She was vaccinated at a hospital facility. Patient received no other vaccines on that day. The adverse events did not require any visit to the emergency room or physician office. Patient did not receive prior vaccines in the previous 4 weeks. Outcome of the events cold sweat and "tested for COVID antibodies and she did not have any" was unknown, nasty headache was reported as worsened (not recovered), and the remaining events was not recovered. The reporter considered the events serious due to medically significant events and related to the suspect drug.; Sender's Comments: Based on the information currently available, a possible contributory role of BNT162B2 vaccine in the development of the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-01-29 flushing 38 year old female observed post 1st COVID vaccine @ 1:18PM. 5 minutes post vaccine patient report... Read more
38 year old female observed post 1st COVID vaccine @ 1:18PM. 5 minutes post vaccine patient reported tinnitus, itchy throat, dizziness and neck/face flush. On exam lungs clear, BP and O2 stable, HR 102 BPM. Patient was administered Benadryl PO and observed. 10 minutes post benadryl patient became tachycardic and reported chest tightness and shortness of breath, patient was then administered EPIPEN to Left outer thigh. EMS activated and patient was sent to ER
38 2021-01-30 tenderness Had shot on Wednesday. Didn?t even feel the injection. Took Tylenol for mild headache and soreness. ... Read more
Had shot on Wednesday. Didn?t even feel the injection. Took Tylenol for mild headache and soreness. Thursday felt fine. Friday had sore elbows and a noticeable mild flare up in my right pointer finger. (Normal for me this time of year to a flare up) by Saturday morning I felt pain in my elbows while doing yoga. By Saturday afternoon my elbow had swollen up and turned bright red - excruciating to the touch. Went to urgent care they said ?bursitis? and gave me prednisone- will follow up with rheumatologist Monday.
38 2021-01-30 numbness, tingling tingling in legs, like numbness x 1 hour
38 2021-01-31 nerve pain 01/22/2021 @ 04:00 AM: Joint pain, fatigue, disorientated, headache, nerve pain, abdominal pain for ... Read more
01/22/2021 @ 04:00 AM: Joint pain, fatigue, disorientated, headache, nerve pain, abdominal pain for two days. Continues with fatigue and not fully recovered.
38 2021-01-31 flushing, tingling Congestion started the night of 1/29/21. The next morning on 1/30/21 she started to get tingling in ... Read more
Congestion started the night of 1/29/21. The next morning on 1/30/21 she started to get tingling in both arms, facial swelling, face became tingling and flushed feeling. Slight tingling in tongue. She took Benadryl with mild relief. No shortness of breath or difficulty swallowing. Tingling of tongue and arms is gone but still has facial swelling and redness.
38 2021-01-31 feeling hot, pain in extremity Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations,... Read more
Day 1 (day of vaccination): Within 15 minutes of receiving the jab i experienced heart palpitations, fever, dizziness, a dry mouth/throat and heat in my head/upper body. After being discharged from recovery an hour later i returned home but felt very anxious all night. Heart palpitations continued on and off. Day 2: Severe cramp/pain started in my arm, neck and shoulders. Headache. Sweating. Days 3 & 4: Flu symptoms; headache, shivers/fever, runny nose, sore throat, cough, severe muscle and joint pain. Skin was so sensitive to touch i could not wash. Muscles hurt so much i could not move around. Extreme fatigue. Days 5 & 6: Cold symptoms started to resolve. Muscle and joint pain still very severe - difficulty walking/moving around, stiffness and aches in every part of my body. Extreme fatigue. Days 7, 8 & 9: Cold symptoms gone. Muscle and joint pain still severe. Extreme fatigue. Day 10: Pain in muscles started to resolve but not in joints. Fatigue still present. Day 11: Fatigue starting to resolve, joints still very sore.
38 2021-01-31 pain in extremity Headache, arm swollen/sore, body aches, back ache, runny nose, hands swollen, unable to sleep
38 2021-01-31 weakness, feeling hot, flushing Heart racing/Palpitations; Hot and flush feeling; Hot and flush feeling; Weakness; Dizzy; This is a ... Read more
Heart racing/Palpitations; Hot and flush feeling; Hot and flush feeling; Weakness; Dizzy; This is a spontaneous report from a contactable nurse (patient). A 38-year-old female patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3248), intramuscular in the right arm on 15Jan2021 at 12:30 PM as a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant, did not receive any other vaccine within four weeks, did not have any other medications in two weeks, had no known allergies, and did not have COVID prior to the vaccination. The patient experienced heart racing, palpitations, hot and flush feeling, weakness, and was dizzy on an unspecified date. Therapeutic measures were taken as a result of the events which included Benadryl. The patient was not COVID tested post-vaccination. Outcome of the events was recovered.
38 2021-01-31 muscle spasms Muscle locking in the left calf. Intense muscle cramping and intense burning pain in the left back q... Read more
Muscle locking in the left calf. Intense muscle cramping and intense burning pain in the left back quadrant.
38 2021-01-31 migraine The same night as the second dose of Pfizer vaccine i was experiencing fever of 101.8 with chills,sw... Read more
The same night as the second dose of Pfizer vaccine i was experiencing fever of 101.8 with chills,sweats, full body aches, migraine, nausea, stomach pain ,lower back pain and diarrhea for 4 days (01/27/2021 @11:45pm till 01/31/2021 pm)
38 2021-01-31 migraine Vomiting for 12 hours, diarrhea for 24 hours, headache/migraines for 7 days, body aches for 7 days, ... Read more
Vomiting for 12 hours, diarrhea for 24 hours, headache/migraines for 7 days, body aches for 7 days, extreme fatigue, slept for 28 hours at one time, no appetite, runny nose, fever, chills,.
38 2021-02-01 pain in extremity Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was d... Read more
Adverse event: 2 of 7 people received a more concentrated dose of the vaccine. One vial of two was diluted incorrectly with less Normal Saline than require. This error was not noticed until person mixing vaccine said they were out of vaccine and did not have enough to get 5 dosages of 0.3ml. Two people mixed one vial of vaccine together demonstrating to the other. It appears the person making the error did not notice they did not have 1.8ml of NS but must have had some air and did not realize it. The error was noticed when all the vaccines were given and one person had not completed pulling up the vaccine. So, 2 of 7 patients received the incorrect dose of vaccine and it could not be determined which two received the incorrect dose. Reported sore arm for several days but it resolved.
38 2021-02-01 tremor, weakness, cold extremities Dizziness, Shaking, Shortness of Breath, Cold extremities, General weakness. Assessed by Fire Depar... Read more
Dizziness, Shaking, Shortness of Breath, Cold extremities, General weakness. Assessed by Fire Department and transported to local hospital for further evaluation.
38 2021-02-01 bell's palsy Immediately following the vaccination, she developed airway compromise, wheezing, hives. Was given I... Read more
Immediately following the vaccination, she developed airway compromise, wheezing, hives. Was given IM epinephrine, and Benadryl, taken to ED. Stabilized, discharged home on prednisone 50 mg x 5 days. Returns 2/2/21 with Bell's Palsy. Negative MRI imaging. Airway symptoms resolved. Discharged on prednisone and acyclovir.
38 2021-02-01 speech disorder, tremor, weakness Patient received first dose of Pfizer Covid-19 Vaccine on 1/13/21. Patient was seen in office on 1/2... Read more
Patient received first dose of Pfizer Covid-19 Vaccine on 1/13/21. Patient was seen in office on 1/27/21 and reported symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors causing change in handwriting for the past 1.5 to 2 weeks after receiving vaccination of first dose of Pfizer Covid-19 Vaccine. Upon review of Neurological symptoms, patient was positive for loss of balance and coordination, 4/5 strength in all extremities, and 4/5 grip strength. CT of Head with and W/O contrast was ordered. CBC, CMP, Free T4, HgbA1c, lipid, TSH, Urinalysis, Vitamin B12, Folate and CK laboratory ordered.
38 2021-02-01 flushing Pt. felt flushing right away with vaccination then quickly after noted tightening of her throat. She... Read more
Pt. felt flushing right away with vaccination then quickly after noted tightening of her throat. She had never experienced that sensation before, she took two doses of Albuterol while under observation with slight improvement but the feeling persisted. It did not worsen either, she had no difficulty breathing, no change in her voice.
38 2021-02-02 pain in extremity, feeling cold About 2-3 hours after injection I noticed an achy low back pain. Not sure if related but my feet and... Read more
About 2-3 hours after injection I noticed an achy low back pain. Not sure if related but my feet and nose were cold and hard to warm up.. The next day my main symptom was tired fatigued. Arm soreness was more moderate than first injection. Not sure if related but I had bouts of dizziness or vertigo. I had loose stools the next day.
38 2021-02-03 numbness, tremor Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and... Read more
Bad cough; Trouble breathing; Tingling around mouth; Numbness in jaw and neck; Shaking; Red face and chest; Slight itching; This is a spontaneous report from a contactable healthcare professional (the patient). A 38-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), intramuscular in the left arm on 18Jan2021 at 10:30 (at the age of 38-years-old) as a single dose for Covid-19 immunization. Medical history was not reported. The patient was allergic to penicillin. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EJ1685) on 28Dec2020 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ALERTEC), both for unknown indication from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Jan2021 at 11:00, the patient experienced bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching. Treatment was given when seen by paramedics with an emergency room visit which included a second dose of allergy medication. The clinical outcome of the events bad cough, trouble breathing, tingling around mouth, numbness in jaw and neck, shaking, red face and chest, and slight itching was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The reported events were likely causally related to the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), considering the plausible temporal relationship and clinical course of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-02-03 feeling hot EMT found Pt in vaccine observation area, sitting in chair. At 2:12 pm (15 min after vaccination). P... Read more
EMT found Pt in vaccine observation area, sitting in chair. At 2:12 pm (15 min after vaccination). Pt c/o scratchy, swollen throat, feeling warm, pain in neck, light headed, nausea. Vitals taken at 2:19 pm: BP 146/100, HR 112, respirations 20. Pt AxO x4, still talking, no SOB or complaints of breathing, no wheezing heard. 50 mg Benedryl liquid given PO at 2:24 pm. PHN on scene at 2:32 pm, 9-1-1 activated, Pt c/o continued neck pain 6/10, feeling hot, worsening of swollen tongue, throat tightness and swelling, now chest tightness, EMT reports no wheezes or stridor with auscultation of lungs and larynx. EMS on scene at 2:35 pm, assumed care. Pt transported to hospital at 2: 50 pm.
38 2021-02-03 pain in extremity Very sore arm; Headache; Very tired; This is a spontaneous report from a contactable healthcare prof... Read more
Very sore arm; Headache; Very tired; This is a spontaneous report from a contactable healthcare professional (reporting for herself). A non-pregnant 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 16Jan2021 05:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced very sore arm, headache and very tired in Jan2021. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.
38 2021-02-03 pain in extremity increased congestion; fatigue; sore throat; congestion; extreme Lethargy; Arm pain; This is a sponta... Read more
increased congestion; fatigue; sore throat; congestion; extreme Lethargy; Arm pain; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 10:15 as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol,/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the influenza vaccine (FLU VACCINE) on an unknown date for immunization and experienced drug allergy. The patient experienced arm pain on 14Jan2021, extreme lethargy on 15Jan2021, congestion on 16Jan2021, sore throat on 16Jan2021, increased congestion on 17Jan2021, and fatigue on 17Jan2021. On 14Jan2021, the patient had a COVID-19 nasal swab which was negative. The patient did not receive any treatment for the events. The clinical outcomes of the arm pain, extreme lethargy, congestion, sore throat, increased congestion, and fatigue were recovering. No follow-up attempts are possible; information about lot number cannot be obtained.
38 2021-02-04 tingling 12-20-20, started with tingling around my left lower lip at night time and the next morning I had ti... Read more
12-20-20, started with tingling around my left lower lip at night time and the next morning I had tingling going up to the left eye and cheek. No rash noted and concerned I was getting shingles. I saw a doctor and he did an eye exam to see if I had any shingles in my eye. My symptoms went away in few days.
38 2021-02-04 pain in extremity Approximately 7:00pm, I began to experience itching from head to toe. No rash noted. Had a little bi... Read more
Approximately 7:00pm, I began to experience itching from head to toe. No rash noted. Had a little bit of throat scratchiness, took 50mg of Benadryl and two Tylenol pills for my arm soreness and went to bed. When I woke up the next morning it was resolved.
38 2021-02-04 numbness Chest pain; numb hands; This is a spontaneous report from a contactable consumer, reporting for hers... Read more
Chest pain; numb hands; This is a spontaneous report from a contactable consumer, reporting for herself. A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 19Jan2021 at 10:30 (at the age of 38 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021, the patient experienced chest pain and numb hands. The patient did not receive treatment for the events. The clinical outcome of chest pain and numb hands was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
38 2021-02-04 pain in extremity Chills/shaking, very sore arm, flu like symptoms, malaise, headache, sore chest, tiredness
38 2021-02-04 flushing Itching that is still ongoing 1 week post vaccination that started 10 minutes after vaccination. I f... Read more
Itching that is still ongoing 1 week post vaccination that started 10 minutes after vaccination. I flushed initially, was dizzy, and then began itching to the head and neck. Itching eventually spread to the torso and legs and became generalized. I began taking benadryl 25-50 mg and continuing pepcid as needed afterwards. GERD also severely worsened and has waxed and waned. Itching overall has waxed and waned, but as soon as medications wear off, itching will very quickly return and is intense to the entire, head, neck, torso and upper extremities. I am also getting breakthrough itching as well even with higher dosages of antihistamines. I had to call out from work 2/5/21 today as a medical provider in primary due to the effects of the antihistamines. I called my allergy/immunology specialist on Tuesday 2/2/21 and he prescribed xyzal 5mg twice daily and hydroxyzine 25 mg at night. I saw him in the office yesterday, and after discussion, overall decided I should not receive the second dose of the vaccine, and when itching subsides and able to be off of antihistamines for 3 days we will do the PEG protocol testing, and in another 1-2 weeks (14-21 days after initial injection) we will do an IgG spike test to see if I developed antibodies.
38 2021-02-04 feeling cold, numbness Report of numbness of left arm, body aches, chills, nausea, HA, dry mouth, throat irritation . Trea... Read more
Report of numbness of left arm, body aches, chills, nausea, HA, dry mouth, throat irritation . Treatment: one dose of Ibuprofen Outcome: No improvement of symptoms, does not interfere with ADLs.
38 2021-02-06 numbness, tingling Began experiencing stiff joints and chills around 9pm Friday 2/5 which quickly proceeded to numbness... Read more
Began experiencing stiff joints and chills around 9pm Friday 2/5 which quickly proceeded to numbness and tingling in my legs making it hard to get up and walk. About an hour later it was followed up with chills which became severe, teeth chattering with full body stiffness which proceeded through the night. Saturday morning 2/6 felt fine after waking up then about 12 I once again began to have extremely stiff joints, tingling in legs and extreme chills. I then took 800mg Ibuprofen and slept for and additional 4 hours. Since waking body is aching but has improved and tolerable as of this morning 2/7
38 2021-02-07 numbness About an hour after receiving the vaccine, I experienced numbness in my left hand. Later in the day... Read more
About an hour after receiving the vaccine, I experienced numbness in my left hand. Later in the day the numbness wore off and I've experienced periods of a weakness in my left hand.
38 2021-02-07 hot flush At 12 hours post-vaccine administration, woke with a sharp headache pain in center of head (felt lik... Read more
At 12 hours post-vaccine administration, woke with a sharp headache pain in center of head (felt like corpus callosum). Then became aware of chills. First, chills felt like running down my nerves (like when you get scared), then changed to body shaking chills. Dressed warmer, took Tylenol, returned to sleep within 30 minutes. Woke again 3 hours after that with more chills and body aches. Fell asleep 1-2 hours after, awoke at 7am experienced chills, body and joint aches, nausea, and headache. Continued these symptoms with the addition of heat flashes for the next approx 16 hours. Lingering headache, grogginess, and chills/hot flashes for the next 12 hours. Symptoms fully resolved within 36 hours post-administration.
38 2021-02-07 pain in extremity For 3 days: injection site reaction, fatigue, headache, loss of appetite, arm soreness. Mild to mod... Read more
For 3 days: injection site reaction, fatigue, headache, loss of appetite, arm soreness. Mild to moderate. Day 7 - 9: Moderate injection site reaction: swelling, hot to touch, hard, 3.5 inch red circle, sore. On going headache.
38 2021-02-07 burning sensation, numbness, breast pain On 2/2/21 at approximately 10:00 am, I began experience a sharp pain in my left breast. Over then n... Read more
On 2/2/21 at approximately 10:00 am, I began experience a sharp pain in my left breast. Over then next 24 hours, this pain developed into a burning sensation under my left arm and across the left side of my my left breast . In addition to the burning sensation, I have been having very sharp pains. The pain is so intense, I cannot even touch it. There is also a numbing sensation to a section of my breast. Approximately 24 hours after the breast pain started, I noticed the same pain in my back directly behind my breast on the left side. It is very sore as well and hurts to touch. On Friday, 2/5, I made an appointment with my gynocologist to help rule out breast cancer. My doctor was not able to physically detect anything that seemed irregular but scheduled me for a mamogram just to be safe.
38 2021-02-07 tenderness Received shot 2/4/21, woke up 02/7/21 with a golf ball size knot under my left arm in my lymph nolde... Read more
Received shot 2/4/21, woke up 02/7/21 with a golf ball size knot under my left arm in my lymph nolde. very tender, hurts to raise arm
38 2021-02-07 pain in extremity Severe chills; Severe lower extremity pain; Headache; Body ache; Shooting joint pain; Nausea; Vomiti... Read more
Severe chills; Severe lower extremity pain; Headache; Body ache; Shooting joint pain; Nausea; Vomiting; Diarrhea; Fever; Sore throat; Swollen glands; Sweating; This is a spontaneous report from a contactable other health professional (patient). A 38-year-old female (not pregnant) patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number El1283), intramuscular at left arm on 12Jan2021 22:45 at single dose for COVID-19 immunization at a hospital. Medical history included asthma and attention deficit hyperactivity disorder (ADD). Concomitant medication within 2 weeks prior to the COVID vaccine included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took sumatriptan succinate (IMITREX) and experienced drug allergy (known allergies: Imitrex). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number El1284), intramuscular at left arm on 22Dec2020 15:30 for COVID-19 immunization at a hospital. The patient had no COVID prior to vaccination, and had been tested for COVID since the vaccination. The patient underwent lab tests and procedures post vaccination which included 2019 Novel Coronavirus RNA Testing by PCR (Nasal Swab) on 21Jan2021: negative, and Influenza/COVID-19 Nucleic Acid Amplification Test (Nasal Swab) on 18Jan2021: negative. It was reported that, started from 12Jan2021 23:30, the patient experienced severe chills, headache, body ache, shooting joint pain, nausea, vomiting, diarrhea, fever, sore throat, swollen glands, severe lower extremity pain, and sweating. All the events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. No treatment was received for the above events. The outcome of all the events was not recovered.
38 2021-02-07 pain in extremity Sore arm and headache started approximately 5 hours after vaccine and resolved within 48 hours. Poo... Read more
Sore arm and headache started approximately 5 hours after vaccine and resolved within 48 hours. Poor appetite and nausea started on day 2 post vaccine and lasted for 2-3 days. Episode of tachycardia and elevated blood pressure 2 days after vaccine, resolved within 24 hours, back to baseline this date. Muscle aches started day 7 post vaccine and continue this date.
38 2021-02-08 feeling cold At 5:30 pm started feeling off with a mild headache. Progressed to nausea and more pronounced headac... Read more
At 5:30 pm started feeling off with a mild headache. Progressed to nausea and more pronounced headache. By 7:30 pm, chills (really just feeling cold and unable to warm up) and fever. Fever reduced with medicine. Woke up with headache and fatigue. Fatigue lasted almost entire next day; I slept almost all day after vaccine and that night. Woke up 2 days after vaccine largely ok, but my heart would beat very hard during strenuous activities (exercise, going up the stairs). Felt same significant increase in my heart rate during exercise 3 days after vaccine. By 4th day, was able to exercise as normal. However, on Monday 2/1, had sore throat for the day my external throat muscles, like the SCM, vs something internal)
38 2021-02-08 facial paralysis, bell's palsy Facial paralysis 22 days following 2nd covid vaccination - Bells Palsy diagnosed
38 2021-02-09 pain in extremity Got super dizzy later last night; arms were bit sore; This is a spontaneous report from a contactabl... Read more
Got super dizzy later last night; arms were bit sore; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248), via an unspecified route of administration in Jan2021 at single dose in arm for COVID-19 immunisation. Medical history was none. Concomitant medications included bupropion, buspirone, fexofenadine hydrochloride (ALLEGRA), ergocalciferol (VITAMIN D [ERGOCALCIFEROL]). The patient got the vaccine yesterday around noon and she was just looking at side effects and everything, one of them was listed under severe allergic reactions dizziness and she got super dizzy later last night (Jan2021), it's gone now. The patient wanted to know if that was something that she should go in for if it's okay because it went away. Patient stated because dizziness was listed under like a sign of a severe allergic reaction it didn't happen until probably about 8 hours after and it lasted a couple of hours, but now it's gone so she didn't know if that's something she needed go in for or not. The patient had taken some Advil just because her arms were bit sore (Jan2021) but other than, that was it. No Investigation Assessment. The outcome of the event "Got super dizzy later last night" was recovered in 2021, of "arms were bit sore" was unknown.
38 2021-02-09 pain in extremity I received my first Pfizer Covid-19 vaccine on January 19, 2021. I didn't have any immediate reacti... Read more
I received my first Pfizer Covid-19 vaccine on January 19, 2021. I didn't have any immediate reaction after receiving the injection, aside from a sore arm. I'd like to note that when I received the vaccine I was breastfeeding as I do not know if this contributed to my reaction. About two days after receiving the vaccine, on January 21, 2021, I noticed a red itchy rash underneath my left breast. I initially thought this could be a complication associated with breastfeeding known as Mastitis. By the weekend the symptoms had decreased around my left breast and I developed a strong itchy sensation on the left side of my back. On January 25, 2021 I noticed I had a red rash on the left side of my back, on my left side and on my left breast. On January 27, 2021, I contacted my dermatologist and made an appointment thinking I had a rash. On January 28, 2021 I went to see Physician Assistant. During this visit diagnosed with Shingles. I do not know if the Covid-19 vaccine lead to developing Shingles. I wanted to share my experience in case there were other patients who received the Covid-19 vaccine and developed Shingles as a rare side effect.
38 2021-02-09 pain in extremity Sore arm after 1st shot. Body aches after 2nd dose that lasted half a day. Second dose was 1/8/2021.... Read more
Sore arm after 1st shot. Body aches after 2nd dose that lasted half a day. Second dose was 1/8/2021. Also developed episcleritis a couple of weeks later that wouldn't go away. This was new an unusual for me so I wondered if it might be because of the vaccine. Currently being treated with prednisolone eye drops.
38 2021-02-10 tremor Body aches, chills, headache (2 days), body shaking/ tremors constantly (5days)
38 2021-02-14 pain in extremity on 2/12/21 within 12 hours, severe headache, fever, myalgias, fatigue, leg pain, difficulty walking,... Read more
on 2/12/21 within 12 hours, severe headache, fever, myalgias, fatigue, leg pain, difficulty walking, and shortness of breath occurred. on 2/15/21 patient still experiencing all symptoms except shortness of breath. symptoms have persisted and not improved.
38 2021-02-15 pain in extremity Woke up feeling fatigued and I took it easy. That week I began having pains - joint pain. Joint pain... Read more
Woke up feeling fatigued and I took it easy. That week I began having pains - joint pain. Joint pain would move around - knees and then hands and then ankles. It didn't stay in one area. I had this pain for 2 1/2 - 3 weeks. Called my Rheumatologist because of my history of auto-immune disease. January 7th was the date. She told me to take Plactinele- anti-malaria medication. I took it for a week. I took Vit D, C and Zinc with this medication. I still had symptoms the week after the medication stopped. The pain didn't stop decreasing until about 3 weeks. Symptoms were not resolved entirely by the time I got second dose of vaccine.. Got the second dose on the 4th week after the 2nd dose of vaccine.
38 2021-02-16 burning sensation Burning and itching sensation when feet are warm/sweating. 2/14 toes became red and swollen, . Light... Read more
Burning and itching sensation when feet are warm/sweating. 2/14 toes became red and swollen, . Light chest cough previous week, possibly unrelated.
38 2021-02-16 pain in extremity Swollen lymph node under left arm. Caused radiating pain through chest and down arm. Painful to move... Read more
Swollen lymph node under left arm. Caused radiating pain through chest and down arm. Painful to move arm. Swelling and pain continues through today's date.
38 2021-02-18 burning sensation, pain in extremity 1/29/21 had mild arm pain and low grade temperature for 24 hours. Headache for multiple days after v... Read more
1/29/21 had mild arm pain and low grade temperature for 24 hours. Headache for multiple days after vaccine. 2/13/2021 noticed rash, like heat rash, on legs bilaterally. Put on hydrocortosone cream and then area burned and got very painful. Employee took zyertec for itching. Swelling noted in both lower legs and feet. Lower legs and feet showed petechaie and purpura from knees to toes. On 2/15/2021 saw MD and prescribed steroid. Petechaie improving but area is still red/purple and itchy. Will follow up with a dermatologist.
38 2021-02-18 tenderness, discomfort Extreme discomfort and swelling in left armpit. Muscle and joint soreness and tenderness in left arm... Read more
Extreme discomfort and swelling in left armpit. Muscle and joint soreness and tenderness in left arm and chest.
38 2021-02-18 flushing, tingling Sudden onset of lip and face tingling, redness and rash to chest, flushed face and increased heart r... Read more
Sudden onset of lip and face tingling, redness and rash to chest, flushed face and increased heart rate
38 2021-02-19 pain in extremity Arm pain: approx. 30 hours Diarrhea and gas: 12 hours Fatigue: 24 hours
38 2021-02-20 facial paralysis I had a major stroke on 12/25/2020, 9 days after receiving the vaccine. I had a clot in my MCA. My ... Read more
I had a major stroke on 12/25/2020, 9 days after receiving the vaccine. I had a clot in my MCA. My left arm was completely flaccid, with left facial droop and garbled speech. Thankfully I was able to receive TPA that day, which resolved all of my symotoms.
38 2021-02-21 weakness 2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness,... Read more
2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM
38 2021-02-21 feeling hot, numbness Pt complained of extremity feeling warm internally, itching, and numbness.
38 2021-02-22 pain in extremity On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really ... Read more
On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really read, red hard rash, my face turned very red, pain on my shoulder & neck, and very bad headaches, my work send me o the emergency room, & also I had hard time seeing everything was very hard to see. I felt very nauseas I couldn't eat for the first couple of days, a lot of body aches & felt very fatigue. In the emergency room they prescribed me Trimodal & Zofran. I had to miss 4 days of work it lasted about 7 days the first 4 days my symptoms were sever but by the 5th day it was getting better.
38 2021-02-22 tingling On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and ... Read more
On the next day the patient started to have fevers, headaches, couldn't stand up. In the second and third day after the vaccination the patient started to feel joint pain, tingling sensation.
38 2021-02-22 pain in extremity Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, head... Read more
Sore arm, swollen eye (lump under the skin and visible in the rim of the eye, fatigue, malaise, headaches, chills, diarrhea. All recovered other than the sore eye.
38 2021-02-22 breast pain, pain in extremity The day they gave me the vaccine I had a lot of pain in my left arm, I felt my arm very tired, if I ... Read more
The day they gave me the vaccine I had a lot of pain in my left arm, I felt my arm very tired, if I grabbed something I could not hold it for a long time, the next day , on Thursday I had the same pain but it was also a pain in the armpit and it went to my left breast, along with a prick, on Friday I continued having pain in my armpit, like I was sore and I noticed that my neck hurt a lot, only on that side, I called my doctor and she told me to take ibuprofen and if I still having problems to go to the emergency room, by late in the night I felt a small ball near to my neck and when I touched it hurt a lot, to this day nothing hurts but the small ball still there, it doesn't hurts when I touch it nothing., I had palpitations but
38 2021-02-22 flushing Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was ... Read more
Within 30 minutes, I turned bright red - my face and my forearms. Not a rash or raised rash. It was a deep red flushing. I took a dose of oral Benadryl it didn't go away. It felt like a sunburn. I had a headache starting at the back of my head. 1st and second day, I had pain in my joints. Not muscular pain. It came and went the joint pain - behind my left knee was hurting really bad and then it went away. Then my right wrist would start hurting and then it would go away, etc. The second day, the headache was more mild - like a mild pressure in my head. The redness was still there - the red face and red arms. My left arm at the site was cherry red and about the size of two inch circle and somewhat raised. The third day, my headache was worse. It was not like a normal headache but an overall pressure in head. Pink and a bit larger but didn't hurt as bad on arm- the redness continued for six days on my face. The headache lasted 14 days straight - Motrin, ice, heat and extra sleep was tried for treatment. On 15th day it started to let up. On 16th day, it was very mild headache. On the 17th day, it was a full blown headache again. Day 18 it was gone. On the second week, I had mild pain in my stomach and then that went away. On day 3, I had about an hour - twice that day - where I was short of breath and then it went away - it was just that day - about noon and at night. I took Benadryl and when I woke up that didn't happen again. Doctor called on day 12 - when my headaches weren't going away. He took some labs. My labs were normal except thyroid (and I already have a condition for my thyroid). Dr. gave me a medication for headache but I didn't take it - it had a possibility of making me tired and I didn't want to take it.
38 2021-02-23 feeling hot Elevated blood pressure 1) 172/107 2) 156/92 (normal for her is around 127/85 per patient), wave of ... Read more
Elevated blood pressure 1) 172/107 2) 156/92 (normal for her is around 127/85 per patient), wave of fatigue, felt a lump in throat, rash across opposite arm and chest, felt heat sensation. Symptoms improved after 20-30 minutes of monitoring and patient went home with instructions to seek medical attention if symptoms begin to worsen.
38 2021-02-23 migraine Ocular Migranes- 6 ocular migranes total- 4 of them just ocular- 2 turned into full blown migraine- ... Read more
Ocular Migranes- 6 ocular migranes total- 4 of them just ocular- 2 turned into full blown migraine- Date of onset was 2/13/2021 and the last one at the moment was 1/21/2021
38 2021-02-23 tingling Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to E... Read more
Patient experienced lip swelling, facial redness & swelling with tingling. Patient transported to ER for further treatment.
38 2021-02-23 weakness, tingling, numbness Weakness, numbness, tingling in upper extremities. Low back pain. Weakness and tingling in lower ext... Read more
Weakness, numbness, tingling in upper extremities. Low back pain. Weakness and tingling in lower extremities. Symptoms x4 weeks and not improving. Not improved with conservative therapy or oral steroids.
38 2021-02-24 bell's palsy, involuntary muscle movements, facial paralysis Bell palsy develop Wednesday early morning some numbness in lip but condition worsen around 7pm at n... Read more
Bell palsy develop Wednesday early morning some numbness in lip but condition worsen around 7pm at night, face droop, blurred vision , and paralysis set in. Thursday seen dr and started prednisone 20mg tablet , 2 tablet once a day and valtrex 20mcg , 3 times daily . Currently a week on meds and symptoms hasn?t improved. Never been diagnosed with bell palsy or have any neuroconditions. Blurred vision and paralysis is still the same. Have some eyelid and mouth movement.
38 2021-02-24 pain in extremity COVID-19 Vaccine Pt received first dose of vaccine in December and states that she only had a sore ... Read more
COVID-19 Vaccine Pt received first dose of vaccine in December and states that she only had a sore arm. She received second dose 1/13/2021 at 0813 and had no side effects. Around 1500, she developed chest pain and wheezing. She used her albuterol inhaler (pt has asthma), which helped. That night, she developed a sore arm. She woke 1/14/2021 around 0100-0200 from pain and was unable to go to back to sleep. She had aching in her left arm, as well as shooting pains through her arm and into palm. She took APAP 1000 mg PO x 1 and doxylamine which helped, but she was still unable to go back to sleep d/t pain. The pain expanded into her chest (especially with deep breaths), and upper back. She developed headache, sore throat, sweats and chills, shooting pain in her ear, painful and swollen left axillary lymph node, and the right side of her tongue became numb (numbness subsided after 1-2 hours). 1/14/21 morning, pt has persistent left hand pain, as well as joint pain in her feet, hips, and knees. She took another 1000 mg of APAP, which helped her pain. by 1/14 evening, she took 1000 mg APAP again and was able to sleep, although pt still endorsed sweats/chills. 1/15: Pt reports her pain is better, less severe, though now she is very fatigued and feels like she has been "hit by a truck". Her left axillary lymph node is still painful and swollen, but less painful than before.
38 2021-02-25 pain in extremity, night sweats sore arm (no pain medication taken for it) fatigue ( has not improved since injection) night sweats ... Read more
sore arm (no pain medication taken for it) fatigue ( has not improved since injection) night sweats (has not improved since injection)
38 2021-02-26 feeling hot I received the shot at 2:50, at about 5pm I had a bad headache and I noticed my left ear was hot. By... Read more
I received the shot at 2:50, at about 5pm I had a bad headache and I noticed my left ear was hot. By 6pm I noticed my ear was extremely red and swollen.
38 2021-02-28 feeling of body temperature change Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetit... Read more
Breathing difficult; Chills; Body aches; Nauseous with and no appetite; Nauseous with and no appetite; Not feeling too well; One minute she was cold, and then one minute she was hot; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL330Z; Expiration date was not reported) on 26Jan2021 (08:45) at a single dose on the left deltoid (left shoulder area), with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK8176; Expiration date was not reported) on 05Jan2021 (when the patient was 38 years old) for COVID-19 immunization. On 26Jan2021, after the second dose of vaccination, the patient was not feeling too well; had difficulty breathing; had chills; body aches; and was nauseous with no appetite. Along with the chills, the patient further stated that one minute she was cold, and then one minute she was hot on 26Jan2021. The patient did not receive any treatment for the reported events. The outcome of the events was not recovered for 'chills' and 'nauseous with and no appetite'; and was unknown for 'breathing difficult', 'body aches', 'not feeling too well' and 'one minute she was cold, and then one minute she was hot'.
38 2021-02-28 flushing Rapid Heart Rate, Flushing, Hives on upper body, Nausea, Dizzy, feeling faint - This reaction occurr... Read more
Rapid Heart Rate, Flushing, Hives on upper body, Nausea, Dizzy, feeling faint - This reaction occurred very quickly in approximately 5 minutes. EMT at site was not alarmed. My heartrate decreased, and after my waiting time was over, I went home. After getting home and sending pictures of rash and list of symptoms to an allergist, I was told to take a double dose of liquid Benadryl and a dose of oral steroids.
38 2021-02-28 flushing tacchycardia, High blood pressue, redness on vaccine arm, mild flushing
38 2021-03-01 feeling hot Redness and itching all over body. Warm/hot sensation.
38 2021-03-01 tingling, numbness bilateral facial numbness/tingling, left more so than right
38 2021-03-02 cold sweat Chills, cold, anxiety, clammy
38 2021-03-02 migraine First was a large 1.5 inch diameter, red welp at site. For the next 60 hours, experienced severe mig... Read more
First was a large 1.5 inch diameter, red welp at site. For the next 60 hours, experienced severe migraine and joint pain. Red welp at site eventually turned purple with a large 4inchx1 inchx0.5 inch deep indention into muscle tissue at vaccine site. Arm has a constant dull ache that worsens with use and on palpation at site with noted weakness.
38 2021-03-02 pain in extremity Initially with severely sore arm, headache, cough, chest tightness/congestion, and heartburn unrelie... Read more
Initially with severely sore arm, headache, cough, chest tightness/congestion, and heartburn unrelieved by medication that began approx 24 hours after vaccination. Then, per patient: "Almost 2 weeks to the day after getting my first shot, on Friday 2/26, I suddenly and unexpectedly went into Rapid Ventricular Response atrial fibrillation. I was admitted to the ER department at Northwestern. I was there 10 hours and multiple tests were completed. At this time, no causes have been found that would have contributed to my going into RVR A-fib. I am wearing a heart monitor for 2 weeks and will undergo a stress echo exam on my heart. I do not have a cardiac history."
38 2021-03-02 feeling hot Itchiness on her arms, legs and body. Feeling hot. Given 25mg Benadryl IM RD. Patient referred to ER... Read more
Itchiness on her arms, legs and body. Feeling hot. Given 25mg Benadryl IM RD. Patient referred to ER by NP.
38 2021-03-02 discomfort My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; My right eye,l... Read more
My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; My right eye,lips and face had discomfort; I felt malaise for the rest of that day; right sided discomfort; This is a spontaneous report from a contactable nurse (patient). This 38-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK9231) via an unspecified route of administration on 21Jan2021 at 14:00 (at the age of 38-years-old) as a single dose in the right arm for COVID-19 immunization. The patient did not have any medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccine, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient reported taking unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 14:30 the patient experienced right sided discomfort. Her right eye, lips, and face had discomfort; not pain but a strange feeling. The patient also felt malaise for the rest of that day (21Jan2021) and the following day. The events were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcome of right sided discomfort, right eye, lips, and face discomfort, and malaise was recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
38 2021-03-03 burning sensation I had palpitations within 15 min from the shot. My nervous system reactions escalated for the rest o... Read more
I had palpitations within 15 min from the shot. My nervous system reactions escalated for the rest of the day, with a peak 2 hours after the shot : burning sensation on my chest, back of the head, down my spine, shakes, digestive issues etc. It seemed to have put my nerves in an electrical plug with little I could do at a cognitive level
38 2021-03-03 cold sweat PATIENT STATED SHE FELT LIKE SHE WAS GOING TO PASSOUT, DIZZY. PT. STATED HISTORY OF FAINTING/SYCOPY.... Read more
PATIENT STATED SHE FELT LIKE SHE WAS GOING TO PASSOUT, DIZZY. PT. STATED HISTORY OF FAINTING/SYCOPY. MEDICAL HISTORY INCLUDES ASTHMA, REACTIONS TO VACCINATIONS, AND VOMITS AFTER FLU SHOT. PT. BP 120/70 HR 79 O2SAT 97 CLAMMY SKIN, BREATH SOUNDS CLEAR BILATERALLYVAT 1555. OBSERVED TREATMENT: BP 130/76 HR 67 02SAT 95 AT 1613 ELEVATED TO SITTING POSITION AT 1616 WITH NO NEGATIVE EFFECTS.
38 2021-03-04 flushing 10 minutes after vaccine, patient experienced flushing to her face, chest, and L arm. Her initial vi... Read more
10 minutes after vaccine, patient experienced flushing to her face, chest, and L arm. Her initial vitals showed pulse Ox: 100%, HR: 123, BP: 138/82. Patient denies SOB, sore throat, or difficulty swallowing. On exam, she has some flushing of her face b/l and chest had some popular erythema. It was not pruritic and blanched. No evidence of urticaria. She did not have any rash involving her b/l arms, abdomen, and back. Her airway was patent, no stidor. She was given a benadyrl. After 20 minutes, her HR decreased to 101. Her rash on her chest improved as well as her facial flushing. Patient was advised to follow up with her primary care physician.
38 2021-03-04 flushing Employee received 2nd dose of Pfizer COVID-19 vaccine on January 18th at about 2pm. By 6 pm, she no... Read more
Employee received 2nd dose of Pfizer COVID-19 vaccine on January 18th at about 2pm. By 6 pm, she noticed that she had bilateral swelling of lymph nodes in neck by the clavicle bone (more prominent on right hand side - same side as injection). She also experienced difficulty swallowing and went to the ER at 9pm. At the ER she received solumedrol IV, Pepcid IV and was discharged with hydroxyzine, Pepcid, solumedrol dosepak, zofran and epi-pen. At this time she was diagnosed with angioedema. Swelling persisted and she contacted an allergist who prescribed additional antihistamines. The allergist advised to her take Zyrtec or Claritin in addition to hydroxyzine day and night. The swelling continued to persist and two weeks later after returning to work for one day, she experienced feeling hot and flushed on right side, increased swelling and difficulty swallowing again and returned to ER on 1/25/21 and was treated with solumedrol and hydroxyzine and was discharged with solumedrol dosepak in addition to continuing antihistamines. Upon returning to allergist, she was advised to take 4 zyrtec, 4 Claritin, Pepcid 40mg bid and hydroxyzine 10mg at bedtime. PCP referred her to oncologist. After CT, oncologist diagnosed condition as bilateral lymphadenopathy and to return in 3 months for follow up. PMH significant for ALL as a child (8 yrs), went into remission at 13yrs. PMH also includes DM2.
38 2021-03-04 numbness Pfizer-BioNTech COVID-19 Vaccine EUA 10:33 am: received vaccine 10:55am: left facility and began d... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA 10:33 am: received vaccine 10:55am: left facility and began drive home 11:00-11:20: sudden entire face numbness (forehead, cheeks, nose, lips, chin?NOT tongue or inside mouth) 11:20-noon: numbness improves Noon-2:30pm: slightly dizzy/lightheaded, ?out of it,? brain fog 2:30 still slightly dizzy/lightheaded, ?out of it,? brain fog, sudden tiredness Felt tired the rest of the day. Sore arm around injection site. Felt completely fine the next day.
38 2021-03-04 muscle twitching, tingling Tingly arm down to finger tips, twitch in muscles in. Legs, diarrhea, and nausea. Sore arm at locati... Read more
Tingly arm down to finger tips, twitch in muscles in. Legs, diarrhea, and nausea. Sore arm at location for two days.
38 2021-03-04 tenderness after receiving shot i had an headache later that day about 3pm. I took ibuprofen 800mg a,d went to ... Read more
after receiving shot i had an headache later that day about 3pm. I took ibuprofen 800mg a,d went to sleep. I woke up about 10:30pm that night feeling sluggish. That Sunday I woke up with the same headache not as bad and i took another ibuprofen 800. My arm was very sore and swollen at the injection site. On Monday, when i woke up my right armpit had swollen up and bruised rally bad. My lymph nodes in my armpits had also swollen and very tender to touch. I went to SCS clinic and they gave me some Cyclobenzaprine for muscle relaxation and told me to follow up with my PCP. I went to my PCP on 3/4/2021 and she prescribed me some Prednisone for swelling.
38 2021-03-04 hot flush face became hot & red, felt dizzy/light headed, went away after about an hour
38 2021-03-05 weakness I got my first Vaccination of the Pfizer shot on Wednesday, with no immediate symptoms. Gradually mu... Read more
I got my first Vaccination of the Pfizer shot on Wednesday, with no immediate symptoms. Gradually muscle soreness and fatigue kicked in, but nothing concerning. The next day, my stomach had a burning and unsettling feeling. I tried a couple of Tums, thinking I was having some pregnancy issues, but that didn't help. I was having waves of nausea. I didn't have much appetite, and could only manage to eat some potato soup for dinner. I was feeling very weak, lethargic, and needed to lay down the majority of the evening. I finally had some uncontrollable vomiting by around 9pm, followed by the chills. I slept all night, struggled the next day at work, and left early to sleep the rest of the day since I was just too weak and lethargic to do anything. I consider myself to be very healthy, I exercise every morning, and the pregnancy has been normal. I am in the early 3rd trimester, and my due date is June 14 - this is my second pregnancy. I am an onsite teacher, thus I have built up a strong immune system and never get sick, so this caught me by surprise. I am feeling much better today, and I will absolutely get the second Pfizer shot later this month. I will try to better prepare myself as I hear the symptoms may be worse on the second shot. My sister, a pharmacist, insisted that I should share this information, in case it is helpful for data.
38 2021-03-05 flushing Nearly immediate flushing of face and neck which mostly resolved. Minimal flushing present 1.5 hour... Read more
Nearly immediate flushing of face and neck which mostly resolved. Minimal flushing present 1.5 hours post-vaccination. Itching also present and ongoing.
38 2021-03-06 tingling Hands and feet were tingling, anxious, requested a b/p check. Evaluated by EMS, cleared.
38 2021-03-06 flushing Patient presented for her first dose of Pfizer covid-19 vaccination today. She had Covid in the fall... Read more
Patient presented for her first dose of Pfizer covid-19 vaccination today. She had Covid in the fall. She has had anaphylactic reaction to antibiotics in the past, was advised she should be evaluated for 30 minutes post vaccination today. She agreed, was seated in the front row of chairs, next to the EMS and RN Observer tables. This RN checked in frequently with patient throughout her 30 minute observation period, conversing throughout the wait time. She reported feeling anxious about the vaccine and potential for side effects. She had her husband drive her to her appointment today. Her earlobes and forehead were flushed red and dry, but her neck was without redness. She had even, regular respirations and was able to speak clearly without issue. RN reassured her that we were here, assessing for any changes and were available to help. After 15 minutes, patient stated her mouth felt dry. RN offered water, patient accepted. She was able to drink and swallow without trouble. Patient's coloring remained the same, but she reported feeling better. She was still able to converse without difficulty. At about 29 minutes, patient stated she was worried that something may happen after her 30 minutes was up, stated her tongue was starting to feeling thick. RN offered her additional observation with EMS, alerted them to the situation. Patient checked out with RN station and this RN walked her into the hallway for EMS evaluation. EMS helped patient out of her sweatshirt and mask. EMS noted lip swelling and increased redness in her face, neck, chest, earlobes. EMS obtained vitals and administered 50 mg benadryl IM in her right deltoid. Patient's husband came in from the parking lot. Patient declined solumedrol injection due to her diabetes. EMS advised patient she needed additional evaluation and she was transported to hospital via ambulance. Patient's husband followed in his car. VAERS report filed.
38 2021-03-07 pain in extremity Morning of March 5th: started feeling pain at the injection site right arm deltoid. Evening of March... Read more
Morning of March 5th: started feeling pain at the injection site right arm deltoid. Evening of March 5th: Pain is still present. I started to rub the arm. My arm became swollen, red, hard, warm to touch, itchy and painful to move. Later that night, I also felt something in my left forearm. I started using a cold pack. Morning of March 6th: right deltoid has not changed. Now alternating between heat and cold on arm. Evening of March 6th: left forearm feels like a sore muscle after exercising. I began to flex my wrist to stretch the muscle. My left forearm then became swollen, red, hard, warm to touch, itchy and painful to move. Morning of March 7th: Went to urgent care. I was prescribed a cream and antibiotics and told to take an allergy pill. Morning of March 8th: Right deltoid has lessened is swelling, redness, pain and itchy feeling. I started to feel the sore muscle feeling in both calf muscles and right forearm. I did not stretch the muscle and it has not produced the same reaction.
38 2021-03-07 flushing, tremor, unresponsive to stimuli Patient experienced three episodes of syncope between 1000-1100 on Sunday, 2/28 after receiving the ... Read more
Patient experienced three episodes of syncope between 1000-1100 on Sunday, 2/28 after receiving the vaccine on Saturday, 2/27 at approximately 1810. Loss of responsiveness ranged from approximately three to twenty seconds. Two of the three episodes were witnessed. Episode one occurred when patient attempted to sit up after waking. Episodes two and three occurred while attempting to change position from sitting to standing. Episodes were preceded by flushing, diaphoresis, graying/blackening vision, and tremulousness. Patient had not experienced syncope prior to these events. Patient recovered at home with increased fluids and rest on Sunday, 2/28 and outpatient infusion of normal saline at a naturopathic clinic on Monday, 3/1. Patient experience no further episodes of syncope as of 3/8 but did have multiple episodes of near-syncope in the week following vaccination. Syncope started at approximately 10 am on Sunday after having received the vaccine on Saturday at approximately 6:10 pm.
38 2021-03-07 numbness overall "odd" feeling throughout my entire body; Right leg numbness; This is a spontaneous report fr... Read more
overall "odd" feeling throughout my entire body; Right leg numbness; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK4176, first dose) solution for injection intramuscular in the left arm on 04Jan2021 at 12:00 (at the age of 38-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included migraines, PFO with closure, stroke, PNA (pneumonia) in 2002 and Covid on an unknown date. Concomitant medications included ASA and ibuprofen for headaches. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The evening of the initial injection (04Jan2021 at 17:00) the patient had an episode of right leg numbness and an overall "odd" feeling throughout my entire body. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was provided for the events odd feeling and right leg numbness. The outcome of the events odd feeling and right leg numbness was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
38 2021-03-08 feeling cold Extreme chills, fever, fatigue, headache, cold sweats, diarrhea, dizziness, swelling and pain in lym... Read more
Extreme chills, fever, fatigue, headache, cold sweats, diarrhea, dizziness, swelling and pain in lymph node in underarm in left arm.
38 2021-03-08 tingling Pfizer-BioNTech Covid-19 Vacine EUA Left side of my face feels tingly. It?s not swollen and still fu... Read more
Pfizer-BioNTech Covid-19 Vacine EUA Left side of my face feels tingly. It?s not swollen and still functional. Just tingly. Same feeling as if your foot falls asleep. No treatment yet. Waiting to see if it goes away in a few days.
38 2021-03-08 flushing Pt. states that she received the covid vaccine at 13:40 pm on 3/09/2021. Around 14:30 on 3/09/2021 p... Read more
Pt. states that she received the covid vaccine at 13:40 pm on 3/09/2021. Around 14:30 on 3/09/2021 patient developed redness to both ears along with feeling flushed and sweaty. BP reportedly was in the 170s-180s/100s. Pt. was given benadryl at 14:35 pm. Pt. states that around 14:40 pm she developed hives to face and itching. Pt. states that she feels as though her symptoms are improving. Patient denies shortness of breath, denies trouble breathing, denies chest pain.
38 2021-03-08 tingling The patient complains of tingling in the left arm from elbow to wrist following injection. She was ... Read more
The patient complains of tingling in the left arm from elbow to wrist following injection. She was place under additional observation for 15 min. The patient has no medical problems, takes no meds, and she is not allergic to any meds. Following the additional observation subject stated the symptoms were no longer present. The patient was released at this point.
38 2021-03-09 tingling, feeling hot, flushing Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash app... Read more
Immediately felt dizzy/woozy. Within 1 minute felt extremely hot and a bright red, splotchy rash appeared all over my chest, neck, face, back. Jaw and tongue felt tingly, but not unsure if that meant swollen. Medic checked heart rate and BP which were elevated. HR was in 120's and BP was 140's/80's for a prolonged period of time. Doctor gave Benadryl which seemed to help. Doctor and Medic watched me for an hour. Rash mostly went away within 5 hours, however once I came home, I noticed it had also been on my legs. The rash never produced hives, but the Doctor onsite confirmed this was an immediate allergic reaction, and said to see my regular doctor and an allergist. Since the shot some flushed look has come back in spots each day for a short period of time (maybe 10 mins or so). Still taking Claritin.
38 2021-03-09 cold sweat, muscle spasms Muscle spasms, vomiting, cold sweats, muscle and joint pain.
38 2021-03-09 weakness Severe chills, headache weakness, fatigue nausea severe thirst
38 2021-03-09 tingling Tingling of the fingers - both hands. BPs 140/79 (pulse 72), 121/75 (pulse 71). O2 sat 100%.
38 2021-03-09 speech disorder, tremor symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; s... Read more
symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; symptoms of headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors; This is a spontaneous report from a contactable Other HCP. A 38-year-old non-pregnant female received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 (Lot number: EL3302) via intramuscular route of administration at SINGLE DOSE for COVID-19 Immunization. The patient's medical history included environmental allergies, Type 2 diabetes mellitus, Mixed hyperlipidemia, Attention deficit hyperactivity disorder, Obesity and Anxiety from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin calcium at 20mg, Desogestrel/Ethinylestradiol (Azurette) at (23) 0.15mg-0.02mg (21)/0.07mg (S), clotrimazole and betamethasone at 1%-5%, cyclobenzaprine at 10mg, escitalopram oxalate (lexapro) at 20mg, metformin at 500mg, esomeprazole magnesium (nexium) at 20mg, montelukast sodium (singulair) at 10mg, amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (Adderall) at 20 mg, cetirizine hydrochloride (zyrtec) at 10 mg, fluticasone proplonate at 50mcg. It was unknown if the patient had illnesses at the time of vaccination and up to one month prior. Patient was seen in office on 27Jan2021 and reported symptoms of Headache, dizziness, speech disturbance, memory loss, balance issue, and hand tremors causing change in handwriting for the past 1.5 to 2 weeks after receiving vaccination. Upon review of Neurological symptom, patient was positive for loss of balance and coordination 4/5 strength. In all extremities, and 4/5 grip strength, CT of Head with and W/O contrast was ordered. CBC, CMP, free T4, HgbA1c, lipid, 'TSH, Urinalysis, Vitamin B12, Folate and CK laboratory ordered. CT Head with and w/o Contrast on 27Jan2021 showed no acute intracranial process Identified. No evidence of enhancing lesion. Patient had not completed laboratory at this time. It was unknown if the patient had doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
38 2021-03-10 numbness I had extreme dizziness, facial numbness, tongue tingling and was observed during the observation pe... Read more
I had extreme dizziness, facial numbness, tongue tingling and was observed during the observation period. Later that day I had nausea and fatigue that lasted for 12 hours.
38 2021-03-11 numbness, feeling cold, tingling I am not sure if this is typical, but it's been really scary and I'm not sure if I should get the 2n... Read more
I am not sure if this is typical, but it's been really scary and I'm not sure if I should get the 2nd dose now... about 7p on 3/11/21 I started noticing my Right hand was feeling cold/tingly/numb. By the time I went to bed it was feeling strange up to my right elbow. I woke up (3/12/21 about 6a) with both hands (mostly all my fingers) looking very white (like Raynaud phenomenon). My right hand to elbow still feels strange and seems most affected (shot was administered on Left deltoid). My right hand almost feels like I have a glove on (wetsuit material).. I've been trying to keep circulation to them by taking hot showers and rubbing them. They now seem more reddish and almost like chilblains might occur. They feel tingling. I have previously had chilblains in my feet when they were cold, but I've been good at managing and don't get that anymore. Never had it in my hands previously..
38 2021-03-12 flushing Hives (chest, injection site), flushing. Evaluated by EMS-Cleared
38 2021-03-13 pain in extremity, tremor Dizziness, nausea, shakiness to the point of extreme difficulty with mobility, excess sweating, pinc... Read more
Dizziness, nausea, shakiness to the point of extreme difficulty with mobility, excess sweating, pinching pain in left fore arm
38 2021-03-14 numbness Entire left side went numb for 8 min; This is a spontaneous report from a contactable consumer (repo... Read more
Entire left side went numb for 8 min; This is a spontaneous report from a contactable consumer (reported for herself, not pregnant). A 38-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration on 26Feb2021 14:00 at single dose in left arm for COVID-19 immunisation. The patient's medical history included known allergies Sulfur. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Health Clinic facility. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient experienced Entire left side went numb for 8 min on 01Mar2021 10:30. No treatment was received for the adverse event. The adverse event result in Doctor or other healthcare professional office/clinic visit. The event was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the event was recovering.
38 2021-03-14 pain in extremity I had sudden rapid heart rate twenty minutes after injection. I let the staff know and they hoked me... Read more
I had sudden rapid heart rate twenty minutes after injection. I let the staff know and they hoked me up to blood pressure monitor and monitored heart rate. My pulse was high at about 103bpm. My blood pressure got as high as 155/84, I believe. I was feeling very uneasy and not like myself. Luckily about twenty minutes later, these symptoms went away. I did not check these two things again, but I felt better. My arm was sore, but I know that was to be expected. I also felt like I could taste a medicine taste for about 24 hours.
38 2021-03-14 nerve pain Nerve pain; lower back pain; Swollen lymph nodes; swollen and tender armpits; severe headaches, stif... Read more
Nerve pain; lower back pain; Swollen lymph nodes; swollen and tender armpits; severe headaches, stiff neck
38 2021-03-15 weakness 1. Fevers 2. Chills 3. Body aches 4. Soreness at site of injection 5. Deliriousness 6. Extreme weakn... Read more
1. Fevers 2. Chills 3. Body aches 4. Soreness at site of injection 5. Deliriousness 6. Extreme weakness Symptoms Lasted for about 48 hours post vaccination time. Was pregnant at the of the second shot (4 weeks pregnant - 01/12/2021). Expected due date was 09/15/2021. Had a sound heartbeat at 8 weeks (02/11/2021). Lost the heartbeat at 12 weeks(03/03/2021). Had a natural miscarriage at 13 weeks (03/09/20201).
38 2021-03-16 cold sweat Nystagmus for less than a minute at onset. Syncope, cold sweats for about 5 hours after onset. Light... Read more
Nystagmus for less than a minute at onset. Syncope, cold sweats for about 5 hours after onset. Lightheadedness and dizziness for about 30 hours (and counting) after onset.
38 2021-03-16 tenderness, pain in extremity Pain/swelling in the injection site the evening of 2/26 and for a day or two after. Lightheadedness... Read more
Pain/swelling in the injection site the evening of 2/26 and for a day or two after. Lightheadedness/fatigue the evening of 2/26 and part of the day after. Some tenderness/soreness in underarm area of the same arm injected. This didn't start for probably a week or so and lasted for maybe a week. I am not 100% sure on the timelines for that, but I know it didn't start right away and I know it was gone by 2.5 weeks after the injection.
38 2021-03-17 pain in extremity Hot, painful, raised lump on left arm lasting over one week.
38 2021-03-17 pain in extremity Side effects included arm soreness in the entire upper arm, pain in my back around the lower lung ar... Read more
Side effects included arm soreness in the entire upper arm, pain in my back around the lower lung area when I would clear my throat, fever, odd sensation in my entire left arm and cheeks, and some body swelling. The pain in my back when clearing the throat shifted towards my spine, then started to radiate outward. All symptoms gone except for soreness in the arm and the feeling in my cheeks. It feels like when you?ve been numbed by the dentist, and that numb tingly fades, but your mouth doesn?t feel awake.
38 2021-03-17 flushing, tingling lightheadedness pressure on forehead, flushed cheek. anxiety. tingling on both tips of fingers.
38 2021-03-18 feeling cold Immediately after vaccination #1 at 0945 pt. noted "fuzziness, then cold at injection site and throu... Read more
Immediately after vaccination #1 at 0945 pt. noted "fuzziness, then cold at injection site and throughout body." BP at 1010 was 140/100. By 1040 BP was 130/88 and "coldness" had resolved and "fuzziness" had improved. States also that her distance vision had been blurred at 0945 but had resolved by 1040. She left the POD ambulatory at 1050. Follow up call 3/19 finds no sequelae; pt. reports complete recovery. Is scheduled for #2 dose 3/31. Advised to report event and BP spike to her doctor and be advised about receiving 2nd dose.
38 2021-03-18 tremor On the day of vaccination in the evening Lightheaded, pain in all joints, body ache and vomiting twi... Read more
On the day of vaccination in the evening Lightheaded, pain in all joints, body ache and vomiting twice. Fever101. Next day shaking hands on and off. As of today still on and off hands shaking, lightheadedness and joints pain
38 2021-03-19 throat numbness 15 mins into observation, pt's throat began to feel numb. VS were BP 141/85, O2 95, HR 78, R 20. Den... Read more
15 mins into observation, pt's throat began to feel numb. VS were BP 141/85, O2 95, HR 78, R 20. Denied SOB or airway closing. RN assessed airway with no obstruction. RN felt it was okay to wait to see if symptoms resolved,. 10 minutes later symptoms did not improve & 25mg of Benadryl was given. Pt felt relief within 5 minutes & was instructed to stay an additional 15 mins.
38 2021-03-19 pain in extremity 20 minutes s/p vaccine administration client stated that she felt pain in her arm, shellfish, corn, ... Read more
20 minutes s/p vaccine administration client stated that she felt pain in her arm, shellfish, corn, wheat, strawberries, oranges, pet dander, grass. Client initial BP hypotensive and recovered on second BP to baseline.
38 2021-03-19 flushing Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating... Read more
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Nausea-Medium
38 2021-03-20 migraine 3/20/2021 1215 - Intensified migraine within 10 minutes of injections - migraine lasted for 8 hours.... Read more
3/20/2021 1215 - Intensified migraine within 10 minutes of injections - migraine lasted for 8 hours. 3/21/2021 0500 - woke with a migraine; chills; body aches in the shoulders, arms, chest and back; fever 100.7; fatigue
38 2021-03-20 tremor began to feel light headed and dizzy during 15 minute wait, after about 15 minutes it did not subsid... Read more
began to feel light headed and dizzy during 15 minute wait, after about 15 minutes it did not subside and her hands began shaking uncontrollably, ems was called and they brought her to the tent and checked vitals, b/p and pulse were elevated. after waiting 30 minutes and drinking a little water patient expressed that they felt better and walked out of center on her own accord.
38 2021-03-20 feeling hot, hot flush blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the admini... Read more
blackout/ I wasn't able to see him only hear his voice; panicking sensation; mild pain in the administration spot; then I vomited; excessive heat coming out of my body like hot flash; fell on my face; like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat; This is a spontaneous report from a contactable consumer, the patient. A 38-years-old (also reported as 45 years old) non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration, in the right arm on 01Mar2021 at 13:30 (at the age of 38-years-old) as a single dose, for covid-19 immunization. The facility in which the vaccine was given was Doctor's office/urgent care The patient had no known medical history or allergies. Concomitant medication were reported as yes but details not provided. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02Mar2021 04:00, the patient experienced blackout/ I wasn't able to see him only hear his voice (medically significant), panicking sensation, , mild pain in the administration spot, vomited, like excessive heat coming out of my body like hot flash, fell on my face, when my husband touched me it became worse I'm talking about the heat. The reporter explained on mild pain in the administration spot, but after I went to bed I woke up to use the restroom and suddenly I had blackout and fell on my face It was panicking sensation my husband rushed for help he was talking to me but I wasn't able to see him only hear his voice then I vomited and there was like excessive heat coming out of my body like hot flash , when my husband touched me it became worse I'm talking about the heat and my eyes were widely open in a scary way. Body temperature was checked with a thermometer and it was 98.1. The patient went back to bed was feeling the same blackout sensation. Consumer stated she is a healthy person in all means and never had such thing before. The patient underwent lab tests and procedures which included body temperature: 98.1 on Mar2021. No treatment was given for the events. The clinical outcome of the events Blackout, Vaccination site pain, fell on face, panicking sensation, vomited, hot flash and Feeling hot was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
38 2021-03-21 tenderness, feeling hot 24 hours after 2nd dose, chills, 30 hours fever 101, body aches, headache 12 days later hot sensiti... Read more
24 hours after 2nd dose, chills, 30 hours fever 101, body aches, headache 12 days later hot sensitive arm, 14 days 2 bumps headache fatigue 15 days several bumps and blisters. Day 19 Diagnosed with Shingles.
38 2021-03-21 bell's palsy Bell?s palsy
38 2021-03-21 pain in extremity red dots in right legs appears on that evening, right leg hurt and can't walk normally ~30 hours af... Read more
red dots in right legs appears on that evening, right leg hurt and can't walk normally ~30 hours after short, and not getting better until now. Will go to see doctor if symptoms last.
38 2021-03-22 weakness 103 .5 fever; dehydration; muscle aches; vomiting; weakness; This is a spontaneous report from a con... Read more
103 .5 fever; dehydration; muscle aches; vomiting; weakness; This is a spontaneous report from a contactable Nurse. A 38-year-old female patient (no pregnant) received 2nd dose of BNT162B2 (lot number=ENS318) Intramuscular on 03Mar2021 10:00 AM on Left arm for COVID-19 immunisation. Medical history was Fibromyalgia, allergic to insect stings and fleas. No other vaccine in four weeks. Other medications in two weeks included venlafaxine hydrochloride (EFFEXOR), gabapentin, cefixime (FLEXERIL), and hydrocodone bitartrate/paracetamol (NORCO). Historical Vaccine was 1st does of BNT162B2 (lot number=ENS 318) Intramuscular on 10Feb2021 11:00 AM on Left arm for COVID-19 immunisation. Patient experienced 103 .5 fever, dehydration, muscle aches, vomiting and weakness from 03Mar2021 06:00 PM with outcome was recovering. Events resulted in Emergency room/department or urgent care, Hospitalization (1 day). Treatment included IV fluids, Tylenol, Zofran. Drew labs which were normal. No covid prior vaccination. Covid test post vaccination: Nasal Swab Negative on 04Mar2021, PCR Result Pending. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Sender's Comments: Based on the close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported fever, dehydration, muscle aches, vomiting and weakness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-03-22 tingling Patient complaining of tingling to chest and neck, mild itching, tightness to throat with swallowing... Read more
Patient complaining of tingling to chest and neck, mild itching, tightness to throat with swallowing and sips of water, and dizziness at 10:15. Blood pressure was elevated. At 10:21, dexamethasone 4 mg was given by mouth. At 10:24, patient noted dizziness upon standing. At 10:53, patient was ambulating in the hallway without dizziness and left symptom free.
38 2021-03-22 tingling Per patient after she was monitor for 30 minutes in clinic for COVID-19 vaccine, she felt fine. Per... Read more
Per patient after she was monitor for 30 minutes in clinic for COVID-19 vaccine, she felt fine. Per patient one hour after she received the vaccine, she had tingling on left side of face that lasted for 1-2 hours and it went away. Per patient she did not follow up with her provider.
38 2021-03-22 muscle twitching, pain in extremity, nerve pain Shot was given at 2:00pm on March 21st 2021. At approx. 10:00am on March 22,2021 patient started t... Read more
Shot was given at 2:00pm on March 21st 2021. At approx. 10:00am on March 22,2021 patient started to experience involuntary leg twitching and severe pain in right leg. Pain was located at the right leg sciatic nerve, as the pain traveled from the back of the heel up to the right buttock. The twitching would occur every 1-2 mintues in 3-5 pulses up the leg. Treatment was 2 Advil every 4 hours to ease the pain. Also use of a roll on pain reliaver was applied( Icy Hot) in attept to ease the pain as well. Patient had to stay in bed during the event due to pain. At approx. 4:30am on March 23, 2021, pain and twiching stopped.
38 2021-03-22 pain in extremity, muscle spasms Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t su... Read more
Started itching a few minutes after received the shot. Felt slight shortness of breath but wasn?t sure if I was having panic attack or reaction. Took Benadryl and used inhaler and that helped. Around 2pm started having cramps as id period was on but it?s not due for a week. Took advil, it helped. Around 5:30pm severe abdominal cramps, nausea, went to bathroom several times. Arm, neck and shoulder pain. Dizziness and just feel weird. If gets worse tonight will go to ER, if same or better will call doctor in the morning
38 2021-03-23 discomfort (note: I had no reaction to the first dose) 13 hours after receiving my second dose I had been in b... Read more
(note: I had no reaction to the first dose) 13 hours after receiving my second dose I had been in bed for a couple of hours unable to get comfortable because I felt weird. That?s when my ankles and feet began to itch. I checked for mosquito bites, none were there but I noticed that my ankles and feet were swollen. I applied a lotion recommended eczema thinking my skin might be dry. Over the next hour the itching got worse and spread up my calves. That?s when I noticed that my tongue felt weird and kinda poofy. I?m used to occasional dry mouth due to my meds, but this was nothing like that. It freaked me out so I got up took Allegra hoping that on top of the Zyrtec I?d taken hours before would help. Since I was restless and desperately needed sleep I took 1/2 of a 15mg trazadone tablet. That did the trip. No itching and I was able to sleep. Now I?ve been in bed all day with flu-like symptoms, I?m miserable and I?ve missed work. Unless I awake tomorrow morning feeling magically better I?ll miss work again. The itching and swollen tongue really freaked me out, hence my report today.
38 2021-03-23 feeling hot Felt lightheaded and warm. Started to lose hearing. BP dropped 90/50's, HR 40's. Recovered in 20 ... Read more
Felt lightheaded and warm. Started to lose hearing. BP dropped 90/50's, HR 40's. Recovered in 20 mins
38 2021-03-23 feeling hot Patient felt hot and became nervous that she was going to faint.
38 2021-03-24 tingling Approx 7 hours after receiving the vaccine, my blood pressure dropped significantly. I had an overwh... Read more
Approx 7 hours after receiving the vaccine, my blood pressure dropped significantly. I had an overwhelming feeling as if I was going to pass out and had a pins & needles feeling in my face. I checked my bp and it was 102/70. Over the course of about 40 minutes it slowly went back up and was at 136/84 the last time I took it last night. I reached out to my pcp to let her know and to see if getting the second dose was safe. She confirmed she believes it was a side effect of the vaccine, but it was safe to get the second dose in 3 weeks.
38 2021-03-24 feeling hot, numbness Facial numbness - entire face. Started about 30 minutes after injection. It is better now (approxi... Read more
Facial numbness - entire face. Started about 30 minutes after injection. It is better now (approximately 5 hours later) but it is still present. A bit hot feeling now.
38 2021-03-24 feeling cold I received the vaccine at 1:10 pm in the afternoon. Around 8:30 pm I started to develop cold chills,... Read more
I received the vaccine at 1:10 pm in the afternoon. Around 8:30 pm I started to develop cold chills, body aches, cough/sore throat, headache. I felt this way Saturday, 3/20/2021 at 8:30pm until Monday, 3/22/2021 11am.
38 2021-03-24 feeling jittery I suffer from PSVT. I had an epside of rapid heart beat this morning, which isn't unusual. What was ... Read more
I suffer from PSVT. I had an epside of rapid heart beat this morning, which isn't unusual. What was unusual was: increased pain during episode, check pain after, increased heart rate (normal hear rate for me is 71, today is 91), jittery, sweaty palms.
38 2021-03-24 facial paralysis Left side of face paralyzed. Called my doctor but they can?t see me for another 2 weeks which isn?t ... Read more
Left side of face paralyzed. Called my doctor but they can?t see me for another 2 weeks which isn?t helpful
38 2021-03-24 tremor, tenderness, tingling Swelling in left neck with tenderness. Also, tingling in the left Arm with mild fatigue and tremors... Read more
Swelling in left neck with tenderness. Also, tingling in the left Arm with mild fatigue and tremors in the arm
38 2021-03-25 hot flush 20 minutes after receiving the vaccine, my face felt very hot (but I thought this was because I was ... Read more
20 minutes after receiving the vaccine, my face felt very hot (but I thought this was because I was wearing a mask and in a large room that was stuffy with a lot of people). I left the facility 10 minutes later and in the car my face felt like it was on fire. When I arrived home, my husband noted that my face was very red. I also developed itching around where my clothes were tight (bra and underwear line). I looked in the mirror and my face was erythematous with a sandpaper like rash (similar to scarlatina). I did not develop a rash in the other areas I was itchy. I took Benadryl 50 mg. The symptoms did not worsen and improved some. Since that time, my face has continued to have a rough, sandpaper like feel and is pink. Yesterday evening it became red again and I took another dose of Benadryl 50 mg. Of note, I was told by 2 different providers to go to an Urgent Care yesterday, but I did not as my symptoms are only cutaneous.
38 2021-03-25 weakness 4 days after shot, nausea, fatigue, loss of strength, body aches, chills.
38 2021-03-25 pain in extremity, tingling Feb. 3, 2021 within first 4 hours of receiving injection I began to experience restless legs. Febru... Read more
Feb. 3, 2021 within first 4 hours of receiving injection I began to experience restless legs. February 6, 2021 I experienced an out of the ordinary nosebleed. February 21, I found a bruise on my right leg. February 26, 2021 my PCP did lab work and determine on March 2, 2021 that my platelet count was 73,000. Repeated lab test on March 3 with results returning March 5 with 33,000 platelets. Had a nosebleed on March 4, 2021. Admitted to Hospital March 5 with 30,000 platelets that fell to 29,000 after being admitted. Throughout February 3-March 5, continued to experienced leg pain that included weakness and tingling in legs.
38 2021-03-25 tremor nausea, shaky. Evaluated by EMS-Cleared
38 2021-03-26 tremor Chills and tremors for 1 hour accompanied by fever. Severe headache, fatigue, and body aches lasted... Read more
Chills and tremors for 1 hour accompanied by fever. Severe headache, fatigue, and body aches lasted the entire day. Fever reached a peak of 102.8 in the late afternoon of 3/24/21. Loss of appetite. Treated fever with Tylenol, liquids and rest. Chills returned in the evening around 7pm. 3/25/21 fever began to subside with a high temp of 100.8 and was treated with Tylenol at half the prior days, dose. However pain in the left armpit began and has continued through 3/27/21.
38 2021-03-26 tremor Fever, chills, shaking, full body pain, sweating, dry mouth, headache, dizziness
38 2021-03-26 tenderness I had very little soreness after receiving first vaccination shot. Then 9 days later, I noticed my a... Read more
I had very little soreness after receiving first vaccination shot. Then 9 days later, I noticed my arm was itchy at injection site. It is rather swollen but not red or hot to touch. My arm is very sore, feels like the muscle is sore & weak. Difficult to use arm and tender to the touch.
38 2021-03-26 weakness, burning sensation Patient reports following injection,, she walked away from vaccination station to the recovery area,... Read more
Patient reports following injection,, she walked away from vaccination station to the recovery area, where she sat down and got an overwhelming urgency to use the bathroom for bowel movement. Patient reports due to weakness she did not ambulate to the bathroom and asked for help. Patient reports that she experienced "burning" sensation in the left arm and throughout torso. Patient then states that she could not stop falling asleep. Patient does not recall any events after this before arrival of public health staff.
38 2021-03-26 tingling tingling in hand & feet fingers
38 2021-03-27 pain in extremity 12 hours after injection- generalized body rash on torso, arms and legs- not on face.. Significant a... Read more
12 hours after injection- generalized body rash on torso, arms and legs- not on face.. Significant arm pain, arm pit pain. 48 hours post injection- generalize swelling of arm pit, with swelling to left pectoral and trapezoid muscles.
38 2021-03-27 pain in extremity 3/26/21 at 10pm Started with dizziness, upset stomach but no diarrhea, sore L arm 3/27/21 at 6am on ... Read more
3/26/21 at 10pm Started with dizziness, upset stomach but no diarrhea, sore L arm 3/27/21 at 6am on dizziness continues and nausea started, sore L arm 3/27/21 at 10am onset of fever at 99.8F, took Tylenol, dizziness continues 3/27/21 at 6pm fever gone, dizziness improving 3/28/21 at 7am dizziness is minimal
38 2021-03-27 pain in extremity About 10 minutes after receiving the shot I got a slight taste and a sensation in the back of my nos... Read more
About 10 minutes after receiving the shot I got a slight taste and a sensation in the back of my nose. Within an hour it moved a little lower to listen station in the back of my throat. Almost a sensation like before you would throw up but not the same. Soon after developed nausea which lasted and intensified until bed around 10pm. A sore arm that eve, but not major. Woke up feeling pretty well with just a sore arm. Developed chills and mild fever which persisted rest of that day and following day. Fever mostly around 100-100.4. Got up t0 100.6. Ear thermometer registered 101 at one point but shortly after jumped down so it seemed unreliable. On day 4 fever subsided and felt normal. On day 5, sensation in back of throat and nausea returned. No fever.
38 2021-03-28 burning sensation I had shingles 3 to 4 weeks prior to receiving my vaccine. Within 2 to 3 hours after the vaccine, I... Read more
I had shingles 3 to 4 weeks prior to receiving my vaccine. Within 2 to 3 hours after the vaccine, I felt a burning sensation on the left side of my forhead going up into my scalp and then the shingles rash appeared. I was put on antiviral medication. I also had to see an eye doctor because the shingles rash started to both my vision.
38 2021-03-28 cold sweat Racing heart very anxious Vitals Signs: B/P: 170/74 HR: 142 O2Sat:98 Skin Signs: Clammy Circulation... Read more
Racing heart very anxious Vitals Signs: B/P: 170/74 HR: 142 O2Sat:98 Skin Signs: Clammy Circulation: Delayed Resp.: Breath sounds clear bilaterally. Denies chest pain. Treatment: controlled breathing with guided imagery. Gave apple juice Reassessment: @16:12 Vitals: B/P: 138/80 (right arm) HR:134 Reassessment @16:16 B/P 132/70 HR:134 Reassessment @16:20 HR:100 O2Sat:97 Treatment: Patient D/C from triage without incident- Laughing and talking. Husband in parking lot in his own car. Pt d/c home by self.
38 2021-03-29 pain in extremity Arm soreness; headache; body aches; low fever; general fatigue; feeling of illness; This is a sponta... Read more
Arm soreness; headache; body aches; low fever; general fatigue; feeling of illness; This is a spontaneous report from a contactable healthcare professional (patient). This 38-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) on 23Feb2021 at 14:00 (at the age of 38-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included psoriatic arthritis and hidradenitis suppurativa. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included spironolactone (ALDACTONE) and women's multivitamin from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 on 27Jan2021 at 14:30 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 23Feb2021 at 23:30 the patient experienced "same as generally expected," arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness. The event were reported as non-serious. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of arm soreness, headache, body aches, low fever, general fatigue, and feeling of illness were recovering. It was also reported that since the vaccine the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
38 2021-03-29 muscle spasms Brain fog, severe headache, blurred vision, constant urination, fatigue , leg cramps, trouble breath... Read more
Brain fog, severe headache, blurred vision, constant urination, fatigue , leg cramps, trouble breathing and irregular heart beat. that have lasted since day of vaccine. Still suffering from some symptoms
38 2021-03-30 numbness, feeling cold After vaccine I felt fine waited fo r15 min monitoring. Then I started getting dizzy, felt cold go u... Read more
After vaccine I felt fine waited fo r15 min monitoring. Then I started getting dizzy, felt cold go up spine up to my arm and my arms went numb (bilateral). One of the monitor personnel stated I look really pale gave me coffee and took me to ER. My blood pressure was elevated slightly and arms was still numb started IV fluids, Benadryl stayed there for observation. Upon me being discharged arms wasn't numb for about 5 days and I was prescribed Prednisone. When i woke up on 1/23 face felt puffy took Benadryl
38 2021-03-30 burning sensation, feeling of body temperature change, discomfort, muscle spasms, tingling, cold extremities, tremor I started feeling pins and needles on my forearms/the pins and needs continued on my forearms and fe... Read more
I started feeling pins and needles on my forearms/the pins and needs continued on my forearms and feet; burning sensation began throughout my legs and arms/hot sensation on and off; muscle spasms; cold sensations on my feet; The pins and needles continued along with cold and hot sensations throughout my arms and legs; At times my arms would feel heavy; This was very painful causing my muscles to be in extreme pain; Nerves were shaky/shakiness; painful and uncomfortable; painful and uncomfortable; This is a spontaneous report from a contactable consumer (Patient), the consumer reported for herself. A 38-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at the left arm on 19Jan2021 01:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Covid test result was Negative. On 21Jan2021, started feeling pins and needles on my forearms throughout the night. On 22Jan2021 the pins and needs continued on my forearms and feet, along with cold sensations on my feet. The pins and needles continued along with cold and hot sensations throughout my arms and legs from 21January - February 4. It was painful and uncomfortable on and throughout the day and nights. At times my arms would feel heavy and achy. This amount of pain led me to go to the ER on January 31, 2021. February 5-8 pins and needles were less. On February 13- 20 burning sensation began throughout my legs and arms. On 21Jan2021, This was very painful causing my muscles to be in extreme pain that led me to go to the Emergency room once again on 20February2021. February 22-24 I felt no burning sensation, but my nerves were shaky. On February 26 in the evening and at bedtime I experienced a hot sensation on and off throughout the night along with muscle spasms on 21Jan2021. Continued to experience burning, spasms and shakiness. Due to events treatment received IV treatment Neurotins. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.
38 2021-03-31 feeling hot angioedema; lymphadenopathy, described as "very impressive swelling" at the base of neck that got in... Read more
angioedema; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; lymphadenopathy, described as "very impressive swelling" at the base of neck that got inflamed when she got hot or stressed out, causing impacts on her swallowing; This is a spontaneous report from a contactable pharmacist via Medical Information team. A 39-year-old female patient (nurse) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown, NDC number), via an unspecified route of administration at the age of 38 years on 18Jan2021 as a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization. Relevant medical history included acute lymphatic leukemia (ALL) when she was 8 years old, but had been in remission since she was 13. The patient's concomitant medications were not reported. The pharmacy manager reported that the patient, who was one of her employees at the hospital, received her second dose of the Pfizer BioNTech COVID-19 vaccine on 18Jan2021 and on an unspecified date had experienced lymphadenopathy afterwards that was still ongoing. The reporter described it as "very impressive swelling" at the base of neck that got inflamed when the patient got hot or stressed out, causing impacts on her swallowing. The reporter stated that the patient had gone to the emergency room twice, where it had been described as angioedema on an unspecified date and had also seen an allergist, who described it as a "robust immune response." The reporter was concerned about the ongoing nature of this lymphadenopathy and would like any information that would help to treat this. The reporter also stated that the patient had gone through "medical procedures and computerized tomography (CT) scans" with unknown results on an unspecified date and would like to know if the patient would be eligible for the Program because of the event. The patient was in the group that got the vaccine first. The patient still had impressive lymphadenopathy and it was persisting. At first it was interfering with the patient's swallowing, but it was still occasionally interfering with her swallowing. The reporter was wondering if there was any more in house data that had been reported on this. The reporter assessed the events as non-serious. Therapeutic measures were taken as a result of angioedema, which included that the patient had been prescribed antihistamines, such as cetirizine (ZYRTEC), fexofenadine (ALLEGRA), hydroxyzine, famotidine (PEPCID), and methylprednisolone (MEDROL) dose packs. The patient was not recovered from the event "lymphadenopathy," while the outcome of the rest of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of angioedema, lymphadenopathy and other events due to temporal relationship. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-04-01 tenderness, pain in extremity Right arm pain, pain under right armpit, tender to the touch, headache
38 2021-04-01 tingling blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordi... Read more
blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordinary nosebleed; restless legs; tingling sensations in my legs; This is a spontaneous report received from a physician (also the patient). A 38-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 08:30 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a workplace clinic. The patient medical history includes: Graves Disease, Lupus, O- Blood, RH-, allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at time of vaccination. Concomitant medication (reported as any other medications the patient received within 2 weeks of vaccination) included gabapentin taken for an unspecified indication, start and stop date were not reported. It was reported that (reported as within first 4 hours of vaccine) on 03Feb2021, the patient experienced restless legs. On 06Feb2021, the patient experienced an out of the ordinary nosebleed. From then until 21Feb2021, the patient would experience tingling sensations in my legs and then on 21Feb2021 found a bruise on right leg near knee. On 26Feb2021 blood work revealed platelet count 73,000; 03Mar2021 blood work revealed platelet count 33,000 (results received on March 5), significant nosebleed on 04Mar2021, hospitalized with 29,000 platelet count on 05Mar2021. The outcome of the event tingling sensations in my legs was recovered on 21Feb2021; for all other events was recovering. The treatment received was a steriod IV. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 4 days (from 05Mar2021 to 09Mar2021).; Sender's Comments: A causal relationship cannot be completely excluded between BNT162B2 injection and serious reported events only due to close chronological sequence. Other evidence or argument supporting a causal relationship cannot be established, so far. Otherwise, multi-morbid current conditions, and concomitant medication may have played as contributory factors to the serious reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
38 2021-04-02 tingling, feeling hot Pain heightened; limbs she feels a little tingle/tingle in her face/face tingling; in her face, ther... Read more
Pain heightened; limbs she feels a little tingle/tingle in her face/face tingling; in her face, there is the warmth; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:01 (Batch/Lot Number: EN6281), at the age of 38-years at vaccination, as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing Low blood pressure, she has this about 8 months, ongoing impaired Gastroparesis,had this about 2 years and takes medication for it, nerve damage in her stomach also, it is to stop abdominal cramping . Concomitant medications included amitriptyline taken for nerve injury, abdominal pain from 29Jan2021 and ongoing. The patient said she had a nerve damage before getting the COVID vaccine shot. She noticed that after getting the first dose of the vaccine the pain heightened, wanting to know if we have information regarding this. She feels the shot has exacerbated the feeling. In her limbs, she feels a little tingle and in her face, there is the warmth she associates with the nerve damage. She is wondering if this is this something we have seen happen. The caller confirms that the first dose was given at 9:01am. The tingling started about 5-10 minutes after the dose was given. It is basically in the face, that is where she notices it the most. The prior nerve damage is on her right side from the top of head to her hip. She explains that right now she mostly noticed in the face tingling and it is about the same since it started. In her legs, they was a little tingle when walking out, after the 15 minutes. This was in both legs and it is still there but she doesn't notice this as much since she has just been sitting there. The outcome of the events was unknown.
38 2021-04-09 numbness, tingling Blurred vision/focus issues/can't focus visually/couldn't see right; floaters; left arm and leg went... Read more
Blurred vision/focus issues/can't focus visually/couldn't see right; floaters; left arm and leg went numb; Both arms and legs tingly; felt disoriented; cold chills; Legs and arm felt heavy; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; my eyes are now having esophoria convergence Excess or vergance dysfunction; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Left arm on 18Mar2021 11:45 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to Penicillin and no other medical history. The patient had no COVID prior vaccination. The patient was no pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ALLERTEC); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D). There was no vaccine in four weeks. The patient stated that right after she drove off, Blurred vision/floaters, left arm and leg went numb. Both arms and legs tingly, felt disoriented, cold chills, had to pull the car over because she couldn't see right. Legs and arm felt heavy. Blurred vision & focus issues had continued and the eye doctor said her eyes were now having esophoria convergence Excess or vergance dysfunction. She still can't focus visually since she drove off from the vaccine. She had to go to the doctor today & they were going to schedule a neurologist appointment to make sure she didn't have a mini stroke. It had been extremely scary since she received it. All events occurred on 18Mar2021 12:00 AM. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events and she needed glasses with a prism and neurologist appointment. The patient had no COVID tested post vaccination. The outcome of the events was not recovered.
38 2021-04-09 tremor Fever; chills; uncontrollable shaking; itching at injection site; pain in injection site; cellulitis... Read more
Fever; chills; uncontrollable shaking; itching at injection site; pain in injection site; cellulitis in right arm; Pregnant patient; This is a spontaneous report from a contactable consumer. A 38-year-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 38-years-old via an unspecified route of administration, administered in arm right on 25Feb2021 23:30 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and alprazolam (XANAX), both taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to Bactrim. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on the right arm on 05Feb2021 (lot number: EM9810) 11:00 for covid-19 immunisation. The patient experienced cellulitis in right arm, fever, chills, uncontrollable shaking, itching at injection site and pain in injection site on 26Feb2021 08:00. The mother reported she became pregnant while taking bnt162b2 on 25Feb2021 23:30. The mother was 6 Weeks pregnant at the onset of the event. The mother was due to deliver on 28Oct2021. Last menstrual period was on 15Jan2021. Therapeutic measures were taken as a result of the events which included treatment with cefalexin. The outcome of maternal exposure during pregnancy was unknown while the patient was recovering from all of the other events.
38 2021-04-09 numbness headache; blurred vision; couldn't stand without assistance; a band of numbness and tightness in my ... Read more
headache; blurred vision; couldn't stand without assistance; a band of numbness and tightness in my right arm that migrated down my arm from the site of the vaccination all the way to my wrist; a band of numbness and tightness in my right arm that migrated down my arm from the site of the vaccination all the way to my wrist; The site of injection also became very sore; a band of vice-like grip appeared around the lower part of my head, near my jaw, and it migrated up my head until it settled around my temples and eyes; faintness; strong vasovagal response; narrowing field of vision; rushing sound in ears; dizziness/severe dizziness; nausea; This is a spontaneous report from a contactable consumer (patient) reported for self. A 38-year-old female patient (not pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 at 16:30 (Lot number: EP7533) on the right arm at single dose for COVID-19 immunization. Medical history included chronic lyme disease, hypothyroidism, allergies to cephalosporin antibiotics. Concomitant medications included levothyroxine, metronidazole, sertraline, clonazepam (KLONOPIN); that all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnosis with covid-19 and patient had not been tested for covid-19 since the vaccination. Patient experienced a strong vasovagal response within 30 seconds of receiving the dose with narrowing field of vision, rushing sound in ears, faintness, dizziness, nausea; all of these symptoms improved after lying on the floor for 15 minutes. 2 hours later, a band of vice-like grip appeared around the lower part of patient head, near patient jaw, and it migrated up patient head until it settled around patient temples and eyes. The patient developed a headache, blurred vision and severe dizziness such that he couldn't stand without assistance. Patient also felt a band of numbness and tightness in his right arm that migrated down his arm from the site of the vaccination all the way to his wrist. The site of injection also became very sore. There was no treatment received for the adverse events. The outcome of events was recovering.
38 2021-04-13 pain in extremity Lethargy, impaired cognitive function began on 3/29. By the morning of 3/30, the lethargy and cogni... Read more
Lethargy, impaired cognitive function began on 3/29. By the morning of 3/30, the lethargy and cognitive function is back to normal. Slight headache, low fever and slight chest pain began. Felt better by the afternoon of 3/30 once I took ibuprofen. That evening at approximately 7 pm, I noticed my heart rate was high. My resting HR is about 70, but my HR was at 125 - 130 and I was not exerting myself and was sitting. My HR remained high after I went to bed, and chest pain became worse. By 12:30 am on 3/31, chest pain was getting severe and had pain in both arms. Went to ER at around 3 am on 3/31. Later learning I had a mild heart attack. Had EKG, Blood work, ECG, and Heart Catheritazion. No blockage and normal results except blood work. Blood work showed elevated enzymes. While in the ER, I was given blood thinner and glycerin tablets, aspirin. Since 4/2, my heart rate and blood pressure have returned to their norm without medication. I once again have perfect blood pressure readings and perfect HR. I have returned to normal daily activities as of 4/4.
38 2021-04-17 feeling cold fever started. 4:30AM - fever so high I thought I could fry an egg on the tops of my thighs; chills ... Read more
fever started. 4:30AM - fever so high I thought I could fry an egg on the tops of my thighs; chills began as I got into bed; quite cold and shaky; quite cold and shaky; Heart rate hit 100 just lying in bed; lethargy; headache; feeling slightly tired but functional; Sweaty all day; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EP7534, second dose) solution for injection intramuscular in the left arm on 20Mar2021 at 08:15 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history dyshidrotic eczema, rosacea, severe seasonal allergies (grass, tree pollen, etc), oral allergy syndrome ((raw tree-based foods, sensitive to nickel, sensitive to some nuts (almonds)), cholesterol tends to be high but is managed and sensitive to nickel. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), biotin, polycarbophil calcium (FIBER) and FLO PMS vitamin. Historical vaccine included BNT162B2 (first dose, lot EN6198, administration time 08:15AM, vaccination location: left arm) for COVID-19 vaccination on 27Feb2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Mar2021 at 23:30, the patient had fever started, chills began as got into bed, quite cold and shaky, heart rate hit 100 just lying in bed, lethargy, headache, feeling slightly tired but functional. On 20Mar2021, the patient was sweaty all day. At 4:30AM on 21Mar2021, the fever so high I thought I could fry an egg on the tops of my thighs. Lab tests included BMI of 32 at time of shot (2021). Cholesterol tends to be high but was managed on an unknown date. There was no treatment for the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness. The outcome of the events fever, chills, coldness, shaky, heart rate increased, lethargy, headache, sweaty, and tiredness was recovered on 23Mar2021. Since the vaccination, the patient has not been tested for COVID-19. Follow-up needed; further information has been requested.
38 2021-04-18 numbness and pain in extremities, numbness I developed numbness that started in my toes which gradually progressed up my legs and then into my ... Read more
I developed numbness that started in my toes which gradually progressed up my legs and then into my hands. This course progressed over a period of 5-6 days. I was initially seen at the Medical Center on 2/8/21 in the ER. Neurology was consulted for my symptoms, suspecting sensory/small fiber acute inflammatory demyelination process such as Gillian Barre Syndrome. At that time, other than the sensory changes, I did not have weakness or ataxia/gait instability, so I was sent home from the ER. The following day, while I was at work, I had some difficulty with my balance. I had spoken to my Neurologist, and decision was made for a direct admission for IVIG treatment. I was admitted to the Medical Center on 2/9/2021 for a 2 day course of IVIG (receiving a total of 2g/kg dose over the two days). I was d/c from the hospital on 2/11/2021. I did not require any rehabilitation and was discharged home. Following discharge, I developed painful neuropathy in my feet, and was started on Pamelor for treatment. Due to side effects of the medication, I was switched to Cymbalta which is what I am on now for neuropathic pain. I continue to have numbness in my hands and feet, but it has not continue to progress at this time.
38 2021-04-21 numbness, tingling For 2 weeks following the second dose of Pfizer I experienced severe adverse reactions: dizziness, v... Read more
For 2 weeks following the second dose of Pfizer I experienced severe adverse reactions: dizziness, vertigo, headaches, Paresthesia (tingling and numbness in hands, feet, arms, and legs), nausea, slow digestion, loss of appetite, extreme fatigue (I could not perform any kind of daily activity for several days). I have been admitted to the ER twice over the 2 weeks. After undergoing multiple exams (ultrasound, detailed blood tests, MRI, CT scan), nothing major was found. My doctor prescribed antisthamine for dizziness and nausea. The symptoms have subsided since then.
38 2021-04-21 tingling, numbness Swollen arms and hands, Numbness pins and needles whole body over first two days, Swollen Numb Face ... Read more
Swollen arms and hands, Numbness pins and needles whole body over first two days, Swollen Numb Face off and on. First 2 days. Face felt like hives but never surfaced. Itchy Red Eyes, body aches, fever/chills, joint pain, nausea, Blurry vision twice the first 2 days lasted briefly. euphoria. Off work for 3 days felt back to normal after 6 days. Traveled Dec end of 2019. Returned with bad Cold out of work for a week +
38 2021-04-22 flushing Complained of lips burning, flushing, tingling to lips. 50 mg Oral Benadryl given. Symptoms dissipa... Read more
Complained of lips burning, flushing, tingling to lips. 50 mg Oral Benadryl given. Symptoms dissipating Taken home by daughter
38 2021-04-28 tingling Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
38 2021-04-28 nerve pain, night sweats anxiety; night sweat; fatigue/extremely fatigued; nerve pain; body aches; had a slight ringing in my... Read more
anxiety; night sweat; fatigue/extremely fatigued; nerve pain; body aches; had a slight ringing in my ear; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in right arm on 25Mar2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included post viral syndrome (chronic fatigue), dry eye, known allergies included lactose intolerance and had adverse reactions to Botox. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications in two weeks included Vitamin B, D, Magnesium, zinc, copper, omega 3. No other vaccine was received in four weeks. On 25Mar2021 (pending clarification) by 2am the patient woke up with a horrible anxiety and night sweat. Evening two the patient had some fatigue, evening three I had a flare up of nerve pain and body aches, same issues night four. By night five the patient felt like her entire body was on fire with nerve pain. Day six on 30Mar2021 the patient was extremely fatigued and had a slight ringing in her ear that remained. The patient slowly regained her strength and functioning. The events resulted in "Doctor or other healthcare professional office/clinic visit, Disability or permanent damage". No treatment was received for events. The outcome of events was recovering. Information on the lot/ batch number has been requested.
38 2021-04-28 weakness runs of Brady; B/P shooting through the roof.; Tachycardia; shortness of breath; wheezing; extreme w... Read more
runs of Brady; B/P shooting through the roof.; Tachycardia; shortness of breath; wheezing; extreme weakness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient reported for herself that she received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route in the left arm on 29Mar2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included fibromyalgia. Allergies to medications, food, or other products included cefazolin (ANCEF), penicillin, and bandage tape. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included pregabalin (LYRICA) for fibromyalgia and BalanceMD (candida supplement). On 31Mar2021 at 09:00, the patient experienced runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof. These events resulted in emergency room/department or urgent care via squad hospital transport and were reported as non-serious. There was no treatment received for runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof. The clinical outcomes of runs of brady and tachycardia, shortness of breath, wheezing, extreme weakness, and blood pressure (B/P) shooting through the roof was recovering. Since the vaccination, the patient has not been tested for COVID-19.
38 2021-04-29 pain in extremity I received my vaccine around 10:00 a.m. Over night, I was sore on my arm, shoulder, neck, and chest ... Read more
I received my vaccine around 10:00 a.m. Over night, I was sore on my arm, shoulder, neck, and chest on the side that I received my vaccine. When I woke up in the morning, my lymph node under my arm pet on the vaccine side was swollen and sore. 2 days later, it seems to be getting smaller.
38 2021-05-04 seizure demyelination with brain inflammation; demyelination with brain inflammation; seizures; Fever; 2 sei... Read more
demyelination with brain inflammation; demyelination with brain inflammation; seizures; Fever; 2 seizures fever vomiting and demyelination with brain inflammation; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 01Apr2021, 06:45 PM, at 38-year-old. Medical history included: diabetes and hypertension; known allergies: penicillin. No other vaccine in four weeks and no other medications in two weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on unknown date, 06:45 PM, at 38-year-old. On 02Apr2021, the patient had 2 seizures, fever, vomiting and demyelination with brain inflammation. Emergency room/department or urgent care visited and hospitalization for 10 days. Treatment included: plasma exchange, steroids, fluids and IV antibiotic. Lab data included: negative COVID test on 02Apr2021. Outcome of the events was resolving. Information about lot/batch number has been requested.
38 2021-05-04 facial pain, numbness developed pain in the left side of cheek, feels as if someone has slapped in the face. there is mild... Read more
developed pain in the left side of cheek, feels as if someone has slapped in the face. there is mild numbness as well. eating/talking or touching my face reproduces the pain.; developed pain in the left side of cheek, feels as if someone has slapped in the face. there is mild numbness as well. eating/talking or touching my face reproduces the pain.; This is a spontaneous report from a contactable physician reported for herself. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history was none. Patient was not pregnant. The patient's concomitant medications were not reported. On 30Jan2021 at 19:00, patient developed pain in the left side of cheek, it felt as if someone had slapped her in the face. There was mild numbness as well. It got worse towards the end of the night. Eating/talking or touching face reproduced the pain. Patient had not been ill or taken any medications since the vaccine and was in good health. No prior symptoms such as this. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events was reported as unknown. Outcome of the events was not resolved. This case was reported as non-serious. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
38 2021-05-04 feeling of body temperature change dizzy; having a hard time to breathe; hard to control walking; kept going from cold and hot; This is... Read more
dizzy; having a hard time to breathe; hard to control walking; kept going from cold and hot; This is a spontaneous report from a contactable consumer (patient's husband). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Apr2021 10:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for Covid-19 immunization. Around 19:00 on 18Apr2021, patient was dizzy, having a hard time to breathe, hard to control walking and kept going from cold and hot. Caller stated they put ice on her head, she took ibuprofen and they put two to three pillows on her head to help her breathe. Outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
38 2021-05-07 pain in extremity, cold extremities, numbness, tremor swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirs... Read more
swollen tongue; joint pain; inability to feel my right hand.; hands were very cold and clammy; thirst; trembling; arm soreness; I felt instantly dehydrated; had difficulty swallowing and breathing; had difficulty swallowing and breathing; throat tightness; This is a spontaneous report from a contactable consumer. A 38-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EW170 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 19:45 (at the age of 38-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism. Concomitant medication included levothyroxine sodium 75mg. The patient was not pregnant at the time of vaccination. It was unknown whether patient had any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Apr2021, 20:00, after inoculation of the 1st dose of the Pfizer COVID 19 vaccine, 'I felt instantly dehydrated, had difficulty swallowing and breathing'. After 30 mins, she felt a little better and went home. At about 21:30 she was able to breathe adequately but had throat tightness and arm soreness. The following day, at around 19:00, her symptoms re-occurred, only more seriously. She felt again swelling of her tongue, throat tightening, difficulty breathing, thirst, joint pain/trembling and inability to feel my right hand. Her hands were very cold and clammy. She sought emergency help at the Emergency room. The patient received treatment- decadron, benadryl, Pepcid. The seriousness of the event was considered as serious hospitalization by reporter consumer. Outcome of the events was unknown. Follow up needed, further information has been requested.
39 2020-12-31 discomfort About 45 mins to an hour of receiving the vaccination , i felt a terrible pounding headache, I took... Read more
About 45 mins to an hour of receiving the vaccination , i felt a terrible pounding headache, I took Tylenol ES 500mg after felt relief but decided to sleep early. When I woke up this morning my injection site arm felt so painful and heavy and i had fevers between 103-101.5 though I took some tylenol 500mg every 6 hours. Tachycardic between 140-120bpm, i still have terrible headache, muscle & joint pains, extreme fatigue. Some dry cough but no shortness of breath.
39 2020-12-31 weakness Severe Headache for 3 days, chills weakness and fevrerish
39 2021-01-01 cold sweat, weakness Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diapho... Read more
Covid Pfizer vaccine dose one on 12/21/20 - at 18 minutes post vaccination, globus sensation, diaphoresis, neuropathic crawling all over scalp, loss of consciousness, heart rate 35 bradycardia event. Responders said I was out for a minute or so then regained consciousness. Pupil dilation during event per responders. ICU MD responder states no radial pulse but had carotid pulse which was weak at initial loss of consciousness. Given fluids. Blood pressure normal during fluids. Improved heart rate without tachycardia. Had recurrence of clammy hands, globus sensation with frequent swallowing/throat clearing about 30 minutes after initial event while still receiving fluids. No airway compromise or stridor. Received PO Benadryl 25 mg. Transferred to ER for monitoring for an additional 90 minutes with complete resolution of globus sensation about 30 minutes after Benadryl. Fatigue and weak post event.
39 2021-01-02 hot flush, pain in extremity, difficulty speaking 23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat, horse voice... Read more
23rd: hot flash/sweating within 15 minutes of receiving vaccine, Sore am, itchy throat, horse voice; 24th: sore arm, headache, fatigue, congestion; 25th: headache, nausea, fatigue, congestion. 26th through today - daily Headache w/nausea (OTC's not helping headaches).
39 2021-01-02 numbness Face became numb 25 minutes after vaccine administered. Relief came the next morning 12/22/2020, 07... Read more
Face became numb 25 minutes after vaccine administered. Relief came the next morning 12/22/2020, 0700.
39 2021-01-03 night sweats 2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dr... Read more
2 hrs post injection sudden onset of severe dry mouth that lingered but gradually resolved. Still dry next morning and a couple hrs later it switched to increased salivation. The evening after injection I had a headache and just felt general malaise and fatigue, "run down". Difficulty sleeping that night due to body aches. HEadache, neck and lower back pain. Skin sensitivity when touched, bed sheets kinda hurt my skin. The bodyaches and malaise persisted through out day 2. Tylenol seemed to help. I slept better that night but woke up with night sweats, completely drenched. Arm pain at injection site on day 2 that resolved by mid day. Now 1 week later I have extreme fatigue yesterday and today. I do have hypersomnia but not even my adderall is helping. Not sure if this is related or not.
39 2021-01-03 weakness Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder an... Read more
Around 24 hours post COVID vaccination into her left delt, she woke up with severe left shoulder and neck muscle pain. She got in touch with her provider and was treated with valium and Celebrex. She reported about 2 cm swelling and fatigue. Thirty hours post vaccination, she had pain and swelling and could barely move. Dr. needed to take valium and Celebrex though for those 48 hours, and would have gone to the ER if they had not helped (the pain was that debilitating)
39 2021-01-03 tingling Erythema, swelling, warm to touch, around injection site. "tingling down arm to metacarpals per pat... Read more
Erythema, swelling, warm to touch, around injection site. "tingling down arm to metacarpals per patient"
39 2021-01-03 flushing I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75b... Read more
I developed immediate flushing, sweating, rapid heartbeat (was around 110bpm, is normally around 75bpm), and lightheadedness. I sat down and had a few sips of water. Within a few minutes, I felt like I was having a difficult time getting a good breath in. I raised my hands over my head and took slow deep breaths to try and keep my breathing under control. I stayed at the hospital for about 45 minutes, over which time I had a few bites to eat and some water. The flushing and sweating resolved within that time. The lightheadedness and "feeling of doom" lasted about 3 hours. I had no anxiety going into this vaccine, nor have I had a reaction like this before.
39 2021-01-03 tingling, numbness I got the vaccine in my right arm. About 30 min after the vaccine, I started feeling numbness/tingli... Read more
I got the vaccine in my right arm. About 30 min after the vaccine, I started feeling numbness/tingling in my right jaw/mandible area that spread behind my ear. Over about an hour or 2 I could feel the numbness/tingling/strange sensation move across the top of my right lip and into my right nostril. I took benadryl and it seemed to stop the spreading but the strange sensation stayed on the right side of my face for about 4 days afterwards.
39 2021-01-03 muscle spasms, numbness, cold extremities Reported lump in her throat and coolness of left arm which was treated with Benadryl 25 mg po; HR=84... Read more
Reported lump in her throat and coolness of left arm which was treated with Benadryl 25 mg po; HR=84 and BP=128/88; then had severe cramping in right leg with foot numbness; patient transported to the Emergency Department
39 2021-01-03 tingling, muscle spasms, numbness and pain in extremities Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Sever... Read more
Tingling in lower legs- neuropathy like; Fever 102.9; Tingling in lower legs- neuropathy like; Severe cramping in hands and feet; Severe bone pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine) lot no: EL0140, via an unspecified route of administration in left arm on 18Dec2020 15:15 at a single dose for COVID-19 immunization. Medical history included acid reflux and known allergies to PCN, both from an unknown date and unknown if ongoing. The patient was not pregnant at the time of report. Concomitant medication included omeprazole (PROTONIX), ibuprofen (MOTRIN). No other vaccines were administered in four weeks. On 19Dec2020 at 14:30, the patient experienced fever 102.9 "normal for vaccines i know", tingling in lower legs neuropathy like, severe cramping in hands and feet, and severe bone pain. The patient recovered from the events in Dec2020. The patient did not receive treatment for the events. The events were reported as non-serious. The patient didn't have COVID prior to vaccination and was not tested post vaccination.; Sender's Comments: A possible causal association between administration of bnt162b2 and the onset of neuropathy like cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-03 pain in extremity arm pain
39 2021-01-03 pain in extremity, numbness injection was administered into left joint and not intramuscular. symptoms included nerve intrapme... Read more
injection was administered into left joint and not intramuscular. symptoms included nerve intrapment for 3 days with severe pain in the left arm, extending into the wrist. muscles weakness, numbness into the thumb , index and middle finger. Inability to raise arm. pain persists today
39 2021-01-03 muscle twitching, pain in extremity, numbness noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and ... Read more
noticed twitching in L arm shortly after receiving vaccine, numbness , weakness and pain in arm and shoulder girdle, diagnosed with parsonage turner syndrome by neurologist, currently taking neurontin for pain as steroids not tolerated
39 2021-01-04 nerve pain 48 hours after covid vaccine, acute onset neuralgia - nerve pain involving entire body (had shingles... Read more
48 hours after covid vaccine, acute onset neuralgia - nerve pain involving entire body (had shingles 1 year ago - same type pain but this time head to toe, comes and goes but consistent).
39 2021-01-04 pain in extremity Fever of 100.2, chills, fatigue, sore arm
39 2021-01-04 numbness I began experiencing tachycardia and numbness in my hands and feet.
39 2021-01-04 pain in extremity I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate ... Read more
I had arm soreness from the time of injection to the next few days, Saturday morning I had moderate tiredness and body aches and headaches that were really bad until the 23rd that was sporadic. I felt feverish malaise really bad headache and body aches. I took Tylenol and Advil around the clock. on the 20th I also had very mild runny nose for 2 days. I went to get a covid test on the 23rd and it was negative. Symptoms resolved by the 25th I had no symptoms
39 2021-01-04 tingling, cold extremities, cold sweat Pfizer-BioNTech COVID-19 Vaccine EUA I recieved the vaccine at 0800 on 1/2/21. By 1430 I started fe... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA I recieved the vaccine at 0800 on 1/2/21. By 1430 I started feeling tired with some chills. By 1700, I was having nausea and vomiting. I woke the next day (1/3) around 0700 still having nausea, but also my hands and feet were very cold and my arms and legs were cold and clammy. This continued throughout the day. It is now 1/5 and I'm still having some nausea and my extremities are still cold and will sometimes tingle.
39 2021-01-04 tenderness about 1 week after first shot, develop hard lumps on clavicle (same side as shot given). site very ... Read more
about 1 week after first shot, develop hard lumps on clavicle (same side as shot given). site very painful and tender. determined to be swollen lymph nodes caused by vaccine.. Currently lumps have decreased in size and no pain.
39 2021-01-04 hot flush, numbness burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had ho... Read more
burning of eyes; hot flashes followed by rigors; severe muscle pain; For hrs post injection I had hot flashes; skin pain; joint pains; numbness of the whole arm; site pain; Headaches; low grade fever; This is a spontaneous report from a contactable nurse (patient). A 39-years-old female patient (no pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot Number: EJ1685, Expiration Date: 31Mar2021), via an unspecified route of administration in left arm on 28Dec2020 09:00 at single dose for COVID-19 immunization. Medical history included obesity, asthma, hypothyroidism, vitamin D deficiency, multiple tendonitis, allergies to horses, cats, and dogs and the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medication included mometasone furoate (ASMANEX), colecalciferol (VITAMIN D), levothyroxine sodium (SYNTHROID) and hydroxychloroquine, all received within 2 weeks of vaccination. The patient stated for hours post injection she had hot flashes but the worst was 12hrs after. She experienced severe muscle pain/ skin pain, joint pains, burning of eyes, Headaches, low grade fever, site pain, numbness of the whole arm, hot flashes followed by rigors. The events started on 28Dec2020 21:00. Treatment received for the events included Tylenol. The events were reported as non-serious. The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.
39 2021-01-04 tremor developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous... Read more
developed a severe tachycardia with no other symptoms.; was nervous and kind of shaking; was nervous and kind of shaking; Allergic reaction; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), intramuscular in the left arm on 24Dec2020 at 08:00 AM in the hospital at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination, has no known allergies, had no other medications in two weeks, and did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. At 3:00 PM of 24Dec2020, the patient developed a severe tachycardia with no other symptoms. She walked herself to the ER (Emergency room/department or urgent care), was nervous and kind of shaking. By the time they got to her, her heart rate was stable and was at 88. Transient tachycardia was at around 120-140 for 7 minutes and resolved with no intervention. Basic labs came back normal. She got discharged from the ER. The patient didn't think they reported it but she was willing to cooperate in any way. The patient was not treated for the adverse events. As per the patient, she reported her adverse reaction (after the 1st dose) on the website as recommended. She experienced "very fast heart beat 8 hours after receiving the vaccine". The patient was inquiring if she would be contacted after. The patient also asked if the very fast heartbeat was related to the vaccine because the reaction did not happen right away like usual, she was not sure if it was an allergic reaction since it happened 8 hours later. Outcome of the event 'Tachycardia' was recovered in Dec2020, while for the other events was unknown. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
39 2021-01-04 feeling cold feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 1... Read more
feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 100; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 vaccine. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient was feeling really dizzy, and it started maybe like 5 to 7 minutes after received it, and patient laid in a room and blood pressure was kind of high and patient was feeling chills and little cold and pulse was like 100. Treatment in response to the adverse events included fluids just like water and juices. Patient drank like 2 or 3 juices and a bottle of water and laid down in the bed at the hospital probably for about an hour. Due date for next shot for patient was 12Jan2021. Outcome of events was unknown.
39 2021-01-04 numbness, tingling in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm... Read more
in the arm where she received the shot, her hand and wrist go numb with pins and needles; in the arm where she received the shot, her hand and wrist go numb with pins and needles; her arm is sore; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration (left arm) on 20Dec2020 06:00 at single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other vaccine administered on same date of the Pfizer vaccine. The patient reported that she had the vaccine on Sunday (20Dec2020) and had a side effect that she didn't see listed. She stated that in the arm where she received the shot, her hand and wrist go numb with pins and needles, it was getting progressively less. She added that her arm is sore, but she expected that. She further stated that last night it just happened one time and it feels a lot better now. The patient asked if those were an expected side effect. The patent clarified that she received the COVID 19 vaccine on 20Dec2020 0600 in the left arm. On 21Dec2020 in the night at 0200 she woke up with pins and needles in her hand and wrist. It happened only when she was asleep and not moving her arm. She added that actually she feels it very faint off and on in the day but each night it has improved. She further clarified that the pins and needles are in her lower arm and wrist radiating up the arm. She added that she will be scheduled for the second dose. The outcome of event vaccination site pain was unknown, while the outcome of other events was recovering.
39 2021-01-05 feeling hot, weakness, flushing 10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness... Read more
10 MINUTES after the injection, I became very hot and flushed, with headache, palpitations, weakness, and shortness of breath. I sat down, my heart rate was 110 on my I watch. I was breathing heavy and feeling sweaty. The healthcare providers had me lie down on a stretcher and gave me oxygen with my feet elevated. After about 20 minutes, I felt better. Later that day, I came home and slept for 2 hours. The next day, (today) I came home early from work because I feel very tired and having difficulty concentrating. But the other symptoms have gone away.
39 2021-01-05 inability to speak Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, hea... Read more
Approximately 3 days after initial injection, experienced significant brain fog, aphasia, panic, headache, dropping things.
39 2021-01-05 tingling, numbness Associate began to c/o hand numbness to left arm with fingers tingling. 1135: 183/98 BP, HR 68, Oxy... Read more
Associate began to c/o hand numbness to left arm with fingers tingling. 1135: 183/98 BP, HR 68, Oxygen 100% on room air. 1140: BP 179/111, HR 79, oxygen 100% 1145: BP 160/104. HR 72. Oxygen 100. Associate states numbness has resolved and to followup with her PCP about elevated BP and numbness.
39 2021-01-05 pain in extremity Dizziness, NauseaVomiting, Arm soreness
39 2021-01-05 weakness, flushing blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular ... Read more
blood pressure went up to 150/101; feeling like fainting; feeling really tired; Weakness; irregular heart beat; sob; feeling like flushing in the body; chills; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on the left arm on 30Dec2020 07:15 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, depression, cardiac murmur and pvc. The patient hadno known drug allergies and had not tested for COVID-19 prior and after vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID), ergocalciferol (VITAMIN D), tocopherol (VITAMIN E) and sertraline hydrochloride (ZOLOFT). The patient experienced weakness, irregular heart beat, feeling like fainting, sob, blood pressure went up to 150/101, feeling like flushing in the body, chills, feeling really tired, all on 30Dec2020 07:15. The patient received treatment. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "blood pressure went up to 150/101" with BNT162b2 can not fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-01-05 pain in extremity extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left ar... Read more
extreme soreness at injection site; GI upset; sleeplessness; mild fever; pain radiating down left arm and up to behind left ear; pain radiating down left arm and up to behind left ear; neck tightness; mild headache; This is a spontaneous report from a non-contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at left arm on 29Dec2020 10:30 at single dose for Covid-19 immunization in a hospital facility. Medical history included hypothyroid, PCOS (polycystic ovarian syndrome), sulfa allergies. Concomitant medications included unknown medications. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. On 29Dec2020 13:00, the patient experienced extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild headache. The patient has not been tested for Covid-19 since the vaccination. The patient did not receive treatment for the events. The outcome of the events extreme soreness at injection site, GI upset, sleeplessness, mild fever, pain radiating down left arm and up to behind left ear, neck tightness, mild head ache was recovering. The reporter considered the events non-serious; did not results in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and no congenital anomaly/birth defect. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
39 2021-01-06 weakness (1/5/21 at 3:45pm) About 20 minutes after the vaccination I felt weak and with a headache, for the ... Read more
(1/5/21 at 3:45pm) About 20 minutes after the vaccination I felt weak and with a headache, for the rest of the day. (1/6/21) It was my day off, I was still weak and headache I took Tylenol for the pain. (1/7/21) About 3:00 am I had a lot of headache I got up and took 2 Tylenols,the pain continued but more bearable I went to work at 6am always with a headache and feeling weak. From work they sent me home so that I could take the Covid Test, and also do this report.
39 2021-01-06 migraine 1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week... Read more
1st night severe rash over torso, arms, and face. 2 days later vomiting and diarrhea. The whole week after vaccine horrible migraines.
39 2021-01-06 flushing, throat numbness, tremor Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and m... Read more
Approx 2 minutes after injection I felt warm, flush, tachycardic, dizzy, my hands were shaking and my throat felt numb and a little swollen. I was still able to swallow and symptoms did improve after 15 minutes.
39 2021-01-06 weakness Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11... Read more
Dizziness and weakness - lasting approximately 45 minutes. Slight dizziness continues now (approx 11am) but is subsiding, but continues. Pfizer's information sheet said this may be a sign of an allergic reaction. No medical follow up seems necessary right now, but important to report.
39 2021-01-06 numbness Felt sharp pain under jaw, then facial numbness. Then quickly developed facial swelling, left eye sw... Read more
Felt sharp pain under jaw, then facial numbness. Then quickly developed facial swelling, left eye swelling and tongue swelling. Then felt like throat closing up within 7 minutes of receiving vaccine. Received vaccine in the clinic, was transported to Emergency Room. In ER received Epinephrine, steroids, Benadryl and Pepcid.
39 2021-01-06 flushing I am not sure if this was a result of the vaccine or not and am trying to be helpful! I woke up 1/4/... Read more
I am not sure if this was a result of the vaccine or not and am trying to be helpful! I woke up 1/4/2020, feeling nauseous. I vomited about 6 times that day and had diarrhea. Next morning, my face was flushed. I had a low grade fever of 99.5, and checked my BP. On my home machine, my pulse was 135. I decided to go to the hospital. My Apple Watch measured my heart rate to be 150 at one time. At the ER, I was diagnosed with sinus tachycardia and dehydration. I was placed on oxygen as my levels were between 90-93, and I was given IV fluids. I have felt fatigued since then, some nausea, and mild diarrhea still.
39 2021-01-06 numbness, tingling Right sided facial numbness and tingling
39 2021-01-06 flushing Sxs 10 minutes post vax with nausea, lightheadedness, flushed. Taken to ED from vax site. Given IVF... Read more
Sxs 10 minutes post vax with nausea, lightheadedness, flushed. Taken to ED from vax site. Given IVF, Zofran inj.
39 2021-01-06 weakness Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibupr... Read more
Woke up at 3am with the chills took my temp was 99.8. Took my morning medicines and then some ibuprofen, was having body aches and severe chills. Went back to bed and took my temp an hour later was 101.0. Had body aches, chills, thirst, weakness, headache for the rest of the day. Temperature went from 99.0 to the highest of 102.0. Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs. If not then I would need to get covid tested. Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done. It has been 24 hour since and now I no longer have a fever and am feeling better just tired.
39 2021-01-06 migraine site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturban... Read more
site soreness (started within 3 hours of injection and is still sore 2 days later) , sleep disturbance night of injection, elevated temp of 100deg (started at 0200 on the 6th and lasted for 24 hours), whole body aches esp neck and back pain (Started when temp started and has lasted after temp has stopped for a total of 31 hours). Migraine with sensitivity to light (started at 0400 on the 6th and lasted for 5 hours). Nausea and heartburn (started on the 6th at 1845 lasting 5 hours despite taking famotidine)
39 2021-01-07 flushing About 3 minutes after I received the vaccine I became flushed for just a few moments and had a stran... Read more
About 3 minutes after I received the vaccine I became flushed for just a few moments and had a strange taste in my mouth. I could feel a tingle in my mouth at the same time. I became panicked of course but the flushing quickly subsided. The mouth sensation lasted a bit longer but there was no airway compromise at all.
39 2021-01-07 numbness Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongu... Read more
Elevated blood pressure (155/95); decrease in heart rate (55); Face & tongue went numb; Face & tongue went numb; Residual ringing in left ear; This is a spontaneous report from a contactable physician, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm on 22Dec2020 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included seasonal allergies and allergies/asthma, from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and montelukast sodium (SINGULAIR). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 22Dec2020 at 16:00, the patient experienced elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear. The patient was treated for the events with diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events elevated blood pressure of 155/95 (normal was 110/60), a decrease in heart rate which was 55, face and tongue went numb and residual ringing in the left ear was resolved with sequel. Information on lot/batch number has been requested.
39 2021-01-07 tingling Employee received COVID vaccine on 1/6/2020 and developed bilateral hip pain that night and then dev... Read more
Employee received COVID vaccine on 1/6/2020 and developed bilateral hip pain that night and then developed numbness and tingling in her buttocks and both legs on 1/7/2020. Employee was sent into Emergency Room.
39 2021-01-07 tingling, numbness Numbness and tingling on whole left side of body from head to toes on side vaccine was administered.... Read more
Numbness and tingling on whole left side of body from head to toes on side vaccine was administered. Swelling to left arm/hand.
39 2021-01-07 facial paralysis, numbness Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and the... Read more
Patient received her vaccination on Monday, 1/4/21. She waited her 15 minutes of observation and then left. She states on her way home she started feeling that her tongue and left side of her face was a little bit numb. It continues to be numb and on examination the left side of her face has diminished sensation. Her left eye is droopy and she has a symmetrical eyebrow raises as well as smile. Her diagnosis is consistent with possible Bell's palsy.
39 2021-01-07 feeling jittery Tickle in throat / throat itching, Can't get a full swallow, anxious, jittery
39 2021-01-07 feeling hot UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left a... Read more
UrticariaPruritus Reported lip numbness c/ injection, reported to monitor no action. Employee left and called staff and reported hives on upper and lower lips, lips warm to touch Narrative: Reported lip numbness c/ injection, reported to monitor no action taken. Employee left after 15mins. Employee reported hives on upper and lower lips, lips warm to touch ( text message) no action taken
39 2021-01-07 pain in extremity, numbness Vaccine was given above deltoid area, given in shoulder area. Right shoulder started to swell. Pain ... Read more
Vaccine was given above deltoid area, given in shoulder area. Right shoulder started to swell. Pain in right arm starting in shoulder and runs down the entire arm. Pain continues 1 week after receiving the injection. Mild swelling continues in right shoulder. Having numbness in right hand.
39 2021-01-07 cold sweat Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had mu... Read more
Vagal presyncope. Tachycardia. Cold sweat, lightheadedness about 15min post injection. Having had multiple vagal episodes before, including with other vaccines, I oncreased my SVR by kneeling down. Symptoms resolved after 15min of continuous kneeling.
39 2021-01-07 cold sweat, cold extremities, tingling extremities were still cold with occasional tingling; hands and feet were very cold and arms and leg... Read more
extremities were still cold with occasional tingling; hands and feet were very cold and arms and legs were cold and clammy; hands and feet were very cold and arms and legs were cold and clammy; feeling tired with some chills; feeling tired with some chills; nausea; vomiting; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 02Jan2021 08:00 at single dose at left arm for covid-19 immunization. Medical history included arthritis, hip replacement, calcified DVT. Concomitant medication within 2 weeks of vaccination included colecalciferol (VITAMIN D, gummies). Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took acetylsalicylic acid (ASPRIN) and experienced allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient received the first dose on 02Jan2021 at 08: 00. At 14: 30, patient started feeling tired with some chills. By 0500 (as reported), patient was having nausea with vomiting. The next morning on 03Jan2021, patient woke at 07:00, patient still had nausea, but also, hands and feet were very cold and arms and legs were cold and clammy. It was 05Jan2021 now and patient still had nausea and extremities were still cold with occasional tingling. Patient didn't receive treatment for events. The report is considered non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of events nausea and extremities were still cold with occasional tingling was not recovered, and outcome of other events was recovering.
39 2021-01-08 pain in extremity I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and bod... Read more
I have had the "normal" reactions such as; sore arm, ear and throat pain, headache, fatigue, and body aches. I have also noticed my neck hurting and this am I notice a knot like form on my left clavicle bone that was not there prior to the the vaccine. I have not had any treatment for this.
39 2021-01-08 pain in extremity No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet pa... Read more
No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet painful pins and needle sensation.
39 2021-01-08 feeling hot One week after the injection my arm began itching. It is red, elevated and warm. Estimated date of... Read more
One week after the injection my arm began itching. It is red, elevated and warm. Estimated date of delivery: August 22, 2021
39 2021-01-08 speech disorder, weakness Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 ... Read more
Pt experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 1/6/21 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Pt had televisit consult with psychiatry and neurology. She is subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. She is noted to have a history of shellfish allergy. She experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time.
39 2021-01-08 flushing, cold sweat Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 mi... Read more
Reported feeling onset of dizziness, right side of eye vision change, flushed, and clammy about 7 minutes after dose #2 of vaccination. No hx of adverse vaccine response. Only seasonal allergies. High-risk pregnancy at 25 weeks. Hx of feeling dizzy when she gets up suddenly, otherwise, no other medical issues. V/S taken over 45 minutes with noted decrease in BPs which was not normal for her. Apple juice x3 given at increments of 15 minutes and finished 1 bottle of water. Reports feeling better and then s/s returned. States she feels tired during episodes and back to normal. Advised to be evaluated in ED since her drive was more than 55 minutes away from hospital. Agreeable and was transported to ED for observation. B/P: 9:51 110/58, 10:09 92/58, 10:25 91/49 HR: 9:49 63, 9:59 80, 10:09 80, 10:25 80 SpO2: 9:49 99, 09:59 99, 10:09 99, 10:25 97 No other interventions given. Wheeled to the ED, room 505 at 10:41. Report given to RN.
39 2021-01-08 flushing c/o feeling flushed and elevated HR post vaccine administration. Vitals stable BP 155/88, HR 92, No ... Read more
c/o feeling flushed and elevated HR post vaccine administration. Vitals stable BP 155/88, HR 92, No CP, no sob. Recovered and discharged home.
39 2021-01-08 flushing c/o feeling flushed and heart racing after vaccination. Vitals stable. P 134/87, HR 86, RR 16, Sats ... Read more
c/o feeling flushed and heart racing after vaccination. Vitals stable. P 134/87, HR 86, RR 16, Sats 94%. No CO, no SOB. Recovered and discharged home.
39 2021-01-08 tingling, numbness numbness and tingling in left side of face (1/8), also in tongue and right hand (1/9)
39 2021-01-09 pain in extremity Fever 101.4 Arm sore
39 2021-01-09 weakness Fever, chills, weakness, fatigue, headache
39 2021-01-09 tingling Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands las... Read more
Hypotension and presyncope within 2 min of receiving the vaccine Tingling on face and both hands lasted for 2 hrs Following day- chills and abd cramping Day 3 -headache
39 2021-01-09 feeling hot Nausea, dry heaves, hot, dizziness after 12 minutes . Observed for 40 minutes. Gave water and snac... Read more
Nausea, dry heaves, hot, dizziness after 12 minutes . Observed for 40 minutes. Gave water and snacks. BP 121/83, HR 98. Resolved after observation. Husband picked up her.
39 2021-01-09 tenderness Swelling in underarm on left side wher shot administered. Lasted less than 24 hours. Congestion and ... Read more
Swelling in underarm on left side wher shot administered. Lasted less than 24 hours. Congestion and tenderserness day 3-4, just over
39 2021-01-10 hot flush 10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours la... Read more
10 minutes later, minor headache and itching. 4 hours later, lightheadedness/dizziness. ~12 hours later (03:30 the next day) fever up to 102, skin felt on fire all over my body, gi cramps, mild intermittent cough, myalgias, fatigue, extreme headache behind my eyes, occiput, and jaw pain, rigors.
39 2021-01-10 pain in extremity Arm soreness Fever (99.6 F) (broke about 1/9/21 4 am) Chills Fatigue Took advil (400 mg) 1/9/21 @ ... Read more
Arm soreness Fever (99.6 F) (broke about 1/9/21 4 am) Chills Fatigue Took advil (400 mg) 1/9/21 @ 2 am and another 400 mg on 1/9/21 at 5:30 pm. Sxs did not recur since 1/10/21
39 2021-01-10 tingling Developed a tingling sensation on the left side of her body and face after getting the first vaccine... Read more
Developed a tingling sensation on the left side of her body and face after getting the first vaccine. She had no weakness and was able to go about her normal day to day activities. The sensation went away with Tylenol and resolved the following day.
39 2021-01-10 feeling cold FEVER, CHILLS
39 2021-01-10 cold extremities, feeling cold, discomfort I had a slight headache while at work but was fine. I was home and was a little cold and my throat w... Read more
I had a slight headache while at work but was fine. I was home and was a little cold and my throat was scratchy. . Then about 9pm all of a sudden I started to get waves of chills. My hand were cold and my feet were frozen. I layered up with sweater and sweatpants to go to bed with a heavy comforter. I just could not get warm. About 1am, I woke up and put on my thick winter socks on because my feet were still frozen. I kept reminding myself to breathe in deeply. I checked my BPM and it was 80-82 and normally its about low 70s. I woke up about 5:30am and had a really bad headache, injection area and arm hurt, my body hurt and felt like I weighed several tons making me so slow. I didn't go to work the next day. My husband took my son to school and I took ibuprofen and went back to bed. Woke up again about 12:30 and felt better.
39 2021-01-10 burning sensation Intense joint pain. Worst in my elbows and shoulders Aching/burning sensation. Most Lasted 2 days, b... Read more
Intense joint pain. Worst in my elbows and shoulders Aching/burning sensation. Most Lasted 2 days, but still have some elbow discomfort 5 days after vaccine.
39 2021-01-10 throat numbness, numbness My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affe... Read more
My tongue became tingley, numb. My heart started to race and I became dizzy. The numbness has affected the right side of face and throat.
39 2021-01-10 pain in extremity Nausea, body aches, fever chills, left arm pain, left axilla pin with adenopathy. Fatigue. Headache... Read more
Nausea, body aches, fever chills, left arm pain, left axilla pin with adenopathy. Fatigue. Headache.
39 2021-01-10 numbness, tingling Within an hour of the injection patient broke out in hives followed by numbness and tingling on the ... Read more
Within an hour of the injection patient broke out in hives followed by numbness and tingling on the left side of the face. Mild headache with body soreness started approximately 8 hours after injection and lasted for about 12 hours. Benadryl was taken to relieve the hives, Advil and Tylenol were alternated to relieve headache and body soreness. The numbness of the face was resolved about 12 hours after onset.
39 2021-01-10 pain in extremity developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract... Read more
developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-10 pain in extremity fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, t... Read more
fatigue, chills, sweating, nausea, 99.1 fever then progressed to a 103 fever, severe pain in legs, took Tylenol and brought fever down to 101.7. Next day, woke up to sunburn rash on face, trunk to groin and legs, fatigue lasting all day. Next day 1/9, rash was still there, fever reached 100 lasting all day and fatigue.
39 2021-01-11 pain in extremity Arm soreness Fever Malaise Chills Body aches
39 2021-01-11 flushing Chills, low grade fever up to 100.4, muscle aches, flushing red skin of neck and chest.
39 2021-01-11 feeling hot Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness.... Read more
Client c/o having blurry vision and splitting headache. Also felt very hot. Loss of consciousness. Able to respond to verbal commands.
39 2021-01-11 cold sweat, numbness Cold, clammy, fast HR rate of 143, just didn't feel well could find words to describe it and shaky. ... Read more
Cold, clammy, fast HR rate of 143, just didn't feel well could find words to describe it and shaky. Left hand numbness opposite site of injection site. Set to ED to be evaluated
39 2021-01-11 tremor Fever 100.8 after Tylenol for 10-24 hours post vaccination. , extreme chills, shaking, waking from s... Read more
Fever 100.8 after Tylenol for 10-24 hours post vaccination. , extreme chills, shaking, waking from sleep. Severe fatigue, unable to work for 2 days post vaccination. Unable to do daily activities. 24 hours after vaccination fever resolved, temp elevated 99.5-99.8, fatigue is mild to moderate.
39 2021-01-11 flushing Flushing dizziness and nausea
39 2021-01-11 pain in extremity Headache, nausea, left arm pain
39 2021-01-11 pain in extremity Mild sore arm
39 2021-01-11 pain in extremity Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a conta... Read more
Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231/expiration date Apr2021), dose number 1, via an unspecified route of administration on 04Jan2021 14:30 at a single dose on the left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient previously had a flu shot for immunization and experienced fever, body aches, jumpiness, and arm hurting. She had no concomitant medications. She did not have any vaccination within 4 weeks prior the administration of the suspect vaccine. The patient was reporting side effects with the Pfizer vaccine. The events started in the morning of 05Jan2021 with the feeling of nausea. She also experienced jumpiness. In the evening, she had body aches, chills, and arm hurting. She also had fever, but it was not a very high fever. She took Tylenol on 05Jan2021 and on 06Jan2021, she had no body aches or fever yet. She felt much better on 06Jan2021. Her second dose is scheduled on the 25Jan2021. The patient received the vaccine at a workplace clinic. The outcome of the event was recovering.
39 2021-01-11 tingling Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the ... Read more
Received IM injection, 5 minutes later she felt tingling down her left arm. Over the course of the afternoon it spread to her left jaw, neck, face and lips. She proceeded to be seen by UC. She took tylenol. She improved. She had nausea and seats as well. This is similar to the symptoms she had of covid the month previous.
39 2021-01-11 tremor Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, ki... Read more
Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, kidney area pain. Fatigue following. Missed work the following day.
39 2021-01-11 pain in extremity The day after I had a sore arm, fatigue, headache.
39 2021-01-11 numbness, facial pain The numbness began to intensify and I could not feel myself blinking or smiling on the left side of ... Read more
The numbness began to intensify and I could not feel myself blinking or smiling on the left side of my face; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; pain and numbness to my left ear and left jaw that began to spread down my left jaw and upward across my left cheek, left eye, and left temple, and above my left eyebrow; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142) via an unspecified route of administration on 07Jan2021 07:00 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was Workplace Clinic. Medical history included food allergy at shrimp. Concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 07Jan2021 at 07:15 AM the patient notice pain and numbness to her left ear and left jaw that began to spread down left jaw and upward across left cheek, left eye, and left temple, and above left eyebrow. The numbness began to intensify and patient could not feel herself blinking or smiling on the left side of my face. The numbness slowly began improving over the next hour in the same order that it began, but she still have mild left ear and jaw pain and mild numbness. Events outcome are recovering. No treatment was received. The action taken was not applicable.; Sender's Comments: Based on the compatible time association, the facial palsy is possibly related to suspect BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-11 pain in extremity fever 101.7 for around 24 hours, headache body aches, arm pain and swelling
39 2021-01-11 feeling cold, feeling hot, tremor intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleepin... Read more
intense chills; uncontrollable shaking; Could not get warm; Had trouble walking; Had trouble sleeping; Felt warm rest of night; Did not have a chance to take my temperature but probably had a fever; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration, at the left arm on Jan2021 09:15 at a single dose for COVID-19 immunization at a hospital. Medical history included obesity. Concomitant medications included ibuprofen (ADVIL), methylphenidate & unspecified multivitamins. The patient previously took tetracycline and experienced allergies. On 06Jan2021 01:00, the patient woke up with intense chills and uncontrollable shaking, could not get warm or stop the shaking, had trouble walking or holding a glass of water shaking was so intense. Patient took ibuprofen helped and symptoms improved after 1-2 hours. The patient also had trouble sleeping and felt warm rest of night. Did not have a chance to take her temperature but probably had a fever. Overslept and missed first work meeting. Patient felt ok by 06Jan2021, 9:30. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for it since the vaccination. The patient recovered from the events on 06Jan2021, 9:30.
39 2021-01-11 feeling cold, tremor left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches... Read more
left arm is really sore; fever/100.7 degrees Fahrenheit; chills/ shivering; feeling cold; body aches; sick; she was shaking and shivering; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular (left deltoid), on 05Jan2021 at 11:00, at a single dose for COVID-19 immunization and preventative (prophylaxis). The patient has no relevant medical history and has no concomitant medications. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. Patient is a registered nurse (RN) and received her first dose of the Pfizer COVID-19 vaccine yesterday. She had side effects from it. Last night (05Jan2021) she was kind of sick, she experienced fever and chills. She was in bed and trying to get cozy, but she was shaking and shivering, she does not know the exact time she experienced these since she was in bed. She checked her fever at 4am and it was 100.7 degrees Fahrenheit. She took Tylenol this morning and she does not think she has a fever as of now. She felt better and but she was still cold but not like last night. She still has body aches, but she is better now, and her body aches were worse when she had the fever. Now that her fever was down, she feels better, she does not know if she feels better since she took the Tylenol. She stated that none of her coworkers got sick. She just wanted to know if she will get better and if these were normal. She hopes she gets better since she never gets sick. She also reported that her left arm was really sore, there is no swelling. When she moves her arm, she can feel it was hurting and she was not able to sleep on her left side. She did not feel pain when she received the injection, she felt the pain after in her left arm. The events did not require emergency or physician visit. Outcome of the event body aches was not recovered, for event "left arm is really sore" was unknown, while for the remaining events was recovering. The reporter assessed the events as non-serious and related to the vaccine.
39 2021-01-11 tingling, tremor, feeling cold muscle joint pint in the fingers on left hand; Feeling shaky and cold; Feeling shaky and cold; HR 10... Read more
muscle joint pint in the fingers on left hand; Feeling shaky and cold; Feeling shaky and cold; HR 100s; SBP 147; left arm started to have tingling sensation. the sensation got worse as the minutes passed/tingling on right side of the face below eye; This is a spontaneous report from a contactable Nurse. A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular (left arm, dose 1) on 05Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccines in four weeks. No other medications in two weeks. The patient previously took rocephine and experienced rash. On 09:03, patient received vaccine. On 09:07, left arm started to have tingling sensation. the sensation got worse as the minutes passed. On 0930; vital signs were taken (SBP 147, HR 100s). On 09:40, second set of Vitals (SBP 117, HR in the 80s). On 1028, tingling on right side of the face below eye. On 10:38, tingling on the face got better. Feeling shaky and cold. On 11:15, muscle joint pint in the fingers on left hand. On 13:30, most of the symptoms disappeared. Tingling on left arm still present mostly on in the tip of fingers and inner aspect of the forearm that comes and goes. Symptoms are not as bad as the first 50 minutes into the vaccine. Events occurred on 05Jan2021. No treatment was given. Since the vaccination, the patient has not been tested for COVID-19. Event outcome was recovering. The reporter considered the events as non-serious.
39 2021-01-11 hot flush, weakness, numbness, pain in extremity swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch... Read more
swollen lymph nodes at neck and sore to the touch; swollen lymph nodes at neck and sore to the touch; swollen and stiff neck; swollen and stiff neck; chills; hot flashes; radiating pain of arms; numb fingers; blue hands and feet; joint pain; muscle aches; weakness; tirednes; lethargic; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EL0140, via an unspecified route of administration in the left arm on 04Jan2021 16:45 at a single dose for COVID-19 immunization. Medical history included hypothyroidism, depression, ADHD, overweight, asthma and known allergies to milk, cat, roach mix, dust mites and bermuda grass. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), trazodone and montelukast. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced swollen lymph nodes at neck and sore to the touch, swollen and stiff neck, chills, hot flashes, radiating pain of arms, numb fingers, blue hands and feet, joint paint, muscle aches, weakness, tiredness, and was lethargic, all on 04Jan2021 at 17:30 PM with outcome of recovering. The events were reported as non-serious with no treatment received. No follow-up attempts are possible. No further information is expected.
39 2021-01-12 weakness Employee complained of dizziness after sitting for 10 min in observation area. Employee became letha... Read more
Employee complained of dizziness after sitting for 10 min in observation area. Employee became lethargic and was unable to stand. She complained of R side chest pain and R sided weakness. Symptoms did not go away. Employee sent to ER.
39 2021-01-12 tingling Nearly one hour after administration of the vaccine, my hands became slightly tingly and itchy. When... Read more
Nearly one hour after administration of the vaccine, my hands became slightly tingly and itchy. When I woke the next morning, my hands were red, swollen and extremely itchy and had whelps around some of the joints. This progressed up into my wrists and elbows as the day went on. This is similar to the symptoms that I experience when I had fifths disease.
39 2021-01-12 feeling hot Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy.... Read more
Patient received her shot on 1/13/2021 at 11:20am. 12 minutes later she started getting very dizzy. Her face was very red. She was extremely hot. Patient first bp was 140/101 with a pulse of 75. We continued to monitor her for the next 1 hour and 20 minutes until family arrived because she refused for us to call 911 because she did not want a bill. Every time we sat her up she was extremely dizzy. BP was 160/107 when she sat up on the bed. Her husband ended up taking her to the ER because she was still very hot and dizzy. Dr. was here. He listened to her breathing multiple times. There was no signs of allergic reaction. Patient reported a history of panic attacks.
39 2021-01-12 tingling, numbness Right sided facial tingling/numbness
39 2021-01-12 weakness Severe body muscle and bone aches, nausea, episodes of feeling faint, Orthostatic hypotension, loss ... Read more
Severe body muscle and bone aches, nausea, episodes of feeling faint, Orthostatic hypotension, loss of color in face and lips, headache, weakness, lethargy
39 2021-01-12 numbness The day of vaccination developed fever and joint pain 24 hrs later nausea and diarrhea, 48 hrs later... Read more
The day of vaccination developed fever and joint pain 24 hrs later nausea and diarrhea, 48 hrs later headache and left hand numbness
39 2021-01-12 feeling hot chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but n... Read more
chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but never had a temperature/ 99 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via unspecified route in the left arm single dose for COVID-19 immunization on 28Dec2020, 16:45 at 39-year-old. No medical history. Concomitant medication was not reported. No additional vaccines administered on same date of the vaccination or within 4 weeks before the vaccination. The patient had a little bit of chills on 31Dec2020. The chills was on and off, it may have even been on 01Jan2021. The patient occasionally felt warmer, but her temperature was normal. She felt warm inside her body or feverish on 29Dec2020 but never had a temperature. She still felt the chills and feverish on and off. She had it all day yesterday 05Jan2021. The temperature was 99 degrees Fahrenheit on 05Jan2021, but she had been working in the house. After she sat down for a while the fever went away. The chills and feeling like she might have fever are persisting through today. She didn't treat the chills or feverish in any way. No physician office or emergency room visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
39 2021-01-13 hot flush After second dose of Pfizer COVID-19 vaccine, patient experienced flushing/hot, dizziness, and light... Read more
After second dose of Pfizer COVID-19 vaccine, patient experienced flushing/hot, dizziness, and lightheadedness. Patient was given water/juice. Patient was instructed to wait an additional 15 minutes for observation but declined and left against medical advice
39 2021-01-13 numbness, burning sensation Asthmatic reaction- breathing issues going on for upwards of 1 week. Completely out of breath and bu... Read more
Asthmatic reaction- breathing issues going on for upwards of 1 week. Completely out of breath and burning sensation when trying to breath. Severe sore throat Numb left had day of injection
39 2021-01-13 numbness Contract employee reports approximately 25 minutes after receiving her second covid vaccination she ... Read more
Contract employee reports approximately 25 minutes after receiving her second covid vaccination she began to experience mild numbness in and slightly below her right ear. She reports her hearing sounding "muffled" in her right ear. This employee was monitored for a total of 60 minutes in the observation area and reports no worsening of symptoms at the 60 minute mark and felt comfortable leaving the location. She reports having similar symptoms with the first Covid vaccination she received but denies reporting it to Employee Health department or submitting a report herself. She does state she reported the symptoms on the daily check-ins.
39 2021-01-13 weakness Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph node... Read more
Fever; chills; SOB; pain while taking a deep breath; swelling/itchiness left arm; swollen lymph nodes on left side under arm; generalized weakness
39 2021-01-13 pain in extremity H/A head is pounding, Chills shivering, took hours to warm up, nausea, 102.4temp, took Tylenol. Thi... Read more
H/A head is pounding, Chills shivering, took hours to warm up, nausea, 102.4temp, took Tylenol. This AM still have H/A, sore arm, 98.8 temp. Pain in right upper arm.
39 2021-01-13 tingling, numbness Numbness tingling in feet, toes progressed to waist. ER Sunday hosp, pt was admitted inpatient, di... Read more
Numbness tingling in feet, toes progressed to waist. ER Sunday hosp, pt was admitted inpatient, diagnosis transverse myelitis.
39 2021-01-13 migraine Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Ras... Read more
Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; Rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), intramuscular, in the left arm on 23Dec2020 at 10:30 AM (at the age of 39-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient previously took prochlorperazine edisylate (COMPAZINE) and experienced drug hypersensitivity. On 23Dec2020 at 8 PM, the patient experienced rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The events were reported as non-serious. The patient did not receive any treatment for the rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week. The clinical outcome of the events rash over face, torso, and arms. Vomiting and diarrhea day 3, and migraines for the firsts week was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-01-13 night sweats, pain in extremity Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Profes... Read more
Sore arm; fatigue; night sweats; This is a spontaneous report from a contactable Other Health Professional (patient). A 39-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm on 22Dec2020 07:15 at a single dose for COVID-19 immunization at the hospital. Medical history included anxiety from an unknown date and unknown if ongoing. The patient has no known allergies. Concomitant medications included ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), escitalopram oxalate (LEXAPRO), birth control and unspecified MVI. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm, fatigue and night sweats on 22Dec2020 with outcome of recovering. No treatment was given for the events. The events were assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on batch/lot number was requested.
39 2021-01-13 tingling Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minute... Read more
Tingling in side of tongue at 10 minutes after vaccine/ tingling on right side of cheek at 45 minutes/ tingling on tongue & cheek; tingling on toes on right side of feet only/ tingling on foot; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female nurse (patient) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular route of administration on the left arm on 29Dec2020 10:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), vitamin B complex, zinc, and curcuma longa (TURMERIC), all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced tingling in side of tongue at 10 minutes after vaccine, tingling on right side of cheek at 45 minutes & tingling on toes on right side of feet only on 29Dec2020 10:15. The tingling on tongue & cheek went away, but she was still getting tingling on foot at times. This never happened to her before the vaccine. No treatment was given and events were reported as non-serious. The outcome of the event tingling on tongue & cheek was recovered on an unspecified date and of tingling on foot was not recovered. The patient had not been tested for COVID-19 since the vaccination.
39 2021-01-13 tingling Tingling, lightheaded, SOB, diaphoretic. Administered 50 IM Benadryl and symptoms were not resolvin... Read more
Tingling, lightheaded, SOB, diaphoretic. Administered 50 IM Benadryl and symptoms were not resolving. Called EMS for transport to ED.
39 2021-01-13 pain in extremity Upper arms soreness; This is a spontaneous report from a contactable other hcp. A 39-year-old female... Read more
Upper arms soreness; This is a spontaneous report from a contactable other hcp. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date: unknown, intramuscular (right arm) on 16Dec2020 07:30 at a SINGLE DOSE then the second dose via intramuscular (left arm) on 06Jan2021 08:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced upper arms soreness on an unspecified date with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
39 2021-01-13 pain in extremity Upper arms soreness; Upper arms soreness; Chills; Headache; lower stomach and lower back cramping; l... Read more
Upper arms soreness; Upper arms soreness; Chills; Headache; lower stomach and lower back cramping; lower back cramping; fever 102; Fatigue; joint and muscle pain; joint and muscle pain; This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 39-year-old female patient (not pregnant) received the second dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine), intramuscularly in left arm on 06Jan2021 08:00 AM at single dose for COVID-19 immunisation. Facility type vaccine was in hospital. Medical history included Sulfa allergy. There were no concomitant medications. The patient received the first dose of BNT162B2 on 16Dec2020 07:30 and experienced upper arms soreness. The patient didn't have other vaccine in four weeks or other medications in two weeks. The patient was not diagnosed with COVID-19 prior vaccination and didn't test COVID-19 post vaccination. After receiving the 2nd dose, the patient experienced upper arm soreness, chills, headache, lower stomach and lower back cramping, fever 102, fatigue, joint and muscle pain on 06Jan2021, 05:00 PM. No treatment was received for the events. Seriousness criteria was no. The outcome of the events was recovering. Information about lot/batch number has been requested.
39 2021-01-13 tingling, pain in extremity, numbness left arm was tingling; numb feeling all the way to fingers; pain in arm down to her finger joints; ... Read more
left arm was tingling; numb feeling all the way to fingers; pain in arm down to her finger joints; pain in arm down to her finger joints; This is a spontaneous report from a contactable other health professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ES1685, via an unspecified route of administration in the left arm, from 08Jan2021 12:45 at a single dose, for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), dairy intolerance and perfume sensitivity. The patient's concomitant medications were not reported. On 08Jan2021 13:15, a half hour after the vaccination, the patient experienced that her left arm was tingling, a numb feeling all the way to fingers; it lasted about one hour after it came on, but now she have pain in arm down to her finger joints. The outcome of events was reported as recovered with sequelae. No treatment was received/given due to the events. No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
39 2021-01-13 pain in extremity pain down left arm and into the armpit/chest swelling in left supraclavicular area going on 7 days
39 2021-01-14 pain in extremity 2ns shot -- headache that started shortly after the shot that worsened and was not alleviated with t... Read more
2ns shot -- headache that started shortly after the shot that worsened and was not alleviated with tylenol. headache lasted about 1.5 days. chills started at about 3 am on 1/13/2021 and lasted for about 1 day. body aches lasted for one day on 1/13. fatigue started on 1/13 and lasted through 1/14. painful left axillary lymph node swelling starting on 1/13 and continuing to present day. 1st shot -- sore arm, painful left axillary lymph node swelling
39 2021-01-14 feeling hot, feeling hot, feeling hot Employee reports sensation of significant warmth/heat that comes in waves. Vital signs checked: 10... Read more
Employee reports sensation of significant warmth/heat that comes in waves. Vital signs checked: 10:35- 144/95 1045- 137/89 1049- 123/90 Episodes of warmth would come in waves. Symptoms would resolve and then return. Improved after 35 minutes of observation
39 2021-01-14 muscle spasms, numbness Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would ... Read more
Muscle pain, from lower back down.; I had no feeling at all below the waist; fatigue; Muscles would feel like they were seizing up and clenching throughout the night; This is a spontaneous report from a contactable nurse. A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration in left arm on 07Jan2021 18:30 at a single dose for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included Von Willebrand's disease. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ibuprofen. On 07Jan2021 23:00, the patient experienced muscle pain, from lower back down, Muscles would feel like they were seizing up and clenching throughout the night, for a short time she had no feeling at all below the waist and incredible fatigue. The outcome of the events was not recovered. The patient was not tested for COVID-19 post vaccination. The events was assessed as non-serious by the nurse. The patient did not received any treatment for the events.
39 2021-01-14 numbness, tingling Numbness and tingling in left side of face starting on morning on 08Jan.; Numbness and tingling in l... Read more
Numbness and tingling in left side of face starting on morning on 08Jan.; Numbness and tingling in left side of face starting on morning on 08Jan.; This is a spontaneous report from a contactable Nurse, the patient. This 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK9231) dose #2, via an unspecified route of administration in the left arm on 06Jan2021 at 08:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. Medical history included guillain-barre syndrome from 2017 (reported as not related to a vaccine) and unknown if ongoing, asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing known, environmental allergy (unspecified) from an unknown date and unknown if ongoing known and an allergy to metals from an unknown date and unknown if ongoing known. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), montelukast sodium (SINGULAIR), drospirenone, ethinylestradiol betadex clathrate (YAZ), omeprazole (PROTONIX [OMEPRAZOLE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and mometasone furoate (FLONASE [MOMETASONE FUROATE]). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK5730), dose #1, via an unspecified route of administration in the left arm on an 19Dec2020 at 08:15 as a single dose for COVID-19 vaccination. On 08Jan2021 at 05:00, the patient experienced numbness and tingling in left side of face. No therapeutic measures were taken as a result of the events. The clinical outcome of numbness and tingling in left side of face was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-01-14 tingling, muscle twitching On my way home from work about 20 min after 2nd vaccine unable to swallow and tingling/numb sensatio... Read more
On my way home from work about 20 min after 2nd vaccine unable to swallow and tingling/numb sensation to right side of face. Lasted approximately 30-45 min. Since then intermittent right sided facial tingling, lip twitching/numbness thats lasts approximately 2 seconds then stops. Increasing in frequency 1/15/21 which is leading me to report symptoms and notify PCP. Today (1/15/21) alone has happened about 20 times
39 2021-01-16 weakness Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept... Read more
Immediately after the shot, felt very weak. took two tablets of Tylenol 500mg and went to bed. slept for 9 hours. the next day began itching around the middle - stomach and back had to work so did not take anything for it. by the second day the itching was generalized. only temporarily relieved by application of cortisone - 10. the 3rd day I took cetirizine but it didn't seem to help much. the 4th day I took Benadryl and the itching reduced for the next few days. took another Benadryl on the 7th day. itching more localized to the stomach and back. Today, it came back to generalized again. from the scalp to the soles of the feet. I have to work so cannot take Benadryl at this time. Thought I would not need to see the Dr, hoping it would get better but as it stands today I will need to go see the Dr.
39 2021-01-16 flushing Severe itching. Welts on chest and neck. Face itchy and flush. 4 days later I am still very itchy w... Read more
Severe itching. Welts on chest and neck. Face itchy and flush. 4 days later I am still very itchy with out allergy meds.
39 2021-01-16 weakness, migraine Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, head... Read more
Sore arm at the injection site 24 hours post vaccine then symptoms of nausea, weakness, tired, headache started 12/20/2020, 4 days post the vaccine. Went to the ER on the 12/21/20-12/22/20 due to increase headache, vomiting, diarrhea, dizzy, dry cough, weak/extremely fatigue. At the ER was given IV fluid, Zofran, Phenergan, tested for the Flu and Covid, also had blood work. All my blood work came back in normal ranges, FLU and Covid test were negative as well. Discharged from the ER with Phenergan, the next 3 days I had a migraine and had to be in a dark room with lights off, still very dizzy, tired, shortness of breath with movement, could not eat it made me nauseas. Called for follow up with PCP he then put me on steroids, for 7 days. 12/28 called PCP office again, was put on another round of steroid treatment with antibiotic. Was off work from 12/21/2020-01/02/21 due to the sickness post the vaccine
39 2021-01-17 pain in extremity ARM SORENESS FIRST 12 HRS. NEXT 24 HRS SEVERE HEADACHES, MYALGIAS, CHILLS ALTERNATING WITH SWEATS. N... Read more
ARM SORENESS FIRST 12 HRS. NEXT 24 HRS SEVERE HEADACHES, MYALGIAS, CHILLS ALTERNATING WITH SWEATS. NAUSEA AND VOMITING X1. TOOK TYLENOL AND ZOFRAN.
39 2021-01-17 feeling of body temperature change Headache, muscle/body aches, hot and cold flashes, fatigue, and low grade fever.
39 2021-01-17 hot flush Nausea, body aches, extreme cold chills then hot flashes, heachache
39 2021-01-17 pain in extremity Reporting side effects to first dose of COVID-19 vaccine. In addition to a sore arm, I also experien... Read more
Reporting side effects to first dose of COVID-19 vaccine. In addition to a sore arm, I also experience a headache, tiredness and fatigue x2 days.
39 2021-01-17 tingling, feeling cold Took Motrin after receiving vaccine on 1/5/21 and felt fine until the evening of 1/6/21 felt like wa... Read more
Took Motrin after receiving vaccine on 1/5/21 and felt fine until the evening of 1/6/21 felt like was freezing with temp 100.4 and body aches. On 1/7/21 continued to have body aches, sweaty, afebrile and that evening felt nauseous requiring medication (zofran). On 1/8 @ 1300 after waking up felt body aches and stiffness on right side of body, right side of face felt tingly, right underarm lymph node swollen. Went to urgent care to be examined and had xray of neck that was negative for acute process and was informed to take motrin and return in 3 days if not better.
39 2021-01-18 hypersensitivity of all senses, numbness Facial numbness and increased sensitivity on the left side of her face. There is no facial droop or ... Read more
Facial numbness and increased sensitivity on the left side of her face. There is no facial droop or lid lag. Other cranial nerves are stable. She did notice some numbness on the right side of face after receiving the first dose of vaccine. Concern for early Bell's Palsy will be treated with valganciclovir and prednisone.
39 2021-01-18 burning sensation I started out with hives on my lower legs, and then it spread up onto my arms and neck. I had a burn... Read more
I started out with hives on my lower legs, and then it spread up onto my arms and neck. I had a burning sensation.
39 2021-01-18 tremor Immediately following vaccine my entire chest began very hot. I was having hard time breathing. I ... Read more
Immediately following vaccine my entire chest began very hot. I was having hard time breathing. I started trembling a little and my vision became blurry. Doctors told me I had bad panic attack.
39 2021-01-18 feeling hot It started about 18 hours after the second dose. I was nauseous and got the chills first. About 3 ho... Read more
It started about 18 hours after the second dose. I was nauseous and got the chills first. About 3 hours later I had body aches and dizziness. Then I got really hot. Friday morning I was better with just a slight body ache that went away that day.
39 2021-01-18 numbness Metalic taste feeling of numbness in face with itching started within 25 min. I self medicated with ... Read more
Metalic taste feeling of numbness in face with itching started within 25 min. I self medicated with 25mg of Benadryl 15 min before injection because I had the same reaction to the first injection. However it did not prevent the reaction as I hoped it would this time. 30 min post injection I took another 25mg of Benadryl. Once med started working symptoms went away. At no time did I have difficulty breathing. By midnight I was woken by chills, body aches, and head ache (possibly secondary to the jaw clenching I woke up with too). I took tylenol which did not appear to help which is abnormal for me. Fever, chills, aches continued on throughout the night and through the day into the night. On tylenol fever was noted to be 100.6 Fahrenheit. I was finally able to sleep with tylenol and motrin by 10 pm on 18th for 8 hours. Next day temp was about 97.6 Fahrenheit with mild sweating throughout the day and aches had subsided. Today Jan. 19th all symptoms are gone.
39 2021-01-18 tremor On Thursday i had hot chest again. My heart rate was raising. Friday I started having the shakes an... Read more
On Thursday i had hot chest again. My heart rate was raising. Friday I started having the shakes and went to hospital.
39 2021-01-18 tenderness ~2wks following first injection, noticed a left submandibular lymph node swelling/tenderness. Follow... Read more
~2wks following first injection, noticed a left submandibular lymph node swelling/tenderness. Following first injection, had occasional transient headache, lightheadedness. ~4 days following the second injection, had an episode of elevated resting and active heart rate for ~1.5hrs. (Normal resting HR is 60-70s, during episode was 100-110s with increase to ~140 with short walk). Following second shot, also had axillary lymph node discomfort, transient on/off headache, lightheadedness, chills, fatigue. My submandibular lymph node has not resolved but HR issue has (why reported as ?no? below).
39 2021-01-19 pain in extremity Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feelin... Read more
Day 2 broke out in hives and headache Day 3- starting feeling extremely fatigue Day started feeling sore, legs hurt, and muscle aches Today Day 9 legs still sore and muscle aches, and fatigue Taking Benadryl at night for itching due to hives and Tylenol for soreness and muscle aches
39 2021-01-19 feeling hot Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hour... Read more
Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea. A few hours after the vaccine, headache, nausea, dizziness continued. Face and left arm (vaccine site) felt like they were internally on fire. Twenty-four hours after the vaccine, flu-like symptoms (cold chills, fever, nausea, muscle aches to the point of it hurting to move, joint pain), headache, skin itching. Treatment was tylenol, ibuprofen, and benadryl.
39 2021-01-19 weakness, unresponsive to stimuli Patient received Vaccine and during observation period began starring forward and not responding to ... Read more
Patient received Vaccine and during observation period began starring forward and not responding to staff. Patient was taken to the emergency room and evaluated and noted to have a flat affect and general weakness. Patient did not loos consciousness or have any signs of distress. Was admitted to the hospital and noted that she had been in out of country for a week (possibly had cosmetic surgery)
39 2021-01-19 weakness Symptoms have worsened. I have an electric feeling in my legs and I am a lot weaker. I am waiting fo... Read more
Symptoms have worsened. I have an electric feeling in my legs and I am a lot weaker. I am waiting for an appointment with a neurologist. I also have a wheelchair that was donated.
39 2021-01-19 pain in extremity day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring ... Read more
day after 2nd injection increased fatigue, arm soreness and shortness of breath overnight requiring rescue inhaler. Fatigue and general malaise continued x 7 days with intermittent shortness of breath requiring use of rescue inhaler. (Prior to vaccine inhaler used 3/year post vaccine requiring inhaler 2x per day). Increased post nasal drip with shortness of breath at night 02-03am each night and head congestion ear fullness during day requiring rest increased benadryl and decongestant use.
39 2021-01-19 pain in extremity fever (101.4), horrible headache with use of medications to relieve, generalized body aches, sore L ... Read more
fever (101.4), horrible headache with use of medications to relieve, generalized body aches, sore L arm
39 2021-01-19 pain in extremity sore arm, chills, low grade fever, body aches, fatigue
39 2021-01-20 tingling 4 minutes post vaccine pt began to have tingling of face, tongue and throat pt states that she also ... Read more
4 minutes post vaccine pt began to have tingling of face, tongue and throat pt states that she also felt that her throat was starting to close and felt mild SOB
39 2021-01-20 pain in extremity Body aches, high fever, headache and sore arm. Ibuprofen helped a little. Tylenol did nothing for an... Read more
Body aches, high fever, headache and sore arm. Ibuprofen helped a little. Tylenol did nothing for any symptoms . At the 24 hours mark, the fever is gone but still have body aches.
39 2021-01-20 muscle spasms GI upset; Cramping; Diarrhea; This is a spontaneous report from a contactable healthcare professiona... Read more
GI upset; Cramping; Diarrhea; This is a spontaneous report from a contactable healthcare professional. A 39-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration right arm on 05Jan2021 06:30 at a single dose for covid-19 immunization. Medical history included lymphoma and was identified with Covid prior vaccination. The patient has not received other vaccines in four weeks. There were no concomitant medications. The patient previously took acetazolamide (DIAMOX) but had allergies. The patient received her vaccine in a hospital. The patient experienced GI (gastrointestinal) upset, cramping and diarrhea on 05Jan2021 13:00. No treatment was received for the adverse events. The patient has not been tested post vaccination. The outcome of the events was recovered on Jan2021. The following information on the batch/lot number has been requested.
39 2021-01-20 hot flush, feeling hot Received the vaccine and waited for 15 min within 10 minutes left arm had a warm heat through to che... Read more
Received the vaccine and waited for 15 min within 10 minutes left arm had a warm heat through to chest to her neck , head and throat . Felt like eyes had to adjust . Hot flushing sensation and got cold water to south her thought. Stayed for an additional 30 minutes . Check Blood pressure was 154/95 and heart rate of 120 We to the ER for observation. 1 hour from the physician 184/96 pulse 121 admitted for observation. Benadryl for observation for 2 hours
39 2021-01-20 hot flush, feeling cold, weakness Started with headache, feeling flush/hot and right side jaw pain around 4pm. At 2am woke up freezing... Read more
Started with headache, feeling flush/hot and right side jaw pain around 4pm. At 2am woke up freezing with the chills, started vomiting and diarrhea. Had a fever of 99.9, extreme body aches, fatigue and joint pain. Around 2:30 pm the body aches eased a little. I continued with a fever into the evening. Woke up the next day feeling fatigued and weak. Finally felt better on 1/16.
39 2021-01-20 weakness diarrhea; weakness; fatigue; low grade fever/my fever reached 102; body aches; This is a spontaneous... Read more
diarrhea; weakness; fatigue; low grade fever/my fever reached 102; body aches; This is a spontaneous report from a contactable Nurse(patient). A 39-year-old female patient received first dose BNT162B2 (lot number EJ1685) , via an unspecified route of administration at Arm Left on 20Dec2020 12:15 at the 39 years old at single dose for COVID-19 immunization. The medical history included septic shock, from 2014 multi organ failure. There were no known allergies. The concomitant medications were topiramate(TROKENDI), lisdexamfetamine mesylate(VYVANSE), bupropion, sertraline, paracetamol(TYLENOL). On 22Dec2020 12:00 the patient started to have a low grade fever and body aches. On 23Dec2020 12:00 her fever reached 102 Fahrenheit, she had body aches, diarrhea, weakness and fatigue. This continued until 27Dec2020. The patient took Tylenol and Advil for fever. Tylenol and Advil helped some with fever but not always. There was no treatment received for body aches, diarrhea and weakness and fatigue. The events low grade fever, fever reached 102, body aches, diarrhea, weakness and fatigue resulted in Emergency Room Visit. There was no other vaccine in four weeks. The patient had not COVID prior vaccination. The patient had not COVID tested post vaccination. The outcome of the events was recovered on 27Dec2020.
39 2021-01-20 pain in extremity fever; Sore arm; body aches; headache; chills; Administration date=09Jan2021/Administration date=21D... Read more
fever; Sore arm; body aches; headache; chills; Administration date=09Jan2021/Administration date=21Dec2020; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second dose of BNT162B2 (Pfizer, lot number: EL1284), via an unspecified route of administration in left arm on 09Jan2021 18:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (lot number: E51685) in left arm on 21Dec2020 13:45 for COVID-19 immunization. On 10Jan2021 07:00, patient experienced sore arm, body aches, headache, chills, and fever. Treatment was not received for these events. Patient was not recovered from these events.
39 2021-01-21 tremor Approx 9pm onset shakes, sweating , increase in temp99-100 F , chest pain , muscular pain and tight... Read more
Approx 9pm onset shakes, sweating , increase in temp99-100 F , chest pain , muscular pain and tightness throughout body. In middle of night started vomiting . Approx 6am called primary MD. Was instructed to go to nearest hospital.
39 2021-01-21 pain in extremity, hot flush Extreme pain in entire L UE, nausea, fatigue, chills, hot flashes, headache, dizziness, brief and mi... Read more
Extreme pain in entire L UE, nausea, fatigue, chills, hot flashes, headache, dizziness, brief and mild SOB, itchy rash over entire torso worse on L side. Pain in UE gone in ~30 hours from injection, headache from 12 hours to 36 hours, rash 30 hours to 54 hours.
39 2021-01-21 pain in extremity Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At inject... Read more
Headache/congestion nausea diarrhea body aches bone ache extreme fatigue very painful arm At injection site
39 2021-01-21 pain in extremity I noticed the night of 1/21/2021 that my arm was itchy. Looking at it there was a red raised bump at... Read more
I noticed the night of 1/21/2021 that my arm was itchy. Looking at it there was a red raised bump at the injection site that had not previously been there. Since having the vaccine the only other effect I had was arm soreness the day of and day after the shot.
39 2021-01-21 feeling hot Immediately after receiving dose #2 developed a warm sensation from her arm that traveled to her che... Read more
Immediately after receiving dose #2 developed a warm sensation from her arm that traveled to her chest. HR 140bpm after receiving vaccine, BP also reported elevated but value not available. Also developed rash over chest. Was sent to ER for observation, given Benadryl, then discharged with epi pen.
39 2021-01-21 tenderness Left axillary lymphadenopathy. Tender. Gradually improved over 10-14 days. Still single enlarged but... Read more
Left axillary lymphadenopathy. Tender. Gradually improved over 10-14 days. Still single enlarged but non-tender mobile lymph node on date of report (1/21/2021)
39 2021-01-21 discomfort, pain in extremity Received the vaccine at 9:30.am on Wednesday. By noon on Thursday,felt soreness in arm. By 6pm, I f... Read more
Received the vaccine at 9:30.am on Wednesday. By noon on Thursday,felt soreness in arm. By 6pm, I felt a heaviness in every muscle- had to go to bed. Took Advil and had a good nights rest. Woke up the next morning, feeling better but I started feeling fatigued and achy by noon. I had to leave my job and went home and slept for 3 hours. Had dinner but had to go back to bed due to fatigue. Took Advil and Tylenol and feeling better on Friday morning.
39 2021-01-21 numbness facial numbness to right side of face, crossing midline at chin and across upper lip, spreading from... Read more
facial numbness to right side of face, crossing midline at chin and across upper lip, spreading from jaw line to periorbital area
39 2021-01-22 pain in extremity I?m received second dose Covid-19 Pfizer, I?m a direct lactating mother of and 11 months old male. ... Read more
I?m received second dose Covid-19 Pfizer, I?m a direct lactating mother of and 11 months old male. I had onset of fever, chills and body aches starting a 230 pm day after vaccine. My baby started having fever 2 hours later. I direct fed him about one hour and a half after receiving the vaccine. He had fever Max of 101.7 and has continued to have after 72hours. He had change in the stool consistency and smell but not diarrhea. He had decrease intake today but otherwise asymptomatic. I?m a pediatrician. His physician exam is normal except for tiny lymph nodes palpable in his axila and inguinal área. Today I checked his urine dip and was negative. No other testing has been completed. Fever has been control easily with Tylenol and the last 2 doses I have chosen to give Motrin. Baby is well appearing, active and playful otherwise. No history of contacts. We have no social contact with anybody for months, no grocery shopping, use N95 when seeing patients but I?m mostly Telehealth. My 5 yo is virtual student and does not have any symptoms. My husband has received first dose Covid and is also asymptomatic. I don?t have any reason to think there is any other etiology rather than my vaccine administration. My symptoms resolved after 30hours. I only had mild arm pain with first dose and baby was completely asymptomatic
39 2021-01-22 feeling hot Patient felt faint, dizzy, and warm within one to two minutes after receiving the vaccine. She repor... Read more
Patient felt faint, dizzy, and warm within one to two minutes after receiving the vaccine. She reports that she typically faints in response to vaccinations in the past. Symptoms lasted approximately 25 minutes and resolved without medical treatment.
39 2021-01-22 cold sweat Rigors, fever, cold sweat began 12 hours after injection. Subsided the next morning. Body Aches and... Read more
Rigors, fever, cold sweat began 12 hours after injection. Subsided the next morning. Body Aches and head ache until 24 hours post vaccination, then all symptoms resolved.
39 2021-01-22 tenderness Swollen underarm/armpit lymph nodes (left armpit) on the side of injection for about a week. Tende... Read more
Swollen underarm/armpit lymph nodes (left armpit) on the side of injection for about a week. Tender to touch. Nothing major, just wanted to let you guys. I wasn't concerned at all.
39 2021-01-22 numbness, pain in extremity The day of the shot about an hour and half I started feeling achy pain in my knee to my toes and my ... Read more
The day of the shot about an hour and half I started feeling achy pain in my knee to my toes and my leg went numb. I had a headache and felt confused, I couldn't remember what to do. The site was sore, I was dizzy, nausea and tired. This lasted for about 2-3 days .I took the next day off. The Dr. at my work said it should go away.
39 2021-01-23 pain in extremity Diaphoretic, tachycardic, muscle pain in leg, difficulty swallowing. Fluid bolus, iv push of benadr... Read more
Diaphoretic, tachycardic, muscle pain in leg, difficulty swallowing. Fluid bolus, iv push of benadry & solumedrol. Later that night nausea. Pepto helped alleviate
39 2021-01-23 feeling hot Red, warm to the touch, welt surrounding injection site began to spread down left arm. Right side of... Read more
Red, warm to the touch, welt surrounding injection site began to spread down left arm. Right side of face became red, warm. Mildly feverish, mildly achy, mild nausea. After approximately 2 hours, symptoms resolved without medication. Redness around injection site resumed previous size.
39 2021-01-24 discomfort 1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdo... Read more
1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.
39 2021-01-24 numbness 20 min after the injection my lips started tingling and getting numb. Under my nose was numb, felt l... Read more
20 min after the injection my lips started tingling and getting numb. Under my nose was numb, felt like I had novacaine. 1 hour and 30 minutes later my throat swelled. I had a hard time getting water down my throat. I took two benadryl pills at 11:10 am. Throat swelling went away within 10 minutes of taking benadryl and I was able to eat without any issues. My lips are still tingling, it's been 7 hours since the injection.
39 2021-01-24 pain in extremity Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fat... Read more
Recieved the 2nd dose of Covid on 1/21/2021 at 8am the symptoms started that night around 9pm. Fatigue, achy, and nausea. Wake up at 11pm with fever 104.8, ears pounding, dizziness, swollen elbow and hand pain on same arm of injection. Fever over the next 24hrs went to 105.9. Nausea and extreme jaw pain and joint pain. fever resolved after 26hrs. Still having dizziness, arm around injection site is warm to touch, swollen, and joint painful. headache and neck pain still. treating with motrin and tylenol that was started 26hrs after the injection.
39 2021-01-24 tingling, pain in extremity, numbness had numbness and tingling in left arm and foot after dose on 1/19/2021 that has since resolved, but ... Read more
had numbness and tingling in left arm and foot after dose on 1/19/2021 that has since resolved, but still has dull pain in foot at 3 out of 10 pain scale 1/25/2021 has seen PCP . this info relayed by director of nursing to vaccine lead.
39 2021-01-25 tingling, numbness 1/15/21 Tingling in lips, fingers and arms 1/16/21 Right sided facial numbness
39 2021-01-25 pain in extremity A swollen armpit; Arm hurts; This is a spontaneous report from a Pfizer-sponsored program. A contact... Read more
A swollen armpit; Arm hurts; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration in right arm on 08Jan2021 at a single dose for COVID-19 immunization. The patient has no medical history. There were no concomitant medications. The patient's arm hurts on 08Jan2021 and developed a swollen armpit on 10Jan2021. The outcome of swollen armpit was not recovered while arm hurts recovered on 10Jan2021.
39 2021-01-25 pain in extremity, inability to speak Had extremely sore arm from the moment of injection. A little over 24 hours post-injection in additi... Read more
Had extremely sore arm from the moment of injection. A little over 24 hours post-injection in addition to sore arm experienced word-finding difficulty. Seemed similar to effects of aphasia. Did not experience yet for second shot and I am 5 days post second shot.
39 2021-01-25 pain in extremity I had left wrist pain distributed up my arm that was severe for 4 days, I've had issues with that be... Read more
I had left wrist pain distributed up my arm that was severe for 4 days, I've had issues with that before and that seemed to flare it. I took Tylenol and rested it and it got better after about 4 days, I saw the Dr 5 days later and he gave me a splint
39 2021-01-25 numbness Patient had the second shot 1/12. Experienced numbness of feet within first 24 hrs. That continued u... Read more
Patient had the second shot 1/12. Experienced numbness of feet within first 24 hrs. That continued up both legs and then weakness set in. Called PCP on the 15th as symptoms were getting worse not better. Patient advised me to go to ED. Went to ED here last Friday and was released. The weakness in legs got much worse and early the following week she started getting the numbness and weakness in arms. She went for the follow up post ED visit with NP at PCP office on 1/20 and due to the continued weakness, after consulting with one of the MDs, decision was made to send her back to ED for further work up to check for GBS including the LP in ED, labs and MRI of head, spine, lumbar and thoracic. Patient was release on Saturday 1/23 and diagnosis was a severe immune response to the vaccine. Patient still has unsteady gait and weakness.
39 2021-01-25 pain in extremity, numbness Patient with sore arm day of event. Next day began to have some blinking of right eye, on medial si... Read more
Patient with sore arm day of event. Next day began to have some blinking of right eye, on medial side, which persisted for next two days. On 1/25/2021 began to have some numbness of right side of face starting on temple/ forehead, then beginning to extend down towards chin, before coming around the left side of face and becoming completely circumferential. Patient states felt leathery to the touch at that time due to decreased sensation. No facial asymmetry or weakness to muscles of facial expression noted by patient at any time. Patient went to sleep that night, fully resolved on waking in the AM.
39 2021-01-25 pain in extremity Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/c... Read more
Sore arm; a little tired; second dose was due 25Jan2021; Tested positive for COVID-19 on 03Jan2021/congestion and cough; Tested positive for COVID-19 on 03Jan2021/congestion and cough; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This 39-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via intramuscular at left deltoid on 28Dec2020 11am at single dose for COVID-19 immunization. Medical history included non-smoker with no other illness. Concomitant medication was none. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. Patient reported after receiving her first dose of the COVID-19 vaccine on 28Dec2020, she had sore arm and a little tired, other than that felt fine. She stated second dose was due 25Jan2021. She was tested positive for COVID-19 (Rapid Covid testing) on 03Jan2021. She already decided going to wait the 90-day-period to get the second dose of the vaccine. Since she was quarantined she wanted to what she should do. She stated her having testing positive for Covid did not have anything to do with the vaccine. She still had some lingering symptoms, congestion and cough. Nothing had worsened, but just wouldn't go away. She did not receive any other vaccines the same day or 4 weeks prior. No history of problems with vaccines in past. She had not had antibodies checked yet. It was reported no AE required a visit to emergency room/physician office. The patient was not hospitalized. The patient received no additional therapies for COVID-19. Patient's outcome with COVID-19 was recovering, and the rest of events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tested positive for COVID-19 (Rapid Covid testing), which is considered ineffective of BNT162B2, and the administration of BNT162B2.
39 2021-01-25 pain in extremity Woke up with a low fever, body aches, left arm pain and a little headache after taking the 2nd Covid... Read more
Woke up with a low fever, body aches, left arm pain and a little headache after taking the 2nd Covid vaccine dose. I took Tylenol and my fever and body aches went away. Still got a minor headache and left arm pain.
39 2021-01-26 numbness, tingling 1/23/21 10:00 am, Developed lower lip and tip of tongue tingling post vaccination. Lower lip tinglin... Read more
1/23/21 10:00 am, Developed lower lip and tip of tongue tingling post vaccination. Lower lip tingling resolved 5 minutes later and tip of tongue tingling continued. Tip of tongue tingling resolved on 1/24/21. 1/25/21: 20:30 pm; developed sudden left leg numbness and left great toe tingling. 2100 pm left leg numbness decreased. Left great toe continued to have tingling sensation. Also had faint tingling right great toe. 1/26/21: 0800 am; left leg numbness improved. Left great toe continued to tingle. Right great toe tingling intermittent. New development of right index finger intermittent tingling. 1/26/21: 1000; Left leg numbness resolved. 1/27/21: Still remain with intermittent left and right great toe tingling and right index finger tingling.
39 2021-01-26 tingling, electric shock sensation Effects presented one hour after administration - Headache, slight stiffness on the left side of the... Read more
Effects presented one hour after administration - Headache, slight stiffness on the left side of the face, discomfort in the arm. After 10 hours of administration of the vaccine - Insomnia, chills, hypersensitivity and tingling throughout the left side of the body. currents that ran from the administered area to the face, and to the hands. and all over the left foot.
39 2021-01-26 pain in extremity Fatigue with insomnia. Skin turned red all over, not itchy, warm to touch. Swelling all over. Benadr... Read more
Fatigue with insomnia. Skin turned red all over, not itchy, warm to touch. Swelling all over. Benadryl seemed to help. Palm of left hand, pain in muscle near thumb. Joint pain in wrist and fingers, not unbearable but consistently noticeable so far. Pain at injection sight, swelling.
39 2021-01-26 night sweats I had a fever, fatigue, achy , night sweats.
39 2021-01-26 discomfort, migraine L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pr... Read more
L Axillary lymphadenopathy; Fever 102.8 (H); muscle aches/heaviness; Migraine; Tachycardia; Chest pressure/pain; Chest pressure/pain; elevated BP; malaise; This is a spontaneous report from a contactable 39-year-old female Nurse reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number E10140), intramuscular in arm left on 11Jan2021 12:30 at single dose for COVID-19 immunization. Medical history included Low BP, depression, insomnia, latex allergy. The patient was allergy to morphine and diltiazem (CARDIZEM). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, E10140) on 24Dec2020 10:45 AM, intramuscular in left arm at age of 39 years old for Covid-19 immunization. Concomitant medication included cefixime (FLEXERIL), diphenhydramine hydrochloride (UNISOM), acetylsalicylic acid (ASPIRIN) and ibuprofen. The patient experienced l axillary lymphadenopathy, fever 102.8, muscle aches/heaviness, migraine, tachycardia, chest pressure/pain, elevated bp, malaise, all on 11Jan2021 23:00 with outcome of recovered with sequelae. The patient underwent lab tests and procedures which included blood pressure: elevated on 11Jan2021, body temperature: 102.8 on 11Jan2021 (H), nasal swab: negative on 12Jan2021 (Covid test post vaccination). The events were non-serious, result in emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient received Bolus of IV (intravenous) fluids for treatment.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
39 2021-01-26 difficulty speaking Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started ... Read more
Patient rec'd Pfizer #1 on 1/22/21 (L deltoid) @ 3:30 p.m. 1/22 @ 4 p.m. - Hives & itching started after obs, "feeling unwell" so patient returned to obs for additional 15 min. Cleared to RTW. After eating, @6 p.m. patient noted difficulty swallowing in evening & change in voice so she thought she had throat swelling. Took Benadryl 25 mg PO and Tylenol rapid release for HA. Hives resolved that evening and patient went to sleep. Over the weekend, had flu like symptoms, nausea, fatigue, HA. Took Benadryl 12.5 mg PO on 1/23 and continued Tylenol through weekend. 1/26 - 1/27: Signs and symptoms resolved
39 2021-01-26 nerve pain Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surfa... Read more
Severe neuralgia pain over 75% of her skin surface; Severe neuralgia pain over 75% of her skin surface; Severe joint pain; Muscle aches; Swollen lymph nodes; Headache; Fatigue; Upper body sporadic shivering; Interval between the first and second doses of BNT162B2 is 27 days; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3246), via an unspecified route of administration in right arm, on 14Jan2021 at 17:15, at a single dose, for COVID-19 immunization. The patient's medical history included sporadic neuralgia, numbness to patches on legs, shift-work sleep disorder, and generalized anxiety. The patient's concomitant medications included armodafinil (NUVIGIL), paracetamol (TYLENOL), and alprazolam (XANAX). The patient previously took ferric subsulfate (MONSELS Solution) and experienced allergy; and the first dose of BNT162B2 (Lot Number: EH9899) on 18Dec2020 (6 PM) for COVID-19 immunization (in left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital facility. On 14Jan2021 (05:15 PM), the interval between the first and second doses of BNT162B2 is 27 days. On 15Jan2021 at 9:15 AM, the patient experienced severe neuralgia pain over 75% of her skin surface beginning at 14 hours post-second dose (as reported) and still continuing now at 30 hours post-dose. Also, the patient experienced severe joint pain, muscle aches, swollen lymph nodes, headache, fatigue, and upper body sporadic shivering (not cold). It was unknown if the patient received treatment for the events. The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.
39 2021-01-26 weakness, tremor The next morning after my vaccine I went into work feeling a little achy and a slight headache then ... Read more
The next morning after my vaccine I went into work feeling a little achy and a slight headache then by 8:00am I felt like a train hit me, my body was chilling, shaking despite being in front of a heater, I had a low grade fever, my right side of my head hurt so incredibly bad like my right eye was going to explode, I then started vomiting. My boss came to help walk me outside because I didn?t even feel like it was me walking. I don?t remember walking out of work. I was there but ?not there?. I was not myself. I didn?t feel like i was in my body. I had to have my husband come get me from work, I slept most the rest of the day and night. Now I?m on day 2 and my joints still ache, my head hurts so bad, I am so tired I either am asleep on the couch or in bed. I have no energy. It takes everything I have to move just to go to the bathroom.
39 2021-01-26 pain in extremity diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site ar... Read more
diarrhea at 3pm same day of vaccine till Saturday night. Friday night Pain to arm/injection site around 10pm. Took Tylenol. Had slight pain to forehead around 8pm started to bruise. Saturday woke up with slight pain to arm/left side of neck. Bruise larger today. Saturday evening swollen. Lots of pain and trouble turn head. Left side neck/shoulder area pain. Applied ice/took Advil. At times hard to move arm, neck. bone pain by injection site. Now had pain from elbow to neck area, and shoulder on left arm for about 5 days now. At times pain feels like my bones hurt in those areas. Still swollen with bruising. Using pain meds ever 4 hours. And placing hot/cold packs with little relief.
39 2021-01-26 hot flush frontal and occipital headaches; hot flashes; exhaustion; This is a spontaneous report from a contac... Read more
frontal and occipital headaches; hot flashes; exhaustion; This is a spontaneous report from a contactable Nurse (patient). A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number=EH9899), on 11Jan2021 07:45 at SINGLE DOSE in Left arm for COVID-19 immunisation. Facility type vaccine was Hospital. Medical history included irritable bowel syndrome (IBS) , anxiety and depression. No other vaccine in four weeks. Concomitant medication in two weeks included buspirone, escitalopram. The patient previously received first dose of BNT162B2 (lot number=EH9899), on 21Dec2020 10:00 AM, at SINGLE DOSE in Left arm for COVID-19 immunisation. The patient experienced Continued frontal and occipital headaches on day 2 with no relief from Tylenol, hot flashes, and exhaustion, all on 12Jan2021 02:00 AM. The outcome was Not recovered. No treatment for hot flashes, and exhaustion. No COVID prior vaccination. Covid test post vaccination included Nasal Swab on 12Jan2021 with result of Negative.
39 2021-01-27 feeling hot, flushing 39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms we... Read more
39 yo female was noted ~40 minutes after vaccine to appear flushed. Her face, neck and upper arms were red. Upon questioning she reported she felt hot and itchy. Upon request she removed her jacket. Vital signs normal. She self-administered 25 mg of Benadryl. About 10 minutes later she reported developing a headache but otherwise reported some improvement in feeling hot and her facial/arm redness improved. She was originally given discharge instructions including home precautions and released to self, however a few minutes after leaving the patient walked back into the vaccination site and reported itching in throat with clearing throat. Patient was administered epinephrine 0.3mg IM and transferred to ER via EMS.
39 2021-01-27 feeling hot After the first COVID19 shot I got very red and very hot. I had a blinding headache for days. I re... Read more
After the first COVID19 shot I got very red and very hot. I had a blinding headache for days. I received the shot on a Wednesday afternoon and by Saturday I felt like I could claw my eye out, that I had something in it. I went to the eye doctor Monday morning and was diagnosed with a corneal ulcer. After the second COVID19 shot I was watched for 30 minutes based on my first reaction. I again turned very red and very hot. I had hives on my arms, neck, and behind my ears. I felt lightheaded and dizzy. I received 25 mg Benadryl by mouth and was observed for another 45 minutes. At that time I walked outside and felt worse. My throat became very itchy and I kept coughing. I went back in to tell provider and received an epi pen injection into my right leg, they took my vitals, and sent me to the hospital by ambulance.
39 2021-01-27 tremor Feeling very cold, 102.6 fever, chills, uncontrollable shaking, and sweats
39 2021-01-27 pain in extremity Left arm pain (mild-moderate) starting 6 hours after administration. Headache and drowsiness (mild- ... Read more
Left arm pain (mild-moderate) starting 6 hours after administration. Headache and drowsiness (mild- moderate) starting 3 hours after administration.
39 2021-01-27 feeling of body temperature change My charge nurse told me he was tested positive that evening. Started feeling my throat hurting in th... Read more
My charge nurse told me he was tested positive that evening. Started feeling my throat hurting in the morning. Because of being exposed to my charge nurse I had to go get tested. By 9AM body aches, headache, cough, chills. Fever went down on Thursday 100.8F, hot and cold sweats. I never felt like that before. I also had some GI issues (diarrhea) and a little bit of shortness of breath, just by walking to the restroom I would be very fatigued and when I checked my oxygen it would drop to 88% just by walking from my bed to the bathroom (Wednesday and Thursday was the worst). I still have fatigue and my throat hurts a little bit, I have congestion again and I started feverish again this Tuesday and lots of cough. Low grade fever (99.9F). My employee health told me to not return due to my symptoms until they subside or go get checked. Coughing and sneezing restarted yesterday. I had returned to work on Monday but then by Tuesday symptoms started reappearing.
39 2021-01-27 tingling, numbness Patient received shot at 12:30pm. Tingling and numbness of hands, legs, and feet started at 12:35pm.... Read more
Patient received shot at 12:30pm. Tingling and numbness of hands, legs, and feet started at 12:35pm. Patient waited to see if it would resolve/improve. By 2pm, patient reported getting worse. She was given 2 Benadryl to self administer. She took 1 25mg capsule, then within a couple of minutes reported shooting pain in her back. She went home to rest, felt the same around 4pm and was instructed to take the second Benadryl and/or some ibuprofen/Tylenol for the pain in back.
39 2021-01-27 pain in extremity left arm pain, right eye throbbing, right side headache, nausea, shortness of breath
39 2021-01-27 migraine migraine from sinuses; migraine from sinuses; This is a spontaneous report from a Pfizer-sponsored p... Read more
migraine from sinuses; migraine from sinuses; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 39-year-old female patient received BNT162B2, via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that the patient got the vaccine on 16Jan2021, and she experienced migraine from sinuses. She asked if it is okay to take Migraine medicine while she had her vaccine. The outcome of the events was unknown. Information about Lot/Batch number is requested.
39 2021-01-28 weakness 1/8/21 (evening): Feeling weakness and tiredness 1/9/21: Itching and redness around the injection si... Read more
1/8/21 (evening): Feeling weakness and tiredness 1/9/21: Itching and redness around the injection site, all joints aching badly (8/10 pain scale) 1/10/21: White ring around injection site; Itching continued 1/11/21: White ring around injection site; Itching continued *Itching continued through 1/15/21. * White ring around injection site currently still visible on 1/29/21. No treaments given; advise by clinic to report via V-Safe.
39 2021-01-28 pain in extremity 10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I w... Read more
10 hrs after I received 1st dose of Pfizer I started feeling my heart beating rapidly and hard. I was short of breath and had nausea and a headache. This lasted for 1.5 hrs. then I laid down. As I was falling asleep I couldn't shake a scary "vision: I was having of myself like my eyes turning bright blue and electricity going through my body and my body ascending into the air. I had nightmares all night. I have never had hallucinations or whatever that was. And nightmares are rare for me. I woke up fine on day 2, just a stiff sore arm. Day 3 I was fine. Day 4 I am developing an itchy, bumpy, rash on my right arm at site of injection and around it. I reported this online on my health chart and will go in if I keep getting strange reactions.
39 2021-01-28 numbness Reports left sided numbness beginning day after receiving vaccine. Lasted for ~ 1 week.
39 2021-01-28 feeling cold This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 39-year-o... Read more
This is a spontaneous report from a contactable Other Healthcare Professional (patient). A 39-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 14Jan2021 16:15 at a single dose on left arm for COVID-19 immunization. Medical history included GERD, sciatica, allergies, asthma, allergies to some foods (non anaphylactic). Concomitant medication included curcuma longa (TURMERIC [CURCUMA LONGA]), metaxalone, mometasone furoate (NASONEX), famotidine. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 26Dec2020 01:00 PM at a single dose on left arm for COVID-19 immunization. About 8 hours after the shot, on 15Jan2021 01:30 AM, patient woke up very cold, checked temp it was 95.9. Remained that way though the night (96F), could not sleep much b/c of chills. In the AM, temp gradually increased back to baseline 97.9. She doesn't think it was thermometer malfunction bc sx (symptoms) correlated with the temperature and she took the value repeated times. No treatment received for the events. The outcome of the events was recovered on 15Jan2021. The patient was not pregnant. Facility type vaccine was Workplace clinic. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.
39 2021-01-28 numbness, tingling by night bilateral arm heaviness; 8 days out: right forearm weakness paresthesia/pins and needles se... Read more
by night bilateral arm heaviness; 8 days out: right forearm weakness paresthesia/pins and needles sensation across neck shoulders extending to upper arms; 7 days after 2nd injection right foot/calf numbness; quadriceps weakness/11 days out left quadriceps weakness; This is spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the second dose of BNT162B2, via an unspecified route of administration in right arm on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hypothyroidism and known allergies: Penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), colecalciferol (VITAMIN D), and ubidecarenone (COQ10). Patient previously received the first dose of BNT162B2 on 15Dec2020 09:00 in right arm for COVID-19 immunization. 7 days after 2nd injection right foot/calf numbness quadriceps weakness on 12Jan2021 21:00. 8 days out: right forearm weakness paresthesia on 13Jan2021. 11 days out left quadriceps weakness, by night bilateral arm heaviness on 16Jan2021. 12 days out pins and needles sensation across neck shoulders extending to upper arms on 17Jan2021. Deep tendon reflexes intact throughout. Bladder function intact. Events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was not received for these events. Outcome of events was not resolved. Information about lot/batch number is requested.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-01-29 pain in extremity At 6 hours after shot, I developed fever to 101, sever chills, body aches, joint pain, my skin hurt... Read more
At 6 hours after shot, I developed fever to 101, sever chills, body aches, joint pain, my skin hurt, headache and extreme fatigue. This lasted for 24 hours resulting in loss of work the next day. Then 6 days later, I am still tired and achy, have soreness in my upper arms, and have a severe headache.
39 2021-01-29 pain in extremity Extreme urticaria (itchiness). Mild hives on arm and redness on neck and arm. Numb lips. Took 50 mg... Read more
Extreme urticaria (itchiness). Mild hives on arm and redness on neck and arm. Numb lips. Took 50 mg diphenhydramine mild relief slept overnight normal in am, arm only sore
39 2021-01-29 numbness, facial paralysis, slurring G4P1 prior uncomplicated pregnancy 35 +1 weeks pregnant EDD 27 Feb. That night I went to drink and ... Read more
G4P1 prior uncomplicated pregnancy 35 +1 weeks pregnant EDD 27 Feb. That night I went to drink and liquid came out my mouth spontaneously, my left side of face had lost normal wrinkles on forehead, eyebrow wouldn't lift, eyelid wouldn't blink, cheek couldn't puff, lips didn't smile. Next day (1) slight cheek numbness noted- resolved Day3 . Day 2 slight difficulty articulating words. Night 3 intermittent sharp outer ear and mastoid area pain duration 30min and at different times intermittent pulsatile heartbeat and whistling sound 10 min or less. Day 4 & 6 notable improvements in cheek ability to puff- not fully resolved though. Day 5 eyelid movement - not fully resolved though. Day 6: less difficulty articulating. Day 1: Spoke to OB office nurse- offered steroids which I declined & spoke to PCP recommended go to ED, which I declined, I'm a family physician and had otherwise normal Cranial nerve testing and no other neurological changes- seems fully consistent with Bell's palsy. Day 3 had co-worker physician use otoscope - normal exam bilaterally.
39 2021-01-29 pain in extremity I had a sore arm the first day and felt tired. The second day I had a stuffy and runny nose, my musc... Read more
I had a sore arm the first day and felt tired. The second day I had a stuffy and runny nose, my muscles were sore especially around trapezoids. Around 3 pm the second day I felt queasy and had diarrhea. I was lethargic the second day. The 3rd day had minor diarrhea and was a bit tired. Diarrhea stopped by 2pm and muscles felt better.
39 2021-01-29 difficulty speaking hoarseness, cough, pruritus, treated with IV solumedrol and diphenhydramine
39 2021-01-30 slurring, speech disorder, inability to speak Headache and fatigue. Pausing during speech. Difficulty recalling words. Using incorrect words. Slu... Read more
Headache and fatigue. Pausing during speech. Difficulty recalling words. Using incorrect words. Slurred and /or garbled speech.
39 2021-01-30 migraine Metallic taste and dry mouth inmediately after injection that stopped on its own and lasted for less... Read more
Metallic taste and dry mouth inmediately after injection that stopped on its own and lasted for less than a minute. Severe headache migraneous type that started an hour after injection, treated with OTC Acetaminophen at home but did not resolved until 6 hrs later. Moderate Myalgia and general malaise without fever or chills that started 20 hours after injection and was treated with Ibuprofen and bed rest at home. Lasted 12 hrs aprox.
39 2021-01-31 tingling "Right after the vaccine I had a tingling feeling in my finger tips" hasn't gotten worse. Still th... Read more
"Right after the vaccine I had a tingling feeling in my finger tips" hasn't gotten worse. Still there a little bit." 8:15 PM SpO2 99%, HR 66, BP 125/86
39 2021-01-31 numbness Approximately 40 minutes after injection, my tongue began to feel thick, my throat tight, and my fac... Read more
Approximately 40 minutes after injection, my tongue began to feel thick, my throat tight, and my face slightly numb. I spoke with a nurse and was given zyrtec. Within an hour, symptoms related to face and tongue were gone. Even 11 hours later, my throat feels like there is a small lump in it.
39 2021-01-31 muscle spasms, pain in extremity, cold extremities, tingling, cold sweat, numbness Day 1: numbness, pins and needles to bilateral lower legs. The pain was severe. They felt frozen. Bo... Read more
Day 1: numbness, pins and needles to bilateral lower legs. The pain was severe. They felt frozen. Body aches ascended from feet up to shoulders and then head. This lasted for 6 hours. Severe pain. Tylenol and ibuprofen did nothing. I could not focus my eyes on an object, and my ears stayed plugged, I kept trying to pop them. My throat became raspy and irritated. (Symptoms started at 16 hrs) Day 2: started having fever symptoms at hr 22, cold sweats and malaise. Couldnt get out of bed.. charley horse cramps to legs, and lower back pain. Gatorade and water didnt seem to help. I became tachycardic. I was all alone and didn't have the energy to take my vitals, I wish I had, but I know my heart was bounding quickly. Im sure I was very dehydrated. My normal HR is 70-80s. Day 3: find my right axillary node is hard and swollen, my right arm still hurts too. General body pain and fatigue still, finally able to get out of bed. Day 4: (today)out of bed most of day but in pain still, fatigued. Lymphadenopathy to right axillary still. Called out from work. Im an RN, and have chosen not to go to the E.R for prolonged symptoms. If I am still symptomatic tomorrow I will. I have a dr. Appt in 2 days with a new primary care doctor.
39 2021-01-31 numbness I had complete numbness on my right side of my tongue and right cheek. The tongue lasted one hour an... Read more
I had complete numbness on my right side of my tongue and right cheek. The tongue lasted one hour and my cheek four hours
39 2021-01-31 numbness, feeling hot I received numbness all down my right side from my finger tips to my toes, my upper and lower back a... Read more
I received numbness all down my right side from my finger tips to my toes, my upper and lower back and my right thigh get super warm when I am more active though out the day. My left arm became weak and I could not lift my arm above my head. This all occurred after the first vaccine. After the second vaccine I just got chills and muscle aches the following day. I am still experience some numbness on my right side and I still can not lift my arm above my head. 2.1.2021
39 2021-01-31 numbness, tingling Progressive body numbness and tingling from chest down, unable to feel when urinating or have a bowe... Read more
Progressive body numbness and tingling from chest down, unable to feel when urinating or have a bowel movement, tight girdle banding feeling on and around chest and back, hand malfunction with drawing, unable to walk without cane/walker, feeling of walking on a bounce house as walking
39 2021-01-31 facial pain Severe swelling, itching and pain in right side of mouth, chin and cheek. Swelling inside the mouth... Read more
Severe swelling, itching and pain in right side of mouth, chin and cheek. Swelling inside the mouth, itching, slight swollen tip of the tongue on the right side
39 2021-01-31 seizure Systemic: Anaphylaxis-Severe, Systemic: Seizure-Severe
39 2021-01-31 numbness Two minutes post injection her arm went numb at site & then shot down to finger tips. At times ther... Read more
Two minutes post injection her arm went numb at site & then shot down to finger tips. At times there is throbbing (like punch) just at the site. Feels like her arm went to sleep.
39 2021-02-01 hypersensitivity of all senses, numbness Early Bell's Palsy; Facial numbness on the left side of her face; Facial numbness on the left side o... Read more
Early Bell's Palsy; Facial numbness on the left side of her face; Facial numbness on the left side of her face; Facial numbness and increased sensitivity on the left side of her face; This is a spontaneous report from a pharmacist. A 39-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), intramuscular at left arm on 06Jan2021 17:00 at single dose for covid-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, factor V leiden, gastroesophageal reflux disease (GERD), history of deep vein thrombosis (DVT), hypertension, neck pain on left side, rhinitis, rhomboid muscle strain and pain. No known allergies. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone for pain, sodium chloride. The historical vaccine included the first dose of BNT162B2 (Lot number: EJ1685) via intramuscular at left arm on 17Dec2020 04:15 PM and the paitent did notice some numbness on the right side of face after receiving the first dose of vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced facial numbness and increased sensitivity on the left side of her face. There was no facial droop or lid lag. Other cranial nerves are stable. Concern for early Bell's Palsy would be treated with valganciclovir and prednisone. The adverse events (AE) started from 15Jan2021 09:00. AE resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment valganciclovir 1gm q8h, prednisone 20mg 3-day taper for AE. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.; Sender's Comments: Based on the temporal relationship, the association between the event early Bell's paly with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-02-01 numbness, inability to speak, muscle twitching, pain in extremity, throat numbness Felt dizzy and nauseous soon after with difficulty swallowing/dysphasia for a few hours. Facial twit... Read more
Felt dizzy and nauseous soon after with difficulty swallowing/dysphasia for a few hours. Facial twitches. Arm pain in evening and next day that went away. Nausea remained and continues (9 days after so far). Evening 8 slight facial numbness and today day 9 face, throat and back of tongue feels slightly numb. Slightly shallow breathing. Dizziness and fatigue/malaise.
39 2021-02-01 tingling Mild fever for a few days after the vaccination as well as muscle aches and fatigue. On the day repo... Read more
Mild fever for a few days after the vaccination as well as muscle aches and fatigue. On the day reported, started getting tingling on right face below nose similar to cold sore have had in the past. Then got much worse and herpatic lesions spread to end of nose and up nose and on face. Had an appointment and got put a week of Valtrex.
39 2021-02-01 numbness Patient developed right lower extremity heaviness, numbness approx. 15 minutes post vaccination. EMS... Read more
Patient developed right lower extremity heaviness, numbness approx. 15 minutes post vaccination. EMS was activated, sent to ED.
39 2021-02-01 flushing flushing to face and swollen cheeks; flushing to face and swollen cheeks; nausea; vomiting; This is ... Read more
flushing to face and swollen cheeks; flushing to face and swollen cheeks; nausea; vomiting; This is a spontaneous report from a contactable Other Health Professional. A female patient (non-pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunisation. Medical history included anxiety, PCOS (polycystic ovarian syndrome), known allergies: sulfa. Concomitant medication included biotin, cannabidiol (CBD OIL), fish oil, ibuprofen, metformin, famotidine (PEPCID AC), spironolactone, ethinylestradiol; ferrous fumarate; norethisterone acetate (TAYTULLA), calcium carbonate (TUMS [CALCIUM CARBONATE]), colecalciferol (VIT D3). The patient experienced flushing to face and swollen cheeks, nausea and vomiting day 4 after vaccine on 18Jan2021 16:00. Therapeutic measures were taken included cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC). This event resulted in: Doctor or other healthcare professional office/clinic visit. Outcome of the event was not resolved. Information on Lot/Batch number has been requested.
39 2021-02-02 pain in extremity Arm pain. Persistent Chest pain and pressure for over 2 weeks and counting
39 2021-02-02 feeling hot, pain in extremity Five hours after receiving vaccine arm became sore and she had difficulty lifting her arm. She then ... Read more
Five hours after receiving vaccine arm became sore and she had difficulty lifting her arm. She then developed joint pain in her left leg and a headache. Then developed joint pain in her hands. By the next day the arm pain had eased but minor joint pain and muscle aches continued. Three days after vaccination, the arm pain returned achiness in joints was throbbing . This is easing 18 days post vaccination but is not gone. The arm pain is gone. The most disturbing symptom occurred two weeks post vaccination. The patient began getting warm sensations in her right foot along the lateral side and occasionally in the heel. This does not hurt but is also persisting and is disturbing. She is uncertain if there is any relationship with her Crohn's disease.
39 2021-02-02 feeling hot I received COVID vaccine #1 on 6 Jan 21. Shortly following the vaccine I turned very red and felt v... Read more
I received COVID vaccine #1 on 6 Jan 21. Shortly following the vaccine I turned very red and felt very hot. The next few days I experienced a very bad headache and flu like symptoms. On 9 Jan 21 my left eye felt very irritated and had redness. I was seen by optometry on 11 Jan 21 and was diagnosed with a corneal ulcer. I received COVID vaccine #2 on 27 Jan 21. I was observed for 30 minutes based on the first vaccine experience. I got very flushed, red, and hot and very itchy. I felt lightheaded and not right. I had hives behind my ears and on my chest. I notified one of the vaccine staff who gave me 25mg Benadryl by mouth and took my vitals. The staff observed me for another 45 minutes. Once I went outside the back of my throat felt very itchy. I felt like I had something in my throat and I had to keep trying to clear my throat. I got very red, hot, and itchy again. I went back inside to tell the staff. They gave me an epi pen injection into my right thigh and called the ambulance. I was taken to the ER to be evaluated. Two days later I noticed the back of my throat was very red and my uvula was large and elongated. I called the clinic and was given cough drops and Cepacol. I have been experiencing hives, redness, and feeling very itchy. To a point I have been having to take Benadryl. I took the 5 days of steroids and ended them on Monday. Yesterday, 2 Feb 21 I woke up and my right eye was bloodshot, irritated, and uncomfortable. I was seen at Urgent Care and prescribed Ofloxacin 4x a day for 10 days. They did not notice any scratches or anything. My right eye is still uncomfortable and red. I am currently on day two of the eye drops.
39 2021-02-02 migraine Nausea, Migraine, Chills, & Body Aches
39 2021-02-02 pain in extremity Pain in arm was so bad I was unable to use my arm for several hours. Was treated five times for a ... Read more
Pain in arm was so bad I was unable to use my arm for several hours. Was treated five times for a bladder infection, was determined that their was blood in my urine. Being referred to urology. Had to take Benadryl and ibuprofen for swelling of face and neck. Burning of urinary tract has been extremely bad and still has not subsided. Still having very bad flare ups of these symptoms including severe nauseas and dizziness (vertigo). Having to eat bland foods and take Pepto everyday. Severe Fatigue. 10 days ago I was sent home from work due to feeling bad and looking ill (very pale). Hospital wanted to keep me overnight.
39 2021-02-02 flushing Patient received the vaccine at 1:41 pm the next morning when she woke up she had a headache, nausea... Read more
Patient received the vaccine at 1:41 pm the next morning when she woke up she had a headache, nausea, and flushing. These symptoms have continued and was evaluated in the clinic on 2/3/21 for continued symptoms.
39 2021-02-02 flushing Patient voiced having metallic taste in mouth and had mild redness on chest and stated chest felt wa... Read more
Patient voiced having metallic taste in mouth and had mild redness on chest and stated chest felt warm. Patient denied any itching.
39 2021-02-02 pain in extremity Same Day Left arm, neck, and back severe pain Next day Fever 101.1 Chills Full body aches Headache... Read more
Same Day Left arm, neck, and back severe pain Next day Fever 101.1 Chills Full body aches Headache Joint pain
39 2021-02-02 cold sweat, tremor Sweaty palms, numb lips, cold sweats, shakiness
39 2021-02-02 grand mal seizure Two tonic clonic seizures experienced 6&12 hours post chemotherapy (4 days post vaccine) regimen, cy... Read more
Two tonic clonic seizures experienced 6&12 hours post chemotherapy (4 days post vaccine) regimen, cycle 2 of adriamycin and cytoxan
39 2021-02-02 migraine Vomiting, Fever >102, diarrhea, arthralgia, myalgia, migraine
39 2021-02-02 numbness, facial paralysis some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a con... Read more
some numbness on the right side of face; early Bell's Palsy; This is a spontaneous report from a contactable pharmacist. A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685), intramuscular in the left arm on 17Dec2020 16:15 at a single dose for COVID-19 immunization. Medical history included allergic rhinitis, deviated nasal septum, Factor V Leiden, GERD (Gastroesophageal reflux disease), DVT (deep vein thrombosis), hypertension, neck pain on left side, rhinitis, and rhomboid muscle strain. Concomitant medication included fluoxetine, acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE), fluticasone nasal spray, hydrochlorothiazide, lisinopril, loratadine, meloxicam, omeprazole, oxycodone, and sodium chloride nasal spray. The patient had no other vaccines in four weeks before covid vaccine. The patient had no prior vaccination and she had not been tested post vaccination. The patient noticed some numbness on the right side of face after receiving the first dose of vaccine on an unknown date. She was concerned for early Bell's Palsy on 15Jan2021 at 09:00 AM. She will be treated with valganciclovir and prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events early Bell's Palsy and some numbness on the right side of face was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported "concerned for early Bell's palsy". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-02-03 tingling -Palpitations -Rash -Tingling of Hands and Feet
39 2021-02-03 flushing, numbness, tremor, tingling After the first shot on 12/26/20 I had dizziness, facial flushing, elevated blood pressure, and tach... Read more
After the first shot on 12/26/20 I had dizziness, facial flushing, elevated blood pressure, and tachycardia within minutes. It lasted about an hour. I had no issues after that. I received the 2nd shot on 1/15/21, I had the exact same reaction however it only lasted 20 min. I then went to my car and started driving home, about 10 minutes later and while on the freeway I had dizziness, flushing, tachycardia, , shakiness, and facial numbness. I took an exit and was able to pull over in a parking lot. It lasted about 20 minutes. Since that time I have had frequent episodes of dizziness, facial flushing, tremulousness, facial numbness/tingling, and presyncope. The worst episodes were on 2/1/21 and 2/3/21. I was unable to work because of these symptoms.
39 2021-02-03 discomfort, pain in extremity I have a lot of muscle pain in my left arm and my shoulder blade, I can't sleep very well because of... Read more
I have a lot of muscle pain in my left arm and my shoulder blade, I can't sleep very well because of the pain, I have taken ibuprofen few times but it calms me down for a few hours, yes I can lift my arm and move it but I feel pain and discomfort all the time.
39 2021-02-03 flushing Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following ... Read more
Patient received Pfizer vaccine #2 today. After the vaccine, the employee reported the following symptoms: flush feeling. She was already in her car. She looked in the mirror and noted redness on her neck. She then came back to the clinic. redness on her neck and chest Lot: EL3247 Time of Administration: 01/29/2021 1106am Time Symptoms Began: 15-20+ minutes _____ When arriving back in the clinic, she was taken to the medical observation area. Initial Assessment @ _1141am_: Patient is AAO. The employee sat on the sofa. The employee is pink and does not appear to be in distress. They are talking and making conversation. She has some redness on her neck. Vitals @:1142 HR: 107 BP: O2: 98 Given a water to drink. NO itching, tingling, scratchy feeling. Vitals @: 1145 HR: 94 BP: O2:99 Allergies: Percocet. Started as a rash on her chest. Then she had facial swelling. Was treated with prednisone. No anaphylaxis ever. Employee was discharged without treatment. Advised to take a benadryl when she gets home. She lives about 15 minutes from the clinic.
39 2021-02-03 burning sensation Two days after receiving the vaccine patient experienced flu-like symptoms, body aches, nausea, and ... Read more
Two days after receiving the vaccine patient experienced flu-like symptoms, body aches, nausea, and swollen lymph nodes in the armpit. The next day she had eye and jaw pain, and burning up and down her arm which she believes is the start of shingles
39 2021-02-03 weakness Was vaccinated on 1/28/21 and around midnight started getting chills followed by feeling feverish. T... Read more
Was vaccinated on 1/28/21 and around midnight started getting chills followed by feeling feverish. This continued on and off until the end of the day on the 1/29. I also felt very weak and nauseous.
39 2021-02-03 cold extremities, tingling, numbness her hands were cold; Her hand went numb/ feels the tingling/numbness for the most part from the wris... Read more
her hands were cold; Her hand went numb/ feels the tingling/numbness for the most part from the wrist down; her left hand has been tingly/ Her hand tingling started almost immediately after getting the vaccine/ feels the tingling/numbness for the most part from the wrist down; This is a spontaneous report from a contactable consumer (patient [dental hygienist]). A 39-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration (injection in left upper arm) from 15Jan2021 13:15 as COVID Vaccine. Vaccination Facility Type: Clinic. Medical history included hands were sometimes cold. Concomitant medication included cyanocobalamin (VITAMIN B12) given as self-injections in upper leg once a week on Sundays. The patient was previously given seasonal flu vaccine on Oct2020. No prior vaccinations within 4 weeks. Patient received her first dose of the COVID Vaccine today around 1:15PM or so the day of reporting and almost immediately started to experience event: She drove off from the waiting area; he was taking pictures; she commented her hands were cold, but her hands were sometimes cold anyway. She received the injection in her left upper arm. Since getting the injection in her left upper arm her left hand has been tingly. It was like it was asleep. She was wondering if they possibly hit a nerve or something when administering. She has called her doctor as well. Her hand tingling started almost immediately after getting the vaccine. She had to wait 15 minutes to be observed if any symptoms occurred. She waited, took selfies and also mentioned she contacted her doctor she works with. Her hand went numb and cold. She thought it was weird. At first, she thought it was just like her hand getting cold, but it never went away. She still feels it and it is like hand went asleep like if lay on it too long. She added she has on a watch and that was around the area where she feels the numbness so during the call she took it off. She feels the tingling/numbness for the most part from the wrist down, but she also feels it higher up as well, but mainly from the wrist down. She was hoping that does not happen where she has to go. She has called the doctor already and was advised what to do. No emergency room visit/ physician office visit was made for the events. Outcome of hand tingly was not recovered (ongoing at the time of reporting) and unknown for the other events.
39 2021-02-04 muscle spasms I woke up the following morning feeling extremely drowsy. Swelling of lymph node under my arm and fi... Read more
I woke up the following morning feeling extremely drowsy. Swelling of lymph node under my arm and fingers and every so often my arm will swell showing my veins. Redness. extreme cramping. Cramping on the 2nd and 3rd day in the lower extremities. 2nd, 3rd and 4th day had headache. I still still get the drowsiness every once in a while as well as other symptoms.
39 2021-02-04 tingling Patient described some swelling and tingling in her injection arm. Patient denied any pain or rednes... Read more
Patient described some swelling and tingling in her injection arm. Patient denied any pain or redness in the injection arm. Patient denied any trouble breathing, chest pain or any other symptoms besides the tingling and swelling. Patient denied any required treatment or transport to the hospital.
39 2021-02-04 tingling, pain in extremity diagnosed at primary care office with SIRVA. 10/10 debilitating pain in left arm and shoulder. Ting... Read more
diagnosed at primary care office with SIRVA. 10/10 debilitating pain in left arm and shoulder. Tingling in left arm and neck. I have had pain and tingling in my arm since I received my second shot, I thought that that was to be expected until it worsened this week. It is now debilitating pain and I am out of work and having to use Earned Time to be out.
39 2021-02-04 weakness severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontane... Read more
severe fatigue; chills/rigors; fever; myalgia; global weakness; sweating; nausea; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 06:45 at single dose (vaccine location=right arm) for covid-19 immunisation. The patient medical history was not reported. No known allergies. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received first dose of BNT162B2 on unspecified date at single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The patient experienced severe fatigue, chills, fever, rigors, myalgia, global weakness, sweating and nausea on 21Jan2021 07:00 PM. It was unknown if treatment received for events. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association. This case will be re-assessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-02-05 feeling hot Adverse event happened immediately after injection. Heat wave, rapid heart rate, increase respiratio... Read more
Adverse event happened immediately after injection. Heat wave, rapid heart rate, increase respirations, feeling of water dripping inside my arm, High Blood Pressure. Since then I have had feelings of "vibrations" running up and down my spine, arms, head, neck, chest, legs. I have been to the Chiropractor, Urgent Care Clinic, PCP, ER. Waiting to see a Neurologist... All of these symptoms happened after the 1st dose of the covid vaccine, and have worsened each day since. January 18 2021 to Current date. I have a detailed list of times, dates, and actions.
39 2021-02-05 pain in extremity Body aches, really bad back ache and legs aching. Left arm were vaccine was given really sore and ar... Read more
Body aches, really bad back ache and legs aching. Left arm were vaccine was given really sore and armpit and whole left side of body hurt. Burning in throat.
39 2021-02-05 feeling hot Facial swelling, neck swelling, dizziness, shortness of breath, nausea, warm feeling, lips itchy, fa... Read more
Facial swelling, neck swelling, dizziness, shortness of breath, nausea, warm feeling, lips itchy, face itchy
39 2021-02-05 seizure Patient experienced seizure activity and respiratory distress approximately 1 hour after receiving t... Read more
Patient experienced seizure activity and respiratory distress approximately 1 hour after receiving the vaccination. Patient does have a history of seizure activity and physician on site was skeptical as to whether this was due to the vaccination or the patients history. Could also have been a result of change in environment or stress of vaccination clinic day.
39 2021-02-05 tenderness Rash/welt on shot arm developed 2 days later underneath arm not at injection site. Red blotchy not i... Read more
Rash/welt on shot arm developed 2 days later underneath arm not at injection site. Red blotchy not itchy but very tender and bruised feeling.
39 2021-02-05 pain in extremity Reported signs and symptoms of aches and chills same as after first does. Significant nausea and dia... Read more
Reported signs and symptoms of aches and chills same as after first does. Significant nausea and diarrhea, arm pain and warmth, unable to turn neck without pain, temperature 100.5.
39 2021-02-05 burning sensation Severe joint pain. Felt like I could feel my bones and that they could shatter. My spine felt like i... Read more
Severe joint pain. Felt like I could feel my bones and that they could shatter. My spine felt like it was on fire. Lasting about 24 hrs. Still having persistent left elbow pain, and have had it since my first COVID vaccine.
39 2021-02-06 tingling, numbness Chills and aches lasting 24 hours. L arm continues to experience numbness and tingling like my arm w... Read more
Chills and aches lasting 24 hours. L arm continues to experience numbness and tingling like my arm was asleep
39 2021-02-07 tenderness 7 days post injection, lump on left arm pit formed. Tender to the touch. Grew the next day, then sta... Read more
7 days post injection, lump on left arm pit formed. Tender to the touch. Grew the next day, then started to decrease in size and tenderness.
39 2021-02-07 muscle spasms, weakness On 2/4/21 around 2:00 a.m. patient had a high fever and head to toe body aches; shortness of breath ... Read more
On 2/4/21 around 2:00 a.m. patient had a high fever and head to toe body aches; shortness of breath to the point of panting. Patient took tylenol and then advil every 4 hrs (400 mg) and would find relieve for a couple hours. Patient had severe pain, also severe constipation and cramping. These reactions went well in the early morning of 2/5/21 and abated some; had to call out from work on 2/4/21 and 2/5/21. On 2/6/21, patient still had weakness and fatigue; tried running errands and had to go home right away and nap. On 2/7/21, patient felt much better and is at work today, 2/8/21.
39 2021-02-07 pain in extremity soreness in arm Chills, fever, body aches, swollen lymph nodes began about 12 hours after the shot a... Read more
soreness in arm Chills, fever, body aches, swollen lymph nodes began about 12 hours after the shot and continued for 36 hours. Headache 36 hours
39 2021-02-08 muscle spasms 2/1/2021: Awoke at 0500 and 0700 drenched in sweat. Muscle spasms started at this time (strong spasm... Read more
2/1/2021: Awoke at 0500 and 0700 drenched in sweat. Muscle spasms started at this time (strong spasms all over body). Heart rate in 90s at rest (my baseline resting heart rate is 60) and up to 130s/140s with minor activity. Shortness of breath with activity. 2/2/2021: Insomnia overnight. More sweating. Strong muscle spasms continue all over body. Heart rate still in 90s at rest. Reported to ER for palpitations. Heart rate at 144 upon checking in. BP and oxygen levels normal.
39 2021-02-08 tremor 20 hours after shot, persistent fever maintained at 102.7 while covered by Tylenol 1 gram and Motrin... Read more
20 hours after shot, persistent fever maintained at 102.7 while covered by Tylenol 1 gram and Motrin 800 mg being taken every 6 hours. Severe chills, shaking, body soreness, and fatigue. Left Arm swelling, redness the size of a softball, hard and hot skin. Arm swelling lasted for 6 days.
39 2021-02-08 pain in extremity Fever 101.8 Muscle Aches Arthralgia Chills Sweats Fatigue Arm soreness
39 2021-02-08 flushing Immediately after her second Covid vaccine injection, she began to have a cluster headache and felt ... Read more
Immediately after her second Covid vaccine injection, she began to have a cluster headache and felt flushed. O2 was administered for 15 minutes to treat headache. All vitals were normal Cardiopulmonary assessment was normal. All abnormal feelings resolved prior to her leaving the vaccine clinic approximately 45 minutes after injection. Later that day, she started to have "lockjaw" symptoms and went to her PCP. She received an IM injection of dexamethasone and has been fine since.
39 2021-02-08 numbness, tingling Numbness and tingling of left arm. Patient was kept for an additional 15 minutes for observation for... Read more
Numbness and tingling of left arm. Patient was kept for an additional 15 minutes for observation for a total of 30 minutes. During observation patient's BP and pulse were elevated and patient stated he had a slight pain in her chest. Taken to Emergency Room immediately after 30 minute observation.
39 2021-02-08 pain in extremity Pain in BOTH arms, elbows to fingertips, unrelenting. Worse when pressure applied (such as when rest... Read more
Pain in BOTH arms, elbows to fingertips, unrelenting. Worse when pressure applied (such as when resting arms on desk). Significantly impacting my ability to be on the computer (and I work on a computer.) Continuous.
39 2021-02-08 one side paralysis Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusi... Read more
Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusitis. She has NKDA. Her medications prior to event included alprazolam 0.25mg Qday, citalopram 20mg, 1 and ½ tabs Qday, Topamax 25mg, 3 tabs Qday and Zyrtec 10mg Qday. She was administered her first dose of the Pfizer COVID vaccine on 1/21/21 at 1:30pm. She presented to the hospital on 1/22/21 @ 9:45am with acute onset of right sided weakness (she is a teacher who collapsed in her classroom without LOC) and was found to have a intraparenchymal hematoma (IPH) in the left posterior paramedian frontal lobe measuring up to 2.9 x 1.8 x 3.4cm with surrounding vasogenic edema and mild local mass effect with no underlying mass lesion or vascular malformation on MRI. She stated that she has had intermittent headaches over the last few weeks not similar to her prior migraines, although with no neuro deficits. She was also noted to have a urine tox screen positive for amphetamines. There is a confirmatory test pending. She was discharged to acute rehab on 1/25/21. Patient is still recovering from the adverse event. She did not receive any other vaccines within a month prior to the event.
39 2021-02-08 feeling cold Pfizer-BioNTech Covid -19 Vaccine EUA 2/6/21 mild headache, body aches around 1800 hours. Insomnia,... Read more
Pfizer-BioNTech Covid -19 Vaccine EUA 2/6/21 mild headache, body aches around 1800 hours. Insomnia, vivid dreams, body aches and feeling cold around 2300 hours. 2/7/21 fatigued, body aches 2/8/21 severe fatigued, stronger headaches, body aches, swollen lymph nodes - contacted primary care (waiting for nurse to return my call. I was able to get an appointment online for March) 2/9/21 mild headaches, a large purple bruise on left inner thigh. Lymph nodes are still painful. (I called my primary care and I?m waiting again for the call back)
39 2021-02-09 weakness, pain in extremity Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the... Read more
Began with fever, tonsillitis, sore throat, sinus drainage, muscle aches. Then on Saturday night the body aches were progressively worse and concentrated on left side of body. Joints were affected including left wlbow, wrist, shoulder. Hot viral rash appeared on arm right above left elbow that became painful with swelling and erythema. In Sunday through the following Wednesday, joint pain continued to worsen and settle in additional joints including first 2 metacarpal bones of both hands almost like arthritic pain. Fingers and joints red and swollen. Pain and swelling next settled in toes of both feet, right side elbow, shoulder and knee. On Monday following vaccine I called employee health and they advised me to come and take covid test. I described symptoms and was told they were side effects of the vaccine and to follow up with a doctor if it continues. My covid test was negative. On the following Thursday I went to urgent care and described my persisting symptoms. I was prescribed a methylprednisolone pack and hydroxyzine. I was told to use naproxen as needed. Yesterday the urgent care sent a check up message. I am still experiencing joint pain although the intensity has decreased but it is still significant pain that is disabling my grip and strengrh overall. The joint pain is mostly just in my upper extremities, hands, fingers and shoulders now consistently. The np prescribed a 10 day pack of meloxicam to try and help minimize the pain.
39 2021-02-09 migraine I had a migraine headache for 2 days that I had never experienced before. It started in the base of ... Read more
I had a migraine headache for 2 days that I had never experienced before. It started in the base of my neck and wrapped around both sides of my head and into my forehead. Nothing made it better. Ice, heat, over the counter pain relievers. I had to wait it out.
39 2021-02-09 feeling cold I woke up Friday with a fever. I suffered from being cold and could not get warm. The fever broke Fr... Read more
I woke up Friday with a fever. I suffered from being cold and could not get warm. The fever broke Friday night. Saturday I had severe body ache and tiredness. Sunday I woke up with the most terrible headache. The headache lasted 6 hours and was very intense. Monday the chills returned as I could not get warm and I still feel fatigued easily.
39 2021-02-09 migraine, hot flush Migraine headache within 3 hours of vaccine. This was the exact same headache I had described a coup... Read more
Migraine headache within 3 hours of vaccine. This was the exact same headache I had described a couple days after my first COVID-19 vaccine on 12/24/20. The pain started in the base of my skull, and radiated up around the outside and back of my head and in the front by my eyes. This lasted about 6 hours this time. I used iced, heat, and Excedrin Migraine. That did help this time. I also had hot flashes for about a week afterwards. My face, ears, chest and palms of my hands turned bright red off and on during the day. I took some Benadryl and that seemed to help.
39 2021-02-09 pain in extremity, migraine Sore arm, chills, body aches, joint soreness, anxiety, migraine type headache, fatigue
39 2021-02-09 pain in extremity The injection of the vaccine was fine. My arm started getting sore about an hour afterwards. The n... Read more
The injection of the vaccine was fine. My arm started getting sore about an hour afterwards. The next morning I could not lift my arm at all. About 18 hours after getting the vaccine I had severe body and joint aches, my lymh node in my armpit was swollen and sore (on injection arm), I had a headache, and I was exhausted. This continued for 48 hours. The swelling of the lymph node went down and the body and joint pain lessened. However 5 days after I am still exhausted, dealing with a headache, my arm is still sore, and am experiencing joint pain and back pain. I was diagnosed with COVID 19 on December 4, 2020, with COVID Pneumonia on Decemeber 13, 2020, and with Post Viral Syndrome on December 28, 2020.
39 2021-02-09 numbness left sided transient facial numbness x 2 occasions
39 2021-02-09 difficulty speaking muscle pain in her arm where she received the injection; cough; hoarseness in her voice; clearing of... Read more
muscle pain in her arm where she received the injection; cough; hoarseness in her voice; clearing of the throat; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. Medical history included has ongoing allergies and has to take an "allergy pill" every day for this condition, diabetes and hypothyroidism. Concomitant medication included levothyroxine, ertugliflozin pidolate (STEGLATRO), loratadine, montelukast, metformin, atorvastatin, lisinopril, colecalciferol (VITAMIN D), cyanocobalamin (VITAMIN B12), dulaglutide (TRULICITY) and ongoing allergy pill. She reported that she received her vaccine in a mass Covid vaccination. The reporter stated that she developed muscle pain in her arm where she received the injection, which she states that she understands this is a commonly reported side effect. She also developed a cough, hoarseness in her voice, and noticed that the cough was worse when she went to bed. She mentioned that her cough started on Wednesday, she felt like it was little bit worse on last night (unspecified date), than it was on Saturday, so she means it was only Sunday after that [pending clarification]. The reporter was heard clearing her throat multiple times on the phone during the conversation. She would like to know if the cough, hoarseness and clearing of the throat are commonly reported symptoms. The patient was informed that the injection side pain was reported last on average between 1-3 days. Per the EUA Prescribing Information, "Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days" and that we did not have information on how long her mild respiratory symptoms may last and referred her to her HCP. The patient was encouraged to contact her healthcare professional if her symptoms did not go away or if they became worrisome and she verbalized understanding. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included blood work showed normal on 15Jan2021. The outcome of the event cough was not recovered while the outcome of the other events was unknown. Information about Batch/Lot number has been requested.
39 2021-02-10 tenderness A few hours after receiving the vaccine, I developed fevers lasting until 3 days as high as 104.7, s... Read more
A few hours after receiving the vaccine, I developed fevers lasting until 3 days as high as 104.7, self-care of Tylenol and Iced towels. I started seeing spots/ floaters in my left eye. I made an appt the following day and was advised I had 3 hemorrhages in my left eye, the spots/floaters are still there. Fatigue, full body pain, vomiting lasted one day, the day after the vaccine, dizziness and Tenderness in left arm where the vaccine was given, still slight pain 3 weeks later.
39 2021-02-10 tingling After 9 minutes my tongue start to swell and tingle .. within a hour my mouth and lips started tingl... Read more
After 9 minutes my tongue start to swell and tingle .. within a hour my mouth and lips started tingling. My moth and lips felt as if they were swollen
39 2021-02-10 breast pain Axillary lymph node swelling, intense shooting & throbbing pain in underarm area, radiating pain to ... Read more
Axillary lymph node swelling, intense shooting & throbbing pain in underarm area, radiating pain to breast tissue- all above on injection side Large, hard, painful hematoma at injection site.
39 2021-02-10 migraine I had a migraine beginning Feb 9 AM. I have chronic migraines that almost always occur on the left s... Read more
I had a migraine beginning Feb 9 AM. I have chronic migraines that almost always occur on the left side of my head, but this one was on the right side, which is unusual for me. The migraine pain was more severe than normal. I also had a stiff right jaw and eye pain primarily on the right side. I took 100 mg Imitrex in the afternoon of Feb 9 and it reduced the pain very effectively (which is also unusual for me). On Feb 10 AM, the migraine returned or a new one started. The pain was also in the right side. I took 100 mg Imitrex and it reduced the pain somewhat effectively. The migraine pain returned Feb 11 AM and hurt on both sides of my head. I took 100 mg Imitrex this evening (Feb 11) and it is helping so far. In addition, my left arm was sore around the injection site beginning when I got the shot and stopped this morning.
39 2021-02-10 tremor, inability to speak, slurring, facial paralysis, one side paralysis Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later h... Read more
Patient received her 1st dose of Pfizer vaccine around 1810 on 2/9. Approximately 10-15 mins later her arm was shaking uncontrollably, she felt that her throat was closing and had chest pressure. Medics noted hives and a rash on her chest and administered Epi and Benadryl. She began exhibiting stroke-like symptoms of expressive aphasia and dysarthria in the medic?s truck around 1850. She was crying and unable to speak. She had right sided facial droop, right sided grip weakness, and right sided arm drift. Patient was transferred to MC. Patient Update: Patient received tPA on 2/9 at 1949. CT revealed no hemorrhage or large territory stroke and no large vessel occlusion. NIHSS on admission to MC was a 3. Patient was also assessed by speech pathology. Patient appears to have been discharged home on 2/10. Patient to follow up with Outpatient Neuro PT Rehab as she is having some issues with mobility, gait, and overall functional mobility. She is using a 2 wheeled walker at this time.
39 2021-02-10 night sweats Patient stated that persistent throbbing pain was present in her lower left back area (kidney area) ... Read more
Patient stated that persistent throbbing pain was present in her lower left back area (kidney area) that lasted for about 2 days. As well as a sharp pain in the left side of her chest - on and off for about 2 hours the evening following the shot. Chills as well as sweats at night when trying to sleep for 2 consecutive nights.
39 2021-02-11 pain in extremity I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headach... Read more
I got a strange vision/hallucination; rapid and hard heartbeat; shortness of breath; nausea; headache; had nightmares all night; stiff, sore arm; stiff, sore arm; my arm has a bumpy, red mild rash at and around injection site; my arm has a bumpy, red mild rash at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 39 years) as a single dose in the right arm for COVID-19 vaccination. Medical history included fatty liver. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unspecified date. Concomitant medications were not reported. The patient reported that on 27Jan2021 at 12:30 AM, approximately ten hours after the vaccine, the patient experienced a rapid and hard heartbeat, shortness of breath, nausea and headache. These lasted for one and one half hours. As she lay down falling asleep she got a strange vision/hallucination (this had never happened to her before) of her eyes turning lightning blue and her body rising up in the bed. She stated that she does not take medications or drugs and does not have a history of mental illness. She could not shake the vision. She fell asleep and had nightmares all night and nightmares are rare for her. One day two she woke up fine just a stiff, sore arm. On day three her arm has a bumpy, red mild rash at and around injection site. The patient did not receive any treatment for the events. Lab data included a COVID SARS CoV-2 positive test on an unspecified date. The clinical outcomes of hallucination, heart rate increased, shortness of breath, nausea, headache, nightmares, pain in arm, limb stiffness and vaccination site rash were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
39 2021-02-11 cold extremities cold extremities; fever; chills; fatigue; rheumatoid arthritis; This is a spontaneous report from a ... Read more
cold extremities; fever; chills; fatigue; rheumatoid arthritis; This is a spontaneous report from a non-contactable physician. A 39-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. Historical Vaccine included received first dose of BNT162B2 intramuscular at the age of 39-year-old on 16Dec2020 at single dose for COVID-19 immunization and did fine. The patient did fine after first dose, after second dose had 36 hours of fever and chills. Covid test negative. Several weeks later she developed fatigue and cold extremities. She was found to have elevated CCP (Cyclic Citrullinated Peptide) antibodies, dx (diagnosis) rheumatoid arthritis. All events occurred on 04Jan2021. The events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Treatment received for the events included medication for pain, specialist referral. There was no other vaccine received in four weeks. The patient was no pregnant. The patient had no COVID prior vaccination. Covid test (Nasal Swab) post vaccination was Negative. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the time association and drug's safety profile, the events fever, chills, fatigue, and cold extremities are possibly related to suspect vaccine BNT162B2 administration. The event rheumatoid arthritis is more likely underlying/intercurrent condition, unrelated to suspect vaccine BNT162B2 injection given the product's safety profile and the pathophysiology of rheumatoid arthritis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-02-14 cold sweat Chest and throat tightness, nausea, dizziness, clammy, BP 160/100.
39 2021-02-15 weakness 1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test w... Read more
1/21/21 pt started experiencing fever about 3:30 PM, went to Urgent care received rapid COVID test which was negative, 1/22/21 still has fever drive thru at hospital covid drive thru pt had PCR and it was also negative, went back to same drive thru on 1/24/21 and had another PCR which was negative, 1/25/21 urgent care visit, pt was tested for flu-Negative, lab work was done which showed CBC all counts were low resulted in ER visit, admitted 1/25/21 afternoon with panside apnea and sepsis and patient stayed in hospital for 9 days 2/2/21 pt was released to go home. Lots of labs and test were done while patient was inpatient, Pt is still weak and has no energy.
39 2021-02-15 pain in extremity Adverse effects: fatigue/dizziness/headache, resolved after 24 hours, left arm pain and swelling ar... Read more
Adverse effects: fatigue/dizziness/headache, resolved after 24 hours, left arm pain and swelling around injection site persist for 2-3 days, swelling is continue getting bigger, warm and tender to touch. Tx: possible post-vaccination cellulitis (left arm), given Keflex 500mg tid for 7 days, OTC NSAID prn for pain, swelling edge marked and advised monitor swelling edge, seek immediate care if getting worse, follow up with PCP.
39 2021-02-15 flushing Headache, flushing, nystamus
39 2021-02-15 numbness Patient reported reaction to first vaccine. After receiving dose, resident started feeling dizzy (at... Read more
Patient reported reaction to first vaccine. After receiving dose, resident started feeling dizzy (at 3:15pm). at 3:25pm patient reported tingling of the bottom lip. Both resident reported with previous dose. AT 3:50PM patient reported no change, and reported to director of nursing that legs felt "heavy" and that her legs had fallen asleep. She did not want Benadryl. Director of nursing let staff member leave facility around 4:10pm, with another nurse driving her home after confirming resident felt well enough to leave.
39 2021-02-16 weakness Tachycardia, dizziness, weakness within 5 minutes of receiving injection. Moderate tinnitus several... Read more
Tachycardia, dizziness, weakness within 5 minutes of receiving injection. Moderate tinnitus several weeks following injection.
39 2021-02-17 tremor Throat tight, hard to swallow, extreme dry mouth, chills, shaking, anxiety
39 2021-02-18 tingling, numbness, weakness About ten minutes after administration, the patient developed transient left hand tingling, numbness... Read more
About ten minutes after administration, the patient developed transient left hand tingling, numbness, and weakness, as well as pain at the injection site. The patient was monitored for another 15 minutes, but it appears that her symptoms, other than the injection site pain, was abating. She denied systemic symptoms.
39 2021-02-18 tingling Ascending tingling that began in left foot and spread to bilateral upper legs/saddle within 30 minut... Read more
Ascending tingling that began in left foot and spread to bilateral upper legs/saddle within 30 minutes, bilteral arm tingling began 2 days later, still with random paresthesia of all extremities; 5 weeks post 2nd dose developed episodes of tachycardia, rapidly increase in BP, feeling of brain fog, pressure on head - episodes last for 5-6 hours and resolve spontaneously
39 2021-02-18 pain in extremity Headache Nausea and vomiting Sore arm
39 2021-02-18 pain in extremity Hives, severe itching, leg pain
39 2021-02-19 numbness, facial paralysis Facial numbness/paralysis started 10 minutes after injection. Paralysis of tongue and jaw muscles fo... Read more
Facial numbness/paralysis started 10 minutes after injection. Paralysis of tongue and jaw muscles followed an hour later. Paralysis of eyelids followed. Medical staff on-site were not informed on how to proceed and recommend to take a benadryl and sleep it off. Muscle function returned 12 hours later.
39 2021-02-19 pain in extremity Sore arm for two days tolerated: regressed 99 percent headache affecting sleep pattern. Interrupte... Read more
Sore arm for two days tolerated: regressed 99 percent headache affecting sleep pattern. Interrupted nausea .
39 2021-02-21 hot flush 3 days after vaccine I woke up with nausea, upset stomach. Symptoms resolved within 6 hours. 1 week... Read more
3 days after vaccine I woke up with nausea, upset stomach. Symptoms resolved within 6 hours. 1 week after vaccine, woke up at 3:00am with nausea and heat wave/chills, resolved within an hour
39 2021-02-22 nerve pain Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after... Read more
Headache for 2 days Body aches for 3 days Striking Nerve pain in my keloid under right breast after first injection and second injection Body aches for 3 days Nauseous day 3 Dizzy day 2 and 3 Hives/itchy rash started day 2 and currently still have itching rash all over body.
39 2021-02-23 burning sensation 2 days after the vaccine I developed a rash around the injection site 2/6/2021. After three days the... Read more
2 days after the vaccine I developed a rash around the injection site 2/6/2021. After three days the rash was gone without treatment. Then on 2/14/2021 I started feeling burning pain all over my neck and chest. It was slightly red that night. The next morning my chest, neck, and upper back had a red rash . My chest was the worst of it. Felt like a chemical burn . I went to the Doctor on 2/17/2021 and was told it was a delayed hypersensitivity reaction to the vaccine. I continued to take Benadryl, Zyrtec and was given Kenalog. On Sunday 2/21/2021 the pain was so pain and the rash was only getting worse and now on my face so I went to urgent care. There I was given a steroid ( prednisone) , derma smoothe and Pepcid. It has been 10 days and no improvement yet.
39 2021-02-24 numbness Numb neck, face and jaw on same side as vaccine. 3 hours later still numb. No Bells Palsey symptoms ... Read more
Numb neck, face and jaw on same side as vaccine. 3 hours later still numb. No Bells Palsey symptoms tho.
39 2021-02-25 migraine 11 hrs post vaccination - intense fatigue, fever (up to 101.3F), chills, migraine, myalgia, joint pa... Read more
11 hrs post vaccination - intense fatigue, fever (up to 101.3F), chills, migraine, myalgia, joint pain and mild injection site pain 30 hrs post vaccination - most of above side effects resolved expect for migraine and occasional myalgia; however, began to experience nausea, bloating, stomach cramps, slight itchiness at injection site 52 hrs post vaccination - finally felt well enough to get out of bed but was still experiencing stomach cramps and migraine The day of the vaccination, I was able to work a full 8 hrs without experiencing side effects as they began 11 hrs post vaccination. I had to call off work for the following 2 days as I barely ate or slept during that time. Seventy-two hrs post vaccination, I was able to return to work with only one remaining side effect: lingering stomach cramps. Self treated with alternating doses of OTC Extra-strength Tylenol and Excedrin Migraine while I was experiencing migraine, fever, myalgia and joint pain. Also took Ultra-strength Rolaids as needed for bloating and stomach cramps.
39 2021-02-25 difficulty speaking, pain in extremity First, I got an extremely sore arm. The arm was so sore I could not sleep because every time I move... Read more
First, I got an extremely sore arm. The arm was so sore I could not sleep because every time I moved it hurt enough to wake me up. The next day (~midday) I broke out in severe hives. At around 12.20 I became very, very sleepy and I lost my voice. At around 12.30 my partner noticed my face was swelling (around my jaw and cheeks).
39 2021-02-25 feeling hot, flushing, tingling Very hot, flushed immediately after injection. She felt panicky, lips, fingers/feet were tingling. ... Read more
Very hot, flushed immediately after injection. She felt panicky, lips, fingers/feet were tingling. She cooled down and was back to normal within 20 minutes of vaccination. No other events reported thereafter.
39 2021-02-25 seizure, slurring, tremor convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her... Read more
convulsing uncontrollably; stroke; rash; chest felt really heavy like someone was sitting on it; her throat felt like it was on fire; shaking uncontrollably/ arms and legs were shaking; Her speech was slurred, she could not communicate; Stuttering; dysphagia; tongue was falling to the side/mile was droopy on the right side/right arm- she would try to move it but it would not go/right leg was almost paralyzed; This is a spontaneous report from a contactable consumer (patient herself). A 39-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 09Feb2021 18:10 at a single dose for COVID-19 immunization. The patient had no relevant medical history. She was healthy and takes no medications. The patient got the vaccine Tuesday night at 6:10 PM. She waited in the parking lot where she got it, which was through (School Name). She had a severe reaction and had to receive an Epi Pen. This reaction occurred maybe 10 minutes after she got it. She had not left the parking lot yet, so it was prior to the 15 minutes. She broke out in a rash, her chest felt really heavy like someone was sitting on it, like an elephant, and her throat felt like it was on fire which is what is started as, then it went to her ears. From there, it escalated. She had gotten out of her car and took her sweatshirt off, she thought she was just hot. As soon as she got back in the car and as soon as she got in she started convulsing uncontrollably and shaking uncontrollably. Two ladies she works with had parked next two her on both sides and they noticed this and went to get the emergency squad. She did not lose consciousness. She could still hear everything but her arms and legs were shaking, and her right leg was shaking and stuck. The emergency squad had to help her out of the car. The ambulance gave her an Epi Pen injection and the squad took her to the hospital. Her speech was slurred, she could not communicate. She was stuttering the same thing over and over. She had a CAT scan with contrast and the stroke team decided she needed TPA - the stoke medication. They administered that and admitted her to the hospital Tuesday night. Wednesday she had an MRI, echocardiogram and another CAT scan and they released her to come home last night. She is still having lingering effects. Her speech is back. Her arm movement is back. The reason they treated her as a stroke patient, they said, is because when they told her to stick her tongue out, she had dysphagia - her tongue was falling to the side, and her smile was droopy on the right side. Her right arm- she would try to move it but it would not go. And her right leg too. She could do everything on her left side and nothing on her right side. She was conscious and could hear but could not get anything to work. After receiving the TPA, Wednesday when she woke up, she was being checked on every 30 minutes throughout the night, she was able to speak and communicate. She will still stutter and have slow words but it is way better and she can communicate. Her right arm is able to move and she can use it but her fine motor is hard. Like writing stuff is a challenge. She also has a walker. Her right leg is almost paralyzed, it drags beside her as she walks. She can move but has to really concentrate to get going. She has not reached out to her doctor yet. She was admitted to the hospital and had a bunch of tests done. The Epi Pen gave her stroke like symptoms. They were not sure in the hospital if it was actually a stroke based on her 2 MRI's and CAT scans. It did not look like a stroke from those but they think that the Epi Pen and the stress it puts into your body made her body shut down. Which the Epi Pen they said can cause stroke like symptoms. They were unsure as they have seen multiple things with the vaccine come in over the last few weeks. They told her she would need to work on the therapies out-patient. She will have to have PT/OT for lingering effects she was suffering from. Outcome of events was recovered with sequelae.
39 2021-02-26 tingling Patient noticed some tingling their right hand after the vaccine was administered in their left delt... Read more
Patient noticed some tingling their right hand after the vaccine was administered in their left deltoid. Pharmacist on duty told them to monitor it and if it got worse to seek medical attention.
39 2021-02-27 tenderness 4-6 painful swollen lymph glands in left armpit. Can see redness as well as a physical lump of sever... Read more
4-6 painful swollen lymph glands in left armpit. Can see redness as well as a physical lump of several. Treating with advil & hot compress to relieve pain. Noticed tenderness in armpit 1-2 days after vaccine #2, then went away. But has since returned worse than previously.
39 2021-02-27 flushing, feeling hot, cold sweat, pain in extremity Approximately 10 minutes after injection my ears got hit and my face flushed. At about 25 minutes af... Read more
Approximately 10 minutes after injection my ears got hit and my face flushed. At about 25 minutes after injection I started to feel my heart race. Medical staff took my pulse and it was extremely high. My blood pressure even on all of my meds was 205/112. My resting pulse topped a little over 140 during monitoring. After about an hour my pulse was 110 and my BP was 190/95 and I went home to rest. Called my physician a couple days after and alerted him. Monitored BP at home that day and it continued to go back to my normal. By that evening I was back to my baseline. Other symptoms following day extremely painful arm cold sweats and feeling of unwell all which I know are common side effect. My pulse racing was extremely scary in that I have a hard time raising my pulse when I exercise due to my medication.
39 2021-02-27 flushing On third day after 2nd vaccine was given, urticaria appeared throughout my body, along with tongue ... Read more
On third day after 2nd vaccine was given, urticaria appeared throughout my body, along with tongue swelling, wheezing, flushing, and eye irritation. Because my daughter suffers from allergic reactions, I knew to immediately administer Benadryl. I also took an additional dose of Zyrtec and Pepcid, which helped temporarily and symptoms subsided when I called my primary care doctor. I had a virtual visit, and she then prescribed Medrol.
39 2021-02-27 pain in extremity Sore arm, nosebleed 3 hrs after the shot. 21 hrs later, headache and nosebleed. No treatment. Nosebl... Read more
Sore arm, nosebleed 3 hrs after the shot. 21 hrs later, headache and nosebleed. No treatment. Nosebleed able to stop
39 2021-02-28 pain in extremity Sore arm. Feeling drowsy and sluggish. Sleepy. Not interested in eating large meals. Desire lots of ... Read more
Sore arm. Feeling drowsy and sluggish. Sleepy. Not interested in eating large meals. Desire lots of liquids and small bites of food.
39 2021-02-28 pain in extremity Sudden onset: Sore arm - really sore. Whole body aches. Headache and neckache. I did not have a feve... Read more
Sudden onset: Sore arm - really sore. Whole body aches. Headache and neckache. I did not have a fever. 24 hours later they all disappeared. I found out I was pregnant on the 8th. I had a normal ultrasound and a heartbeat at the end of January (the 29th) and February 8, there was no heartbeat anymore. I miscarried. This was my fifth pregnancy. I had one other miscarriage. I had a pregnancy where I had twins and one of the twins miscarried. So I have miscarried three babies. The expected date of delivery for this pregnancy was September 13, 2021.
39 2021-02-28 tingling patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse ... Read more
patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse received Pfizer Covid 19 vaccine; Paresthesias to bilateral hands to elbows, right foot/leg; brain fog; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK-5730; expiration date: unknown) at 39-year-old age of vaccination intramuscularly in the left arm on 26Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included myelitis transverse from 2015 to an unknown date and depression. The patient has no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other vaccine in four weeks but has other medications in two weeks. It was reported that the patient with myelitis transverse received Pfizer Covid 19 vaccine on 26Dec2020. On Dec2020, the patient had paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. Symptoms appeared approximately 12-18hrs after injection. There was no treatment receive for the adverse events. The events resolved 48 hours after. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test) with the result of negative on 22Jan2021. The outcome of the events was recovered on Dec2020.
39 2021-03-01 breast pain, feeling hot breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line ... Read more
breast infection; left breast pain/breast became sore; breast became red, sore, warm and had a line traveling to my armpits; breast became red, sore, warm and had a line traveling to my armpits; breast became sore, warm and had a line traveling to my armpits; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received second single dose (BNT162B2, Pfizer, Solution for injection, lot number: EL3249, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 19Jan2021 06:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient medical history was not reported. There were no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. There were no other medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 (Pfizer, lot number: EL1284) on 30Dec2020 06:00 (vaccine location: left arm). On 24Jan2021, the patient started to have left breast pain. Her breast became red, sore, warm and had a line traveling to the armpit. The doctor stated the red area felt full. The patient was treated for a breast infection. Treatment received for the adverse events included: Clindomycin. The events were considered non-serious by the reporter. The events resulted to doctor or other healthcare professional office/clinic visit. Since the vaccination, has the patient had not been tested for COVID-19. The events recovered on an unspecified date in 2021.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2and the event mastitis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-03-02 weakness 2 weeks after the vaccine, I woke up dizzy and it was debilitating. Went to urgent care and was diag... Read more
2 weeks after the vaccine, I woke up dizzy and it was debilitating. Went to urgent care and was diagnosed with vertigo.
39 2021-03-02 nerve pain Client c/o a nerve discomfort from the vaccine site to the side of Left neck up to the jaw area. Adv... Read more
Client c/o a nerve discomfort from the vaccine site to the side of Left neck up to the jaw area. Advised client for another 15 minutes of observation. Client stated OK. NP was made aware and NP spoke with client. BP was taken at 146/84. Ox at 98% HR at 76, temp 98.7. Client was monitored for another 15 minutes BP was taken 10 minutes later with 143/83, Ox at 98, HR 75. Patient stated that she is okay. stated that the nerve discomfort is no longer present. Client left clinic stable with steady gait.
39 2021-03-02 pain in extremity My right arm was very sore, I had extreme fatigue, my legs felt as if they couldn't sustain my body,... Read more
My right arm was very sore, I had extreme fatigue, my legs felt as if they couldn't sustain my body, I had a headache, and chills. Also, when I laid down for bed I could briefly hear my heart pounding in my ear (24 hours after receiving vaccine. I took one 500mg acetaminophen tablet and most of the symptoms disappeared except the fatigue.
39 2021-03-02 pain in extremity Sore arm. Low grade fever next day and light head ness. Felt anxiety and muscle aches.
39 2021-03-02 weakness post vaccine - c/o pain to right arm and back, feeling tired and weak. and "out of it"
39 2021-03-03 weakness, numbness 1. Sudden feeling of weakness 2. Legs felt numb 3. Drowsy/sleepy/ tired
39 2021-03-03 tingling, numbness Information provided by patient as follows: Slight throat tightening within first 20 minutes and th... Read more
Information provided by patient as follows: Slight throat tightening within first 20 minutes and then after an hour had some amount of numbness in left side of face only. About after 4 hours, I had complete numbness of the left side of my face. The numbness persisted through the rest of the day. The day following the vaccine, the numbness still persisted in areas by my left eye and upper cheek area. After over a week, those areas are still affected. My left eye feels weak, photosensitive, and strained. I am experiencing frequent headaches and pain around/above my eye. I am also noticing intermitted numbness/tingling in my upper extremities and hands. Scheduled to see provider on 2/24/21 regarding if 2nd dose should be given (findings from that visit unknown)
39 2021-03-03 pain in extremity Low grade fever on/off Fatigue Sore arm Length of time was 2 days
39 2021-03-04 pain in extremity, breast pain I had a very sore arm the night following my injection. Then I woke up with chills, fever, and could... Read more
I had a very sore arm the night following my injection. Then I woke up with chills, fever, and couldn?t sleep. The next day I had chills, fever, tired, sore arm, and spit on my left breast that hurt more than the injection sight. That night I had a headache that was not going away with medicine and couldn?t sleep. I also continued to have fever. The next day I still have breast pain, fatigue, and dizziness.
39 2021-03-05 flushing, involuntary muscle movements, feeling cold, seizure 24 hours after the 2nd dose my temperature rose 4 degrees, full body aches and sweating for 24 hours... Read more
24 hours after the 2nd dose my temperature rose 4 degrees, full body aches and sweating for 24 hours. Followed by dizziness and headache. Within two days my body began having seizures accompanied with ongoing flushing/cold sensations in the occipital region/top of spine, with a feeling of fainting and dizziness, nausea, without loss of consciousness. Sudden jerking movements of the arms, legs and the head/neck range from 2-5 minutes in duration and continue in clusters for 8-20 hours per day. This seizure activity has not subsided since February 17th, and is ongoing to date. MRI confirms no new structural abnormalities in the brain. CBC and metabolic panels are all within normal range. EKG normal. I am not epileptic. No history of drug use. No alcohol use.
39 2021-03-05 breast pain, flushing The shot was given well and I waited for 30 minutes after at the facility. No issues at that time. A... Read more
The shot was given well and I waited for 30 minutes after at the facility. No issues at that time. About 2.5 hours later I got a red rash on both arms and hands ( looks and feels like sunburn but it?s not). Rash persists off and on since ( even today). I?ve had a temperature of about 99 off and on for several days. Only my head and face are flushed and hot, but rest of me cold. I have soreness in both breasts. My left shoulder and breast had small sores ( looks like small scrape but no injury occurred). Those areas sting internally with some pain and redness. Feels like bruise but nothing visible. I?ve had fatigue almost every day. I have brain fog ( can?t spell simple words, forgetting words, lack of focus).
39 2021-03-07 burning sensation Burning around my R breast where there is an implant. This burning was INTENSE and lasted 5 days aft... Read more
Burning around my R breast where there is an implant. This burning was INTENSE and lasted 5 days after my 2nd shot.; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 39-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown), via an unspecified route of administration on 09Jan2021 at 09:00 am (at the age of 39-years-old) on left arm at single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included citalopram (CITALOPRAM), cyanocobalamin (VIT B12), ergocalciferol (VIT D), ascorbic acid (VIT C). The patient previously took first dose of BNT162B2 (Lot number: EH9899, Expiry date: unknown) on 19Dec2020 at 09:00 am (at the age of 39-years-old) on left arm at single dose for covid-19 immunisation. The patient stated that, burning around my r breast where there is an implant. this burning was intense and lasted 5 days after my 2nd shot on 10Jan2021 at 09:00 am. The patient recovered from the event burning around my r breast where there is an implant on 14Jan2021. The event was considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the adverse event.
39 2021-03-07 feeling hot Erythema Nodosum, both knees/legs. Red, swollen bumps. Hot to touch, painful. Bruising and swelli... Read more
Erythema Nodosum, both knees/legs. Red, swollen bumps. Hot to touch, painful. Bruising and swelling
39 2021-03-07 pain in extremity sore arm and aches in whole body, stiffness in legs, fatigue
39 2021-03-07 tremor tremors, questionable seizure like activity
39 2021-03-08 pain in extremity 30 minutes after pain in arm and shoulder, an hour and half later headache and fever 101, by 2:30pm ... Read more
30 minutes after pain in arm and shoulder, an hour and half later headache and fever 101, by 2:30pm hives behind right ear, 30 minutes later hives behind left ear. Applied Benadryl cream on areas and went away in 30 minutes but then hives appeared in face around eyes and eyebrows. Applied cream there and within 30 minutes hives went away. An hour later they reappeared on cheeks. Applied cream and hives went away. However fatigue worsened but fever reduced to 99.
39 2021-03-08 bell's palsy Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable ph... Read more
Patient developed right Bells Palsy on 18Feb2021; This is a spontaneous report from a contactable physician. A 39-year-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose on 20Jan2021, first dose on 30Dec2020, both at single dose for COVID-19 immunisation. Facility type vaccine was hospital. Medical history was none. Known allergies was no. If COVID prior vaccination was no. If COVID tested post vaccination was no. If other vaccine in four weeks was no. Other medications in two weeks was no. Concomitant medications were not reported. Patient developed right Bells Palsy on 18Feb2021. AE resulted in emergency room/department or urgent care. AE treatment included prednisone, magnetic resonance imaging (MRI) in Feb2021. The outcome of the event was not recovered. Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, drug causality cannot be completely excluded. Serious Facial paralysis may be considered as late sequel to BNT162B2 injection, due to appropriate chronological relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
39 2021-03-09 night sweats 3/9 severe dizziness that comes and goes, accompanied by nausea 3/10 night sweats followed but stoma... Read more
3/9 severe dizziness that comes and goes, accompanied by nausea 3/10 night sweats followed but stomach cramps and diarrhea. Then chills and drop in body temp to.95* Intermittent dizziness and diarrhea throughout the day Heavy sensation in back of head Called Dr, spoke to nurse. Nurse recommended hydration and rest and seek ER help if symptoms worsen
39 2021-03-09 pain in extremity Flu like symptoms; Full body rash with itching; Full body rash with itching; localized arm pain with... Read more
Flu like symptoms; Full body rash with itching; Full body rash with itching; localized arm pain with ancillary edema x 5 days; localized arm pain with ancillary edema x 5 days; This is a spontaneous report from a contactable nurse (patient). The nurse reported 2 reports for same patient, same product. This is the second report. A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ3246), intramuscular in the right arm on 12Jan2021 08:30 AM at single dose for covid-19 immunisation. Known allergies included Tramadol and Lexapro. No other medical history. Concomitant medication (Other medications in two weeks) included VITAMIN B complex (B COMPLEX), collagen marine, methylsulfonylmethane (MARINE COLLAGEN PEPTIDES WITH MSM), saw palmetto [serenoa repens] and zinc. No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EJ1685, administrator route=Intramuscular, vaccine location=Left arm) on 22Dec2020 at age of 39-year-old for covid-19 immunisation and experienced general malaise with nausea and diarrhea, localized pain 3-4/10 after first dose x 5 days. The patient experienced full body rash with itching, localized arm pain with ancillary edema x 5 days. Flu like symptoms. After second dose in 2021. Treatment for events included Antihistamine. No Covid prior vaccination. The outcome of events was recovering. Unknown if Covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021123153 same patient, same product (first dose), different events.
39 2021-03-09 cold extremities, tingling Left hand tingling and cold.; Left hand tingling and cold.; This is a spontaneous report from a cont... Read more
Left hand tingling and cold.; Left hand tingling and cold.; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9264), via an unspecified route of administration in left arm on 06Feb2021 15:30 at single dose for COVID-19 immunisation. Medical history included asthma. She had no known allergies. Concomitant medication included beclometasone dipropionate (QVAR) and mometasone furoate (FLONASE). The patient experienced left hand tingling and cold on 06Feb2021 15:30. No treatment received for the events. The patient was not pregnant. The patient had no COVID prior vaccination. She had no COVID tested post vaccination. The outcome of the events was recovering.
39 2021-03-09 pain in extremity Pain in the arm, neck and back. Fever of 100.1 starting 3/10/21.
39 2021-03-09 flushing Within 5 minutes of injection,, Red rash strip down middle of face from forehead to chin, Face Flush... Read more
Within 5 minutes of injection,, Red rash strip down middle of face from forehead to chin, Face Flushing, Face itching. Within 1 hour of injection,, Sore joints. Treated with OTC benadryl and Ibuprophen Symptoms Resolved in 2 hours
39 2021-03-10 pain in extremity Approximately 2.5 hours after injection, a fiery pain started at the injection site, went up to the ... Read more
Approximately 2.5 hours after injection, a fiery pain started at the injection site, went up to the shoulder, and down the left side of my chest. This was accompanied by chest tightening and slight shortness of breath. The pain ended after about a minute while I was getting my phone to call an ambulance because it was so bad. I chose not to complete the call as the pain began to fade. The chest tightening and breathing issue resolved a couple minutes later. My arm was extremely painful the rest of the day (achy, not the fiery sensation). I have never had a reaction like this to any vaccine or medication.
39 2021-03-10 migraine I had a migraine approximately 30 minutes after vaccine and took Excedrin (2 tabs) for migraine.
39 2021-03-10 difficulty speaking Tingling in lips and tongue. Raspy voice. Some shortness of breath and chest pain. Pt reported hx of... Read more
Tingling in lips and tongue. Raspy voice. Some shortness of breath and chest pain. Pt reported hx of asthma and pt took a breathing treatment of albuterol. No tongue swelling, rash, or airway closure reported.
39 2021-03-11 feeling hot C/O feeling hot, dizziness, racing heart. HR 122 per smart watch. 0900 BP 132/80, HR 96. At 0920 ... Read more
C/O feeling hot, dizziness, racing heart. HR 122 per smart watch. 0900 BP 132/80, HR 96. At 0920 BP 125/84, HR 72, RR 16, Denies SOB, denies tachycardia. Pt states still feels weird. At 0930 pt refused transport to ED. Called for family member to pick up. Escorted to car w/o incident.
39 2021-03-11 pain in extremity My arm was sore a couple hours after vaccine. The next day, I was tired and my arm (right) was sore.... Read more
My arm was sore a couple hours after vaccine. The next day, I was tired and my arm (right) was sore. No fever or anything. Sunday, the 2nd, I had headaches and it came on and it was painful. It is always in my sinus area - above the bridge of my nose and forehead. They have been coming every day in the afternoon and it stays until I go to bed unless I take a medicine - if I take medicine it's a 2 out of 10 instead of 6 out of ten for pain. My doctor put me on Steroids before second dose . That helped get rid of the headaches for the five day course but after the course of steroids I got them every day again. I had about two or three doctor visits after that first visit - at least 2 in person and one or two telehealth. And now after the second dose, she has referred me to specialist. I got the second dose on January 29th. I saw an ENT - in February for this and he said I have some congestion but nothing crazy.
39 2021-03-11 facial pain, flushing Reaction: patient felt facial "soreness", flushing and swelling in right side of face Outcomes: ext... Read more
Reaction: patient felt facial "soreness", flushing and swelling in right side of face Outcomes: extended observation (1.5 hours), oral Benadryl and water given, symptoms improved
39 2021-03-11 numbness, tingling Receive 0.3 ml of Pfizer vaccine. Discovered later than vial had been diluted with 1.6 ml instead of... Read more
Receive 0.3 ml of Pfizer vaccine. Discovered later than vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Patient experienced Tingling/numbness on same arm as injection. Reports feeling odd. Observed and symptoms resolved within 20 minutes. Released home. Contacted 3/11/2021 and reports "Dizziness; cloudy headed feeling; feeling a lot better now but not completely back to normal; some bumps on her tongue that are improving; HR was elevated for remainder of day after "
39 2021-03-11 tingling She had chest tightness and facial tingling 5 to 15 minutes after receiving vaccine. Her blood press... Read more
She had chest tightness and facial tingling 5 to 15 minutes after receiving vaccine. Her blood pressure was elevated to 149/96 and heart rate increased to 100-136. Oxygen saturation remained at 99-100%. She did not have loss of consciousness, complaints of tongue swelling, or difficulty swallowing. EMT was called; they evaluated her and recommended emergency room, but symptoms improved within 60 minutes. She had similar symptoms after a bee sting last year.
39 2021-03-11 difficulty speaking Staff member reported itchy throat, chest tighness, hoarse voice and swelling of neck area and eyes.... Read more
Staff member reported itchy throat, chest tighness, hoarse voice and swelling of neck area and eyes. On site physician was called, and staff member was evaluated. Pharmacist (myself) and director of nursing was present. Patient O2 sat was checked at 99% and BP noted to be 170/116. Staff member was able to swallow water and speak however recommendation made to call 911. EMT brought staff member to hospital where throat and chest tightness progressed. Staff member was given epinephrine, steroids and benadryl q6h and referred to her allergist.
39 2021-03-13 migraine Fever, chills, muscle aches, joint pain, bones hurt, migraine, tired, nausea.
39 2021-03-13 cold sweat Flu-like symptoms, chills, fever 101, sweating, fatigue, dizziness, lightheaded. Lasted about 24 hou... Read more
Flu-like symptoms, chills, fever 101, sweating, fatigue, dizziness, lightheaded. Lasted about 24 hours from onset, then fatigue, tiredness and clammy for 24 hours
39 2021-03-14 weakness Dizzy, Nauseous, Headache, Dry Mouth, Fatigue and barely able to walk... Weakness, Dehydration, Low... Read more
Dizzy, Nauseous, Headache, Dry Mouth, Fatigue and barely able to walk... Weakness, Dehydration, Low Magnesium at 1.6 and Sodium at 131 also High BP and a lowered pulse rate...
39 2021-03-14 pain in extremity Localized left arm pain began immediately after injection and continually worsened and spread throug... Read more
Localized left arm pain began immediately after injection and continually worsened and spread throughout arm for approximately 48 hours. Fever of 101 degrees Fahrenheit, body aches, and chills with shivering began approximately 18 hours post-injection and lasted for approximately 12 hours. Nausea and loss of appetite began approximately 22 hours post-injection and vomiting began approximately 10 hours after nausea began and lasted for 5 hours.
39 2021-03-14 tingling Paresthesias affecting right lower extremity, bilateral hands, right lower face
39 2021-03-14 numbness Patient developed nausea (no vomiting), transient numbness of the feet, dizziness, and some palpitat... Read more
Patient developed nausea (no vomiting), transient numbness of the feet, dizziness, and some palpitations starting about 45 minutes following the vaccination.
39 2021-03-15 numbness, tingling 39 YO F AT COVID 19 SHOT CLINIC OBSERVATION AREA C/O ALL OVER TINGLING AND NUMBNESS WITH MILD NAUSEA... Read more
39 YO F AT COVID 19 SHOT CLINIC OBSERVATION AREA C/O ALL OVER TINGLING AND NUMBNESS WITH MILD NAUSEA. DENIES SOB, WHEEZING, DIFFICULTYSWALLOWING, HOARSENESS, ITCHING, HIVES, RASH, NAUSEA OR OTHER C/O. FOUND PT IN PASSENGER SEAT OF CAR APPEARING ANXIOUS WITH ABOVE C/O. HEENT - PERRL, NO JVD, NORM SOUNDING VOICE, NO SIGNS OF ANGIOEDEMA, NOSTRIDOR TO TRACHEA WITH AUSCULTATION, CX - LS =/CLEAR BILAT, NO RASH/HIVES TO CHEST OR BACK. EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE.
39 2021-03-15 flushing 4:13pm vaccine given 4:20 dizziness, flush feeling in the face bp 72/45 hr 51 oxygen 99% 4:27 112/6... Read more
4:13pm vaccine given 4:20 dizziness, flush feeling in the face bp 72/45 hr 51 oxygen 99% 4:27 112/65 hr 62 oxygen 98 no dizziness, feeling better 4:40 113/61 hr 65 oxygen 99 sitting up ,no dizziness, feels like able to walk 4:45 108/71 hr 66 oxygen 99 feeling fine, no symptoms
39 2021-03-15 tingling, numbness TINGLING IN THE FACE, EAR, HAND AND FOOT RING AND PINKY TOE ON THE LEFT SIDE.. ON 3/14/21 LEFT SIDE ... Read more
TINGLING IN THE FACE, EAR, HAND AND FOOT RING AND PINKY TOE ON THE LEFT SIDE.. ON 3/14/21 LEFT SIDE RIBS TINGLING PAIN NUMB FEELING. ON 3/15/21 RIGHT HAND STARTED TINGLING.
39 2021-03-15 hot flush, numbness felt intense heat in her armpit lymph nodes on the right side; streaks of heat along the back of her... Read more
felt intense heat in her armpit lymph nodes on the right side; streaks of heat along the back of her scalp; heat in her chest; right side felt numb from her leg to her shoulder; hot flashes; This is a spontaneous report from a contactable consumer. A non-pregnant 39-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 19Jan2021 at 39-years-old at a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient's medical history included heart murmur, Latex allergy; both from an unknown date and unknown if ongoing. The patient did not have COVID prior to the vaccination. Concomitant medications were not reported; and no other medications were received within two weeks of the suspect vaccine. On 19Jan2021, the patient experienced: felt intense heat in her armpit lymph nodes on the right side (non-serious), streaks of heat along the back of her scalp (non-serious), heat in her chest (non-serious), right side felt numb from her leg to her shoulder (non-serious), hot flashes (non-serious). The clinical course was reported as follows: The patient, ten minutes after the vaccination, felt intense heat in her armpit lymph nodes on the right side. This was followed by streaks of heat along the back of her scalp, and heat in her chest. After about an hour, the right side felt numb from her leg to her shoulder. The patient's "body stayed that way for about 20 hours." The patient also experienced hot flashes, which was not something that she ever had before. The patient feared getting the second dose because her body felt so off after the first dose. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was recovered on an unspecified date. The patient was not tested for COVID post vaccination with the suspect vaccine. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
39 2021-03-16 muscle spasms, breast pain Adverse Event: Unusual/increased pre-menstrual symptoms: irritability/variable moods, breast sorenes... Read more
Adverse Event: Unusual/increased pre-menstrual symptoms: irritability/variable moods, breast soreness, cramping, fatigue - day of vaccine and day after vaccine (3/13-3/14/2021) Treatment: Increase water intake, gentle yoga, rest Outcome: No improvement Unusual/increased menstrual symptoms: heavier than normal flow, increased irritability/variable moods, increased fatigue - (upon onset and throughout menses 3/15-3/17/2021) Treatment: Increase water intake, gentle yoga, added dietary/herbal remedy night of 3/16 & morning of 3/17 (tea of raw cacao, red clover, raspberry leaf, yarrow, linden, motherwort, angelica root, local honey) Outcome: irritability and cramping decreased after cacao & herbs were added; menstrual flow is still heavier than normal and fatigue is still quite pronounced
39 2021-03-16 numbness, pain in extremity Left sided arm and facial redness and numbness for 2 hours that then went away with no other issues
39 2021-03-16 tremor NAUSEA, DIZZINESS,SHAKING
39 2021-03-16 tingling Nauseous (felt a little tired). Left arm feels tingling.
39 2021-03-16 feeling cold Shivers, cold, body aches, fever, headache,
39 2021-03-16 feeling hot VERY flu-like 20 hours following shot. Severe headache, aches, chills, hot (no fever), nausea (dry-h... Read more
VERY flu-like 20 hours following shot. Severe headache, aches, chills, hot (no fever), nausea (dry-heaving), fatigue
39 2021-03-16 feeling of body temperature change, tingling, feeling hot, numbness, feeling cold Within minutes of receiving the vaccine (I was on the phone at the time and noted that my left inner... Read more
Within minutes of receiving the vaccine (I was on the phone at the time and noted that my left inner wrist felt internally hot). My left arm from injection to fingertips felt internally as if I was injected with peppermint oil. A hot/overly cold prickly feeling started and then proceeded to feel hotter and my arm felt tingly, numb, as if an epidural was put on my left arm or it fell asleep. These feelings were internal (no rash or external redness). I also felt a bit of this same on my lower left jaw (again no outside rash or redness just inside feeling). I reported it immediately to the pharmacist who administered the shot and he said there looks to be no redness and that after my 15 minutes was up it was ok to go home. It is 5 hours now after the shot and it feels as if a nerve has been hit - my arm feels very internally cold. Fingers and arm functions fine, but it feels like its slightly detached from myself (none of this occurs anywhere other than the injection site down to fingertips and left jaw bone).
39 2021-03-17 pain in extremity My arm was very sore after the second dose of Pfizer. A few weeks later I noticed the pain in my mus... Read more
My arm was very sore after the second dose of Pfizer. A few weeks later I noticed the pain in my muscles still persist. Now, I'm continuing to have elbow pain and pain in my upper shoulder
39 2021-03-17 pain in extremity headache, nausea, vomiting, fatigue and left arm soreness
39 2021-03-17 speech disorder, weakness ~3-4 days post vaccination, developed new "brain fog", moderate to severe difficulty with short term... Read more
~3-4 days post vaccination, developed new "brain fog", moderate to severe difficulty with short term memory and conversation recall, difficulty focusing on any task (including driving), word finding difficulty, easily misplacing items and sometimes not finding them again, increase in daytime fatigue, lack of energy.
39 2021-03-18 tingling 0945 Patient reported feeling nausea, lightheaded, dizzy, weakness in legs, and tingling in the left... Read more
0945 Patient reported feeling nausea, lightheaded, dizzy, weakness in legs, and tingling in the left side of her face that radiated down to the left lateral side of her neck. Upon assessment, patient noted to be visibly anxious. Patient reported that she has history of anxiety and has been anxious about shot for the past week. States "This is common when I become anxious, however, I have never felt tingling in my mouth and neck before." Also noted some drooling out the side of her left mouth. Patient vitals were BP: 136/90, O2: 100%, HR: 96. No visible signs of stroke with further assessment. After talking with patient and easing anxiety with relaxation techniques for 10 mins, all symptoms resolved. Patient feels she is going to be ok and doesn't want further treatment or intervention. Patient walked out clinic at 1010 with no further issues.
39 2021-03-18 tremor Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling ... Read more
Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered. Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-03-18 tremor Fever up to 103, chills and shaking over the entire course of 3/17/21
39 2021-03-18 tremor, flushing I sat down for 15 min, but after the first minute I started to feel flush and like I was about to pa... Read more
I sat down for 15 min, but after the first minute I started to feel flush and like I was about to pass out. The worker had me to lay down and took my BP, which was 158/90 and I'm usually 108/60. I remained in that position for about 15 min. My entire body was shaking uncontrollably. My BP came down and they gave me Benadryl before sending me to the ER. Within an hour post Benadryl, I felt drowsy, but back to myself.
39 2021-03-18 pain in extremity Right lymph node under collar bone is swollen, hard, and tender. Muscles on top of right thigh are ... Read more
Right lymph node under collar bone is swollen, hard, and tender. Muscles on top of right thigh are painful to touch (feels like a very deep bruise).
39 2021-03-20 tingling, feeling hot At exact time of infection, whole left arm started getting tingly and warm, especially from crook ... Read more
At exact time of infection, whole left arm started getting tingly and warm, especially from crook of elbow down through fingers. My usual comfortable watch felt tight and annoying. Was able to walk to observation area, then started getting dizzy and light- headed. Still had warm, tingly feeling in arm that received injection. My normal resting heart rate is 61 but now it was up to 111 per smart watch (possibly 121 but can't confirm since I was dizzy and blurry-eyed). In addition to tingly arm, racing heart, dizziness, I felt immediate fatigue and wanted to lay down and sleep. Also, had dull headache on left-side. Nurse sat me down and elevated my feet. Also got me some frozen peas for my forehead and neck. After 12-13 mintues, I started feeling better. She kept me under observation for full hour. Got better and went home. Heart rate remained elevated at 78-89 rest of evening. Dull headache remained on left- side only. Similar feeling to when wearing a tight pony tail and you take it out.
39 2021-03-20 tingling, numbness Numbest and tingling left shoulder, neck and face
39 2021-03-20 numbness Numbness on left side of body. Patient was treated at Emergency Department.
39 2021-03-21 burning sensation Arm still has a burning achy feeling that radiates from shoulder down to fingers. Muscle and joints ... Read more
Arm still has a burning achy feeling that radiates from shoulder down to fingers. Muscle and joints feel swollen and painful. Still having issues 25 days after first dose. Have tried NSAIDS / APAP to try to reduce pain and inflammation. It doesn't help much at all.
39 2021-03-21 tenderness At 11:14 am on the morning of Saturday, March 20, 2021, I received my first COVID vaccination in my ... Read more
At 11:14 am on the morning of Saturday, March 20, 2021, I received my first COVID vaccination in my right arm. Overnight Sunday to Monday, the lymph node in my armpit of the same arm became swollen and tender. I sent a note to my PCP through the Patient Portal so he was aware and could note it in my medical chart. I know from researching this that a small percentage of people experience this side effect after receiving their COVID vaccination. While I will continue to monitor it, it should most likely resolve on its own over time (days to months).
39 2021-03-21 numbness Day 0:Within a few hours, I felt extremely dizzy and had numbness in my extremities. I had trouble c... Read more
Day 0:Within a few hours, I felt extremely dizzy and had numbness in my extremities. I had trouble concentrating. By the evening, i felt like I had a mastiff sitting on my chest and was having trouble filling my lungs. I took a benadryl and tylenol before bed. Day 1: In the morning, I felt somewhat better, feeling like I had a 20lb dog on my chest. Severe fatigue (slept for 5 hours in the afternoon/evening). Headache. Day 2: Continued pressure in chest. Feeling of something stuck in esophagus. More severe fatigue (slept another 5 hours in the afternoon). Injection site still tender. Cough began at bedtime and continued through morning. Day 3 (today): continued pressure in chest and feeling of something stuck in esophagus. Loss of appetite. Severe fatigue. Ache down injection arm to wrist.
39 2021-03-21 feeling hot, pain in extremity, flushing Day 1: high heart rate for about 12 hours after injection - would not go below 100 even lying down; ... Read more
Day 1: high heart rate for about 12 hours after injection - would not go below 100 even lying down; warm flushing feeling randomly through body. Chills and fatigue 2 hours after shot. Day 2: arm sore; as day went on got achy all the way down to rest. heart rate back to normal but still high when walking. Very fatigued - head pressure Day 3: Still fatigued; heart rate normalized - no appetite, some stomach discomfort and head pressure Day 4: Fatigue, stomach discomfort and achy joints down left side of body - still have head pressure Day 5: Low fever of 99, ear canals swollen and waves of nausea; head pressure; ear ringing Day 6: Fatigue is gone, aches are gone and ear canals/pressure/ringing seem to be getting better. Day 11: Off and on stomach distress
39 2021-03-21 pain in extremity I had really bad pain started in the middle of the night pain on my left side traveled from left arm... Read more
I had really bad pain started in the middle of the night pain on my left side traveled from left arm to upper back. I went to ER thought I was having a heart attack. The lymph nodes was swollen had Cardiac work up and Xray(muscular).
39 2021-03-21 pain in extremity Immediately after injection I had a sore arm in a warm spot. And the following days I had a headache... Read more
Immediately after injection I had a sore arm in a warm spot. And the following days I had a headache and felt very under the weather with a low-dose fever. On Saturday 3/20, I started to get achy muscles and joints. On 3/21, I had around five incidents of diarrhea. Today, 3/22 I called my doctor about the joint and muscle pain. We decided constantly taking ibuprofen for a few dates is the course of treatment for now. I would consider it moderate pain, I?m struggling doing daily activities without pain intervention. Most of the pain is in my hips, knees, ankles, toes, and hands.
39 2021-03-21 feeling hot, seizure Patient with PMH of poorly controlled siezures and no regular health care who reported symptoms of f... Read more
Patient with PMH of poorly controlled siezures and no regular health care who reported symptoms of feeling warm and lightheaded after recieving her vaccine. Pt had a generalized siezure with postictal symtpoms, AOx2. She was then observed and evaluated by medical staff and EMS, during which time she had a second witnessed generalized seizure. Pt was sent by EMS to a local hospital.
39 2021-03-22 feeling hot 3:20 Client stated she felt hot and her neck was red. We took her out observation area and took bloo... Read more
3:20 Client stated she felt hot and her neck was red. We took her out observation area and took blood pressure. BP 130/88- P 75. The redness in her neck had spread to her face and ears. At the time a whelp had started forming on her right cheek. We put an ice pack on her neck and started to fan her. She stated that her face felt like it was swelling. 3:45 her redness had started to recede and she felt that her face was feeling better. We continued to monitor her symptoms and at 4:10 her spouse arrived to drive her home and the whelp was gone or right cheek, the redness had receded from her cheeks and ears. Her neck was not as red and she stated that she was not hot and she was able to return home.
39 2021-03-22 migraine Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a s... Read more
Headache/Sharp pain across the forehead; chills; body aches; tiredness; severe migraine; This is a spontaneous report from a contactable nurse, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 04Feb2021 at 14:45 (at the age of 39-years-old) as a single dose for COVID-19 immunization. Medical history included depression-anxiety and birth control use; the patient had no known allergies. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Concomitant medications included vilazodone hydrochloride (VIIBRYD), drospirenone/ethinylestradiol betadex clathrate (YAZ) for birth control, clonazepam (KLONOPIN). The patient did not receive any other vaccinations within 4 weeks of the vaccine. On 04Feb2021 at 15:00 (also reported as within 3 minutes post vaccination), the patient experienced headache as a sharp pain across the forehead. On 04Feb2021 at 15:00, the patient also experienced chills, body aches and tiredness that lasted 24 hours. The headache remained 6 days post vaccination as a severe migraine, as of an unspecified date in Feb2021, for which no medications worked. The patient iced, applied heat to the area, dark room, no sound for 2 days and finally was relieved with acupuncture. This headache was like no headache the patient had ever had and she had come very close to an emergency room visit but realized it was from the vaccine. The events "Headache/Sharp pain across the forehead" and severe migraine resulted in a healthcare professional visit and the patient was treated for these events with acupuncture. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "Headache/Sharp pain across the forehead" and severe migraine was resolving; chills, body aches and tiredness were resolved on 05Feb2021 at 15:00. Information on the lot/batch number has been requested.
39 2021-03-22 flushing Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-... Read more
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Additional Details: PATIENT WAS VERY ANXIOUS AFTER FEW MINUTES OF TAKIMG HER PFIZER COVID VACCINE.SHE FELT VERY DIZZY,FLUSHED& LIGHT HEADED & ASKED US TO CALL 911, WHO CAME OVER IN A COUPLE OF MINUTES & TOOK HER,I TRIED CALLING HER TO CHECK ON HER ,BUT WAS NOT ABLE TO REACH HER
39 2021-03-23 cold sweat, difficulty speaking "Approximately 15 minutes following the patient's initial vaccine shot, the observation nurse report... Read more
"Approximately 15 minutes following the patient's initial vaccine shot, the observation nurse reported that patient began to feel throat tightening, and feeling clamy. Observation nurse also noticed that patient's voice began to become raspy. The nurse checked the patient's vitals and reported that they were normal, and proceeded to take the patient to the ED for further evaluation. Patient received diphenhydramine 25mg IV x 1, famotidine 40mg PO x 1, methylprednisolone 125mg x 1.
39 2021-03-23 feeling cold, tremor About 10-12 minutes after receiving the vaccine, it felt like my heart started to beat fast. I plac... Read more
About 10-12 minutes after receiving the vaccine, it felt like my heart started to beat fast. I placed my hand over my chest and I could feel it beating. With a couple minutes I began to feel a little dizzy/light headed. Then a wave of cool came over my body and I was feeling better. I was a little shaky after that. I did not report the syptoms at the time, because I was uncomfortable raising my hand unless I was sure I was really having a serious issue and it did not seem to escalate from there.
39 2021-03-23 weakness Dizzy, weak. Patient felt better after going outside. Patient suffered panic attacks in the past, fe... Read more
Dizzy, weak. Patient felt better after going outside. Patient suffered panic attacks in the past, felt better 10 minutes after symptoms onset. Refused to go to hospital.
39 2021-03-23 facial pain, pain in extremity, numbness Had sore arm for first two days. On the third day started getting palpitations and racing heart. Thi... Read more
Had sore arm for first two days. On the third day started getting palpitations and racing heart. This came and went and woke me up in the middle of the night and early morning several times. Today is day 10 and I was prescribed a 24 hour holter monitor. In the last 3 days I've had several episodes of facial nerve pain in my jaw and teeth, numbness in my face and also pins and needles in various parts of my body. Sore and painful spot to the touch under left ribs. Extreme palpitations and heart racing that make me feel like Im going to pass out, sudden pressure on the left side of my neck and ear heartbeat in my left ear during these episodes, trouble breathing , pain and tingling in upper left chest and coughing that goes away in about 30 minutes. Each episode ends with uncontrollable urge to sleep. Almost feels like an intense food allergy reaction but it happens on a completely empty stomach. They seem to be getting progressively worse
39 2021-03-23 weakness, flushing Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection... Read more
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Cutaneous skin reaction on chest and thighs yellow and purple color
39 2021-03-24 one side paralysis, numbness For several weeks after the vaccine, she felt more fatigued but did not make anything out of it. On ... Read more
For several weeks after the vaccine, she felt more fatigued but did not make anything out of it. On February 22, she developed a very severe fatigue associated with the right leg heaviness and numbness. Over the next 3 days, the right leg became weak to the point that she needed to use a cane to ambulate. She also felt heaviness and numbness in the right hand but no clear weakness. She was then treated with 5 days of high dose steroids (1250 mg of prednisone on day one or early followed by 4 days of 1000 milligrams IVMP. The right hand symptoms improve most, the leg weakness moderately improved but she still required a cane to walk especially the latter half of the day even 2 weeks after the infusions. The fatigue remains an important symptom for her.
39 2021-03-24 cold sweat Nausea. Vomiting. Cold sweat. Fever. Chills. Muscle aches.
39 2021-03-24 unresponsive to stimuli Patient received her 1st Pfizer vaccination dose at 12:37PM. Patient was seated in the vaccination w... Read more
Patient received her 1st Pfizer vaccination dose at 12:37PM. Patient was seated in the vaccination waiting area for her 15 minutes observation window. About 5 minutes after vaccination the patient fainted and fell out of her chair on to the ground. She hit her head on the wall behind her, and ground when falling. Pharmacy staff immediately went to check on patient. She was found to be breathing, but unresponsive for about 20 seconds. 911 was called immediately by another employee. She was positioned lying on the ground with her feet up and came to consciousness quickly. Once awake patient was alert, verbal, and seemed to have a normal mental status. She reported no respiratory issues, no throat or lip symptoms, and no itching or hives. She states that she felt fine other than her head hurting from the fall. She reported no symptoms prior to waking up on the ground. She was speaking in full sentences, responsive, and had a strong, steady pulse at 98 bpm and a normal respiratory rate. No hives, swelling were observed. Patient reported she was a type 1 diabetic and her blood sugar was found to be normal (approx. 145) after she was able to sit. No medications were administered on site as she did not report any additional symptoms indicative of anaphylaxis. The ambulance and local PD arrived quickly. She was walked outside for observation and appeared to be taken away in the ambulance. The patient was not reached for a follow-up call to check in on her later the same afternoon.
39 2021-03-24 discomfort Patient reported feeling lightheaded and her left deltoid was itchy. At 1000 she had a sublingual 10... Read more
Patient reported feeling lightheaded and her left deltoid was itchy. At 1000 she had a sublingual 10 mg Zyrtec, at 1022 itching progressed to her abdomen, upper and lower back, more dizzy, lips felt heavy. At 1030 50mg Benadryl IM given. At 1100, itching, rash, and dizziness resolved.
39 2021-03-24 tremor Patient was exhibiting shaking hands for 2-3 minutes; alert & oriented with no color change; able to... Read more
Patient was exhibiting shaking hands for 2-3 minutes; alert & oriented with no color change; able to verbalize; no SOB; vaccine given at 1:37 and exhibited s/s 5-10 minutes later; Vital signs BP 140-78, HR-90, O2 94%, no medication given; monitored for 30 minutes then released home.
39 2021-03-24 numbness, flushing, tingling She reported a previous reaction to initial Pfizer dose: complained of left facial numbness/tingling... Read more
She reported a previous reaction to initial Pfizer dose: complained of left facial numbness/tingling as well as flushing, she also reported facial swelling. She was treated with Benadryl 25mg PO. She was unable to make an appointment with allergy/immunology prior to obtaining this dose. She received the dose and was given a 30-minute observation time. While in observation, I spoke to patient and she reported right-sided facial numbness and tingling but no flushing or swelling. She was otherwise feeling fine. Approx 10 minutes after injection, she complained of difficulty swallowing and mild throat swelling. Pulse was 110, O2 was 98% on room air. She denied SOB, wheezing. No stridor was noted and oropharyngeal exam was normal, no swelling or erythema noted. At this point, Benadryl liquid 50mg was given. After another 15 minutes of direct observation, her swallowing had improved and she felt stable to go home. Her pulse was 82, O2 98%. Suggested that they keep Benadryl at home, she can use every 6 hours as needed. If symptoms worsen, seek higher level of care. Patient and partner stated understanding.
39 2021-03-25 migraine Approximately 45 after injection a migraine began with visual disturbance. Wavy lines across field o... Read more
Approximately 45 after injection a migraine began with visual disturbance. Wavy lines across field of vision obscuring eyesight. This was accompanied by fatigue. That night racing thoughts throughout the night. I felt as if I was awake all night cataloging my daily life. The following day only sore muscles and muscle weakness in left arm.
39 2021-03-25 tingling, pain in extremity, numbness Dizziness Right after, fatigue, chills, racing heart, sore arm, pins and needles and numbness in lim... Read more
Dizziness Right after, fatigue, chills, racing heart, sore arm, pins and needles and numbness in limbs
39 2021-03-25 numbness, pain in extremity Right Arm began to go numb once I was seated in observation tent. Heaviness was felt from the should... Read more
Right Arm began to go numb once I was seated in observation tent. Heaviness was felt from the shoulder as if the arm was pulling down. After observation period ended, pain in arm was present. Pain intensified over the next hour. Shot was given at 2:45pm. By 4:30pm, I could not move the arm. A simple muscle twitch would send severe pain radiating from neck down to wrist. Pain persisted through the evening and began to improve overnight. Pain was gone by day 4. Treated with Advil, Tylenol and rest. Nausea began on day 2 and still persists along with diarrhea-no vomiting.
39 2021-03-26 feeling cold, hot flush 13 hours post vaccination felt absolutely freezing with chills although 2 heavy blankets were on me.... Read more
13 hours post vaccination felt absolutely freezing with chills although 2 heavy blankets were on me. Cheeks were hot. Could not sleep. Fever persisted through 24 hours post vaccination. Severe Throbbing piercing headache also began about 14 hours post vaccination. Headache is much worse upon standing. Headache still persisting 32 hours post vaccination.
39 2021-03-26 muscle spasms Patient experienced severe muscle cramping and spasms around her chest and back. Intensity severe a... Read more
Patient experienced severe muscle cramping and spasms around her chest and back. Intensity severe and affected the depths of breaths she could take. Received vaccination around 11:00 AM and went to ER around 3:00 PM. Blood work and EKG were normal. Received methocarbamol and Prilosec. Symptoms resolved in 48 hrs. Not believed to be an allergic reaction.
39 2021-03-26 pain in extremity Symptoms showed up one at a time. Arm soreness was gone by Tuesday. Tuesday night with right upper ... Read more
Symptoms showed up one at a time. Arm soreness was gone by Tuesday. Tuesday night with right upper back dull pain. Headache, chills, swollen lymph nodes to neck and left armpit, body ages, fatigue, multiple bruising to both legs associated with soreness and pain. Went to ED 0300 am Thursday. 2 liters IV bills plus IV Toradol. Had minimal relief at the time so released with Tylenol #3. Takes pain away but comes right back once med wore off. Added Ibuprofen. Helps but pain comes back with bad chills and headache.
39 2021-03-27 bell's palsy neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned these symptoms following v... Read more
neck and jaw pain; neck and jaw pain; has clicking in her jaw; concerned these symptoms following vaccine could be Bell's Palsy/Palsy; dull ear; She stated she could not walk on her left foot on 11Mar2021 but recovered the next day; This is a spontaneous report from a contactable consumer (the patient). This 39-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EN6204), via an unspecified route of administration, in the right arm on 10Mar2021 at 10:45 AM (at the age of 39 years) as a single dose for COVID-19 immunization. Medical history included skin wrinkling. Concomitant medication taken within two weeks of vaccination included botulinum toxin type a (BOTOX) taken for skin wrinkling, and unspecified birth control pills. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot # EN6200, on 18Feb2021, in the right arm COVID-19 immunization, and experienced fatigue. The patient reported that while she was sleeping last night on 11Mar2021 around 02:00-3:00, she had onset of dull ear, neck and jaw pain on left side. She had clicking in her jaw. The patient mentioned she never had a droopy face. She stated she could not walk on her left foot on 11Mar2021 but recovered the next day. She's concerned these symptoms following vaccine could be Bell's Palsy - what should I do. She looked online and saw that these are some of the first symptoms of Bell's palsy. She called to ask if these events could be Bell's palsy, and for information on events and Bell's palsy relative to the COVID-19 Vaccine. She informed that she had an upcoming appointment with her doctor "today" at 14:00 to see if she has Bell's palsy. The patient stated she went to the doctor on 11Mar2021 at 03:00 pm. Event term of Palsy with onset date of 11Mar2021 was reported. The physician did not prescribe medication, no treatment given. The clinical outcome of dull ear, neck and jaw pain, has clicking in her jaw, and palsy was recovered on 13Mar2021
39 2021-03-29 pain in extremity Fatigue; rash on my front torso, left side.; patient accidently may have received the vaccine withou... Read more
Fatigue; rash on my front torso, left side.; patient accidently may have received the vaccine without being diluted/I was the victim of a medication error; patient accidently may have received the vaccine without being diluted/I was the victim of a medication error; arm sore/right arm soreness; Headache; This is a spontaneous report from a contactable pharmacist and nurse (patient) and consumer via Medical information team. A 39 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: 01Mar2021), via intramuscular in the right arm (deltoid) on 19Jan2021 09:30 at 1.8 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 19Jan2021 and stated that she was a victim of a medication error and needed some guidance on how to move forward. An RN (registered nurse) injected her with a 1 ml syringe and then proceeded to say that she didn't give her the diluent and proceeded to give the patient a 3 ml syringe in the same deltoid. She was having some side effects including arm sore and a headache, so the patient was assuming that she at least got some medicine, but she was not sure how much or what was in either injection she received. She was not sure what kind of dose she received. The patient accidently may have received the vaccine without being diluted. The patient wanted to know what to do now for getting the correct dosage of the vaccine and if she should repeat the series or continue with the second dose and get antibody tests. The patient wanted to know what her options are. Upon follow up on 01Feb2021 and 10Feb2021, it was reported that COVID-19 vaccine was administered incorrectly to the patient and was reported as medically significant serious event. The patient reported that she tried to place a report a couple of weeks ago regarding the vaccine potentially being administered incorrectly. She was not able to reach anyone when she contacted us previously. She reached medical information, but she is unsure if she was able to make a report. The patient further clarified COVID 19 vaccine being administered incorrectly as they had an immunization nurse come to help with their vaccine clinic. For some unknown reason the nurse was giving people two shots at that vaccine administration. Nurse administered one shot that was of the diluted vaccine and one was of the diluent. Caller stated she does not know why the nurse did it this way. The patient has had no side effects from this occurrence that she is aware of. The pharmacist considered the event initially as serious then later provided as medically significant. She feels this way as the patient did not get the full dose and may not fully be protected against COVID. The patient did not directly show the immunization nurse the process of how to administer. The pharmacist was informed by the patient that she got two shots in one setting. The patient received the diluent first the 1.8ml injected and then another injection, the actual vaccine. The diluent was sodium chloride 0.9%. The facility where the most recent COVID-19 vaccine was administered was in the Pharmacy/Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The nurse was given a vial of Pfizer COVID vaccine and a vial of sodium chloride 0.9% (2mL single dose vial, NDC 63323-186-04). It was explained to the nurse to dilute the active vaccine with 1.8 mL (using 3mL 23G x 1" syringe/needle) of diluent and draw shots from this mixture (using 1mL 25G x 1") vanish point syr/needle). 1.8mL of diluent was injected into the vaccine vial and the nurse was told to draw up vaccine with the smaller needles. She asked if the patients should expect 2 doses. Assuming she meant the two-dose COVID vaccine series (21 days apart), the reported said yes, each patient gets two shots. Based on the report, the nurse then drew up 0.3mL of diluted vaccine into a new syringe/needle (23G) and filled up the other smaller syringe with diluent. Since there were two vials of Pfizer COVID vaccine to be reconstituted, the original fear was that she used the undiluted Pfizer COVID vial to draw up the first dose, but based on the volume in the second COVID vial (had not been used or added to), the only opened vial at the time was the vial already mixed with diluent. So the patient received 0.3mL of diluted vaccine in the 23G syringe and then received 0.3mL of diluent as a second injection. The patient was not admitted to the hospital. The patient provided information to the nurse regarding the reported adverse events with the use of BNT162B2. It was unknown if the nurse considered the Pfizer product had a causal effect to the adverse event. No treatment was given to the patient for the events. The patient stated, "I received my first dose of Pfizer COVID-19 vaccine on Tuesday, 19Jan2021. I was injected with a 1 mL syringe in the right deltoid by the Registered Nurse administering the vaccine. I was then injected with a 3 mL syringe in the right deltoid by the Registered Nurse administering the vaccine. I am unable to validate the dose because it was not administered according to Pfizer's instructions and because there are discrepancies in the documentation. These discrepancies include, order of the injections and the amount of fluid present in the 3mL syringe. Since the injections received on 19Jan2021, I have experienced the following symptoms: headache, fatigue, right arm soreness and a 1" x 0.5" rash on my front torso, left side. I contacted Pfizer on Thursday, 21Jan2021. Pfizer had no previous record of a medication error of this nature and was unable to offer guidance since the medications administered could not be verified. Pfizer was not able to provide guidance on an invalid dose because there was no recommendations for an invalid dose of Pfizer COVID-19 vaccine at this time. The outcome of the events was unknown. Information on the lot/batch number has been requested. Amendment: This follow-up report is being submitted to amend previously reported information: suspect product data (lot number was unknown). Follow-up (28Jan2021 and 28Jan2021): New information received from contactable pharmacist and consumer in response to HCP telephonic follow up activity includes: reporter's fax number added and clinical information updated. Information about lot and batch number was requested. Follow-up (06Mar2021): This follow up report contains no new safety information. Follow-up (15Mar2021): This is a follow-up report combining information from duplicate reports 2021057789 and 2021045475. The current and all subsequent information will be reported under manufacturer report number 2021045475. New information included: new reporter, product details, upgrade the case to serious (patient accidently may have received the vaccine without being diluted upgraded from non-serious to serious), new events (arm sore/right arm soreness, Headache, Fatigue, rash on my front torso, left side.).; Sender's Comments: The patient accidently may have received the vaccine without being diluted. It was noted that "An RN (registered nurse) injected her with a 1 ml syringe and then proceeded to say that she didn't give her the diluent and proceeded to give the patient a 3 ml syringe in the same deltoid."
39 2021-04-01 feeling of body temperature change, tremor, flushing 12:46 (one min after shot) flushed feeling 12:47 waves of nausea and hot/cold feelings begin 12:50 ... Read more
12:46 (one min after shot) flushed feeling 12:47 waves of nausea and hot/cold feelings begin 12:50 I started shaking a little (still in waves) 1:06 I left the facility to relax at home (hoping it would get better, not knowing how sick was sick enough to tell someone) 1:25 home - waves of hot/cold and nausea continue, along with agitation and occasional shaking - lasting for four more hours. Arm stiffness and swelling continue for two days.
39 2021-04-01 seizure Increased seizures after 12 hours.; This is a spontaneous report from a contactable consumer (patien... Read more
Increased seizures after 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 12Mar2021 09:30 as single dose for COVID-19 immunisation. Medical history included cerebral palsy and seizure and covid-19 (prior vaccination). The patient was not pregnant and had no known allergies. Concomitant medications included baclofen, rufinamide (BANZEL), levothyroxine sodium (SYNTHROID), and clobazam (ONFI) and valero acid syrup. In Mar2021, the patient experienced increased seizures after 12 hours. Had to call ambulance, and went to the emergency room (ER) at a hospital. The patient received Ativan, and Depakote and IV fluids. The patient had no other vaccine in 4 weeks and was not covid tested post vaccination. Outcome of event was recovered in Mar2021. Information about Lot/Batch number is requested.
39 2021-04-01 seizure Seizure - 5 minutes
39 2021-04-01 tingling, pain in extremity, muscle spasms, numbness, weakness The first abnormal effect I experienced was numbness in my inner upper lip. This was intermittent an... Read more
The first abnormal effect I experienced was numbness in my inner upper lip. This was intermittent and lasted roughly 24-48 hours after vaccine administration. Then on 3/25, I had muscle cramping/soreness in my lower leg muscles (calves). The next day (3/26), the muscle soreness continued, and my lower leg muscles began to feel tight when walking. On 3/27, I woke up with numbness and tingling in my right 5th digit, which then spread to all my fingers and toes. That morning, the muscle soreness had also spread into my thighs and bilateral upper extremities. I also noted mild swelling in my hands and feet and could not put my rings on or wear socks or shoes. By that evening, walking became more difficult as the muscle soreness had now turned into muscle weakness. This prompted me to go the ER for evaluation. A CT scan of my head and lab work was done. I was given IV fluids and sent home with instructions to return to the ER the following day for a MRI of my brain. Overnight, the weakness and swelling in my hands and feet progressed . I became unable to walk, go to the bathroom, or feed my self without assistance. The numbness and tingling I first experienced in my inner upper lip returned, and these symptoms were also now noted in the rest of my face as well. I also began having muscle soreness in my neck, my jaw felt sore when chewing food, and I began seeing some floaters. I returned to the ER the morning of 3/28. They did more blood work, imaging, as well as a lumbar puncture, and I was admitted to hospital. Once admitted, the hospitalist consulted with another hospital and recommended transfer by EMS there where I was admitted under a neurologist's care. When I arrived at that hospital, I began to feel somewhat better as the soreness and swelling appeared to be improving, and I could walk without assistance. They did a full neurological workup and kept me overnight for observation. Overnight, I did experience a mild headache that was relieved with Tylenol and rest. I woke up the next morning (3/29) with nausea and did have a few episodes of vomiting that turned into dry heaving and was given Zofran with relief. The swelling in my hand went down enough that I was able to make a fist and grasp objects with my fingers again. After the neurologist reviewed my labs and work up the morning of 3/29, I was allowed to return home to await final test results as all my tests were looking normal, my symptoms were continuing to improve, and PT had cleared me to be able to return home. Upon discharge, I was instructed to not get my 2nd COVID vaccination as it was possible that my symptoms were an adverse reaction to the COVID vaccination as no other diagnosis was found with testing. I was instructed to follow up with my PCP in one week. Since returning home, I have continued to be very easily fatigued and have had some headaches, nausea, and dizziness. I continue to feel weak when walking and have some muscle stiffness when first waking from sleep. I also continue to have some intermittent episodes of numbness and tingling.
39 2021-04-01 feeling hot Throat fullness/tightness, heart racing, hot feeling, chest tightness and wheezing approximately 26 ... Read more
Throat fullness/tightness, heart racing, hot feeling, chest tightness and wheezing approximately 26 to 27 minutes or so after the vaccine
39 2021-04-04 numbness 12 hours after receives the vaccine I experienced heart palpatations, high blood pressure, hives ins... Read more
12 hours after receives the vaccine I experienced heart palpatations, high blood pressure, hives inside mouth (on tongue and throat), numbness in arm, numbness in left side of face, numbness in left neck and ear. Primary care doctor advised I was having a reaction and to go to the ER/Hospital. I was admitted and treated for reaction at the hospital.
39 2021-04-06 involuntary muscle movements, muscle spasms Dystonic reaction; Involuntary muscle movements and spasm; Involuntary muscle movements and spasm; T... Read more
Dystonic reaction; Involuntary muscle movements and spasm; Involuntary muscle movements and spasm; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 23Mar2021 at 02:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications, taken within two weeks of vaccination, included ethinylestradiol, norgestimate (MANUFACTURER UNKNOWN) taken for birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced dystonic reaction and involuntary muscle movements and spasm on 23Mar2021 at 18:15. Therapeutic measures were taken as a result of the events, which included diphenhydramine (MANUFACTURER UNKNOWN) and lorazepam (MANUFACTURER UNKNOWN). The clinical outcome of dystonic reaction and involuntary muscle movements and spasm was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
39 2021-04-08 numbness Right leg numbness and unable to move it, partial right arm numbness and left leg numbness unable to... Read more
Right leg numbness and unable to move it, partial right arm numbness and left leg numbness unable to walk. Bladder infection secondary at time. Severe back pain.
39 2021-04-09 tingling, facial paralysis Headache on the right side of the head, tingling on the right side of the face, facial paralysis, lo... Read more
Headache on the right side of the head, tingling on the right side of the face, facial paralysis, loss of sense of taste,
39 2021-04-09 flushing decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Al... Read more
decreased hearing; Allergic reaction which included hives; Mild vasovagal reaction; itchy throat; Allergic reaction which included hives, itchy throat, eyes, nose, and ears, and hives; fast heart rate; flushing; lightheaded; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; itchy throat, eyes, nose, and ears; This is a spontaneous report from a contactable other HCP (patient). A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 39-year-old via an unspecified route of administration, administered in Arm Left on 26Mar2021 17:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma, allergies, inflammatory bowel disease. There was no COVID prior vaccination, no other vaccine within 4 weeks prior to the COVID vaccine, and no COVID tested post vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); lisdexamfetamine mesilate (VYVANSE); breo all within 2 weeks of vaccination. The patient experienced allergic reaction which included hives, itchy throat, eyes, nose, and ears; mild vasovagal reaction which included flushing, fast heart rate, lightheaded, and decreased hearing all on 26Mar2021 17:15 and resulted in Doctor or other healthcare professional office/clinic visit. Treatments included antihistamines and steroids. The events outcome was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association and profile of the product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the contributory role of the suspect product is possible.
39 2021-04-14 tingling Red rash on chest and face, tingling feet, tongue swollen (patient said), child. Drove home. Refuse... Read more
Red rash on chest and face, tingling feet, tongue swollen (patient said), child. Drove home. Refused transportation to hospital.
39 2021-04-17 numbness and pain in extremities, tingling, flushing, weakness Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, an... Read more
Immediate flushing, tachycardia, elevated blood pressure, dizziness, and neuropathy/paresthesias, and diarrhea after each vaccine. Worsening POTS/Dysautonomia Sx with severe flushing episodes that left me unable to work as a physician for 6wks. The episodes got progressively worse. I eventually ended up on steroids which did improve my symptoms. I was diagnosed officially with POTS and small fiber neuropathy. I attempted to go back to work but became too fatigued and weak to be able to walk, my husband had to come get me and I was taken to his care in a wheelchair. I could not get out of bed for 5 days. I saw rheumatology and am back on steroids. I am now showing lab evidence of lupus. I have polyarthritis and polymyalgia on exam as well as muscle weakness in the quads. I continue to have neuropathy.
39 2021-04-19 numbness, face paralysis Received my first Pfizer vaccine on 3/19/21. Approximately a week later I woke up with numbness in t... Read more
Received my first Pfizer vaccine on 3/19/21. Approximately a week later I woke up with numbness in the right side of my groin. Over the next couple of days the numbness was accompanied by weakness and spread to my right buttocks; my right leg and foot; my left leg and foot; my right cheek and top lip on right side of face. I was advised to go to the ER by my doctor; I went to ER. I was kept overnight for observation and discharged with a diagnosis of a pinched nerve. For the length of the following week the numbness, particularly in my legs and feet, became even more intense and I became unable to drive (because I could not use my feet on the floor pedals)... (see attached)
39 2021-04-19 tingling Woke up this morning to tingles/ pins and needles in my ankle. It has moved to the top of my foot an... Read more
Woke up this morning to tingles/ pins and needles in my ankle. It has moved to the top of my foot and is going up my shin on my right foot.
39 2021-04-22 pain in extremity Light headed. Almost lost consciousness 6-7 times. Nausea. Fatigue. Sore arm.
39 2021-04-24 tremor, feeling hot, flushing difficulty swallowing; dizzy; Flush; Felt very hot; lips tingling; tongue felt a little bit numb; sh... Read more
difficulty swallowing; dizzy; Flush; Felt very hot; lips tingling; tongue felt a little bit numb; shaky; really thirsty suddenly; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration in the left arm on 08Apr2021 at 13:45 (at the age of 39-years-old) at as a single dose for COVID-19 immunization. Medical history included allergic to Compazine and allergic to dogs, both from unspecified dates and unspecified if ongoing. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (medications received within 2 weeks of the vaccination) included vitamins NOS and ibuprofen, occasional, both taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 08Apr2021 the patient experienced, difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly. The adverse events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was received for the events and included Benadryl, Prednisone and an Epipen was prescribed but was not used. The clinical outcomes of the events difficulty swallowing, dizzy, flush, felt very hot, lips tingling, tongue felt a little bit numb, shaky and really thirsty suddenly were all recovering/resolving. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot number cannot be obtained.
39 2021-04-27 feeling hot Patient was sitting in waiting area after receiving first dose of COVID19 vaccine. She began to feel... Read more
Patient was sitting in waiting area after receiving first dose of COVID19 vaccine. She began to feel like she might pass out. Patient was laid on the floor. Other symptoms reported included hot and sweaty and nauseous. Patient was observed in the waiting area for longer until she felt better.
39 2021-04-27 pain in extremity armpit is swollen; lymph nodes are huge; pain in armpit radiating down my arm & bicep and thru my sh... Read more
armpit is swollen; lymph nodes are huge; pain in armpit radiating down my arm & bicep and thru my shoulder blade; This is a spontaneous report from a contactable health professional reporting for herself. A 39-years-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 25Jan2021 as a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 on 05Jan2021 at 09:00 AM. The patient medical history and concomitant medications were not reported. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. The patient didn't receive other medication in two weeks. On 25Jan2021 patient experienced armpit is swollen, lymph nodes are huge and pain in armpit radiating down my arm and bicep and through my shoulder blade. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
39 2021-04-27 pain in extremity miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable cons... Read more
miscarriage; super tired; super sore; sore arm; This is a spontaneous report from a contactable consumer (patient's husband). A 39-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 13:30 (at the age of 39-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing colitis. Concomitant medications included mesalazine (MESALAMINE) taken for colitis from an unspecified start date and ongoing and other unspecified medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) into left arm on 19Mar2021 (at the age of 39-year-old) for COVID-19 immunization and patient received first dose of BNT162B2 while pregnant. On 09Apr2021, it was reported that the patient experienced sore arm. On 10Apr2021 she was super tired and super sore. On 11Apr2021, patient reportedly had miscarriage. The mother was 3 weeks pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. The fetal outcome was intrauterine death. The events reportedly resulted to emergency room visit. The patient underwent lab tests and procedures which included blood test on 11Apr2021 showing she was only 3 weeks pregnant and sonogram: no fetal heartbeat on 11Apr2021. The event miscarriage was treated with 10 pills of Hydrocodone. Outcome of event miscarriage was unknown while for all other events was not recovered.
39 2021-04-28 seizure Severe nausea; vomiting; loss of consciousness; seizures; This is a spontaneous report from a contac... Read more
Severe nausea; vomiting; loss of consciousness; seizures; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727 and expiration date not provided) via an unspecified route of administration, administered in left arm on 25Mar2021 as a single dose for COVID-19 immunisation. Medical history included Cancer hx, Supraventricular tachycardia (SVT), Sjogrens, Epilepsy, Chronic kidney disease (CKD), Hyperthyroidism, Short gut, Osteoarthritis, malnutrition, Bartter's Syndrome Type 3, Hashimoto's Disease, Allergies to Penicillin, Adhesive, Vicryl sutures and cobalt. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydroxychloroquine; doxycycline; and levothyroxine sodium (SYNTHROID) and more (unspecified). The patient previously took iron dextran, povidone-iodine (BETADINE), metronidazole (FLAGYL), lamotrigine (LAMICTAL) and doxepin and experienced Allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) in the left arm on 04Mar2021, 01:15 PM for COVID-19 Immunization. The patient did not receive any other vaccine in 4 weeks. On 26Mar2021 19:00, the patient experienced Severe nausea, vomiting, loss of consciousness, seizures. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Treatment was given in response to the events which included IV antiemetics, IV hydration, IV Benadryl, Antiepileptics. The patient underwent COVID test post vaccination via nasal swab (rapid antigen test) on 01Apr2021 which was negative and via nasal swab (PCR) on 16Apr2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: Based on the close temporal relationship, the association between the events nausea, vomiting, loss of consciousness, and seizures with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-04-28 numbness, muscle spasms, tingling numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hand... Read more
numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hands and feet; muscle weakness; unable to walk unassisted; Vitamin D deficiency; muscle cramps in her lower extremities that progressed to her upper extremities and neck; muscle soreness in her lower extremities that progressed to her upper extremities and neck; intermittent numbness/tingling of my inner upper lip; intermittent numbness/tingling of my inner upper lip; This is a spontaneous report from a contactable other healthcare professional (HCP) reported for herself. A 39-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: EN16208) at the age of 39-years-old as single dose for covid-19 immunisation. Patient was not pregnant. Medical history included Hormonal Acne, gastrooesophageal reflux disease (GERD). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for an unspecified indication, start and stop date were not reported; aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergy. The patient initially had some intermittent numbness/tingling of her inner upper lip that began within the first hour of receiving the vaccine on 19Mar2021 and lasted about 24 hours. Six days following vaccination on 25Mar2021, the patient began having muscle cramps/muscle soreness in her lower extremities that progressed to her upper extremities and neck, By the eighth day on 27Mar2021, she had developed numbness, tingling, and swelling of her hands and feet. On this day, she also began having muscle weakness and was unable to walk unassisted by the end of the day. She was seen in the Emergency room (ER), admitted, and transferred to another facility. The patient hospitalized for 1 day. She underwent a Computerised tomogram (CT) scan of my head, Magnetic resonance imaging (MRI) of my brain/neck, lumbar puncture, and extensive blood work. All of her work up was unremarkable except for showing that she had a Vitamin D deficiency. Her symptoms began to improve without treatment in the hospital, and she was discharged home with the diagnosis that she had most likely had an unusual, adverse reaction to her 1st dose of the COVID 19 vaccine and was instructed not to receive my 2nd dose. Covid tested post vaccination (Nasal swab) on 28Mar2021: Negative. The outcome of the events 'numbness/tingling of my inner upper lip' was recovered on 20Mar2021 and the outcome of the other events was recovering.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Myalgia, Muscle cramps, Hypoasthesia, Parasthesia, Pheripheral swelling, Muscle weakness and Vitamin D Defiency. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 2021-04-30 facial pain Right ear was losing hearing sporadically; Pain in surrounding area on face and cranium on same sid... Read more
Right ear was losing hearing sporadically; Pain in surrounding area on face and cranium on same side; Pain in surrounding area on face and cranium on same side/Periodic headaches on same side; Feels a bit like swimmer's ear with pain and muffled sounds; Feels a bit like swimmer's ear with pain and muffled sounds; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 14Apr2021 14:15 (at the age of 39-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included irritable bowel syndrome (IBS) from an unknown date. The patient had known allergies with lactose (lactose intolerance). The patient had no covid-19 prior vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in arm left on 24Mar2021 02:45 PM (at the age of 39-years-old) for covid-19 immunisation. Concomitant medications included vitamin d3; zinc; magnesium; calcium; and vitamin b6; all were taken for an unspecified indication, start and stop date were not reported. On 15Apr2021 12:00PM, the right ear was losing hearing sporadically. Pain in surrounding area on face and cranium on same side. Periodic headaches on same side. Feels a bit like swimmer's ear with pain and muffled sounds. It was unknown if the patient did received any treatment for the events. The outcome of the events was not recovered. The patient did not covid-19 tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
39 2021-05-03 tingling I?m three weeks post vaccine #2. During weeks 2 and 3 I have had vertigo off and on and almost fain... Read more
I?m three weeks post vaccine #2. During weeks 2 and 3 I have had vertigo off and on and almost fainted once. It wasn?t clear that it was related to the vaccine until my husband started having the same symptom. I also had some leg tingling which may or may not be related. My blood pressure is normal. 70s / 120s. I am still currently having these symptoms and have not contacted my doctor.
39 2021-05-04 numbness The left side of my face felt numb starting after the first hour and for the whole day. Also, my thr... Read more
The left side of my face felt numb starting after the first hour and for the whole day. Also, my throat was slightly tightening; The left side of my face felt numb starting after the first hour and for the whole day. Also, my throat was slightly tightening; This is a spontaneous report from a contactable Nurse (Patient, self-reported). A 39-years-old not pregnant female patient received first dose of ( COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29 Jan 2021 09:15AM as an unspecified dose for covid-19 immunisation. Medical history included hypothyroid, known allergies was No. Concomitant medications included levothyroxine sodium (SYNTHROID); aspirin [acetylsalicylic acid], vitamins. On 29 Jan 2021 10:00, the patient experienced the left side of my face felt numb starting after the first hour and for the whole day. also, my throat was slightly tightening. Treatment received for the evets was unknown. The clinical outcome of the event was recovered on unspecified date of 2021. Information about lot/batch number has been requested. Follow-up (16 Apr 2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
39 2021-05-06 burning sensation, tingling Intense tingling sensation in my head, spine and face immediately. My face still has a constant tin... Read more
Intense tingling sensation in my head, spine and face immediately. My face still has a constant tingling sensation. A week after my vaccine, I had an intense burning sensation in my chest and spine that kept me up all night. I went to urgent care the next day. It felt like someone had put icy/hot on my body. That sensation comes and goes, but the face tingling has remained constant since my shot.
39 2021-05-07 numbness Severe unexplained back pain; legs went completely numb; couldn't move them; then traveled to my arm... Read more
Severe unexplained back pain; legs went completely numb; couldn't move them; then traveled to my arms; sediment rate and other labs to be off on my bloodwork; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP6955 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 23Mar2021 at 13:00 (at the age of 39-years-old) as a single dose for covid-19 immunisation and patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6202 and expiry date was not provided) via an unspecified route of administration, in the left arm, on 02Mar2021 at 12:45 as a single dose for covid-19 immunisation. Patient had allergy due to Shellfish and fish. Patient's medical history included Asthma, high blood pressure, high cholesterol, depression and anxiety. Past drug history included iodine, Flagyl, Levaquin, ceftin, stations, valium and adhesive on tape. Concomitant medications received within 2 weeks of vaccination includes venlafaxine hydrochloride (EFFEXOR), ezetimibe (ZETIA), montelukast sodium (SINGULAIR), olmesartan medoxomil (BENICAR), fluticasone propionate (FLONASE) and prednisolone sodium phosphate (PREDNESOL). Patient was not diagnosed with COVID, prior vaccination. Patient did not receive other vaccine in four weeks of vaccination. On 26Mar2021 patient experienced severe unexplained back pain, legs went completely numb and patient couldn't move them then travelled to her arms and caused her sediment rate and other labs to be off on bloodwork. Patient went to physician office and emergency room. Treatment received was intravenous immunoglobulin (IVIG) transfusions and hospital stay but not prolonged. Patient was not been tested for COVID, since the vaccination. The outcome of events was not resolved. Information on Lot/Batch number was available. Additional information has been requested.
39 2021-05-07 numbness, paralysis, tingling legs were heavy and numb; weakness in legs; bladder was now the problem/brain doesn't tell the body ... Read more
legs were heavy and numb; weakness in legs; bladder was now the problem/brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over; reason for hospitalization;her kidneys; totally became paralyzed from the waist down; legs were heavy and numb; Patient was a little nervous; painful tingling feeling she have that kind of feeling in her legs; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program,. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 at 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization and pregabalin (LYRICA), via an unspecified route of administration from an unspecified date at 100 mg, 3x/day for neuropathy. Medical history included neuropathy from 2020 and ongoing. The patient's concomitant medications were not reported. It was reported that the patient got the vaccine and she was taking pregabalin as well and after vaccination, she experienced an adverse event, her legs were heavy and numb and also her bladder was now the problem she was actually now at the emergency room. Patient was a little nervous. The patient was still in the hospital and she was not getting any care. What happened at the beginning was that she totally became paralyzed from the waist down, when your foot fall asleep you get painful tingling feeling she have that kind of feeling in her legs not able to move any part of her anywhere from her waist down later on that night, after she took pregabalin, went to sleep about an hour she was able to move her left toes and able to drag one leg a little bit. She was supposed to take pregabalin 3 times a day and they were giving her a difficult time about it, she took one at 12 O' clock on Wednesday and the hospital they did not give another one until 11 o clock that evening because she was supposed to take 3 times a day. After she no longer feel from the waist down, she took a pregabalin and it didn't help her it didn't work and her physician told her to take 3 times a day and then at 10 O' clock yesterday morning she was still asking the hospital to give her another one. When asked to repeat the concern, patient stated "weakness in her legs that felt very heavy like she was dragging. The date of hospitalization was reported as 21Apr2021. The reason for hospitalization was reported as numbness in her legs and weakness in legs, became paralyzed from the waist down, and her kidneys. So her brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over and the body doesn't know to get it out its leaking because it is filling up it is so full. The patient underwent lab test in the hospital. The action taken with pregabalin in response to the events was unknown. Outcome of the events was unknown.
39 2021-05-10 muscle spasms Intermittent, severe, spasmodic neuro muscular facial contracture and eye closure, worse on right si... Read more
Intermittent, severe, spasmodic neuro muscular facial contracture and eye closure, worse on right side began approximately 3 weeks after 2nd Covid-19 vaccination injection.
39 2021-05-11 weakness, migraine Extreme fatigue; fever; headache; migraine; swollen lymph nodes; dizziness; weakness; nausea; high h... Read more
Extreme fatigue; fever; headache; migraine; swollen lymph nodes; dizziness; weakness; nausea; high heart rate; inflammation in joints and spine; inflammation in joints and spine; high ESR; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7533) via an unspecified route of administration into left arm on 09Apr2021 17:30 (at the age of 39-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included autoimmune disorder, anemia and hypothyroidism. Patient was not pregnant. The patient's concomitant medications were not reported. The patient previously took cephalexine and experienced drug allergy. On 09Apr2021 21:00, patient experienced extreme fatigue, fever, headache, migraine, swollen lymph nodes, dizziness, weakness, nausea, high heart rate, inflammation in joints and spine and high ESR (erythrocyte sedimentation rate). The event extreme fatigue was reported as serious, medically significant. The events resulted in emergency room and physician office visit. It was also reported that the patient was treated with IV fluids, ondansetron (ZOFRAN) and ketorolac (TORADOL). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 24Apr2021. Outcome of events was recovering. Additional information has been requested.
39 2021-05-12 numbness and pain in extremities, flushing, burning sensation Neuropathy of the tongue, legs, hands etc; Lymphocytic colitis; My face started flushing and burning... Read more
Neuropathy of the tongue, legs, hands etc; Lymphocytic colitis; My face started flushing and burning all the time; Tachycardia; Elevated blood pressure; Dizziness; After the second shot these episodes starred happening frequently along with diarrhea; My face started flushing and burning all the time; I was diagnosed with Dysautonomia/POTS; I was diagnosed with Dysautonomia/POTS; Small fiber neuropathy; now I have profound fatigue; Proximal muscle weakness; Testing positive for ANA and dsDNA; Testing positive for ANA and dsDNA; Became so ill; possible allergic reaction or mast cell activation syndrome; Ipossible allergic reaction or mast cell activation syndrome; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EL3302) as 2nd dose, single (at the age of 39-year-old) for COVID-19 immunisation. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient previously received the first dose of bnt162b2 (Lot number: EK9231) in Arm Left on 26Dec2020 at the age of 39-year-old for COVID-19 immunisation and experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness. The patient reported immediately after each shot she got flushed, tachycardia, elevated blood pressure, and dizziness. After the second shot these episodes starred happening frequently along with diarrhea, neuropathy of the tongue, legs, hands etc. Her face started flushing and burning all the time. She became so ill she couldn't work for 6 weeks. The patient was diagnosed with Dysautonomia/POTS (Postural orthostatic tachycardia syndrome), lymphocytic colitis, and small fiber neuropathy. The patient took 17 days of steroids for possible allergic reaction or mast cell activation syndrome. She spoke with Dr who believed she had an autoimmune reaction to the vaccine causing inflammatory Dysautonomia and was enrolled in their trial. She had to take more time off work because now she had profound fatigue and proximal muscle weakness. The patient was testing positive for ANA (Antinuclear antibody) and dsDNA (Double stranded DNA antibody) but her rheumatologist did not think she had lupus. He and her neurologist felt that had have a vaccine induced autoimmune inflammatory disorder and that IVIG was the best treatment. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included ANA: positive on unknown date, dsDNA: positive on unknown date, PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date. The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: The events were most likely intercurrent conditions and unlikely related to suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EL3302). This case will be reassessed upon receipt of follow-up information.
39 2021-05-12 flushing flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contac... Read more
flushed; tachycardia; elevated blood pressure; dizziness; This is a spontaneous report from a contactable physician reported for herself. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Dec2020 (Batch/Lot Number: EK9231) as 1ST dose, single (at the age of 39-year-old) for COVID-19 immunization. Medical history included Remote history of SVT (supraventricular tachycardia) from an unknown date and Tuberculin skin tests. Concomitant medications included vitamin B complex; vitamin D [vitamin D nos]; minerals nos, vitamins nos (PRENATAL VITAMINS), all taken for an unspecified indication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at time of vaccination. The patient experienced immediately flushed, tachycardia, elevated blood pressure, and dizziness after shot on 26Dec2020. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included PCR Nasal Swab: negative on 26Mar2021, Tuberculin skin tests: unknown results on unknown date. The patient received Prednisone as treatment for the adverse events. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Disability or permanent damage. The outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.